Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as GENERIC have had a generic equivalent approved for at least one strength of the product.
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7112592 DS* DP* [Extended 1413 days (3.9 years)] Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015 | Jan 7, 2026 | U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium U-282: Method of treating bacterial infections U-3818: Treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adult and pediatric patients (at least 31 weeks gestational age) |
| Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Nov 12, 2026 | |
| Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015 | Oct 8, 2030 | |
| Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Mar 17, 2015 | Aug 12, 2031 | |
| Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Mar 17, 2015 | Jun 15, 2032 | |
| Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 24, 2017 | Jun 15, 2032 | |
| Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof Claim Types: Formulation; Compound; Composition Pat. Sub. Date(s): 001: Aug 8, 2017 | Jun 15, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Feb 25, 2025 GAIN | |
| Exclusivity Code: NPP - New patient population | Dec 20, 2025 | |
| Exclusivity Code: NPP - New patient population | Jan 26, 2027 |
RECORLEV (TABLET) (ORAL) LEVOKETOCONAZOLE
Drug Classes: cortisol synthesis inhibitor
NDA Applicant: STRONGBRIDGE NDA No.: 214133 Prod. No.: 001 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9918984 Methods and compositions for treating diabetes, metabolic syndrome and other conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 27, 2022 | Jan 10, 2026 | U-3283: Treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome for whom surgery is not an option or has not been curative |
| Pat. No. 10098877 Methods and compositions for treating diabetes, metabolic syndrome and other conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 27, 2022 | Jan 10, 2026 | U-3283: Treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome for whom surgery is not an option or has not been curative |
| Pat. No. 10517868 Methods and compositions for treating diabetes, metabolic syndrome and other conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 27, 2022 | Jan 10, 2026 | U-3283: Treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome for whom surgery is not an option or has not been curative |
| Pat. No. 10835530 Methods and compositions for treating diabetes, metabolic syndrome and other conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 27, 2022 | Jan 10, 2026 | U-3283: Treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome for whom surgery is not an option or has not been curative |
| Pat. No. 11478471 Methods And Compositions For Treating Diabetes, Metabolic Syndrome And Other Conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 31, 2022 | Jan 10, 2026 | U-3283: Treatment of endogenous hypercortisolemia in patients with Cushing’s syndrome for whom surgery is not an option or has not been curative |
| Pat. No. 11020393 Methods of treating disease with levoketoconazole Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 27, 2022 | Mar 2, 2040 | U-3282: During levoketoconazole dosage titration for the treatment of Cushing's syndrome in patients who concomitantly use metformin, monitoring glycemia, kidney function and vitamin B-12 and adjusting dosage of metformin as needed |
| Pat. No. 11278547 Methods of treating disease with levoketoconazole Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 24, 2022 | Mar 2, 2040 | U-3282: During levoketoconazole dosage titration for the treatment of Cushing's syndrome in patients who concomitantly use metformin, monitoring glycemia, kidney function and vitamin B-12 and adjusting dosage of metformin as needed |
| Pat. No. 11903940 Methods of treating disease with levoketoconazole Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 8, 2024 | Mar 2, 2040 | U-3821: During levoketoconazole dosage titration for the treatment of Cushing's Syndrome in patients who concomitantly use an OCT2 substrate, monitoring the subject for a dose limiting event and adjusting the dosage of the OCT2 substrate as needed |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE* - NEW CHEMICAL ENTITY (an enantiomer of previously approved racemic mixture) | Dec 30, 2026 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Dec 30, 2028 | ODE-385: For treatment of endogenous hypercortisolemia in adult patients with Cushing's syndrome for whom surgery is not an option or has not been curative |
FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE [Has competitive generic]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ABBVIE NDA No.: 204168 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 80MG BASE); 004 RX (EQ 120MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43879 [Extended 953 days (2.6 years)] Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Jan 11, 2026 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8481598 Stable dosage forms of levomilnacipran Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Aug 15, 2013 | Mar 2, 2031 | U-839: Treatment of major depressive disorder (MDD) |
| Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Nov 20, 2014 | May 23, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Mar 24, 2026 | M-304: Information added to section 8.4 of the labeling to describe the results from study LVM-MD-11 and LVM-MD-14 |
BELRAPZO (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS NDA No.: 205580 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 12, 2026 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9265831 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 28, 2031 | |
| Pat. No. 9572796 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9572797 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 10010533 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 3, 2018 | Jan 28, 2031 | |
| Pat. No. 11103483 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 31, 2021 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 11844783 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2023 | Jan 28, 2031 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 11872214 DP* Formulations of Bendamustine Claim Types: Drug in a container; Formulation Pat. Sub. Date(s): 001: Jan 16, 2024 | Jan 28, 2031 | |
| Pat. No. 12138248 DP* Formulations of bendamustine Claim Types: Drug in a container; Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jan 27, 2025 | Jan 28, 2031 | |
| Pat. No. 8609707 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 1, 2018 | Aug 11, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
BENDEKA (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: EAGLE PHARMS NDA No.: 208194 Prod. No.: 001 RX (100MG/4ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 7, 2016 | Jan 12, 2026 | U-1790: For use in treatment of patients with chronic lymphocytic leukemia (CLL) and/or non-hodgkin's lymphoma |
| Pat. No. 9265831 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016 | Jan 28, 2031 | |
| Pat. No. 9572796 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9572797 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 10010533 DP* Formulations of bendamustine Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 3, 2018 | Jan 28, 2031 | |
| Pat. No. 11103483 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 31, 2021 | Jan 28, 2031 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 11844783 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 19, 2023 | Jan 28, 2031 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 11872214 DP* Formulations of Bendamustine Claim Types: Drug in a container; Formulation Pat. Sub. Date(s): 001: Jan 16, 2024 | Jan 28, 2031 | |
| Pat. No. 12138248 DP* Formulations of bendamustine Claim Types: Drug in a container; Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Jan 27, 2025 | Jan 28, 2031 | |
| Pat. No. 8609707 DP* Formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Aug 11, 2031 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 9000021 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Mar 15, 2033 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 9034908 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Mar 15, 2033 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 9144568 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 11, 2015 | Mar 15, 2033 | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 9572887 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9579384 Method of treating bendamustine-responsive conditions in patients requiring reduced volumes for administration Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 28, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9597397 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 9597398 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia |
| Pat. No. 9597399 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 21, 2017 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
| Pat. No. 10052385 Formulations of bendamustine Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2018 | Mar 15, 2033 | U-1971: For the treatment of patients with chronic lymphocytic leukemia U-1972: For the treatment of patients with indolent B-cell Non-Hodgkin Lymphoma |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE [GENERIC AB]
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 001 RX (EQ 25MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 001: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE [GENERIC AB]
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 002 RX (EQ 50MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 002: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE [GENERIC AB]
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 003 RX (EQ 75MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 003: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Dec 7, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 003: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE [GENERIC AB]
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 004 RX (EQ 12.5MG ACID)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 004: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Pat. No. 8052993 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8052994 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene] hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8062665 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1 ,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-ylidene]hydrazino]-2'-hydroxy-[1,1- '-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Jul 10, 2015 | Feb 1, 2028 *PED | U-1714: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Pat. No. 8071129 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Dec 21, 2011 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Pat. No. 8828430 DP* 3'-[(2Z)-[1-(3,4-dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4H-pyrazol-4-y- lidene]hydrazino]-2'-hydroxy-[1,1'-biphenyl]-3-carboxylic acid bis-(monoethanolamine) Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 004: Oct 7, 2014 | Feb 1, 2028 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-2451: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA (TABLET) (ORAL) ELTROMBOPAG OLAMINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 022291 Prod. No.: 005 DISC (EQ 100MG ACID**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 005: None | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-930: Treatment of idiopathic thrombocytopenic purpura (ITP) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 16, 2025 | ODE-210: Indicated in combination with standard immunosuppressive therapy for the first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
PROMACTA KIT (FOR SUSPENSION) (ORAL) ELTROMBOPAG OLAMINE [GENERIC AB]
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: NOVARTIS NDA No.: 207027 Prod. No.: 001 RX (EQ 25MG ACID/PACKET); 002 RX (EQ 12.5MG ACID/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7547719 DS* DP* 3'-[(2z)-[1-(3,4-Dimethylphenyl)-1,5-dihydro-3-methyl-5-oxo-4h-pyrazol-4-y- lidene]hy-drazino]-2'-hydroxy-[1,1'-piphenyl]-acid bis-(monoethanolamine) Claim Types: Compound; Composition; Method of use; Formulation; Process Pat. Sub. Date(s): 001: Sep 21, 2015; 002: Apr 5, 2019 | Jan 13, 2026 *PED | U-1306: Treatment of thrombocytopenia in patients with chronic hepatitis C to allow the initiation and maintenance of interferon-based therapy U-1575: Patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy U-1736: Treatment of thrombocytopenia in adult and pediatric patients 1 year and older with chronic immune (idiopathic) thrombocytopenia (itp) U-2452: Combination with immunosuppressive therapy for first-line treatment of adult and pediatric patients 2 years and older with severe aplastic anemia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Nov 16, 2025 |
DUVYZAT (SUSPENSION) (ORAL) GIVINOSTAT HYDROCHLORIDE
NDA Applicant: ITALFARMACO SPA NDA No.: 217865 Prod. No.: 001 RX (EQ 8.86MG BASE/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7329689 DS* DP* Monohydrate hydrochloride of the 4-hydroxycarbamoyl-phenyl)-carbamic acid (6-diethylaminomethyl-naphtalen-2-yl) ester Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Apr 19, 2024 | Jan 15, 2026 | |
| Pat. No. 9421184 Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 19, 2024 | Feb 3, 2032 | U-3885: A method for the treatment of Duchenne muscular dystrophy (DMD) using givinostat |
| Pat. No. 9867799 Diethyl-[6-(4-hydroxycarbamoyl-phenyl-carbamoyloxy-methyl)-naphthalen-2-yl-methyl]-ammonium chloride for use in the treatment of muscular dystrophy Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 19, 2024 | Feb 3, 2032 | U-3885: A method for the treatment of Duchenne muscular dystrophy (DMD) using givinostat |
| Pat. No. 10688047 DP* Physically and chemically stable oral suspensions of givinostat Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Apr 19, 2024 | Oct 28, 2036 | U-3885: A method for the treatment of Duchenne muscular dystrophy (DMD) using givinostat |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 21, 2029 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 21, 2031 | ODE-473: Treatment of Duchenne Muscular Dystrophy (DMD) in patients 6 years of age and older |
ATELVIA (TABLET, DELAYED RELEASE) (ORAL) RISEDRONATE SODIUM [GENERIC AB]
NDA Applicant: APIL NDA No.: 022560 Prod. No.: 001 RX (35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8246989 DP* Dosage forms of bisphosphonates Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 28, 2012 | Jan 16, 2026 | |
| Pat. No. 7645459 DP* Dosage forms of bisphosphonates Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 | Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
| Pat. No. 7645460 DP* Dosage forms of risedronate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 | Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
DEXILANT (CAPSULE, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE [GENERIC AB]
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022287 Prod. No.: 001 RX (30MG); 002 RX (60MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: May 1, 2015 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jul 17, 2026 *PED | |
| Pat. No. 7790755 DP* Controlled release preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 29, 2010; 002: None | Feb 2, 2027 *PED | |
| Pat. No. 8105626 DP* Granules containing acid-unstable chemical in large amount Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 28, 2012; 002: None | Mar 27, 2027 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 1, 2014 | Jan 11, 2028 | |
| Pat. No. 8173158 Methods of treating gastrointestinal disorders independent of the intake of food Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 1, 2012; 002: None | Sep 17, 2030 *PED | U-949: Healing of all grades of erosive esophagitis (EE) for up to 8 weeks U-950: Maintain healing of erosive esophagitis (EE) for up to 6 months U-951: Treatment of heartburn associated with non-erosive gastroesophageal reflux disease (GERD) for 4 weeks |
| Pat. No. 9233103 Methods for treating heartburn, gastric bleeding or hemorrhage in patients receiving clopidogrel therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 11, 2016 | Mar 5, 2032 | U-1805: Use of dexlansoprazole in patients taking clopidogrel without meaningful cyp2c19 interactions |
DEXILANT SOLUTAB (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) DEXLANSOPRAZOLE
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 208056 Prod. No.: 001 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9238029 DP* Multiple PPI dosage form Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jan 17, 2026 | |
| Pat. No. 9011926 DP* Method for producing granules Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Feb 25, 2016 | Feb 24, 2026 | |
| Pat. No. 8461187 DP* Multiple PPI dosage form Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 17, 2026 *PED | |
| Pat. No. 8871273 DP* Method for producing granules Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 25, 2016 | Jul 11, 2028 *PED | |
| Pat. No. 9241910 DP* Orally-disintegrating solid preparation Claim Types: Formulation Pat. Sub. Date(s): 001: None | Mar 10, 2029 |
TAVALISSE (TABLET) (ORAL) FOSTAMATINIB DISODIUM
NDA Applicant: RIGEL PHARMS NDA No.: 209299 Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE48898 DP* Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 23, 2022 | Jan 19, 2026 | |
| Pat. No. 8211889 DS* Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound Pat. Sub. Date(s): All strengths: May 16, 2018 | Jan 19, 2026 | |
| Pat. No. 9266912 Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Jan 19, 2026 | U-2294: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
| Pat. No. 7538108 DS* Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Mar 28, 2026 | U-2294: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
| Pat. No. 7989448 DS* Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound; Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Jun 12, 2026 | U-2294: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
| Pat. No. 8163902 DS* Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: New polymorph, salt or hydrate; Composition; Method of administration; Method of use; Process Pat. Sub. Date(s): All strengths: May 16, 2018 | Jun 17, 2026 | U-2294: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
| Pat. No. 8445485 DP* Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 16, 2018 | Jun 17, 2026 | |
| Pat. No. 8912170 Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Jun 17, 2026 | U-2294: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
| Pat. No. 9283238 Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Jun 17, 2026 | U-2294: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
| Pat. No. 8652492 DP* Wet granulation using a water sequestering agent Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: May 16, 2018 | Nov 6, 2028 | |
| Pat. No. 8263122 DP* Wet granulation using a water sequestering agent Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 16, 2018 | Nov 24, 2030 | |
| Pat. No. 7449458 DS* [Extended 5 years] Prodrugs of 2,4-pyrimidinediamine compounds and their uses Claim Types: Compound Pat. Sub. Date(s): All strengths: May 16, 2018 | Sep 4, 2031 | |
| Pat. No. 8771648 DP* (Trimethoxyphenylamino) pyrimidinyl formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 16, 2018 | Jul 27, 2032 | |
| Pat. No. 8951504 (trimethoxyphenylamino) pyrimidinyl formulations Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 16, 2018 | Jul 27, 2032 | U-2294: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 17, 2025 | ODE-174: For the treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia (ITP) who have had an insufficient response to a previous treatment |
OTREXUP (SOLUTION) (SUBCUTANEOUS) METHOTREXATE
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: OTTER PHARMS NDA No.: 204824 Prod. No.: 001 RX (10MG/0.4ML (10MG/0.4ML)); 002 RX (15MG/0.4ML (15MG/0.4ML)); 003 RX (20MG/0.4ML (20MG/0.4ML)); 004 RX (25MG/0.4ML (25MG/0.4ML)); 006 RX (12.5MG/0.4ML (12.5MG/0.4ML)); 007 RX (17.5MG/0.4ML (17.5MG/0.4ML)); 008 RX (22.5MG/0.4ML (22.5MG/0.4ML)) NDA No.: 204824 Prod. No.: 005 DISC (7.5MG/0.4ML (7.5MG/0.4ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8562564 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 4, 2013; 002: Nov 4, 2013; 003: Nov 4, 2013; 004: Nov 4, 2013; 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016 | Jan 24, 2026 | |
| Pat. No. 9533102 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 2, 2017 | Jan 24, 2026 | |
| Pat. No. 9629959 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: May 25, 2017 | Jan 24, 2026 | |
| Pat. No. 11446441 DP* Prefilled syringe injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 19, 2022 | Jan 24, 2026 | |
| Pat. No. 8021335 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): 001: Nov 4, 2013; 002: Nov 4, 2013; 003: Nov 4, 2013; 004: Nov 4, 2013; 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016 | Oct 4, 2026 | |
| Pat. No. 9867949 DP* Injector safety device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 14, 2020 | Mar 10, 2029 | |
| Pat. No. 10709844 DP* Injector safety device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 14, 2020 | Mar 10, 2029 | |
| Pat. No. 11684723 DP* Injector safety device Claim Types: Device Pat. Sub. Date(s): All strengths: Jul 19, 2023 | Mar 10, 2029 | |
| Pat. No. 8480631 DP* Hazardous agent injection system Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Nov 4, 2013; 002: None; 003: None; 004: None; 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016 | Mar 19, 2030 | U-1442: Subcutaneous injection of methotrexate |
| Pat. No. 8579865 DP* Hazardous agent injection system Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Nov 21, 2013; 002: Nov 21, 2013; 003: Nov 21, 2013; 004: Nov 21, 2013; 005: Dec 2, 2014; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016 | Mar 19, 2030 | U-1442: Subcutaneous injection of methotrexate |
| Pat. No. 8945063 DP* Hazardous agent injection system Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Mar 2, 2015; 002: Mar 2, 2015; 003: Mar 2, 2015; 004: Mar 2, 2015; 005: Mar 2, 2015; 006: Jun 1, 2016; 007: Jun 1, 2016; 008: Jun 1, 2016 | Mar 19, 2030 | U-1442: Subcutaneous injection of methotrexate |
| Pat. No. 9421333 DP* Hazardous agent injection system Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): All strengths: Sep 21, 2016 | Mar 19, 2030 | U-1442: Subcutaneous injection of methotrexate |
| Pat. No. 11497753 DP* Hazardous agent injection system Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 13, 2022 | Mar 19, 2030 | |
| Pat. No. 8814834 DP* Injector safety device Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 14, 2020 | May 27, 2031 |
XYOSTED (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) TESTOSTERONE ENANTHATE
Drug Classes: androgen
NDA Applicant: ANTARES PHARMA INC NDA No.: 209863 Prod. No.: 001 RX (50MG/0.5ML (50MG/0.5ML)); 002 RX (75MG/0.5ML (75MG/0.5ML)); 003 RX (100MG/0.5ML (100MG/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8562564 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 9180259 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 9533102 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 9629959 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Jan 24, 2026 | |
| Pat. No. 10478560 DP* Prefilled syringe injector Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Jan 24, 2026 | |
| Pat. No. 11446441 DP* Prefilled syringe injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 7, 2022 | Jan 24, 2026 | |
| Pat. No. 8021335 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Oct 4, 2026 | |
| Pat. No. 11497753 DP* Hazardous agent injection system Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 14, 2022 | Mar 19, 2030 | |
| Pat. No. 10279131 DP* Injection device with cammed RAM assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Jul 31, 2031 | |
| Pat. No. 10357609 DP* Needle assisted jet injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Aug 21, 2031 | |
| Pat. No. 10905827 DP* Injection device with cammed ram assembly Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 2, 2021 | Aug 21, 2031 | |
| Pat. No. 11446440 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 7, 2022 | Aug 21, 2031 | |
| Pat. No. 10821072 DP* Needle assisted jet injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Nov 23, 2020 | Jun 4, 2033 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 11844804 Administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jan 18, 2024 | Jun 4, 2033 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 10881798 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 4, 2021 | Feb 11, 2034 | |
| Pat. No. 11160751 DP* Hematocrit modulation through needle assisted jet injection of testosterone Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 6, 2022 | Oct 7, 2034 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 10238662 DP* Needle assisted jet injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Feb 19, 2035 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 10912782 DP* Needle assisted injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Mar 2, 2021 | Feb 19, 2035 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 11813435 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 22, 2023 | Feb 25, 2035 | |
| Pat. No. 11191908 DP* Syringe shock absorber for use in an injection device Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 6, 2022 | Oct 18, 2035 | |
| Pat. No. 9744302 DP* Needle assisted jet injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Nov 19, 2035 | |
| Pat. No. 9950125 DP* Needle assisted jet injection administration of testosterone compositions Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Oct 24, 2018 | Sep 4, 2036 | U-2418: Method of administering testosterone enanthate subcutaneously |
| Pat. No. 10646495 DP* Testosterone ester triglyceride formulations Claim Types: Compound; Formulation Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Aug 30, 2038 |
ZURNAI (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALMEFENE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 218590 Prod. No.: 001 DISC (EQ 1.5MG BASE/0.5ML (EQ 1.5MG BASE/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8562564 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Jan 24, 2026 | |
| Pat. No. 9180259 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Jan 24, 2026 | |
| Pat. No. 9533102 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Jan 24, 2026 | |
| Pat. No. 9629959 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Jan 24, 2026 | |
| Pat. No. 10478560 DP* Prefilled syringe injector Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Jan 24, 2026 | |
| Pat. No. 11446441 DP* Prefilled syringe injector Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Jan 24, 2026 | |
| Pat. No. 8021335 DP* Prefilled syringe jet injector Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Oct 4, 2026 | |
| Pat. No. 10279131 DP* Injection device with cammed RAM assembly Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Jul 31, 2031 | |
| Pat. No. 8496619 DP* Injection device with cammed ram assembly Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 21, 2031 | |
| Pat. No. 9364610 DP* Injection device with cammed ram assembly Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 21, 2031 | |
| Pat. No. 9364611 DP* Needle assisted jet injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 21, 2031 | |
| Pat. No. 9446195 DP* Injection device with cammed ram assembly Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 21, 2031 | |
| Pat. No. 10357609 DP* Needle assisted jet injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 21, 2031 | |
| Pat. No. 10905827 DP* Injection device with cammed ram assembly Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 21, 2031 | |
| Pat. No. 11446440 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 21, 2031 | |
| Pat. No. 11185642 DP* Injection device with cammed ram assembly Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Sep 5, 2024 | Aug 28, 2031 | |
| Pat. No. 10881798 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Feb 11, 2034 | |
| Pat. No. 11813435 DP* Needle assisted injection device having reduced trigger force Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Feb 25, 2035 | |
| Pat. No. 11191908 DP* Syringe shock absorber for use in an injection device Claim Types: Device Pat. Sub. Date(s): 001: Sep 5, 2024 | Oct 18, 2035 | |
| Pat. No. 11857547 DP* Compositions and methods for opioid antagonist delivery Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Sep 5, 2024 | Nov 5, 2039 | |
| Pat. No. 11865112 DP* Compositions and methods for opioid antagonist delivery Claim Types: Formulation; Method of administration; Drug in a container Pat. Sub. Date(s): 001: Sep 5, 2024 | Nov 5, 2039 | U-3630: Treating opioid overdose |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Aug 7, 2027 |
PRIMATENE MIST (AEROSOL, METERED) (INHALATION) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARMSTRONG PHARMS NDA No.: 205920 Prod. No.: 001 OTC (0.125MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8367734 DP* Stable epinephrine suspension formulation with high inhalation delivery efficiency Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 17, 2018 | Jan 26, 2026 |
VERKAZIA (EMULSION) (OPHTHALMIC) CYCLOSPORINE
Drug Classes: calcineurin inhibitor immunosuppressant
NDA Applicant: HARROW EYE NDA No.: 214965 Prod. No.: 001 RX (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7973081 DP* Emulsion compositions containing quaternary ammonium compounds Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 15, 2021 | Jan 27, 2026 | |
| Pat. No. 8524779 DP* Emulsion compositions containing quaternary ammonium compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2021 | Jan 27, 2026 | |
| Pat. No. 9220694 DP* Emulsion compositions containing cetalkonium chloride Claim Types: Formulation; Process; Kit Pat. Sub. Date(s): 001: Jul 15, 2021 | Jan 27, 2026 | |
| Pat. No. 9956289 DP* Emulsion compositions containing quaternary ammonium compounds Claim Types: Formulation; Process; Kit Pat. Sub. Date(s): 001: Jul 15, 2021 | Jan 27, 2026 | |
| Pat. No. 11612658 Oil-in-water emulsions comprising cetalkonium chloride and methods of making and using the same Claim Types: Method of use; Process; Kit Pat. Sub. Date(s): 001: Apr 25, 2023 | Jan 27, 2026 | U-3560: For the treatment of vernal keratoconjunctivitis in children and adults |
| Pat. No. 8298568 DP* Oil-in-water type emulsion with low concentration of cationic agent and positive zeta potential Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2021 | Nov 3, 2027 | |
| Pat. No. 9132071 DP* Compositions containing quaternary ammonium compounds Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 15, 2021 | Jun 2, 2029 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 23, 2028 | ODE-358: For the treatment of vernal keratoconjunctivitis (VKC) in children and adults |
MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: estrogen == progestin == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA NDA No.: 214846 Prod. No.: 001 RX (1MG;0.5MG;40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jun 21, 2021 | Jan 28, 2026 | |
| Pat. No. 8058280 DS* DP* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Jun 21, 2021 | Jan 28, 2026 | |
| Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 25, 2023 | Sep 27, 2033 | |
| Pat. No. 11033551 Methods of treating uterine fibroids Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 21, 2021 | Sep 29, 2037 | U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women |
| Pat. No. 11957684 Treatment of heavy menstrual bleeding associated with uterine fibroids Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2024 | Sep 29, 2037 | U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women |
| Pat. No. 11793812 Methods of treating endometriosis Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 25, 2023 | May 3, 2038 | U-2360: Management of moderate to severe pain associated with endometriosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 5, 2025 | I-898: For the management of moderate to severe pain associated with endometriosis |
| Exclusivity Code: M - Miscellaneous | Jan 27, 2026 | M-289: Information added to the labeling to describe the results of MVT-601-035 |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2025 |
ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: SUMITOMO PHARMA NDA No.: 214621 Prod. No.: 001 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof Claim Types: Compound Pat. Sub. Date(s): 001: Jan 14, 2021 | Jan 28, 2026 | |
| Pat. No. 8058280 DS* DP* Substituted thieno[2,3-d]pyrimidin-2,4-dione compounds and uses thereof Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Jan 14, 2021 | Jan 28, 2026 | |
| Pat. No. 11795178 DS* DP* Compositions of thienopyrimidine derivatives Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 25, 2023 | Sep 27, 2033 | |
| Pat. No. 10350170 DP* Solid preparation Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jan 14, 2021 | Feb 25, 2036 | |
| Pat. No. 10449191 Treatment of prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 14, 2021 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Pat. No. 10786501 Treatment of prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 14, 2021 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Pat. No. 11583526 Treatment of prostate cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2023 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Pat. No. 12097198 Treatment of prostate cancer Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Sep 25, 2024 | Sep 29, 2037 | U-3020: Treatment of adult patients with advanced prostate cancer |
| Pat. No. 12144809 Treatment of prostate cancer Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Nov 21, 2024 | Sep 29, 2037 | U-4035: Treatment of adult patients with advanced prostate cancer, modified by dose-separating administrations of relugolix and a P-GP inhibitor, when co-administration of relugolix and the P-GP inhibitor is unavoidable |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Dec 18, 2025 |
FLYRCADO (SOLUTION) (INTRAVENOUS) FLURPIRIDAZ F-18
NDA Applicant: GE HLTHCARE NDA No.: 215168 Prod. No.: 001 RX (5-55mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9161997 DS* DP* Contrast agents for myocardial perfusion imaging Claim Types: Compound; Kit; Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 22, 2024 | Feb 4, 2026 | U-4011: Method of positron emission tomography (PET) for cardiac imaging |
| Pat. No. 7344702 DS* Contrast agents for myocardial perfusion imaging Claim Types: Compound Pat. Sub. Date(s): 001: Oct 22, 2024 | May 26, 2026 | |
| Pat. No. 8226929 Contrast agents for myocardial perfusion imaging Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 22, 2024 | Jun 21, 2028 | U-4011: Method of positron emission tomography (PET) for cardiac imaging |
| Pat. No. 9603951 Methods and apparatus for synthesizing imaging agents, and intermediates thereof Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 22, 2024 | May 2, 2031 | U-4011: Method of positron emission tomography (PET) for cardiac imaging |
| Pat. No. 8936777 Methods and apparatus for synthesizing imaging agents, and intermediates thereof Claim Types: Process; Compound; Method of use; Device Pat. Sub. Date(s): 001: Oct 22, 2024 | Jun 30, 2031 | U-4011: Method of positron emission tomography (PET) for cardiac imaging |
| Pat. No. 9687571 DP* Stabilization of radiopharmaceutical compositions using ascorbic acid Claim Types: Formulation; Process; Diagnostic or surgical method Pat. Sub. Date(s): 001: Oct 22, 2024 | Nov 1, 2032 | U-4011: Method of positron emission tomography (PET) for cardiac imaging |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 27, 2029 |
SKELAXIN (TABLET) (ORAL) METAXALONE
Drug Classes: muscle relaxant
NDA Applicant: KING PHARMS NDA No.: 013217 Prod. No.: 003 DISC (800MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7122566 Metaxalone products, method of manufacture, and method of use Claim Types: Method of administration Pat. Sub. Date(s): 003: None | Feb 6, 2026 | U-915: Treatment of musculoskeletal conditions |
WAKIX (TABLET) (ORAL) PITOLISANT HYDROCHLORIDE
Drug Classes: histamine-3 (H3) receptor antagonist/inverse agonist
NDA Applicant: HARMONY NDA No.: 211150 Prod. No.: 001 RX (EQ 4.45MG BASE); 002 RX (EQ 17.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8354430 Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy]propyl]-piperidine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Feb 6, 2026 | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy U-1102: Method of treating cataplexy in patients with narcolepsy |
| Pat. No. 8486947 Treatment of Parkinson's disease, obstructive sleep apnea, dementia with Lewy bodies, vascular dementia with non-imidazole alkylamines histamine H.sub.3-receptor ligands Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Sep 26, 2029 | U-1101: Method of treating excessive daytime sleepiness in patients with narcolepsy U-1102: Method of treating cataplexy in patients with narcolepsy |
| Pat. No. 8207197 DS* DP* [Extended 375 days (1 years)] Monohydrochloride salt of 1-[3-[3-(4-chlorophenyl) propoxy] propyl] -piperidine Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Sep 11, 2019 | Mar 7, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 14, 2024 | |
| Exclusivity Code: NPP - New patient population | Jun 21, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 14, 2026 | ODE-255: Indicated for the treatment of excessive daytime sleepiness (EDS) in adult patients with narcolepsy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 13, 2027 | ODE-331: Treatment of cataplexy in adult patients with nacrolepsy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 21, 2031 | ODE-489: Treatment of excessive daytime sleepiness (EDS) in pediatric patients 6 years of age and older with narcolepsy |
VICTOZA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE [GENERIC AP]
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NORDISK INC NDA No.: 022341 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8114833 DS* DP* Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 13, 2012 | Feb 13, 2026 *PED | |
| Pat. No. 9265893 DP* Injection button Claim Types: Device Pat. Sub. Date(s): 001: Mar 14, 2016 | Mar 23, 2033 *PED | |
| Pat. No. 9968659 Liraglutide in cardiovascular conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 12, 2018 | Jul 9, 2037 *PED | U-2313: Method of reducing the risk of cardiovascular death, non-fatal myocardial infarction, and/or non-fatal stroke in adults with Type 2 diabetes mellitus and established cardiovascular disease by administering liraglutide |
BRIVIACT (TABLET) (ORAL) BRIVARACETAM
NDA Applicant: UCB INC NDA No.: 205836 Prod. No.: 001 RX (10MG); 002 RX (25MG); 003 RX (50MG); 004 RX (75MG); 005 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6911461 DS* DP* [Extended 5 years] 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: Feb 25, 2016 | Feb 21, 2026 | U-2295: Treatment of partial-onset seizures in patients 4 years of age and older |
| Pat. No. 10729653 DP* Pharmaceutical compositions comprising 2-oxo-1-pyrrolidine derivatives Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 18, 2020 | Apr 9, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Aug 27, 2024 |
BRIVIACT (SOLUTION) (INTRAVENOUS) BRIVARACETAM
NDA Applicant: UCB INC NDA No.: 205837 Prod. No.: 001 RX (50MG/5ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6911461 DS* DP* [Extended 5 years] 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Feb 25, 2016 | Feb 21, 2026 | U-1815: Treatment of partial-onset seizures as adjunctive therapy in patients with epilepsy aged 16 years and older with epilepsy U-2130: Treatment of partial onset seizures in patients with epilepsy aged 16 years and older with epilepsy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Aug 27, 2024 |
BRIVIACT (SOLUTION) (ORAL) BRIVARACETAM
NDA Applicant: UCB INC NDA No.: 205838 Prod. No.: 001 RX (10MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6911461 DS* DP* [Extended 5 years] 2-oxo-1-pyrrolidine derivatives, processes for preparing them and their uses Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Feb 25, 2016 | Feb 21, 2026 | U-2295: Treatment of partial-onset seizures in patients 4 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Aug 27, 2024 |
CORLANOR (SOLUTION) (ORAL) IVABRADINE
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC NDA No.: 209964 Prod. No.: 001 RX (5MG/5ML (1MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: May 3, 2019 | Feb 22, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): 001: May 3, 2019 | Feb 22, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: May 3, 2019 | Feb 22, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7867996 DS* DP* [Extended 293 days (0.8 years)] .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: May 3, 2019 | Dec 12, 2026 | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 22, 2026 PED | ODE-234: Indicated for the treatment of stable symptomatic heart failure due to dilated cardiomyopathy (DCM) in pediatric patients aged 6 months and older, who are in sinus rhythm with an elevated heart rate |
ELEPSIA XR (TABLET, EXTENDED RELEASE) (ORAL) LEVETIRACETAM [Has competitive generic]
NDA Applicant: TRIPOINT NDA No.: 204417 Prod. No.: 001 DISC (1GM); 002 DISC (1.5GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8425938 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 11, 2019 | Feb 22, 2026 | |
| Pat. No. 8535717 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 11, 2019 | Feb 22, 2026 | |
| Pat. No. 8163306 DP* Oral drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 11, 2019 | Sep 3, 2027 | |
| Pat. No. 8431156 DP* Pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 11, 2019 | Oct 31, 2027 | |
| Pat. No. 8470367 DP* Oral drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 11, 2019 | Oct 31, 2027 |
JUBLIA (SOLUTION) (TOPICAL) EFINACONAZOLE [GENERIC AB]
Drug Classes: azole antifungal
NDA Applicant: BAUSCH NDA No.: 203567 Prod. No.: 001 RX (10%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7214506 [Extended 1601 days (4.4 years)] Method for treating onychomycosis Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 20, 2014 | Feb 22, 2026 | U-281: Antimycotic uses, specifically treatment of onychomycosis |
| Pat. No. 9566272 Compositions and methods for treating diseases of the nail Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 22, 2017 | Jan 3, 2028 | U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 9877955 Compositions and methods for treating diseases of the nail Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 31, 2018 | Jan 3, 2028 | U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 10512640 Compositions and methods for treating diseases of the nail Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2020 | Jan 3, 2028 | U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 10828369 DP* Compositions and methods for treating diseases of the nail Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 2, 2020 | Jan 3, 2028 | |
| Pat. No. 11213519 Compositions and methods for treating diseases of the nail Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 20, 2022 | Jan 3, 2028 | U-2720: Antimycotic uses, specifically treatment of onychomycosis; topical treatment of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 11872218 Compositions and methods for treating diseases of the nail Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 9, 2024 | Jan 3, 2028 | U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 8039494 Compositions and methods for treating diseases of the nail Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 20, 2014 | Jul 8, 2030 | U-281: Antimycotic uses, specifically treatment of onychomycosis |
| Pat. No. 9861698 DP* Compositions and methods for treating diseases of the nail Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jan 10, 2018 | Jul 8, 2030 | |
| Pat. No. 10105444 DP* Compositions and methods for treating diseases of the nail Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 | Jul 8, 2030 | |
| Pat. No. 8486978 DP* Compositions and methods for treating diseases of the nail Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 20, 2014 | Oct 24, 2030 | |
| Pat. No. 9302009 DP* Compositions and methods for treating diseases of the nail Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 25, 2016 | Oct 24, 2030 | |
| Pat. No. 9662394 DP* Stabilized efinaconazole compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 30, 2017 | Oct 2, 2034 | |
| Pat. No. 10342875 DP* Stabilized efinaconazole compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 12, 2019 | Oct 2, 2034 | U-2720: Antimycotic uses, specifically treatment of onychomycosis; topical treatment of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 10828293 Anti-infective methods, compositions, and devices Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 2, 2020 | Oct 2, 2034 | U-2720: Antimycotic uses, specifically treatment of onychomycosis; topical treatment of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 10864274 Stabilized efinaconazole formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 7, 2021 | Oct 2, 2034 | U-2720: Antimycotic uses, specifically treatment of onychomycosis; topical treatment of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 11654139 Anti-infective methods, compositions, and devices Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 14, 2023 | Oct 2, 2034 | U-1969: Topical treatment of onychomycosis of the toenail(s) due to trichophyton rubrum and trichophyton mentagrophytes |
| Pat. No. 10478601 DP* Applicator Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 17, 2019 | Apr 25, 2035 | U-2721: Topical treatment of tinea unguium by using an applicator for applying a solution for treating tinea unguium to an affected part of a patient |
NEXTSTELLIS (TABLET) (ORAL) DROSPIRENONE; ESTETROL
Drug Classes: progestin
NDA Applicant: MAYNE PHARMA NDA No.: 214154 Prod. No.: 001 RX (3MG;14.2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7732430 DP* Drug delivery system comprising a tetrahydroxilated estrogen for use in hormonal contraception Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Apr 30, 2021 | Mar 2, 2026 | U-3152: Use by females of reproductive potential to prevent pregnancy |
| Pat. No. 11793760 DP* Orodispersible dosage unit containing an estetrol component Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 31, 2023 | Jun 17, 2036 | |
| Pat. No. 11957694 DP* Orodispersible dosage unit containing an estetrol component Claim Types: Formulation claimed by its inherent performace characteristics; Method of use; Process Pat. Sub. Date(s): 001: Apr 29, 2024 | Jun 17, 2036 | |
| Pat. No. 11964055 DP* Orodispersible dosage unit containing an estetrol component Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 29, 2024 | Jun 17, 2036 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 15, 2026 |
NAPROXEN SODIUM (CAPSULE) (ORAL) NAPROXEN SODIUM [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: BIONPHARMA NDA No.: 021920 Prod. No.: 001 OTC (EQ 200MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9693978 DP* Solvent system for enhancing the solubility of pharmaceutical agents Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Nov 13, 2017 | Mar 3, 2026 | |
| Pat. No. 9693979 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Nov 13, 2017 | Mar 3, 2026 | |
| Pat. No. 10022344 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jul 23, 2018 | Mar 3, 2026 | U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever |
| Pat. No. 10028925 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Jul 24, 2018 | Mar 3, 2026 | U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever |
| Pat. No. 11090280 DP* Liquid dosage forms of sodium naproxen Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 24, 2021 | Mar 3, 2026 | U-1731: Temporary relief of minor aches and pains U-1732: Temporary reduction of fever |
VALCHLOR (GEL) (TOPICAL) MECHLORETHAMINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: HELSINN NDA No.: 202317 Prod. No.: 001 RX (EQ 0.016% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7838564 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | |
| Pat. No. 8450375 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | |
| Pat. No. 8501818 DP* Stabilized compositions of alkylating agents and methods of using same Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | |
| Pat. No. 8501819 Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Mar 7, 2026 | U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy |
| Pat. No. 9382191 DP* Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Composition Pat. Sub. Date(s): 001: Jul 26, 2016 | Mar 7, 2026 | |
| Pat. No. 7872050 Stabilized compositions of volatile alkylating agents and methods of using thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2013 | Jul 8, 2029 | U-1427: Alkylating drug indicated for the topical treatment of stage ia and ib mycosis fungoides-type cutaneous T-cell lymphoma in patients who have received prior skin directed therapy |
PRADAXA (CAPSULE) (ORAL) DABIGATRAN ETEXILATE MESYLATE [GENERIC AB]
Drug Classes: direct thrombin inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 022512 Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 110MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Aug 1, 2011; 002: None; 003: Dec 15, 2015 | Mar 7, 2026 *PED | |
| Pat. No. 9034822 Methods of using antibodies during anticoagulant therapy of dabigatran and/or related compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 9, 2015; 002: Nov 9, 2015; 003: Dec 15, 2015 | Jul 20, 2031 *PED | U-1759: Method of reversing the anticoagulant effect of dabigatran using idarucizumab |
PRADAXA (PELLETS) (ORAL) DABIGATRAN ETEXILATE MESYLATE
Drug Classes: direct thrombin inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 214358 Prod. No.: 001 RX (EQ 20MG BASE/PACKET); 002 RX (EQ 30MG BASE/PACKET); 003 RX (EQ 40MG BASE/PACKET); 004 RX (EQ 50MG BASE/PACKET); 005 RX (EQ 110MG BASE/PACKET); 006 RX (EQ 150MG BASE/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7932273 DS* DP* 3-[(2-{[4-(hexyloxycarbonylaminoiminomethyl) phenylamino]methyl}-1-methyl-1H-benzimidazol-5-carbonyl)pyridin-2-ylamino- ]propionic acid ethylester methansulfonate and its use as a medicament Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jul 28, 2021 | Mar 7, 2026 *PED |
COREG CR (CAPSULE, EXTENDED RELEASE) (ORAL) CARVEDILOL PHOSPHATE [Has competitive generic]
Drug Classes: alpha adrenergic blocker == beta-adrenergic receptor inhibitor
NDA Applicant: WAYLIS THERAP NDA No.: 022012 Prod. No.: 001 DISC (10MG); 002 DISC (20MG); 003 DISC (40MG); 004 DISC (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8101209 DP* Microparticulate oral galenical form for the delayed and controlled release of pharmaceutical active principles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2012; 002: None; 003: None; 004: None | Mar 11, 2026 *PED |
TYGACIL (POWDER) (INTRAVENOUS) TIGECYCLINE [GENERIC AP]
Drug Classes: tetracycline class antibacterial
NDA Applicant: PF PRISM CV NDA No.: 021821 Prod. No.: 001 RX (50MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9254328 DP* B2Tigecycline compositions and methods of preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2016 | Mar 13, 2026 | |
| Pat. No. 9694078 DP* Tigecycline compositions and methods of preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 1, 2017 | Mar 13, 2026 | |
| Pat. No. 10588975 DP* Tigecycline compositions and methods of preparation Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 15, 2020 | Mar 13, 2026 | |
| Pat. No. 8975242 DP* Tigecycline compositions and methods of preparation Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 10, 2015 | Oct 24, 2028 | |
| Pat. No. 7879828 DP* Tigecycline compositions and methods of preparatio Claim Types: Formulation Pat. Sub. Date(s): 001: None | Feb 5, 2029 | |
| Pat. No. 8372995 DP* Crystalline solid forms of tigecycline and methods of preparing same Claim Types: New polymorph, salt or hydrate; Composition; Process; Product-by-process Pat. Sub. Date(s): 001: Feb 28, 2013 | Oct 8, 2030 |
RYBELSUS (TABLET) (ORAL) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 213051 Prod. No.: 001 RX (3MG); 002 RX (7MG); 003 RX (14MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 15, 2019 | Mar 20, 2026 | U-2628: Method of treating Type 2 diabetes mellitus |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 15, 2019 | Dec 5, 2031 | U-2628: Method of treating Type 2 diabetes mellitus |
| Pat. No. 9278123 DP* Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Oct 15, 2019 | Dec 16, 2031 | U-2628: Method of treating Type 2 diabetes mellitus |
| Pat. No. 10086047 DP* Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 15, 2019 | Dec 16, 2031 | |
| Pat. No. 10960052 DP* Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl) amino) caprylic acid Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 26, 2021 | Dec 16, 2031 | |
| Pat. No. 11382957 DP* Solid compositions comprising a GLP-1 agonist and a salt of N-(8-(2-hydroxybenzoyl)amino)caprylic acid Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 26, 2022 | Dec 16, 2031 | |
| Pat. No. 10933120 DP* Compositions of GLP-1 peptides and preparation thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 31, 2021 | Mar 15, 2033 | |
| Pat. No. 11759501 DP* Compositions of GLP-1 peptides and preparation thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 12, 2023 | Mar 15, 2033 | |
| Pat. No. 11759502 DP* Compositions of GLP-1 peptides and preparation thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 12, 2023 | Mar 15, 2033 | |
| Pat. No. 11759503 DP* Compositions of GLP-1 peptides and preparation thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 12, 2023 | Mar 15, 2033 | |
| Pat. No. 10278923 Oral dosing of GLP-1 compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 15, 2019 | May 2, 2034 | U-2628: Method of treating Type 2 diabetes mellitus |
WEGOVY (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 215256 Prod. No.: 001 RX (0.25MG/0.5ML (0.25MG/0.5ML)); 002 RX (0.5MG/0.5ML (0.5MG/0.5ML)); 003 RX (1MG/0.5ML (1MG/0.5ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2021 | Mar 20, 2026 | |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2021 | Dec 5, 2031 | |
| Pat. No. 9764003 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2021 | Jun 21, 2033 | U-3161: Method for weight management according to a dose escalation schedule |
| Pat. No. 10888605 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2021 | Aug 24, 2038 | U-3162: Method for weight management |
| Pat. No. 11752198 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): All strengths: Oct 10, 2023 | Aug 24, 2038 | U-3162: Method for weight management |
| Pat. No. 11318191 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): All strengths: Jun 29, 2022 | Feb 17, 2041 | U-3162: Method for weight management |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 8, 2027 | I-935: In combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight |
| Exclusivity Code: NPP - New patient population | Dec 23, 2025 |
WEGOVY (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 215256 Prod. No.: 004 RX (1.7MG/0.75ML (1.7MG/0.75ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Jun 30, 2021 | Mar 20, 2026 | |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 004: Jun 30, 2021 | Dec 5, 2031 | |
| Pat. No. 9764003 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 004: Jun 30, 2021 | Jun 21, 2033 | U-3161: Method for weight management according to a dose escalation schedule |
| Pat. No. 10888605 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): 004: Jun 30, 2021 | Aug 24, 2038 | U-3162: Method for weight management |
| Pat. No. 11752198 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): 004: Oct 10, 2023 | Aug 24, 2038 | U-3162: Method for weight management |
| Pat. No. 11318191 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): 004: Jun 29, 2022 | Feb 17, 2041 | U-3162: Method for weight management |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: D - New Dosing Schedule | Jul 21, 2026 | D-190: Use of semaglutide 1.7 mg subcutaneous weekly as an additional maintenance dose |
| Exclusivity Code: I - New Indication | Mar 8, 2027 | I-935: In combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight |
| Exclusivity Code: NPP - New patient population | Dec 23, 2025 |
WEGOVY (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 215256 Prod. No.: 005 RX (2.4MG/0.75ML (2.4MG/0.75ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8536122 DS* DP* Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 005: Jun 30, 2021 | Mar 20, 2026 | |
| Pat. No. 8129343 DS* DP* [Extended 1040 days (2.8 years)] Acylated GLP-1 compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 005: Jun 30, 2021 | Dec 5, 2031 | |
| Pat. No. 9764003 Use of long-acting GLP-1 peptides Claim Types: Method of use Pat. Sub. Date(s): 005: Jun 30, 2021 | Jun 21, 2033 | U-3161: Method for weight management according to a dose escalation schedule |
| Pat. No. 10888605 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): 005: Jun 30, 2021 | Aug 24, 2038 | U-3162: Method for weight management |
| Pat. No. 11752198 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): 005: Oct 10, 2023 | Aug 24, 2038 | U-3162: Method for weight management |
| Pat. No. 12029779 Semaglutide in medical therapy Claim Types: Method of use Pat. Sub. Date(s): 005: Jul 9, 2024 | Oct 10, 2038 | U-3162: Method for weight management |
| Pat. No. 11318191 DP* GLP-1 compositions and uses thereof Claim Types: Formulation; Kit; Method of use Pat. Sub. Date(s): 005: Jun 29, 2022 | Feb 17, 2041 | U-3162: Method for weight management |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 8, 2027 | I-935: In combination with a reduced calorie diet and increased physical activity to reduce the risk of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and either obesity or overweight |
| Exclusivity Code: NPP - New patient population | Dec 23, 2025 |
OFEV (CAPSULE) (ORAL) NINTEDANIB ESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 205832 Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6762180 DS* DP* [Extended 1824 days (5 years)] Substituted indolines which inhibit receptor tyrosine kinases Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Oct 22, 2014 | Apr 1, 2026 *PED | |
| Pat. No. 10154990 Medicaments for the treatment or prevention of fibrotic diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 18, 2019 | Jul 8, 2026 *PED | U-2620: Use of nintedanib for slowing the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD) |
| Pat. No. 10105323 DP* Pharmaceutical dosage form for immediate release of an indolinone derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 6, 2018 | Dec 4, 2029 *PED | |
| Pat. No. 9907756 DP* Capsule pharmaceutical dosage form comprising a suspension formulation of an indolinone derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2018 | Dec 7, 2029 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 6, 2027 PED | ODE-261: Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD) |
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 021926 Prod. No.: 001 RX (500MG;EQ 85MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 001: None | Apr 2, 2026 *PED | U-867: Treatment of migraine |
TREXIMET (TABLET) (ORAL) NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
Drug Classes: nonsteroidal anti-inflammatory drug == serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: CURRAX NDA No.: 021926 Prod. No.: 002 DISC (60MG;EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7332183 DP* Multilayer dosage forms containing NSAIDs and triptans Claim Types: Formulation; Method of use; Method of administration Pat. Sub. Date(s): 002: Jul 27, 2015 | Apr 2, 2026 *PED | U-1719: Acute treatment of migraine |
SINUVA (IMPLANT) (IMPLANTATION) MOMETASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: INTERSECT ENT INC NDA No.: 209310 Prod. No.: 001 RX (1.35MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9585681 Device and methods for treating paranasal sinus conditions Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Apr 4, 2026 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 7544192 Sinus delivery of sustained release therapeutics Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 26, 2018 | Nov 29, 2026 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 8025635 DP* Device and methods for treating paranasal sinus conditions Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Apr 26, 2018 | Jun 12, 2027 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 10357640 Expandable devices and methods for treating a nasal or sinus condition Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 6, 2019 | Oct 3, 2031 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
| Pat. No. 8763222 DP* Methods and devices for crimping self-expanding devices Claim Types: Device Pat. Sub. Date(s): 001: Apr 26, 2018 | Feb 8, 2032 | |
| Pat. No. 10406332 DP* Systems, devices, and method for treating a sinus condition Claim Types: Device Pat. Sub. Date(s): 001: Dec 6, 2019 | Mar 13, 2034 | |
| Pat. No. 10232152 DP* Systems, devices, and method for treating a sinus condition Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Dec 6, 2019 | Nov 24, 2034 | U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant |
XIGDUO XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB NDA No.: 205649 Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (10MG;500MG); 004 RX (10MG;1GM); 005 RX (2.5MG;1GM)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6515117 DS* DP* [Extended 5 years] C-aryl glucoside SGLT2 inhibitors and method Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 24, 2014 | Apr 4, 2026 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 8501698 DP* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017 | Dec 20, 2027 *PED | U-493: Treatment of Type 2 Diabetes Mellitus |
| Pat. No. 7919598 DS* Crystal structures of SGLT2 inhibitors and processes for preparing same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017 | Jun 16, 2030 *PED | |
| Pat. No. 8685934 Methods for treating extreme insulin resistance in patients resistant to previous treatment with other anti-diabetic drugs employing an SGLT2 inhibitor and compositions thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017 | Nov 26, 2030 *PED | U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone |
| Pat. No. 9616028 DP* Bilayer tablet formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 30, 2017 | May 12, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Dec 12, 2027 PED |
FLONASE SENSIMIST ALLERGY RELIEF (SPRAY, METERED) (NASAL) FLUTICASONE FUROATE
Drug Classes: corticosteroid
NDA Applicant: HALEON US HOLDINGS NDA No.: 022051 Prod. No.: 002 OTC (0.0275MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8062264 DP* Fluid dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Aug 31, 2016 | Apr 5, 2026 | |
| Pat. No. 8347879 DP* Fluid dispensing device Claim Types: Device; Drug in a container Pat. Sub. Date(s): 002: Aug 31, 2016 | Jul 15, 2028 | |
| Pat. No. 8147461 DP* Fluid dispensing device Claim Types: Device Pat. Sub. Date(s): 002: Aug 31, 2016 | Oct 15, 2028 |
ADZENYS XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: NEOS THERAPS NDA No.: 204326 Prod. No.: 001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003 RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX (EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 26, 2016 | Apr 9, 2026 | |
| Pat. No. 8709491 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 28, 2032 | |
| Pat. No. 9017731 DP* Composition comprising a mixture of dextro- and levo-amphetamines complexed with ion-exchange resin particles to form drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 28, 2032 | |
| Pat. No. 9265737 DP* Pharmaceutical composition comprising amphetamines complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None | Jun 28, 2032 | |
| Pat. No. 9839619 DP* Method for treating ADD or ADHD comprising administering amphetamine complexed with ion-exchange resin particles Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 22, 2024 | Jun 28, 2032 |
JATENZO (CAPSULE) (ORAL) TESTOSTERONE UNDECANOATE
Drug Classes: androgen
NDA Applicant: TOLMAR NDA No.: 206089 Prod. No.: 001 RX (158MG); 002 RX (198MG); 003 RX (237MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11179402 DS* DP* Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 21, 2021 | Apr 14, 2026 | |
| Pat. No. 11331325 Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 2, 2022 | Jan 6, 2027 | U-2506: Method of treating testosterone deficiency |
| Pat. No. 8241664 DP* Pharmaceutical delivery systems for hydrophobic drugs and compositions comprising same Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Mar 29, 2029 | U-2506: Method of treating testosterone deficiency |
| Pat. No. 8778916 DP* Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Apr 12, 2030 | |
| Pat. No. 10543219 Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 18, 2020 | Apr 12, 2030 | U-2506: Method of treating testosterone deficiency |
| Pat. No. 10617696 DS* DP* Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 5, 2020 | Apr 12, 2030 | |
| Pat. No. 11179403 Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 21, 2021 | Apr 12, 2030 | U-2506: Method of treating testosterone deficiency |
| Pat. No. 11426416 Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 12, 2022 | Apr 12, 2030 | U-3420: A method of treating testosterone deficiency in men |
| Pat. No. 8492369 DP* Oral testosterone ester formulations and methods of treating testosterone deficiency comprising same Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Apr 8, 2019 | Dec 20, 2030 | U-2506: Method of treating testosterone deficiency |
| Pat. No. 11564933 Methods of treating testosterone deficiency Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2023 | Apr 12, 2039 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
AURYXIA (TABLET) (ORAL) FERRIC CITRATE
NDA Applicant: KERYX BIOPHARMS NDA No.: 205874 Prod. No.: 001 RX (EQ 210MG IRON)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8093423 Pharmaceutical-grade ferric organic compounds, uses thereof and method of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 | Apr 21, 2026 | U-1577: Control of serum phosphorous levels |
| Pat. No. 9387191 DP* Ferric citrate dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2016 | Jul 21, 2030 | |
| Pat. No. 10300039 Ferric citrate dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jul 21, 2030 | U-2549: Control of serum phosphorus levels |
LENVIMA (CAPSULE) (ORAL) LENVATINIB MESYLATE
Drug Classes: kinase inhibitor
NDA Applicant: EISAI INC NDA No.: 206947 Prod. No.: 001 RX (EQ 4MG BASE); 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7253286 DS* DP* [Extended 1466 days (4 years)] Nitrogen-containing aromatic derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Mar 10, 2015 | Apr 24, 2026 *PED | |
| Pat. No. 7612208 DS* DP* Crystalline form of the salt of 4-(3-chloro-4-(cyclopropylaminocarbonyl)aminophenoxy)-7-methoxy-6- Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Mar 10, 2015 | Mar 19, 2027 *PED | |
| Pat. No. 9006256 Antitumor agent for thyroid cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 12, 2015 | Jan 27, 2028 *PED | U-1695: Method for treating thyroid carcinoma including differentiated thyroid cancer |
| Pat. No. 10259791 DS* High-purity quinoline derivative and method for manufacturing same Claim Types: Impurity content limitation; Process Pat. Sub. Date(s): All strengths: May 13, 2019 | Feb 26, 2036 *PED | |
| Pat. No. 10407393 DS* High-purity quinoline derivative and method for manufacturing same Claim Types: New polymorph, salt or hydrate with purity limitation Pat. Sub. Date(s): All strengths: Oct 4, 2019 | Feb 26, 2036 *PED | |
| Pat. No. 11186547 DS* High-purity quinoline derivative and method for manufacturing same Claim Types: Compound Pat. Sub. Date(s): All strengths: Dec 17, 2021 | Feb 26, 2036 *PED | |
| Pat. No. 12083112 Combination of a PD-1 antagonist and a VEGFR/FGFR/RET tyrosine kinase inhibitor for treating cancer Claim Types: Method of use; Method of administration; Kit Pat. Sub. Date(s): All strengths: Oct 3, 2024 | Mar 3, 2036 | U-3996: First-line treatment of adults patients with advanced renal cell carcinoma by administering LENVIMA in combination with pembrolizumab U-3997: Treatment of patients with PMMR/NOT MSI-H advanced endometrial carcinoma, have disease progression following prior systemic therapy, and are not candidates for curative surgery or radiation, by administering LENVIMA in combination with pembrolizumab |
| Pat. No. 11090386 Method for suppressing bitterness of quinoline derivative Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2023 | Aug 23, 2036 *PED | U-3519: Treatment with LENVIMA by administering LENVIMA as a suspension |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Aug 10, 2024 | I-868: Lenvatinib in combination with pembrolizumab, is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC) |
| Exclusivity Code: M - Miscellaneous | Oct 3, 2027 PED | M-14: Additional clinical trial information added to pediatric use subsection |
| Exclusivity Code: M - Miscellaneous | Jul 21, 2024 | M-269: Revisions to the labeling to include results from clinical study 309/KEYNOTE-775 to support PMR 3696-1 and 3700-1 |
| Exclusivity Code: M - Miscellaneous | Dec 19, 2024 | M-272: Revisions to the labeling to include results from clinical study E7080-G000-211 to support PMR 2865-1 |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 15, 2026 PED | ODE-196: Indicated for the first-line treatment of patients with unresectable hepatocellular carcinoma (HCC) |
ZYKADIA (CAPSULE) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 205755 Prod. No.: 001 DISC (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 13, 2014 | Apr 25, 2026 | |
| Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2014 | Nov 20, 2027 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jun 15, 2017 | Nov 20, 2027 | |
| Pat. No. 7964592 DS* DP* [Extended 586 days (1.6 years)] 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 13, 2014 | Apr 29, 2028 | |
| Pat. No. 8039479 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: May 13, 2014 | Jun 29, 2030 | |
| Pat. No. 9309229 DS* DP* Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Apr 22, 2016 | Jan 18, 2032 | |
| Pat. No. 8703787 Methods of using ALK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 23, 2014 | Feb 2, 2032 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
ZYKADIA (TABLET) (ORAL) CERITINIB
Drug Classes: kinase inhibitor
NDA Applicant: NOVARTIS NDA No.: 211225 Prod. No.: 001 RX (150MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7893074 DS* DP* 2, 4-pyrimidinediamines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Apr 25, 2026 | |
| Pat. No. 8377921 Compounds and compositions as protein kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Nov 20, 2027 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
| Pat. No. 8399450 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 2, 2019 | Nov 20, 2027 | |
| Pat. No. 7964592 DS* DP* [Extended 586 days (1.6 years)] 2,4-di (phenylamino) pyrimidines useful in the treatment of neoplastic diseases, inflammatory and immune system disorders Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Apr 29, 2028 | |
| Pat. No. 8039479 DS* DP* Compounds and compositions as protein kinase inhibitors Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Aug 2, 2019 | Jun 29, 2030 | |
| Pat. No. 9309229 DS* DP* Crystalline forms of 5-chloro-N2-(2-isopropoxy-5-methyl-4-piperidin-4-yl-phenyl)-N4-[2-(propan- e-2-sulfonyl)-phenyl]-pyrimidine-2, 4-diamine Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 2, 2019 | Jan 18, 2032 | |
| Pat. No. 8703787 Methods of using ALK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2019 | Feb 2, 2032 | U-1179: Treatment of a cancer mediated by an anaplastic lymphoma kinase (ALK) |
ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 203496 Prod. No.: 001 RX (EQ 0.125MG BASE); 005 RX (EQ 5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9393203 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2016; 005: Feb 9, 2017 | Apr 27, 2026 | U-1877: Method of treating pulmonary hypertension by orally administering a formulation of a pharmaceutically acceptable salt of treprostinil |
| Pat. No. 7417070 DS* Compounds and methods for delivery of prostacyclin analogs Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017 | Jul 30, 2026 | |
| Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Mar 14, 2017 | Dec 15, 2028 | |
| Pat. No. 9604901 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM. Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Mar 28, 2017 | Dec 15, 2028 | |
| Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin® Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 15, 2023 | Dec 15, 2028 | |
| Pat. No. 8410169 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Formulation; Method of use; Composition Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017 | Feb 13, 2030 | |
| Pat. No. 8349892 DP* Solid formulations of prostacyclin analogs Claim Types: Drug in a container; Process Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017 | Jan 22, 2031 | |
| Pat. No. 8747897 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 13, 2014; 005: Feb 9, 2017 | Aug 11, 2031 | U-2724: A method of oral delivery of treprostinil comprising administering an oral osmotic pharmaceutical dosage form U-2725: A method of treating pulmonary hypertension and pulmonary arterial hypertension by administering an oral osmotic pharmaceutical dosage form |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2026 | ODE-272: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression |
ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: prostacycline vasodilator
NDA Applicant: UNITED THERAP NDA No.: 203496 Prod. No.: 002 RX (EQ 0.25MG BASE); 003 RX (EQ 1MG BASE); 004 RX (EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9393203 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2016 | Apr 27, 2026 | U-1877: Method of treating pulmonary hypertension by orally administering a formulation of a pharmaceutically acceptable salt of treprostinil |
| Pat. No. 7417070 DS* Compounds and methods for delivery of prostacyclin analogs Claim Types: Compound; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Jul 30, 2026 | |
| Pat. No. 8497393 DS* DLR* Process to prepare treprostinil, the active ingredient in Remodulin.RTM Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Dec 15, 2028 | |
| Pat. No. 9593066 DS* Process to prepare treprostinil, the active ingredient in remodulin.RTM. Claim Types: Composition; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Mar 14, 2017 | Dec 15, 2028 | |
| Pat. No. 11723887 DS* Process to prepare treprostinil, the active ingredient in Remodulin® Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 15, 2023 | Dec 15, 2028 | |
| Pat. No. 8410169 DP* Compounds and methods for delivery of prostacyclin analogs Claim Types: Formulation; Method of use; Composition Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Feb 13, 2030 | |
| Pat. No. 8349892 DP* Solid formulations of prostacyclin analogs Claim Types: Drug in a container; Process Pat. Sub. Date(s): All strengths: Jan 9, 2014 | Jan 22, 2031 | |
| Pat. No. 8747897 DP* Osmotic drug delivery system Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jun 13, 2014 | Aug 11, 2031 | U-2724: A method of oral delivery of treprostinil comprising administering an oral osmotic pharmaceutical dosage form U-2725: A method of treating pulmonary hypertension and pulmonary arterial hypertension by administering an oral osmotic pharmaceutical dosage form |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 18, 2026 | ODE-272: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression |
ABILIFY MYCITE KIT (TABLET) (ORAL) ARIPIPRAZOLE [Has competitive generic]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 207202 Prod. No.: 001 DISC (2MG); 002 DISC (5MG); 003 DISC (10MG); 004 DISC (15MG); 005 DISC (20MG); 006 DISC (30MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11476952 DP* Pharma-informatics system Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Apr 28, 2026 | |
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 7978064 DP* Communication system with partial power source Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 14, 2026 | |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 9444503 DP* Active signal processing personal health signal receivers Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 19, 2027 | U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 9119554 DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 16, 2028 | |
| Pat. No. 9060708 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 9258035 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 5, 2029 | |
| Pat. No. 8674825 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 9, 2029 | U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
| Pat. No. 8956288 DP* In-body power source having high surface area electrode Claim Types: Device; Method-of-use; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jul 6, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 10441194 DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 | Jul 26, 2029 | |
| Pat. No. 8945005 DP* Controlled activation ingestible identifier Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Aug 19, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 9433371 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Sep 15, 2029 | |
| Pat. No. 8718193 DP* Active signal processing personal health signal receivers Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 5, 2029 | |
| Pat. No. 9149577 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2029 | |
| Pat. No. 8847766 DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Mar 29, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 8545402 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Apr 27, 2030 | |
| Pat. No. 8114021 DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Jun 21, 2030 | |
| Pat. No. 11464423 DP* In-body power source having high surface area electrode Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 9, 2022 | Sep 15, 2030 | |
| Pat. No. 9941931 DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 | Nov 4, 2030 | |
| Pat. No. 8961412 DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 17, 2030 | |
| Pat. No. 8258962 DP* Multi-mode communication ingestible event markers and systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Nov 25, 2030 | |
| Pat. No. 8547248 DP* Implantable zero-wire communications system Claim Types: Device; Method of use; Kit Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 18, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
| Pat. No. 11229378 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Feb 18, 2022 | Jul 11, 2031 | |
| Pat. No. 9320455 DP* Highly reliable ingestible event markers and methods for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Dec 15, 2031 | |
| Pat. No. 10517507 DP* Communication system with enhanced partial power source and method of manufacturing same Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2020 | Jun 13, 2032 | |
| Pat. No. 9268909 DP* Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 | Oct 15, 2033 | U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver |
APRETUDE (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand
NDA Applicant: VIIV HLTHCARE NDA No.: 215499 Prod. No.: 001 RX (600MG/3ML (200MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410103 DS* DP* (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 14, 2022 | Apr 28, 2026 | |
| Pat. No. 10927129 DS* DP* N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 14, 2022 | Apr 28, 2026 | |
| Pat. No. 11224597 DP* Pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 10, 2022 | Sep 15, 2031 | |
| Pat. No. 12138264 DP* Pharmaceutical compositions Claim Types: Formulation; Dosaage regimen; Method of use Pat. Sub. Date(s): 001: Dec 5, 2024 | Sep 15, 2031 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 21, 2026 |
VOCABRIA (TABLET) (ORAL) CABOTEGRAVIR SODIUM
Drug Classes: human immunodeficiency virus type 1 (HIV-1) integrase strand
NDA Applicant: VIIV HLTHCARE NDA No.: 212887 Prod. No.: 001 RX (EQ 30MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410103 DS* DP* (3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5- ,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide useful as anti-HIV agent Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Feb 16, 2021 | Apr 28, 2026 | U-3061: Treatment of HIV-1 in an adult in combination with rilpivirine U-3348: Treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 35 kg |
| Pat. No. 10927129 DS* DP* N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a- -hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide having HIV integrase inhibitory activity Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 22, 2021 | Apr 28, 2026 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jan 31, 2025 | M-273: Revision to the labeling to include results from clinical study 207966 ATLAS-2M |
| Exclusivity Code: NCE - New chemical entity | Jan 21, 2026 | |
| Exclusivity Code: NPP - New patient population | Mar 29, 2025 |
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207500 Prod. No.: 001 RX (186MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6812238 DS* [Extended 5 years] N-substituted carbamoyloxyalkyl-azolium derivatives Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 001: Apr 1, 2015 | Apr 30, 2026 *PED | |
| Pat. No. 10206879 DP* Active ingredient containing stabilised solid forms and method for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 3, 2021 | Mar 14, 2028 *PED | |
| Pat. No. 10603280 DP* Active ingredient containing stabilised solid medicinal forms and methods for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 3, 2021 | Mar 14, 2028 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | |
| Exclusivity Code: NPP - New patient population | Jun 8, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-305: Treatment of invasive aspergillosis |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older |
CRESEMBA (CAPSULE) (ORAL) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207500 Prod. No.: 002 RX (74.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6812238 DS* [Extended 5 years] N-substituted carbamoyloxyalkyl-azolium derivatives Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 002: Jun 29, 2023 | Apr 30, 2026 *PED | |
| Pat. No. 10206879 DP* Active ingredient containing stabilised solid forms and method for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 21, 2022 | Mar 14, 2028 *PED | |
| Pat. No. 10603280 DP* Active ingredient containing stabilised solid medicinal forms and methods for the production thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 21, 2022 | Mar 14, 2028 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | |
| Exclusivity Code: NPP - New patient population | Jun 8, 2027 PED | |
| Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) | Sep 6, 2022 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-454: treatment of invasive mucormycosis in pediatric patients 6 years of age and older who weigh 16 kg and greater |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-458: Treatment of invasive aspergillosis in pediatric patients 6 years of age and older who weigh 16 kilograms (kg) and greater |
CRESEMBA (POWDER) (INTRAVENOUS) ISAVUCONAZONIUM SULFATE
NDA Applicant: ASTELLAS NDA No.: 207501 Prod. No.: 001 RX (372MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6812238 DS* [Extended 5 years] N-substituted carbamoyloxyalkyl-azolium derivatives Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 001: Apr 1, 2015 | Apr 30, 2026 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Sep 6, 2020 PED | |
| Exclusivity Code: NPP - New patient population | Jun 8, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-305: Treatment of invasive aspergillosis |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-453: Treatment of invasive mucormycosis in pediatric patients 1 year of age and older |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 8, 2031 PED | ODE-459: Treatment of invasive aspergillosis in pediatric patients 1 year of age and older |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 6, 2022 PED | ODE-90: Treatment of invasive mucormycosis in patients 18 years of age and older |
ZETIA (TABLET) (ORAL) EZETIMIBE [GENERIC AB]
Drug Classes: dietary cholesterol absorption inhibitor
NDA Applicant: ORGANON NDA No.: 021445 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7612058 Methods for inhibiting sterol absorption Claim Types: Method of use Pat. Sub. Date(s): 001: None | Apr 30, 2026 *PED | U-1027: Reduction of elevated plasma sterol and/or stanol levels in a mammal U-1173: To reduce elevated total-c, LDL-c, apo b and non-HDL-c in patients with primary hyperlipidemia by administration of ezetimibe alone or in combination with a statin or with fenofibrate |
AFINITOR (TABLET) (ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant: NOVARTIS NDA No.: 022334 Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (2.5MG); 004 RX (7.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8410131 Cancer treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2013 | May 1, 2026 *PED | U-1368: Treatment of solid excretory system tumors; advanced renal cell carcinoma (RCC), after failure of treatment with sunitinib or sorafenib |
| Pat. No. 9006224 Neuroendocrine tumor treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 20, 2015 | Jul 1, 2028 | U-1681: Treatment of patients with progressive neuroendocrine tumors of pancreatic origin (pnet) that are unresectable, locally advanced or metastatic |
GATTEX KIT (POWDER) (SUBCUTANEOUS) TEDUGLUTIDE
Drug Classes: glucagon-like peptide-2 (GLP-2) analog
NDA Applicant: TAKEDA PHARMS USA NDA No.: 203441 Prod. No.: 001 RX (5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7847061 DLR* Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2013 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Pat. No. 9060992 DLR* Treatment of short bowel syndrome patients with colon-in-continuity Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 17, 2015 | May 1, 2026 *PED | U-1320: Treatment of adult patients with short bowel syndrome who are dependent on parenteral support |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 16, 2026 | ODE-240: Treatment of pediatric patients 1 year of age and older with short bowel syndrome (SBS) who are dependent on parenteral support |
TOSYMRA (SPRAY) (NASAL) SUMATRIPTAN
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: TONIX MEDS NDA No.: 210884 Prod. No.: 001 RX (10MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8268791 DP* Alkylglycoside compositions for drug administration Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2019 | May 9, 2026 | |
| Pat. No. 8440631 DP* Compositions for drug administration Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2019 | May 9, 2026 | U-1719: Acute treatment of migraine |
| Pat. No. 9283280 DP* Compositions for drug administration Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 21, 2019 | May 9, 2026 | |
| Pat. No. 9610280 DP* Formulations comprising triptan compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2019 | Jun 16, 2030 | U-1719: Acute treatment of migraine |
| Pat. No. 9974770 DP* Formulations comprising triptan compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 21, 2019 | Jun 16, 2030 | U-1719: Acute treatment of migraine |
| Pat. No. 10603305 DP* Formulations comprising triptan compounds Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 31, 2020 | Jun 16, 2030 | U-1719: Acute treatment of migraine |
| Pat. No. 11337962 DP* Formulations comprising triptan compounds Claim Types: Formulation; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: May 25, 2022 | Jun 16, 2030 | U-1719: Acute treatment of migraine |
| Pat. No. 12090139 DP* Formulations comprising triptan compounds Claim Types: Formulation; Method of use; Device Pat. Sub. Date(s): 001: Oct 17, 2024 | Jun 16, 2030 | |
| Pat. No. 9211282 DP* Formulations comprising triptan compounds Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 21, 2019 | Jul 19, 2031 | U-1719: Acute treatment of migraine |
MYDAYIS (CAPSULE, EXTENDED RELEASE) (ORAL) AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE [GENERIC AB2]
Drug Classes: adrenergic agonist == amphetamine anorectic == central nervous system (CNS) stimulant == central nervous system stimulant
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022063 Prod. No.: 001 RX (3.125MG;3.125MG;3.125MG;3.125MG); 002 RX (6.25MG;6.25MG;6.25MG;6.25MG); 003 RX (9.375MG;9.375MG;9.375MG;9.375MG); 004 RX (12.5MG;12.5MG;12.5MG;12.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9173857 Controlled dose drug delivery system Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2017 | May 12, 2026 | U-2025: Treatment of attention deficit hyperactivity disorder |
| Pat. No. 8846100 DP* Controlled dose drug delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 7, 2017 | Aug 24, 2029 |
NATAZIA (TABLET) (ORAL) DIENOGEST; ESTRADIOL VALERATE
Drug Classes: progestin == estrogen
NDA Applicant: BAYER HLTHCARE NDA No.: 022252 Prod. No.: 001 RX (N/A,2MG,3MG,N/A,N/A;3MG,2MG,2MG,1MG,N/A)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8071577 DP* Multi-phase contraceptive preparation based on a natural estrogen Claim Types: Drug in a container; Method of use Pat. Sub. Date(s): 001: Dec 30, 2011 | May 13, 2026 | U-1: Prevention of pregnancy |
| Pat. No. 8153616 Combination preparation for oral contraception and oral therapy of dysfunctional uterine bleeding containing estradiol valerate and dienogest and method of using same Claim Types: Method of administration Pat. Sub. Date(s): 001: May 9, 2012 | Jan 30, 2028 | U-1240: Treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception |
TRACLEER (TABLET, FOR SUSPENSION) (ORAL) BOSENTAN [GENERIC AB]
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 209279 Prod. No.: 001 RX (32MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8309126 DP* Dispersible bosentan tablet Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Oct 3, 2017 | May 15, 2026 | |
| Pat. No. 7959945 DP* Dispersible bosentan tablet Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 3, 2017 | Dec 28, 2027 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 5, 2024 | ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability |
XTANDI (CAPSULE) (ORAL) ENZALUTAMIDE [GENERIC AB]
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS NDA No.: 203415 Prod. No.: 001 RX (40MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 7, 2015 | May 15, 2026 | U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC). U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Pat. No. 8183274 [Extended 101 days (0.3 years)] Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 27, 2012 | Aug 24, 2026 | U-1281: The treatment of patients with metastatic castration-resistant prostate cancer who have previously received docetaxel U-1588: The treatment of patients with metastatic castration-resistant prostate cancer (CRPC). U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Pat. No. 7709517 DS* DP* Diarylhydantoin compounds Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 27, 2012 | Aug 13, 2027 | |
| Pat. No. 12161628 Combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 8, 2025 | Feb 23, 2037 | U-4101: Treatment of patients with castration-resistant prostate cancer to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide U-4102: Treatment of patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide U-4103: Treatment of patients with metastatic castration-sensitive prostate cancer to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide U-4104: Treatment of patients with metastatic castration-resistant prostate cancer to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 17, 2026 | I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis |
XTANDI (TABLET) (ORAL) ENZALUTAMIDE
Drug Classes: androgen receptor inhibitor
NDA Applicant: ASTELLAS NDA No.: 213674 Prod. No.: 001 RX (40MG); 002 RX (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9126941 Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 3, 2020 | May 15, 2026 | U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Pat. No. 8183274 [Extended 101 days (0.3 years)] Treatment of hyperproliferative disorders with diarylhydantoin compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 3, 2020 | Aug 24, 2026 | U-2345: Treatment of patients with castration-resistant prostate cancer (CRPC) U-2708: The treatment of patients with metastatic castration-sensitive prostate cancer U-3763: Treatment of patients with non-metastatic castration-sensitive prostate cancer (NMCSPC) with biochemical recurrence (BCR) at high risk for metastasis |
| Pat. No. 7709517 DS* DP* Diarylhydantoin compounds Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 3, 2020 | Aug 13, 2027 | |
| Pat. No. 11839689 DP* Formulations of enzalutamide Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 19, 2023 | Sep 11, 2033 | |
| Pat. No. 12161628 Combination therapy Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 8, 2025 | Feb 23, 2037 | U-4101: Treatment of patients with castration-resistant prostate cancer to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide U-4102: Treatment of patients with non-metastatic castration-sensitive prostate cancer with biochemical recurrence at high risk for metastasis to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide U-4103: Treatment of patients with metastatic castration-sensitive prostate cancer to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide U-4104: Treatment of patients with metastatic castration-resistant prostate cancer to whom rifampin is administered with the co-administration of a daily dose of 240 mg enzalutamide |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 17, 2026 | I-926: Treatment of patients with non-metastatic castration-sensitive prostate cancer (nmcspc) with biochemical recurrence at high risk for metastasis |
SORILUX (AEROSOL, FOAM) (TOPICAL) CALCIPOTRIENE
Drug Classes: vitamin D analog
NDA Applicant: MAYNE PHARMA NDA No.: 022563 Prod. No.: 001 RX (0.005%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8629128 DP* Vitamin formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Apr 17, 2014 | May 26, 2026 | U-1280: Use of a calcipotriene containing foam for the treatment of psoriasis U-1767: Use of calcipotriene foam for the topical treatment of plaque psoriasis in patients aged 18 years and older U-2662: Use of calcipotriene foam for the topical treatment of plaque psoriasis in patients aged 4 years and older |
| Pat. No. 8263580 DP* Vitamin formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 21, 2012 | May 7, 2028 | U-1280: Use of a calcipotriene containing foam for the treatment of psoriasis U-2662: Use of calcipotriene foam for the topical treatment of plaque psoriasis in patients aged 4 years and older |
TOPICORT (SPRAY) (TOPICAL) DESOXIMETASONE [GENERIC AT]
Drug Classes: corticosteroid
NDA Applicant: TARO NDA No.: 204141 Prod. No.: 001 RX (0.25%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8715624 DP* Stable liquid desoximethasone compositions with reduced oxidized impurity Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jun 13, 2014 | May 26, 2026 | U-1408: Treatment of plaque psoriasis in patients 18 years of age or older |
| Pat. No. 8277780 DP* Stable liquid desoximethasone compositions with reduced oxidized impurity Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jun 26, 2013 | Sep 1, 2028 | U-1408: Treatment of plaque psoriasis in patients 18 years of age or older |
ZELSUVMI (GEL) (TOPICAL) BERDAZIMER SODIUM
NDA Applicant: LNHC NDA No.: 217424 Prod. No.: 001 RX (EQ 10.3% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8282967 DS* Nitric oxide-releasing particles for nitric oxide therapeutics and biomedical applications Claim Types: Product-by-process Pat. Sub. Date(s): 001: Feb 2, 2024 | May 30, 2026 | |
| Pat. No. 8956658 DS* Nitric oxide-releasing particles for nitric oxide therapeutics and biomedical applications Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Feb 2, 2024 | May 30, 2026 | |
| Pat. No. 9737561 Topical gels and methods of using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 2, 2024 | Aug 20, 2030 | U-3802: Method of treating skin ailment with nitric oxide releasing macromolecules and hydrophilic gel |
| Pat. No. 10376538 DP* Topical gels and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 2, 2024 | Aug 20, 2030 | |
| Pat. No. 9526738 DP* Topical gels and methods of using the same Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 2, 2024 | Sep 3, 2031 | |
| Pat. No. 9289442 DP* Topical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 2, 2024 | Jul 3, 2032 | U-3803: Method of application of topical pharmaceutical composition to treat dermatological condition |
| Pat. No. 10265334 DP* Anhydrous compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 2, 2024 | Jul 3, 2032 | |
| Pat. No. 9855211 DP* Topical compositions and methods of using the same Claim Types: Formulation; Kit; Method of improving a treatment Pat. Sub. Date(s): 001: Feb 2, 2024 | Feb 27, 2034 | U-3800: Method of applying released nitric oxide to skin from combination including anhydrous alcohol gel U-3801: Method of increasing release of nitric oxide from anhydrous alcohol gel |
| Pat. No. 11285098 DP* Topical compositions and methods of using the same Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 2, 2024 | Feb 28, 2034 | |
| Pat. No. 10258564 Topical compositions and methods of using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 2, 2024 | Nov 22, 2034 | U-3797: Method of topically reducing lesions with two separately stored components U-3798: Method of topically reducing lesions with two separately stored components where one component includes a nitric oxide releasing compound U-3799: Method of topically reducing lesions with two separately stored components where one component includes water |
| Pat. No. 10322081 Topical antiviral compositions and methods of using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 2, 2024 | Jul 10, 2035 | U-3793: Method of administering a nitric oxide releasing api in a combination topical composition U-3794: Method of treating and/or preventing viral infection with a topical composition including a nitric oxide releasing API U-3795: Method of treating and/or preventing molluscum contagiosum with a topical composition including a nitric oxide releasing API U-3796: Method of preventing and/or reducing appearance and/or size of malignant lesion with a topical composition including a nitric oxide releasing API |
| Pat. No. 10736839 Topical antiviral compositions, delivery systems, and methods of using the same Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 2, 2024 | Jul 10, 2035 | U-3790: Method of treating and/or preventing molluscum contagiosum with a nitric oxide releasing topical composition U-3791: Method of treating, preventing, or reducing lesions caused by molluscum contagiosum U-3792: Method of treating and/or preventing viral infection with a topical nitric oxide releasing component |
| Pat. No. 11040006 DP* Topical antiviral compositions, delivery systems, and methods of using the same Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Feb 2, 2024 | Jul 10, 2035 | U-3789: Method of treating and/or preventing viral infection using a nitric oxide releasing active ingredient |
| Pat. No. 11723858 DP* Topical antiviral compositions, delivery systems, and methods of using the same Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Feb 2, 2024 | Jul 10, 2035 | U-3788: Method of administering a nitric oxide releasing active pharmaceutical ingredient to treat and/or prevent viral infection |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jan 5, 2029 |
MAVENCLAD (TABLET) (ORAL) CLADRIBINE
Drug Classes: purine antimetabolite
NDA Applicant: EMD SERONO INC NDA No.: 022561 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8377903 Cladribine regimen for treating multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2019 | May 31, 2026 | U-2522: Treating RRMS or SPMS with oral cladribine: (i) 2-4 months induction with 1.7 mg/kg - 3.5 mg/kg cladribine; (ii) cladribine-free period of about 8-10 months; (iii) 2-4 months maintenance with about 1.7 mg/kg cladribine; (iv) cladribine-free period |
| Pat. No. 7713947 Cladribine regimen for treating multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2019 | Oct 16, 2026 | U-2520: Treating MS with oral cladribine acc. to the steps (i) induction period with about 1.7 mg/kg-3.5 mg/kg cladribine; (ii) cladribine-free period of about 8-10 months; (iii) maintenance period with about 1.7 mg/kg cladribine; (iv) cladribine-free period |
| Pat. No. 10849919 Cladribine regimen for treating progressive forms of multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 9, 2022 | Nov 23, 2038 | U-3411: Treating non-early SPMS by administering oral cladribine at a fixed dose per patient, per body weight and per treatment year, which fixed dose is 1.75 +/- 0.2 mg/kg, to be administered within months 1 and 2 in each of 2 adjacent treatment years |
AXIRON (SOLUTION, METERED) (TRANSDERMAL) TESTOSTERONE
Drug Classes: androgen
NDA Applicant: ELI LILLY AND CO NDA No.: 022504 Prod. No.: 001 DISC (30MG/1.5ML ACTUATION**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8993520 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 9180194 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2015 | Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 8419307 Spreading implement Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2013 | Feb 26, 2027 | U-1386: A method of increasing the testosterone blood level of a person in need thereof |
| Pat. No. 8807861 DP* Spreading implement Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Sep 10, 2014 | Feb 26, 2027 | U-1563: A method of transdermal administration of a physiologically active agent to a subject. |
| Pat. No. 9289586 Spreading implement Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 19, 2016 | Feb 26, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
| Pat. No. 8435944 Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: None | Sep 27, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
OMONTYS PRESERVATIVE FREE (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) PEGINESATIDE ACETATE
Drug Classes: erythropoiesis-stimulating agent (ESA)
NDA Applicant: TAKEDA PHARMS USA NDA No.: 202799 Prod. No.: 001 DISC (EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML)); 002 DISC (EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML)); 003 DISC (EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML)); 004 DISC (EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML)); 005 DISC (EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML)); 006 DISC (EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML)); 007 DISC (EQ 10MG BASE/ML (EQ 10MG BASE/ML)); 008 DISC (EQ 20MG BASE/2ML (EQ 10MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7550433 Erythropoietin receptor peptide formulations and uses Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | Jun 2, 2026 | U-1238: Treatment of anemia due to chronic kidney disease |
| Pat. No. 7919461 Erythropoietin receptor peptide formulations and uses Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None | Jun 2, 2026 | U-1238: Treatment of anemia due to chronic kidney disease |
COTEMPLA XR-ODT (TABLET, ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) METHYLPHENIDATE
Drug Classes: central nervous system stimulant
NDA Applicant: NEOS THERAPS INC NDA No.: 205489 Prod. No.: 001 RX (8.6MG); 002 RX (17.3MG); 003 RX (25.9MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8840924 DP* Compositions and methods of making rapidly dissolving ionically masked formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 20, 2017 | Jun 5, 2026 | |
| Pat. No. 9072680 DP* Compositions comprising methylphenidate complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 20, 2017 | Jun 28, 2032 | |
| Pat. No. 9089496 DP* Compositions comprising methylphenidate complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 20, 2017 | Jun 28, 2032 | |
| Pat. No. 11166947 Effective dosing of a child for the treatment of ADHD with methylphenidate Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Feb 10, 2022 | Jan 25, 2038 | U-3299: Treatment of attention deficit hyperactivity disorder (ADHD) in pediatric patients |
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA NDA No.: 211230 Prod. No.: 001 RX (EQ 75MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8877806 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 9604917 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10351517 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 16, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11753368 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2023 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 8440715 [Extended 1386 days (3.8 years)] Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 | Jun 11, 2031 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10195151 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 24, 2019 | Sep 5, 2037 | |
| Pat. No. 10512609 Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2020 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11439597 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 13, 2022 | Sep 5, 2037 | |
| Pat. No. 11998639 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 10, 2024 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10912754 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 10, 2021 | Jun 1, 2038 | U-3082: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 10959976 Methods and compositions for treating excessive sleepiness Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Apr 27, 2021 | Jun 1, 2038 | U-3151: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11648232 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 001: May 26, 2023 | Jun 1, 2038 | U-3602: Treatment of excessive daytime sleepiness with a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11865098 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 8, 2024 | Jun 1, 2038 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11560354 DP* Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof Claim Types: Composition Pat. Sub. Date(s): 001: Feb 13, 2023 | Mar 6, 2039 | U-3520: Treatment of excessive daytime sleepiness by administering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane |
| Pat. No. 10940133 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Apr 7, 2021 | Mar 19, 2040 | U-3099: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in a patient with moderate renal impairment |
| Pat. No. 11160779 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 13, 2023 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11839598 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Dec 15, 2023 | Mar 19, 2040 | U-3765: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having moderate or severe renal impairment |
| Pat. No. 11839599 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 001: Dec 15, 2023 | Mar 19, 2040 | U-3764: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having obstructive sleep apnea (OSA) and no, mild, moderate, or severe renal impairment |
| Pat. No. 11850226 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850227 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850228 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11857528 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11969404 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: May 2, 2024 | Mar 19, 2040 | U-3892: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having a history of bipolar disorders and moderate or severe renal impairment |
| Pat. No. 11986454 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2024 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11986455 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: May 31, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 12194016 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 16, 2025 | Mar 19, 2040 | U-4106: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no or mild renal impairment |
| Pat. No. 11771666 Methods of administering solriamfetol to lactating women Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11771667 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11779554 Methods of administering solriamfetol to lactating women Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Oct 12, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11793776 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 27, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11872203 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11872204 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12005036 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jun 13, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12036194 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 5, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12064411 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Aug 26, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12090126 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 27, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12102609 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 001: Oct 15, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 17, 2026 | ODE-254: Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy |
SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA NDA No.: 211230 Prod. No.: 002 RX (EQ 150MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8877806 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 9604917 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 24, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10351517 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 16, 2019 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11753368 Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 14, 2023 | Jun 7, 2026 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 8440715 [Extended 1386 days (3.8 years)] Treatment of sleep-wake disorders Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 24, 2019 | Jun 11, 2031 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10195151 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 24, 2019 | Sep 5, 2037 | |
| Pat. No. 10512609 Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2020 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11439597 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Oct 13, 2022 | Sep 5, 2037 | |
| Pat. No. 11998639 DP* Formulations of (R)-2-amino-3-phenylpropyl carbamate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Jun 10, 2024 | Sep 5, 2037 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 10912754 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 002: Mar 10, 2021 | Jun 1, 2038 | U-3082: Treatment of excessive daytime sleepiness associated with obstructive sleep apnea (OSA) in an adult through a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 10959976 Methods and compositions for treating excessive sleepiness Claim Types: Dosaage regimen Pat. Sub. Date(s): 002: Apr 27, 2021 | Jun 1, 2038 | U-3151: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) with a dosing regimen that includes a dose of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11648232 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 002: May 26, 2023 | Jun 1, 2038 | U-3602: Treatment of excessive daytime sleepiness with a dosing regimen that includes oral administration of 75 mg once daily for at least 3 days followed by 150 mg once daily |
| Pat. No. 11865098 Methods and compositions for treating excessive sleepiness Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 8, 2024 | Jun 1, 2038 | U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA) |
| Pat. No. 11560354 DP* Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof Claim Types: Composition Pat. Sub. Date(s): 002: Feb 13, 2023 | Mar 6, 2039 | U-3520: Treatment of excessive daytime sleepiness by administering a composition comprising solriamfetol hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane |
| Pat. No. 11160779 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 13, 2023 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11839598 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 002: Dec 15, 2023 | Mar 19, 2040 | U-3765: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having moderate or severe renal impairment |
| Pat. No. 11839599 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Dosaage regimen Pat. Sub. Date(s): 002: Dec 15, 2023 | Mar 19, 2040 | U-3764: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having obstructive sleep apnea (OSA) and no, mild, moderate, or severe renal impairment |
| Pat. No. 11850226 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850227 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11850228 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Dec 29, 2023 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11857528 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 19, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 11969404 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: May 2, 2024 | Mar 19, 2040 | U-3892: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having a history of bipolar disorders and moderate or severe renal impairment |
| Pat. No. 11986454 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: May 31, 2024 | Mar 19, 2040 | U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment |
| Pat. No. 11986455 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: May 31, 2024 | Mar 19, 2040 | U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment |
| Pat. No. 12194016 Methods of providing solriamfetol therapy to subjects with impaired renal function Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 16, 2025 | Mar 19, 2040 | U-4106: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no or mild renal impairment |
| Pat. No. 11771666 Methods of administering solriamfetol to lactating women Claim Types: Method of administration Pat. Sub. Date(s): 002: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11771667 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 6, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11779554 Methods of administering solriamfetol to lactating women Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 002: Oct 12, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11793776 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 27, 2023 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11872203 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 11872204 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Jan 19, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12005036 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Jun 13, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12036194 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 5, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12064411 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment Pat. Sub. Date(s): 002: Aug 26, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12090126 Methods of administering solriamfetol to lactating women Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 27, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Pat. No. 12102609 Methods of administering solriamfetol to lactating women Claim Types: Method of improving a treatment; Method of use Pat. Sub. Date(s): 002: Oct 15, 2024 | Dec 30, 2042 | U-3693: Treatment of excessive daytime sleepiness in a breast-feeding patient while reducing infant exposure to solriamfetol |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 17, 2026 | ODE-254: Indicated to improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy |
JEVTANA KIT (SOLUTION) (INTRAVENOUS) CABAZITAXEL [GENERIC AP]
Drug Classes: microtubule inhibitor
NDA Applicant: SANOFI AVENTIS US NDA No.: 201023 Prod. No.: 001 RX (60MG/1.5ML (40MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7241907 DS* Acetone solvate of dimethoxy docetaxel and its process of preparation Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: None | Jun 10, 2026 *PED | |
| Pat. No. 10583110 Antitumoral use of cabazitaxel Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 17, 2020 | Oct 27, 2030 | U-2753: Increasing survival in metastatic castration-resistant prostate cancer patients previously treated with docetaxel by administering as a 3 week cycle cabazitaxel after 5 mg dexchlorpheniramine, 8 mg dexamethasone, and an H2-agonist |
| Pat. No. 10716777 Antitumoral use of cabazitaxel Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Jul 21, 2020 | Oct 27, 2030 | U-2856: Increasing survival in metastatic castration-resistant prostate cancer patients previously treated with docetaxel by administering 20 to 25 mg/m2 cabazitaxel after a premedication regimen that includes an H2-antagonist |
| Pat. No. 8927592 Antitumoral use of cabazitaxel Claim Types: Method of administration Pat. Sub. Date(s): 001: Jan 12, 2015 | Apr 27, 2031 *PED | U-3200: Increasing survival in mcrpc patients previously treated with docetaxel by administering cabazitaxel in combination with prednisone or prednisolone after a premedication regimen that includes an antihistamine, a corticosteroid, and an H2-antagonist |
BOSULIF (TABLET) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203341 Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 500MG BASE); 003 RX (EQ 400MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | Jun 11, 2026 *PED | U-1283: A method of treating chronic myelogenous leukemia U-3707: A method of treating patients 1 year of age and older with chronic phase PH+ CML, newly-diagnosed or resistant or intolerant to prior therapy U-3708: A method of treating patients with accelerated, or blast phase PH+ CML with resistance or intolerance to prior therapy |
| Pat. No. 7919625 DP* 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | Jun 11, 2026 *PED | |
| Pat. No. 7767678 DS* DP* Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017 | May 23, 2027 *PED | |
| Pat. No. 11103497 Treatment of imatinib resistant leukemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 29, 2021 | Aug 28, 2034 *PED | U-3216: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the BCRABL protein at 949T>C U-3217: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the bcrabl protein at F317L |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 26, 2027 PED | I-923: For the treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 19, 2025 PED | ODE-163: Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML) |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 26, 2031 PED | ODE-444: Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy |
BOSULIF (CAPSULE) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 217729 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7417148 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2023 | Jun 11, 2026 *PED | U-3707: A method of treating patients 1 year of age and older with chronic phase PH+ CML, newly-diagnosed or resistant or intolerant to prior therapy U-3708: A method of treating patients with accelerated, or blast phase PH+ CML with resistance or intolerance to prior therapy |
| Pat. No. 7919625 DP* 4-anilino-3-quinolinecarbonitriles for the treatment of chronic myelogenous leukemia (CML) Claim Types: Formulation Pat. Sub. Date(s): All strengths: Oct 26, 2023 | Jun 11, 2026 *PED | |
| Pat. No. 7767678 DS* DP* Crystalline forms of 4-[(2,4-dichloro-5-methoxyphenyl)amino]-6-methoxy-7-[3-(4-methyl-1-pipera- zinyl)propoxy]-3-quinolinecarbonitrile and methods of preparing the same Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Oct 26, 2023 | May 23, 2027 *PED | |
| Pat. No. 11103497 Treatment of imatinib resistant leukemia Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 26, 2023 | Aug 28, 2034 *PED | U-3216: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the BCRABL protein at 949T>C U-3217: A method for treating a bcrabl positive leukemia in a subject that is resistant to imatinib comprising administering to the subject a therapeutically effective amount of bosutinib, wherein the subject has a mutation in the bcrabl protein at F317L |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Mar 26, 2027 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 26, 2031 PED | ODE-444: Treatment of pediatric patients 1 year of age and older with chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (PH+ CML), newly-diagnosed or resistant or intolerant to prior therapy |
ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [Has competitive generic]
Drug Classes: HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES NDA No.: 021937 Prod. No.: 001 DISC (600MG;200MG;300MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9018192 Unitary pharmaceutical dosage form Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2015 | Jun 13, 2026 | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of HIV-1 infection in adults |
| Pat. No. 9545414 DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Method of use; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Feb 13, 2017 | Jun 13, 2026 | U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older U-750: Treatment of HIV-1 infection in adults |
| Pat. No. 8598185 DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None | Apr 28, 2029 |
CAMBIA (FOR SOLUTION) (ORAL) DICLOFENAC POTASSIUM [GENERIC AB]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: ASSERTIO NDA No.: 022165 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7759394 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of administration Pat. Sub. Date(s): 001: None | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 8097651 DS* DP* Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 8927604 Diclofenac formulations and methods of use Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2015 | Jun 16, 2026 | U-436: Acute treatment of migraine attacks with or without aura in adults |
| Pat. No. 9827197 DP* Diclofenac formulations and methods of use Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Dec 5, 2017 | Jun 16, 2026 |
SUPPRELIN LA (IMPLANT) (SUBCUTANEOUS) HISTRELIN ACETATE
Drug Classes: gonadotropin releasing hormone (GnRH) agonist
NDA Applicant: ENDO OPERATIONS NDA No.: 022058 Prod. No.: 001 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8062652 Compositions and methods for treating precocious puberty Claim Types: Method of use Pat. Sub. Date(s): 001: None | Jun 16, 2026 | U-1197: Method of treatment of children with central precocious puberty |
ZELBORAF (TABLET) (ORAL) VEMURAFENIB
Drug Classes: kinase inhibitor
NDA Applicant: HOFFMANN LA ROCHE NDA No.: 202429 Prod. No.: 001 RX (240MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8143271 DS* DP* Compounds and methods for kinase modulation, and indications therefor Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Apr 20, 2012 | Jun 21, 2026 | |
| Pat. No. 8470818 Compounds and methods for kinase modulation, and indications therefor Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 23, 2013 | Aug 2, 2026 | U-1418: Treatment of patients with unresectable or metastatic melanoma with BRAFV600E mutation as detected by an FDA approved test U-2164: ZELBORAF is indicated for the treatment of patients with Erdheim-Chester disease with BRAF V600 mutation |
| Pat. No. 7504509 DS* DP* Compounds and methods for development of Ret modulators Claim Types: Compound; Composition; Kit Pat. Sub. Date(s): 001: None | Oct 22, 2026 | |
| Pat. No. 7863288 DS* DP* Compounds and methods for kinase modulation, and indications therefor Claim Types: Compound; Composition; Kit Pat. Sub. Date(s): 001: None | Jun 20, 2029 | |
| Pat. No. 8741920 DS* DP* Process for the manufacture of pharmaceutically active compounds Claim Types: Composition Pat. Sub. Date(s): 001: Sep 3, 2014 | Jul 27, 2030 | |
| Pat. No. 9447089 DP* Compositions and uses thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 18, 2016 | Jun 6, 2032 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 6, 2024 | ODE-158: Treatment of patients with erdheim-chester disease with BRAF V600 mutation |
CERDELGA (CAPSULE) (ORAL) ELIGLUSTAT TARTRATE [GENERIC AB]
Drug Classes: glucosylceramide synthase inhibitor
NDA Applicant: GENZYME CORP NDA No.: 205494 Prod. No.: 001 RX (EQ 84MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7196205 DS* [Extended 1519 days (4.2 years)] Synthesis of UDP-glucose: N-acylsphingosine glucosyltransferase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Oct 21, 2014 | Jun 26, 2026 | |
| Pat. No. 11458119 DS* DP* Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase Claim Types: New polymorph, salt or hydrate; Composition; Formulation Pat. Sub. Date(s): 001: Nov 2, 2022 | Nov 24, 2030 | |
| Pat. No. 10888547 Amorphous and a crystalline form of genz 112638 hemitartrate as inhibitor of glucosylceramide synthase Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2021 | Jan 31, 2031 | U-3042: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 poor metabolizers with 84 mg once daily of eliglustat (equivalent to 100 mg of eliglustat tartrate) U-3043: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive or intermediate metabolizers with 84 mg twice per day of eliglustat (equivalent to 100 mg of eliglustat tartrate twice per day) |
| Pat. No. 10888544 Methods for treating Gaucher disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 21, 2021 | Dec 13, 2038 | U-3040: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive metabolizers with mild hepatic impairment and are concurrently taking a strong or moderate cyp3a inhibitor U-3041: Long-term treatment of adults with Gaucher Disease Type 1 who are CYP2D6 extensive metabolizers with moderate to severe renal impairment |
PERSERIS KIT (FOR SUSPENSION, EXTENDED RELEASE) (SUBCUTANEOUS) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: INDIVIOR NDA No.: 210655 Prod. No.: 001 RX (90MG); 002 RX (120MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 10406160 DP* Sustained release small molecule drug formulation Claim Types: Formulation; Device; Method of administration Pat. Sub. Date(s): All strengths: Sep 26, 2019 | Jun 26, 2026 | U-2608: Method of treating schizophrenia |
| Pat. No. 9597402 DP* Sustained release small molecule drug formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 31, 2018 | Sep 26, 2026 | |
| Pat. No. 10058554 Sustained release small molecule drug formulation Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Aug 28, 2018 | Sep 26, 2026 | U-2363: Administration of risperidone |
| Pat. No. 11110093 DP* Sustained release small molecule drug formulation Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: Sep 7, 2021 | Nov 5, 2026 | U-3135: Treating schizophrenia |
| Pat. No. 9180197 DP* Sustained delivery formulations of risperidone compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 31, 2018 | Feb 13, 2028 | |
| Pat. No. 9186413 Sustained delivery formulations of risperidone compounds Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 31, 2018 | Feb 13, 2028 | U-543: Treatment of schizophrenia |
| Pat. No. 10010612 DP* Sustained delivery formulations of risperidone compounds Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jul 31, 2018 | Feb 13, 2028 | |
| Pat. No. 10376590 Sustained delivery formulations of risperidone compound Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 29, 2019 | Feb 13, 2028 | U-2608: Method of treating schizophrenia |
| Pat. No. 11013809 DP* Sustained delivery formulations of risperidone compound Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 1, 2021 | Feb 13, 2028 | U-3135: Treating schizophrenia |
| Pat. No. 11712475 Sustained delivery formulations of risperidone compound Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 31, 2023 | Feb 13, 2028 | U-3135: Treating schizophrenia |
APLENZIN (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes: aminoketone
NDA Applicant: BAUSCH NDA No.: 022108 Prod. No.: 001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7241805 DP* Modified release formulations of a bupropion salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7569610 Modified release formulations of a bupropion salt Claim Types: Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours |
| Pat. No. 7572935 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7585897 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7645802 DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7649019 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7662407 DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 | |
| Pat. No. 7671094 DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Jun 27, 2026 |
VALTURNA (TABLET) (ORAL) ALISKIREN HEMIFUMARATE; VALSARTAN
Drug Classes: renin inhibitor == angiotensin II receptor blocker
NDA Applicant: NOVARTIS NDA No.: 022217 Prod. No.: 001 DISC (EQ 150MG BASE;160MG); 002 DISC (EQ 300MG BASE;320MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8168616 DP* Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 6, 2012 | Jul 3, 2026 |
RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL MESYLATE
Drug Classes: Rho kinase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 208254 Prod. No.: 001 RX (EQ 0.02% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2020 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jun 10, 2020 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 21, 2023 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Dec 21, 2017 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Dec 21, 2017 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Apr 11, 2018 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10588901 DS* DP* Combination therapy Claim Types: Formulation; Compound; Method of use Pat. Sub. Date(s): 001: Apr 15, 2020 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11020385 Combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2024 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 |
ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: prostaglandin analog == Rho kinase inhibitor
NDA Applicant: ALCON LABS INC NDA No.: 208259 Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 30, 2020 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jul 11, 2026 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): 001: Jun 10, 2020 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 28, 2021 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 21, 2023 | Jan 27, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Nov 10, 2030 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9415043 DS* Combination therapy Claim Types: Compound Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | |
| Pat. No. 9931336 DS* DP* Combination therapy Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 9993470 DS* DP* Combination therapy Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Mar 28, 2019 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 10588901 DS* DP* Combination therapy Claim Types: Formulation; Compound; Method of use Pat. Sub. Date(s): 001: Apr 15, 2020 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11020385 Combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 12, 2024 | Mar 14, 2034 | U-1524: Reduction of elevated intraocular pressure |
| Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 | |
| Pat. No. 11197853 DP* Combination therapy Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 16, 2021 | Mar 14, 2034 |
TREANDA (POWDER) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: alkylating drug
NDA Applicant: CEPHALON NDA No.: 022249 Prod. No.: 001 RX (100MG/VIAL); 002 RX (25MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8609863 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): All strengths: Jan 16, 2014 | Jul 12, 2026 *PED | |
| Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 29, 2014 | Jul 12, 2026 *PED | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 8895756 DP* Bendamustine pharmaceutical compositions Claim Types: Drug in a container Pat. Sub. Date(s): All strengths: Nov 26, 2014 | Jul 12, 2026 *PED | |
| Pat. No. 8445524 DS* DP* Solid forms of bendamustine hydrochloride Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Jun 4, 2013 | Sep 26, 2029 *PED | U-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL) |
| Pat. No. 8669279 DP* Solid forms of bendamustine hydrochloride Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 30, 2014 | Sep 26, 2029 *PED | U-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL) |
| Pat. No. 8883836 DP* Solid forms of bendamustine hydrochloride Claim Types: Method of use; Product-by-process; Process Pat. Sub. Date(s): All strengths: Nov 13, 2014 | Sep 26, 2029 *PED | U-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL) |
| Pat. No. 9533955 DP* Solid forms of bendamustine hydrochloride Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: None; 002: Jan 13, 2017 | Sep 26, 2029 *PED | U-1949: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) U-1952: For use in the treatment of patients with indolent B-cell non-Hodgkin lymphoma |
| Pat. No. 8436190 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 4, 2013 | Apr 26, 2031 *PED |
TREANDA (SOLUTION) (INTRAVENOUS) BENDAMUSTINE HYDROCHLORIDE
Drug Classes: alkylating drug
NDA Applicant: CEPHALON NDA No.: 022249 Prod. No.: 003 DISC (45MG/0.5ML (90MG/ML)); 004 DISC (180MG/2ML (90MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8791270 DP* Bendamustine pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 9, 2014 | Jul 12, 2026 *PED | U-1542: For use in the treatment of patients with chronic lymphocytic leukemia and/or non-hodgkins lymphoma |
| Pat. No. 8445524 DS* Solid forms of bendamustine hydrochloride Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Sep 17, 2013 | Sep 26, 2029 *PED | |
| Pat. No. 8344006 DP* Liquid formulations of bendamustine Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None | Mar 23, 2030 *PED | U-1402: For use in the treatment of patients with chronic lymphocytic leukemia (CLL) and/or indolent B-cell non-Hodgkin lymphoma (NHL) |
GILOTRIF (TABLET) (ORAL) AFATINIB DIMALEATE
Drug Classes: kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 201292 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 30MG BASE); 003 RX (EQ 40MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE43431 DS* [Extended 1452 days (4 years)] Quinazoline derivatives and pharmaceutical compositions containing them Claim Types: Compound Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Jul 13, 2026 *PED | |
| Pat. No. 9539258 Quinazoline derivatives for the treatment of cancer diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 2, 2017 | May 9, 2027 *PED | U-1950: Treatment of patients with advanced (metastatic) non-small cell lung cancer whose disease progressed during or after platinum-based chemotherapy |
| Pat. No. 8426586 DS* Process for preparing amino crotonyl compounds Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Aug 1, 2013 | Apr 10, 2030 *PED | |
| Pat. No. 8545884 DP* Solid pharmaceutical formulations comprising BIBW 2992 Claim Types: Intermediate; Formulation; Process; Product-by-process Pat. Sub. Date(s): All strengths: Oct 28, 2013 | Jun 19, 2030 *PED | |
| Pat. No. 10004743 DP* Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 2, 2018 | Jan 5, 2031 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Oct 7, 2025 PED | M-276: Revisions to the pediatric use subsection of labeling to include the results from clinical study 1200.120, conducted to fulfill a pediatric written request |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jul 12, 2025 PED | ODE-230: First-line treatment of metastatic non-small cell lung cancer whose tumors have non-resistant epidermal growth factor (EGFR) mutations other than exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test |
DUEXIS (TABLET) (ORAL) FAMOTIDINE; IBUPROFEN
Drug Classes: histamine-2 (H2) receptor antagonist == nonsteroidal anti-inflammatory drug
NDA Applicant: HORIZON NDA No.: 022519 Prod. No.: 001 DISC (26.6MG;800MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8067451 DP* Methods and medicaments for administration of ibuprofen Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 30, 2011 | Jul 18, 2026 | U-1196: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications |
| Pat. No. 8309127 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 13, 2012 | Jul 18, 2026 | |
| Pat. No. 8318202 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 27, 2012 | Jul 18, 2026 | |
| Pat. No. 8449910 DP* Stable compositions of famotidine and ibuprofen Claim Types: Formulation Pat. Sub. Date(s): 001: May 28, 2013 | Jul 18, 2026 | |
| Pat. No. 8501228 Stable compositions of famotidine and ibuprofen Claim Types: Method of administration Pat. Sub. Date(s): 001: Aug 6, 2013 | Jul 18, 2026 | U-1196: Relief of signs and symptoms of rheumatoid arthritis and osteoarthritis and to decrease risk of developing upper gastrointestinal ulcers in patients who are taking ibuprofen for those indications |
MITOSOL (FOR SOLUTION) (TOPICAL) MITOMYCIN
Drug Classes: alkylating drug
NDA Applicant: MOBIUS THERAP NDA No.: 022572 Prod. No.: 001 RX (0.2MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8186511 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Drug in a container Pat. Sub. Date(s): 001: Jun 25, 2012 | Jul 19, 2026 | |
| Pat. No. 9205075 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Kit Pat. Sub. Date(s): 001: Jan 6, 2016 | Jul 19, 2026 | |
| Pat. No. 9539241 DS* DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 10, 2017 | Jan 2, 2028 | U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery |
| Pat. No. 7806265 DP* Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Drug in a container; Kit Pat. Sub. Date(s): 001: Mar 22, 2012 | Feb 1, 2029 | |
| Pat. No. 9649428 Apparatus and method for reconstituting a pharmaceutical and preparing the reconstituted pharmaceutical for transient application Claim Types: Kit Pat. Sub. Date(s): 001: Jun 9, 2017 | May 21, 2029 | U-2095: MITOSOL is an antimetabolite indicated as an adjunct to ab externo glaucoma surgery. It is intended for topical application to the site of glaucoma filtration surgery |
SPIRIVA (POWDER) (INHALATION) TIOTROPIUM BROMIDE [GENERIC AB]
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021395 Prod. No.: 001 RX (EQ 0.018MG BASE/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8022082 DP* Method for the administration of an anticholinergic by inhalation Claim Types: Method of administration; Kit Pat. Sub. Date(s): 001: Oct 24, 2011 | Jul 19, 2026 *PED | U-1186: Administration of an inhalable powder comprising tiotropium via device |
| Pat. No. 7694676 DP* Dry powder inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jun 13, 2011 | Sep 12, 2027 *PED | |
| Pat. No. 9010323 DP* Inhaler and sieve for an inhaler Claim Types: Device Pat. Sub. Date(s): 001: Apr 20, 2017 | Apr 19, 2030 |
TORISEL (SOLUTION) (INTRAVENOUS) TEMSIROLIMUS [GENERIC AP]
Drug Classes: kinase inhibitor
NDA Applicant: PF PRISM CV NDA No.: 022088 Prod. No.: 001 RX (25MG/ML (25MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8026276 DP* Parenteral CCI-779 formulations containing cosolvents, an antioxidant, and a surfactant Claim Types: Formulation Pat. Sub. Date(s): 001: None | Jul 20, 2026 *PED | |
| Pat. No. 8791097 Anti-tumor activity of CCI-779 in papillary renal cell cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2014 | Nov 10, 2032 *PED | U-1550: Method of treating metastatic papillary renal cell carcinoma with temsirolimus. U-1551: Method of treating papillary renal cell carcinoma with temsirolimus, in the absence of interferon alpha. |
AKTEN (GEL) (OPHTHALMIC) LIDOCAINE HYDROCHLORIDE
Drug Classes: amide local anesthetic == antiarrhythmic
NDA Applicant: THEA PHARMA NDA No.: 022221 Prod. No.: 001 RX (3.5%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8759401 DP* Aqueous gel formulation and method for inducing topical anesthesia Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2014 | Jul 24, 2026 | U-1523: Method of inducing topical anesthesia in the eye |
ONGENTYS (CAPSULE) (ORAL) OPICAPONE
Drug Classes: catechol-O-methyltransferase (COMT) inhibitor
NDA Applicant: AMNEAL NDA No.: 212489 Prod. No.: 001 RX (25MG); 002 RX (50MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9550759 Nitrocatechol derivatives as COMT inhibitors Claim Types: Method of improving a treatment; Method of use; Process Pat. Sub. Date(s): All strengths: May 19, 2020 | Jul 26, 2026 | U-3870: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by increasing L-dopa amounts that reach the brain U-3871: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by inhibiting comt in the periphery U-3872: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by reducing o-methylation of l-dopa |
| Pat. No. 8907099 DS* Nitrocatechol derivatives as COMT inhibitors Claim Types: Compound Pat. Sub. Date(s): All strengths: May 19, 2020 | May 12, 2027 | |
| Pat. No. 9745290 DP* Dosage regimen for COMT inhibitors Claim Types: Composition; Formulation; Method of use; Kit Pat. Sub. Date(s): All strengths: May 19, 2020 | Oct 10, 2027 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 8168793 DS* DP* Nitrocatechol derivatives as COMT inhibitors Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): All strengths: May 19, 2020 | Apr 2, 2029 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 8524746 Dosage regimen for COMT inhibitors Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2020 | Jul 14, 2029 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 10071085 DP* Pharmaceutical formulations comprising nitrocatechol derivatives and methods of making thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 19, 2020 | Mar 31, 2030 | |
| Pat. No. 10583130 Pharmaceutical formulations compromising nitrocatechol derivatives and methods of making thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2020 | Mar 31, 2030 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Pat. No. 12129247 Administration regime for nitrocatechols Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): All strengths: Nov 26, 2024 | Jan 11, 2032 | U-4038: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's disease experiencing off episodes by administering without food |
| Pat. No. 9630955 DS* DP* Chemical compound useful as intermediate for preparing a catechol-O-methyltransferase inhibitor Claim Types: New polymorph, salt or hydrate; Product-by-process; Formulation; Method of use Pat. Sub. Date(s): All strengths: May 19, 2020 | Dec 12, 2032 | U-3869: Adjunctive treatment to levodopa/carbidopa in patients with Parkinson's Disease experiencing off episodes |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Apr 24, 2025 |
BRIDION (SOLUTION) (INTRAVENOUS) SUGAMMADEX SODIUM [GENERIC AP]
NDA Applicant: MSD SUB MERCK NDA No.: 022225 Prod. No.: 001 RX (EQ 500MG BASE/5ML (EQ 100MG BASE/ML)); 002 RX (EQ 200MG BASE/2ML (EQ 100MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE44733 DS* DP* 6-mercapto-cyclodextrin derivatives:reversal agents for drug-induced neuromuscular block Claim Types: Compound; Composition; Kit; Method of use Pat. Sub. Date(s): All strengths: Jan 12, 2016 | Jul 27, 2026 *PED | U-1794: Reversal of drug-induced neuromuscular block |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NPP - New patient population | Jun 12, 2028 PED |
ABILIFY (TABLET) (ORAL) ARIPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021436 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (5MG); 006 RX (2MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
ABILIFY (TABLET, ORALLY DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 021729 Prod. No.: 002 DISC (10MG**); 003 DISC (15MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9125939 Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 | Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
| Pat. No. 8759350 Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 | Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
ACTOPLUS MET XR (TABLET, EXTENDED RELEASE) (ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes: biguanide == peroxisome proliferator-activated receptor (PPAR) alpha agonist == peroxisome proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant: TAKEDA PHARMS USA NDA No.: 022024 Prod. No.: 001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7785627 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Jul 31, 2026 | |
| Pat. No. 7959946 DP* Pharmaceutical formulation containing a biguanide and a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None | Jul 31, 2026 |
SUMAVEL DOSEPRO (INJECTABLE) (SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has competitive generic]
Drug Classes: serotonin 5-HT1B/1D receptor agonist (triptan)
NDA Applicant: ENDO OPERATIONS NDA No.: 022239 Prod. No.: 001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7901385 DP* Casing Claim Types: Device Pat. Sub. Date(s): 001: Mar 23, 2011 | Jul 31, 2026 | |
| Pat. No. 7776007 DP* Device for readying a needle free injector for delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 4, 2011 | Nov 22, 2026 |
GIAZO (TABLET) (ORAL) BALSALAZIDE DISODIUM
Drug Classes: aminosalicylate
NDA Applicant: VALEANT PHARMS INTL NDA No.: 022205 Prod. No.: 001 DISC (1.1GM**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9192616 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2016 | Aug 2, 2026 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
| Pat. No. 7452872 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 2, 2012 | Aug 24, 2026 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
| Pat. No. 7625884 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 2, 2012 | Aug 24, 2026 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
| Pat. No. 8497256 Formulations and uses of 2-hydroxy-5-phenylazobenzoic acid derivatives for the treatment of males Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Aug 23, 2013 | Jun 23, 2031 | U-1229: Treatment of mildly to moderately active ulcerative colitis in male patients |
BELEODAQ (POWDER) (INTRAVENOUS) BELINOSTAT
Drug Classes: histone deacetylase (HDAC) inhibitor
NDA Applicant: ACROTECH BIOPHARMA NDA No.: 206256 Prod. No.: 001 RX (500MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6888027 DS* DP* [Extended 1778 days (4.9 years)] Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Aug 1, 2014 | Aug 10, 2026 | U-1544: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). |
| Pat. No. 8835501 DP* Pharmaceutical formulations of HDAC inhibitors Claim Types: Formulation; Drug in a container; Kit Pat. Sub. Date(s): 001: Oct 9, 2014 | Oct 27, 2027 |
NUEDEXTA (CAPSULE) (ORAL) DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE [GENERIC AB]
Drug Classes: sigma-1 agonist == uncompetitive NMDA receptor antagonist == antiarrhythmic == CYP450 2D6 inhibitor
NDA Applicant: AVANIR PHARMS NDA No.: 021879 Prod. No.: 001 RX (20MG;10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7659282 Pharmaceutical compositions comprising dextromethorphan and quinidine for the treatment of neurological disorders Claim Types: Method of use Pat. Sub. Date(s): 001: None | Aug 13, 2026 | U-1093: Treatment of pseudobulbar affect |
CABOMETYX (TABLET) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: kinase inhibitor
NDA Applicant: EXELIXIS INC NDA No.: 208692 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 60MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7579473 DS* DP* [Extended 689 days (1.9 years)] c-Met modulators and methods of use Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: May 24, 2016 | Aug 14, 2026 | |
| Pat. No. 11091439 DS* Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms therof for the treatment of cancer Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | |
| Pat. No. 11091440 DP* Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)- N'-(4-fluorophenyl)cyclopropane-1,1 -dicarboxamide, and crystalline forms thereof for the treatment of cancer Claim Types: Composition Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | |
| Pat. No. 11098015 Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms thereof for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | U-1220: Treatment of renal cell carcinoma U-1480: Treatment of advanced renal cell carcinoma U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib U-3225: Treatment of differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy |
| Pat. No. 8877776 DS* DP* (L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: May 24, 2016 | Oct 8, 2030 | U-3225: Treatment of differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy |
| Pat. No. 10034873 C-met modulator pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 12, 2019 | Jul 18, 2031 | U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
| Pat. No. 10039757 C-Met modulator pharmaceutical compositions Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Jul 18, 2031 | U-1480: Treatment of advanced renal cell carcinoma |
| Pat. No. 11298349 DP* Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 12, 2022 | Feb 10, 2032 | |
| Pat. No. 12128039 DP* Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 25, 2024 | Feb 10, 2032 | U-1220: Treatment of renal cell carcinoma U-1480: Treatment of advanced renal cell carcinoma U-2488: Treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib U-3225: Treatment of differentiated thyroid cancer that has progressed following prior VEGFR-targeted therapy |
| Pat. No. 9724342 DP* C-met modulator pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 25, 2017 | Jul 9, 2033 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Sep 17, 2024 | I-873: Treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jan 14, 2026 | ODE-227: Indicated for treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 17, 2028 | ODE-375: The treatment of adult and pediatric patients 12 years of age and older with locally advanced or metastatic differentiated thyroid cancer (DTC) that has progressed following prior VEGFR-targeted therapy and who are radioactive iodine-refractory or ineligible |
COMETRIQ (CAPSULE) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: kinase inhibitor
NDA Applicant: EXELIXIS NDA No.: 203756 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 80MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7579473 DS* DP* [Extended 689 days (1.9 years)] c-Met modulators and methods of use Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 26, 2012; 002: None | Aug 14, 2026 | |
| Pat. No. 11091439 DS* Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms therof for the treatment of cancer Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | |
| Pat. No. 11091440 DP* Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)- N'-(4-fluorophenyl)cyclopropane-1,1 -dicarboxamide, and crystalline forms thereof for the treatment of cancer Claim Types: Composition Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | |
| Pat. No. 11098015 Malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de, and crystalline forms thereof for the treatment of cancer Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 31, 2021 | Jan 15, 2030 | U-1617: Method of treating medullary thyroid cancer |
| Pat. No. 8877776 DS* DP* (L)-malate salt of N-(4-{[6,7-bis(methyloxy) quinolin-4-yl]oxy}phenyl)-N'-(4-fluorophenyl)cyclopropane-1,1-dicarboxami- de Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 4, 2014 | Oct 8, 2030 | U-1617: Method of treating medullary thyroid cancer |
| Pat. No. 9717720 DP* Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Aug 23, 2017 | Feb 10, 2032 | |
| Pat. No. 11298349 DP* Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 12, 2022 | Feb 10, 2032 | |
| Pat. No. 12128039 DP* Processes for preparing quinoline compounds and pharmaceutical compositions containing such compounds Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Nov 25, 2024 | Feb 10, 2032 | U-1617: Method of treating medullary thyroid cancer |
OVIDE (LOTION) (TOPICAL) MALATHION
Drug Classes: cholinesterase inhibitor
NDA Applicant: TARO NDA No.: 018613 Prod. No.: 001 DISC (0.5%**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7977324 DP* Process for preparing malathion for pharmaceutical use Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 8, 2011 | Aug 14, 2026 | |
| Pat. No. 7560445 DS* DP* Process for preparing malathion for pharmaceutical use Claim Types: Formulation; Method of use; Product-by-process; Process Pat. Sub. Date(s): 001: None | Feb 1, 2027 | U-986: Treatment of patients infected with pediculus humanus capitis (head lice and their ova) of the scalp hair |
TEKTURNA (TABLET) (ORAL) ALISKIREN HEMIFUMARATE [GENERIC AB]
Drug Classes: renin inhibitor
NDA Applicant: NODEN PHARMA NDA No.: 021985 Prod. No.: 001 RX (EQ 150MG BASE); 002 RX (EQ 300MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8617595 DP* Galenic formulations of organic compounds Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: None | Aug 19, 2026 *PED |
CORLANOR (TABLET) (ORAL) IVABRADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: hyperpolarization-activated cyclic nucleotide-gated channel blocker
NDA Applicant: AMGEN INC NDA No.: 206143 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 7.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7361649 DS* DP* .beta.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: May 11, 2015 | Aug 22, 2026 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7361650 DS* DP* .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use Pat. Sub. Date(s): All strengths: May 11, 2015 | Aug 22, 2026 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7879842 DS* DP* Beta-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: May 11, 2015 | Aug 22, 2026 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
| Pat. No. 7867996 DS* DP* [Extended 293 days (0.8 years)] .gamma.-crystalline form of ivabradine hydrochloride, a process for its preparation and pharmaceutical compositions containing it Claim Types: New polymorph, salt or hydrate; Method of use; Composition Pat. Sub. Date(s): All strengths: May 11, 2015 | Jun 12, 2027 *PED | U-1694: A method for treating heart failure in a human using a crystalline form of ivabradine hydrochloride |
ISTURISA (TABLET) (ORAL) OSILODROSTAT PHOSPHATE
Drug Classes: cortisol synthesis inhibitor
NDA Applicant: RECORDATI RARE NDA No.: 212801 Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 5MG BASE) NDA No.: 212801 Prod. No.: 003 DISC (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8835646 DS* DP* Organic compounds Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 3, 2020 | Aug 23, 2026 | |
| Pat. No. 8314097 DS* DP* Organic compounds Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 3, 2020 | Mar 27, 2029 | |
| Pat. No. 8609862 Use of an adrenal hormone-modifying agent Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 3, 2020 | Jan 13, 2031 | U-2770: Cushing's disease |
| Pat. No. 9434754 DS* Use of an adrenal hormone-modifying agent Claim Types: Compound Pat. Sub. Date(s): All strengths: Apr 3, 2020 | Jan 13, 2031 | |
| Pat. No. 10143680 DP* Pharmaceutical dosage forms Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Apr 3, 2020 | Jul 6, 2035 | |
| Pat. No. 10709691 Pharmaceutical dosage forms Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 6, 2020 | Oct 12, 2035 | U-2770: Cushing's disease |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 6, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 6, 2027 | ODE-286: Indicated for the treatment of adult patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative |
DYMISTA (SPRAY, METERED) (NASAL) AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE [GENERIC AB]
Drug Classes: histamine-1 (H1) receptor antagonist == corticosteroid
NDA Applicant: MYLAN SPECIALITY LP NDA No.: 202236 Prod. No.: 001 RX (0.137MG/SPRAY;0.05MG/SPRAY)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8168620 DP* Combination of azelastine and steroids Claim Types: Formulation; Process Pat. Sub. Date(s): 001: May 11, 2012 | Aug 24, 2026 *PED |
FLOVENT HFA (AEROSOL, METERED) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: GLAXO GRP LTD NDA No.: 021433 Prod. No.: 001 RX (0.22MG/INH); 002 RX (0.11MG/INH)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7500444 DP* DLR* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): All strengths: None | Aug 26, 2026 *PED |
NEXPLANON (IMPLANT) (IMPLANTATION) ETONOGESTREL
Drug Classes: progestin
NDA Applicant: ORGANON NDA No.: 021529 Prod. No.: 002 RX (68MG/IMPLANT)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8888745 DP* Applicator for inserting an implant Claim Types: Device Pat. Sub. Date(s): 002: Dec 3, 2014 | Aug 28, 2026 | |
| Pat. No. 10821277 DP* Kit for and method of assembling an applicator for inserting an implant Claim Types: Kit Pat. Sub. Date(s): 002: Nov 16, 2020 | May 31, 2027 | |
| Pat. No. 8722037 DP* X-ray visible drug delivery device Claim Types: Device; Kit Pat. Sub. Date(s): 002: May 15, 2014 | Sep 28, 2027 | |
| Pat. No. 9757552 DP* Applicator for inserting an implant Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Oct 4, 2017 | Jul 28, 2030 | U-1: Prevention of pregnancy |
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN [Has competitive generic]
Drug Classes: beta-adrenergic receptor inhibitor == angiotensin II receptor blocker
NDA Applicant: ABBVIE NDA No.: 206302 Prod. No.: 001 DISC (EQ 5MG BASE;80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7803838 DP* Compositions comprising nebivolol Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 5, 2016 | Aug 29, 2026 | |
| Pat. No. 7838552 Compositions comprising nebivolol Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 5, 2016 | Oct 4, 2027 | U-185: Method of treating hypertension |
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 001 RX (145MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2012 | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 12, 2026 | I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 002 RX (290MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 002: None | Aug 30, 2026 | U-1278: Method of treating irritable bowel syndrome with constipation in adults U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Feb 6, 2015 | Feb 17, 2031 | |
| Pat. No. 8748573 Formulations comprising linaclotide Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 11, 2014 | Oct 30, 2031 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. U-1516: Method of treating chronic idiopathic constipation in adult patients. |
| Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration Claim Types: Formulation Pat. Sub. Date(s): 002: Aug 19, 2014 | Oct 30, 2031 | |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 002: Aug 10, 2017 | Aug 16, 2033 | U-1515: Method of treating irritable bowel syndrome with constipation in adult patients. |
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE NDA No.: 202811 Prod. No.: 003 RX (72MCG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)] Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 003: Feb 24, 2017 | Aug 30, 2026 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Feb 24, 2017 | Feb 17, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 10675325 DP* Stable formulations of linaclotide Claim Types: Composition Pat. Sub. Date(s): 003: Jun 22, 2020 | Aug 11, 2031 | |
| Pat. No. 10702576 Stable formulations of linaclotide Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 4, 2020 | Aug 11, 2031 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Aug 10, 2017 | Aug 16, 2033 | U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Jun 12, 2026 | I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age |
JYNARQUE (TABLET) (ORAL) TOLVAPTAN [Has competitive generic]
Drug Classes: vasopressin V2-receptor antagonist
NDA Applicant: OTSUKA NDA No.: 204441 Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG); 004 RX (60MG); 005 RX (90MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8501730 DS* Process for preparing benzazepine compounds or salts thereof Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: May 21, 2018 | Sep 1, 2026 | |
| Pat. No. 10905694 DP* Pharmaceutical solid preparation comprising benzazepines and production method thereof Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Feb 26, 2021 | Apr 7, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Apr 23, 2025 | ODE-178: Indicated to slow kidney function decline in adults at risk of rapidly progressing autosomal dominant polycystic kidney disease (ADPKD) |
SAMSCA (TABLET) (ORAL) TOLVAPTAN [GENERIC AB]
Drug Classes: vasopressin V2-receptor antagonist
NDA Applicant: OTSUKA NDA No.: 022275 Prod. No.: 001 RX (15MG); 002 RX (30MG) NDA No.: 022275 Prod. No.: 003 DISC (60MG**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8501730 DS* Process for preparing benzazepine compounds or salts thereof Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Sep 27, 2013 | Sep 1, 2026 | |
| Pat. No. 10905694 DP* Pharmaceutical solid preparation comprising benzazepines and production method thereof Claim Types: Product-by-process Pat. Sub. Date(s): All strengths: Feb 26, 2021 | Apr 7, 2030 |
CLOROTEKAL (SOLUTION) (INTRATHECAL) CHLOROPROCAINE HYDROCHLORIDE
Drug Classes: ester local anesthetic
NDA Applicant: B BRAUN MEDICAL INC NDA No.: 208791 Prod. No.: 001 DISC (50MG/5ML (10MG/ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8969412 DP* Use for a composition comprising chloroprocaine HCl, a new composition comprising chloroprocaine HCl and a method for its manufacture Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Sep 3, 2019 | Sep 5, 2026 | U-2609: A method for inducing a regional anaesthesia via intrathecal administration of a patented preservative free solution for injection (with a specific composition, pH, osmolality and density) containing 9-11 mg/ml chloroprocaine HCl |
| Pat. No. 9504666 DP* Chloroprocaine-based pharmaceutical composition for repeated intrathecal administration Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 3, 2019 | Dec 11, 2033 |
REZDIFFRA (TABLET) (ORAL) RESMETIROM
NDA Applicant: MADRIGAL NDA No.: 217785 Prod. No.: 001 RX (60MG); 002 RX (80MG); 003 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7452882 DS* DP* Thyroid hormone analogs Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 3, 2024 | Sep 12, 2026 | |
| Pat. No. 9266861 DS* DP* Method of synthesizing thyroid hormone analogs and polymorphs thereof Claim Types: New polymorph, salt or hydrate; Composition; Process Pat. Sub. Date(s): All strengths: Apr 3, 2024 | Sep 17, 2033 | |
| Pat. No. 10376517 Methods of synthesizing thyroid hormone analogs and polymorphs thereof Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 3, 2024 | Sep 17, 2033 | U-3861: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) |
| Pat. No. 11564926 DS* DP* Methods of synthesizing thyroid hormone analogs and polymorphs thereof Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Apr 3, 2024 | Sep 17, 2033 | U-3861: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) |
| Pat. No. 11986481 Method of synthesizing thyroid hormone analogs and polymorphs thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 5, 2024 | Sep 17, 2033 | U-3861: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis) |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Mar 14, 2029 |
DIFFERIN (LOTION) (TOPICAL) ADAPALENE
Drug Classes: retinoid
NDA Applicant: GALDERMA LABS LP NDA No.: 022502 Prod. No.: 001 DISC (0.1%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8435502 DP* Cosmetic/dermatological compositions comprising naphtholic acid compounds and polyurethane polymers Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: May 22, 2013 | Sep 15, 2026 | U-1078: Treatment of acne |
| Pat. No. 8709392 DP* Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers Claim Types: Formulation; Process; Method of use; Product-by-process Pat. Sub. Date(s): 001: May 16, 2014 | Sep 15, 2026 | U-1078: Treatment of acne |
| Pat. No. 7998467 DP* Cosmetic/dermatological compositions comprising naphthoic acid compounds and polyurethane polymers Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Aug 19, 2011 | May 31, 2028 | U-1078: Treatment of acne |
ESBRIET (CAPSULE) (ORAL) PIRFENIDONE [GENERIC AB]
Drug Classes: pyridone
NDA Applicant: GENENTECH INC NDA No.: 022535 Prod. No.: 001 RX (267MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7767225 DP* Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 14, 2014 | Sep 22, 2026 | U-1602: Method of administering pirfenidone capsules to treat a fibrotic condition |
| Pat. No. 7988994 DP* Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 14, 2014 | Sep 22, 2026 | U-1602: Method of administering pirfenidone capsules to treat a fibrotic condition |
| Pat. No. 8753679 DP* Capsule formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 14, 2014 | Sep 22, 2026 | U-1602: Method of administering pirfenidone capsules to treat a fibrotic condition |
| Pat. No. 7696236 Method of providing pirfenidone therapy to a patient Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Dec 18, 2027 | U-1601: Dose escalation over 14 days for treatment of idiopathic pulmonary fibrosis |
| Pat. No. 7767700 Method of providing pirfenidone therapy to a patient Claim Types: Method of administration; Method of improving a treatment Pat. Sub. Date(s): 001: Nov 14, 2014 | Dec 18, 2027 | U-1601: Dose escalation over 14 days for treatment of idiopathic pulmonary fibrosis |
| Pat. No. 8420674 DP* Method of providing pirfenidone therapy to a patient Claim Types: Drug in a container; Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Dec 18, 2027 | U-1608: Dose escalation over 14 days for treatment of a fibrosis condition |
| Pat. No. 8383150 DP* [Extended 596 days (1.6 years)] Granulate formulation of pirfenidone and pharmaceutically acceptable excipients Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 14, 2014 | May 10, 2028 | U-2361: Method of administering a granulate formulation of 5-methyl-1-phenyl-2-(1h)-pyridone as recited in claim 1, to treat idiopathic pulmonary fibrosis |
| Pat. No. 7566729 Modifying pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Apr 22, 2029 | U-1600: Dosage modification following elevated liver enzymes in treatment of idiopathic pulmonary fibrosis |
| Pat. No. 7635707 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Apr 22, 2029 | U-1609: Continued dosing or dosage modification following elevated liver enzymes in treatment of idiopathic pulmonary fibrosis |
| Pat. No. 8592462 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Apr 22, 2029 | U-1609: Continued dosing or dosage modification following elevated liver enzymes in treatment of idiopathic pulmonary fibrosis |
| Pat. No. 8609701 Pirfenidone treatment for patients with atypical liver function Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Apr 22, 2029 | U-1610: Continued dosing or dosage modification following elevated liver enzymes in use of pirfenidone |
| Pat. No. 7816383 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Jan 8, 2030 | U-1603: Method for administering pirfenidone to reduce drug interactions with fluvoxamine |
| Pat. No. 7910610 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Jan 8, 2030 | U-1604: Method for administering pirfenidone to reduce drug interactions with a strong inhibitor of CYP1A2 |
| Pat. No. 8013002 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Jan 8, 2030 | U-1603: Method for administering pirfenidone to reduce drug interactions with fluvoxamine |
| Pat. No. 8084475 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Jan 8, 2030 | U-1605: Method for administering pirfenidone to avoid reduced efficacy by discontinuing smoking or by discontinuing or avoiding another strong CYP1A2 inducer |
| Pat. No. 8318780 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Jan 8, 2030 | U-1606: Method for administering pirfenidone while avoiding or discontinuing concomitant use of a moderate to strong inhibitor of both CYP1A2 and another CYP enzyme involved in pirfenidone metabolism |
| Pat. No. 8648098 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Nov 14, 2014 | Jan 8, 2030 | U-1611: Method for administering pirfenidone to avoid reduced efficacy by discontinuing smoking or by discontinuing a strong CYP1A2 inducer |
| Pat. No. 8754109 Pirfenidone therapy and inducers of cytochrome P450 Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Nov 14, 2014 | Jan 8, 2030 | U-1612: Method for administering pirfenidone to avoid reduced efficacy by avoiding smoking or by avoiding another strong CYP1A2 inducer |
| Pat. No. 8778947 Methods of administering pirfenidone therapy Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 14, 2014 | Aug 30, 2033 | U-1613: Dosage modification in treatment with pirfenidone to reduce drug interactions with ciprofloxacin |
SENSIPAR (TABLET) (ORAL) CINACALCET HYDROCHLORIDE [Has competitive generic]
Drug Classes: calcium-sensing receptor agonist
NDA Applicant: AMGEN NDA No.: 021688 Prod. No.: 001 DISC (EQ 30MG BASE); 002 DISC (EQ 60MG BASE); 003 DISC (EQ 90MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7829595 DP* Rapid dissolution formulation of a calcium receptor-active compound Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 2, 2010; 002: None; 003: None | Sep 22, 2026 | U-1098: Method of treating hyperparathyroidism; method of treating hypercalcemia |
| Pat. No. 9375405 DP* Rapid dissolution formulation of a calcium receptor-active compound Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 22, 2016 | Sep 22, 2026 |
GILENYA (CAPSULE) (ORAL) FINGOLIMOD HYDROCHLORIDE [GENERIC AB]
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: NOVARTIS NDA No.: 022527 Prod. No.: 001 RX (EQ 0.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8324283 DP* Solid pharmaceutical compositions comprising a SIP receptor agonist and a sugar alcohol Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2013 | Sep 29, 2026 *PED | |
| Pat. No. 10543179 Dosage regimen of an S1P receptor modulator Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 28, 2020 | Dec 25, 2027 | U-2719: Treatment of relapsing remitting multiple sclerosis by determining varicella zoster virus (VZV) status and vaccinating prior to commencing treatment |
| Pat. No. 9187405 S1P receptor modulators for treating relapsing-remitting multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 2, 2015 | Dec 25, 2027 *PED | U-2613: Treatment of relapsing-remitting sclerosis (MS) |
ARICEPT (TABLET) (ORAL) DONEPEZIL HYDROCHLORIDE [GENERIC AB]
Drug Classes: acetylcholinesterase inhibitor
NDA Applicant: EISAI INC NDA No.: 022568 Prod. No.: 001 RX (23MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8481565 DP* Method for stabilizing anti-dementia drug Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2013 | Oct 4, 2026 |
COTELLIC (TABLET) (ORAL) COBIMETINIB FUMARATE
Drug Classes: kinase inhibitor
NDA Applicant: GENENTECH INC NDA No.: 206192 Prod. No.: 001 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 11597699 MEK inhibitors and methods of their use Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 29, 2023 | Oct 5, 2026 | U-3554: As a single agent for the treatment of adult patients with histiocytic neoplasms |
| Pat. No. 8362002 Azetidines as MEK inhibitors for the treatment of proliferative diseases Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2015 | Apr 5, 2027 *PED | U-1776: Method of using cobimetinib for the treatment of melanoma |
| Pat. No. 7803839 DS* DP* [Extended 1013 days (2.8 years)] Azetidines as MEK inhibitors for the treatment of proliferative diseases Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Dec 9, 2015 | May 10, 2030 *PED | |
| Pat. No. 11087354 Combination therapies Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 8, 2021 | Dec 22, 2034 *PED | U-1776: Method of using cobimetinib for the treatment of melanoma |
| Pat. No. 10478400 DS* DP* Immediate-release tablets containing combimetinib and methods of making and using the same Claim Types: Formulation; Process; Kit; Method of use Pat. Sub. Date(s): 001: Dec 18, 2019 | Dec 29, 2036 *PED | U-1776: Method of using cobimetinib for the treatment of melanoma |
| Pat. No. 10590102 DS* DP* Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]methanone Claim Types: New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): 001: Apr 8, 2020 | Dec 30, 2036 *PED | U-1776: Method of using cobimetinib for the treatment of melanoma |
| Pat. No. 11254649 DS* DP* Crystalline fumarate salt of (S)-[3,4-difluoro-2-(2-fluoro-4-iodophenylamino)phenyl] [3-hydroxy-3-(piperidin-2-yl) azetidin-1-yl]-methanone Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: Mar 21, 2022 | Dec 30, 2036 *PED | U-1776: Method of using cobimetinib for the treatment of melanoma |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Oct 28, 2025 | I-902: Treatment of adult patients with histiocytic neoplasms |
| Exclusivity Code: M - Miscellaneous | Jan 28, 2026 PED | M-278: Information added to section 8.4 of the labeling to include the result of study GO29665 |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 28, 2029 | ODE-416: Treatment of adult patients with histiocytic neoplasms |
SYMPROIC (TABLET) (ORAL) NALDEMEDINE TOSYLATE
Drug Classes: opioid antagonist
NDA Applicant: BDSI NDA No.: 208854 Prod. No.: 001 RX (EQ 0.2MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. RE46375 DS* DP* 6,7-unsaturated-7-carbamoyl substituted morphinan derivative Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: May 2, 2017 | Oct 5, 2026 | U-1185: Treatment of opioid-induced constipation |
| Pat. No. RE46365 DS* DP* [Extended 1140 days (3.1 years)] 6,7-unsaturated-7-carbamoyl substituted morphinan derivative Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 2, 2017 | Jan 11, 2028 | |
| Pat. No. 9108975 DS* DP* Crystal of 6,7-unsaturated-7-carbamoyl morphinan derivative and method for producing the same Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 31, 2017 | Nov 11, 2031 | |
| Pat. No. 10952968 DS* DP* Preparation containing 6,7-unsaturated-7-carbamoyl morphinan derivatives Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 21, 2021 | May 13, 2033 |
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 10, 2017 | Oct 6, 2026 *PED | U-1064: Treatment of bipolar disorder and schizophrenia U-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult) U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults |
| Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jul 29, 2014 | Oct 6, 2026 *PED |
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: ALLERGAN NDA No.: 022117 Prod. No.: 003 RX (EQ 2.5MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 003: Sep 12, 2016 | Oct 6, 2026 *PED | U-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17 |
| Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 003: Sep 12, 2016 | Oct 6, 2026 *PED |
JUVISYNC (TABLET) (ORAL) SIMVASTATIN; SITAGLIPTIN PHOSPHATE
Drug Classes: HMG-CoA reductase inhibitor (statin) == dipeptidyl peptidase-4 (DPP-4) inhibitor
NDA Applicant: MERCK SHARP DOHME NDA No.: 202343 Prod. No.: 001 DISC (10MG;EQ 100MG BASE**); 002 DISC (20MG;EQ 100MG BASE**); 003 DISC (40MG;EQ 100MG BASE**); 004 DISC (10MG;EQ 50MG BASE**); 005 DISC (20MG;EQ 50MG BASE**); 006 DISC (40MG;EQ 50MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7326708 DS* DP* Phosphoric acid salt of a dipeptidyl peptidase-IV inhibitor Claim Types: Compound; New polymorph, salt or hydrate; Method of use; Process Pat. Sub. Date(s): 001: Nov 4, 2011; 002: None; 003: None; 004: None; 005: None; 006: None | Oct 11, 2026 *PED | U-1188: Method of treating Type 2 diabetes mellitus in patients for whom treatment with both sitagliptin and simvastatin is appropriate |
ANDROGEL (GEL, METERED) (TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes: androgen
NDA Applicant: BESINS HLTHCARE NDA No.: 022309 Prod. No.: 001 RX (1.62% (20.25MG/1.25GM ACTUATION)); 002 RX (1.62% (20.25MG/1.25GM PACKET)**); 003 RX (1.62% (40.5MG/2.5GM PACKET)**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8466136 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | |
| Pat. No. 8466137 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8466138 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8486925 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2013 | Oct 12, 2026 | |
| Pat. No. 8729057 DP* Testosterone gel and method of use Claim Types: Composition Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014 | Oct 12, 2026 | |
| Pat. No. 8741881 Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2014 | Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
| Pat. No. 8754070 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 16, 2014 | Oct 12, 2026 | |
| Pat. No. 8759329 DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2014 | Oct 12, 2026 |
REXULTI (TABLET) (ORAL) BREXPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 205422 Prod. No.: 001 RX (0.25MG); 002 RX (0.5MG); 003 RX (1MG); 004 RX (2MG); 005 RX (3MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7888362 DS* DLR* Piperazine-substituted benzothiophenes for treat Claim Types: Compound; Process Pat. Sub. Date(s): 001: Jul 17, 2015; 002: Jul 17, 2015; 003: Jul 23, 2015; 004: Jul 23, 2015; 005: Jul 23, 2015 | Oct 12, 2026 *PED | |
| Pat. No. 8349840 DP* Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jul 17, 2015; 002: Jul 17, 2015; 003: Jul 23, 2015; 004: Jul 23, 2015; 005: Jul 23, 2015 | Oct 12, 2026 *PED | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8618109 Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 17, 2015; 002: Jul 17, 2015; 003: Jul 23, 2015; 004: Jul 23, 2015; 005: Jul 23, 2015 | Oct 12, 2026 *PED | U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older U-543: Treatment of schizophrenia |
| Pat. No. 9839637 DP* Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 9, 2018 | Oct 12, 2026 *PED | U-1529: Adjunctive treatment of major depressive disorder (MDD) U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older U-543: Treatment of schizophrenia |
| Pat. No. RE48059 DS* [Extended 986 days (2.7 years)] Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Compound; Process Pat. Sub. Date(s): All strengths: Jul 20, 2020 | Jun 23, 2029 *PED | |
| Pat. No. 10307419 DP* Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof Claim Types: Formulation; Process Pat. Sub. Date(s): All strengths: Jun 14, 2019 | Apr 12, 2033 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 10, 2026 PED | I-913: Treatment of agitation associated with dementia due to Alzheimer’s disease |
| Exclusivity Code: M - Miscellaneous | Nov 8, 2027 PED | M-14: Additional clinical trial information added to pediatric use subsection |
| Exclusivity Code: NPP - New patient population | Dec 27, 2024 |
REXULTI (TABLET) (ORAL) BREXPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA NDA No.: 205422 Prod. No.: 006 RX (4MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7888362 DS* DLR* Piperazine-substituted benzothiophenes for treat Claim Types: Compound; Process Pat. Sub. Date(s): 006: Jul 23, 2015 | Oct 12, 2026 *PED | |
| Pat. No. 8349840 DP* Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Composition; Method of use Pat. Sub. Date(s): 006: Jul 23, 2015 | Oct 12, 2026 *PED | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
| Pat. No. 8618109 Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Method of use Pat. Sub. Date(s): 006: Jul 23, 2015 | Oct 12, 2026 *PED | U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older U-543: Treatment of schizophrenia |
| Pat. No. 9839637 DP* Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 006: Jan 9, 2018 | Oct 12, 2026 *PED | U-1529: Adjunctive treatment of major depressive disorder (MDD) U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older U-543: Treatment of schizophrenia |
| Pat. No. RE48059 DS* [Extended 986 days (2.7 years)] Piperazine-substituted benzothiophenes for treatment of mental disorders Claim Types: Compound; Process Pat. Sub. Date(s): 006: Jul 20, 2020 | Jun 23, 2029 *PED | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Nov 10, 2026 PED | I-913: Treatment of agitation associated with dementia due to Alzheimer’s disease |
| Exclusivity Code: M - Miscellaneous | Nov 8, 2027 PED | M-14: Additional clinical trial information added to pediatric use subsection |
| Exclusivity Code: NPP - New patient population | Dec 27, 2024 |
ADASUVE (POWDER) (INHALATION) LOXAPINE
NDA Applicant: ALEXZA PHARMS NDA No.: 022549 Prod. No.: 001 RX (10MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same Claim Types: Device Pat. Sub. Date(s): 001: Mar 29, 2013 | Oct 23, 2026 |
SIGNIFOR LAR KIT (FOR SUSPENSION) (INTRAMUSCULAR) PASIREOTIDE PAMOATE
Drug Classes: somatostatin analog
NDA Applicant: RECORDATI RARE NDA No.: 203255 Prod. No.: 001 RX (EQ 20MG BASE/VIAL); 002 RX (EQ 40MG BASE/VIAL); 003 RX (EQ 60MG BASE/VIAL); 004 RX (EQ 10MG BASE/VIAL); 005 RX (EQ 30MG BASE/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7759308 DP* Microparticles comprising somatostatin analogues Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Jan 13, 2015; 002: Jan 13, 2015; 003: Jan 13, 2015; 004: Sep 11, 2019; 005: Sep 11, 2019 | Oct 25, 2026 | |
| Pat. No. 7473761 DS* DP* [Extended 871 days (2.4 years)] Somatostatin analogues Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jan 13, 2015; 002: Jan 13, 2015; 003: Jan 13, 2015; 004: Sep 11, 2019; 005: Sep 11, 2019 | Dec 14, 2026 | |
| Pat. No. 9351923 DP* Extended-release composition comprising a somatostatin derivative in microparticles Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Nov 13, 2017; 002: Nov 13, 2017; 003: Nov 13, 2017; 004: Sep 11, 2019; 005: Sep 11, 2019 | May 23, 2028 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 29, 2025 | ODE-268: Indicated for treatment of patients with Cushing's disease for whom pituitary surgery is not an option or has not been curative |
SYFOVRE (SOLUTION) (INTRAVITREAL) PEGCETACOPLAN
Drug Classes: complement inhibitor
NDA Applicant: APELLIS PHARMS NDA No.: 217171 Prod. No.: 001 RX (15MG/0.1ML (15MG/0.1ML))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9056076 Method of treating age-related macular degeneration comprising administering a compstatin analog Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Oct 25, 2026 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 8168584 Methods of treating age-related macular degeneration by compstatin and analogs thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Apr 7, 2027 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan U-3542: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan and also administering an anti-VEGF agent |
| Pat. No. 9169307 DS* Potent compstatin analogs Claim Types: Compound; Process; Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 18, 2027 | U-3541: Treatment of geographic atrophy secondary to age-related macular degeneration by administering complement inhibitor pegcetacoplan |
| Pat. No. 7888323 DS* Potent compstatin analogs Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Dec 4, 2027 | |
| Pat. No. 7989589 DS* Compstatin analogs with improved activity Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Dec 4, 2027 | |
| Pat. No. 11661441 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Claim Types: Method of use; Process Pat. Sub. Date(s): 001: Jun 26, 2023 | Jan 13, 2033 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 10125171 DS* Cell-reactive, long-acting, or targeted compstatin analogs and uses thereof Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Aug 2, 2033 | |
| Pat. No. 10035822 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 15, 2033 | |
| Pat. No. 10875893 DS* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound; Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 15, 2033 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 11292815 DS* DP* Cell-reactive, long-acting, or targeted compstatin analogs and related compositions and methods Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 9, 2023 | Nov 15, 2033 | U-3540: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of pegcetacoplan |
| Pat. No. 11903994 Dosing regimens Claim Types: Method of use; Dosaage regimen Pat. Sub. Date(s): 001: Mar 18, 2024 | Feb 22, 2037 | U-3826: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan every other month U-3827: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan monthly U-3828: Treatment of geographic atrophy secondary to age-related macular degeneration by intravitreal administration of 15 mg pegcetacoplan monthly or every other month |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | May 14, 2026 | |
| Exclusivity Code: NP - New product | Feb 22, 2026 |
SYNRIBO (POWDER) (SUBCUTANEOUS) OMACETAXINE MEPESUCCINATE
NDA Applicant: TEVA PHARMS INTL NDA No.: 203585 Prod. No.: 001 DISC (3.5MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6987103 [Extended 1216 days (3.3 years)] Treatment of chronic myelogenous leukmia, resistant or intolerant to ST1571, involving homoharringtonine alone or combined with other agents Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 20, 2012 | Oct 26, 2026 | U-1300: Treatment of patients with tyrosine kinase inhibitor (TKI) resistant or intolerant chronic myeloid/myelogenous leukemia (CML) |
XEGLYZE (LOTION) (TOPICAL) ABAMETAPIR
NDA Applicant: HATCHTECH NDA No.: 206966 Prod. No.: 001 DISC (0.74%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7812163 DP* [Extended 5 years] Methods and compositions for controlling ectoparasites Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 31, 2020 | Oct 28, 2026 | U-2863: Topical treatment of head lice infestation in patients 6 months of age and older |
| Pat. No. 10292389 DP* Pediculicidal composition Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 31, 2020 | Dec 17, 2034 | U-2863: Topical treatment of head lice infestation in patients 6 months of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jul 24, 2025 |
UPTRAVI (TABLET) (ORAL) SELEXIPAG [GENERIC AB]
Drug Classes: prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 207947 Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (0.8MG); 005 RX (1MG); 006 RX (1.2MG); 007 RX (1.4MG); 008 RX (1.6MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7205302 DS* DP* [Extended 1306 days (3.6 years)] Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Oct 31, 2026 | U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag |
| Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 12, 2029 | U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan |
| Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 12, 2016 | Jun 25, 2030 | U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag |
| Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Jan 19, 2016 | Aug 1, 2030 | |
| Pat. No. 10821108 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020 | Dec 1, 2036 | U-2992: Method of treating pulmonary arterial hypertension comprising administering a solid preparation containing selexipag |
| Pat. No. 10828298 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2020 | Dec 1, 2036 | U-2991: Method of treating pulmonary arterial hypertension comprising administering a tablet containing selexipag |
UPTRAVI (POWDER) (INTRAVENOUS) SELEXIPAG
Drug Classes: prostacyclin receptor agonist
NDA Applicant: ACTELION NDA No.: 214275 Prod. No.: 001 RX (1.8MG/VIAL)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7205302 DS* DP* [Extended 1306 days (3.6 years)] Heterocyclic compound derivatives and medicines Claim Types: Composition; Compound; Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Oct 31, 2026 | U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag |
| Pat. No. 9173881 Therapeutic compositions containing macitentan Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Aug 12, 2029 | U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan |
| Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2021 | Jun 25, 2030 | U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag |
| Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Aug 27, 2021 | Aug 1, 2030 |
BEVYXXA (CAPSULE) (ORAL) BETRIXABAN
Drug Classes: factor Xa inhibitor
NDA Applicant: PORTOLA PHARMS INC NDA No.: 208383 Prod. No.: 001 DISC (40MG); 002 DISC (80MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9555023 Pharmaceutical salts and polymorphs of a factor Xa inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 21, 2017 | Nov 7, 2026 | U-1502: Prophylaxis of pulmonary embolism |
| Pat. No. 7598276 DS* Pharmaceutical salts and polymorphs of a factor Xa inhibitor Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Jul 21, 2017 | Nov 8, 2026 | |
| Pat. No. 8557852 Methods of using crystalline forms of a salt of a factor Xa inhibitor Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 21, 2017 | Sep 8, 2028 | U-1167: Prophylaxis of deep vein thrombosis (DVT) U-2030: Prophylaxis of venous thrombosis |
| Pat. No. 8987463 DP* Methods of synthesizing factor Xa inhibitors Claim Types: Composition Pat. Sub. Date(s): All strengths: Jul 21, 2017 | Dec 28, 2030 | |
| Pat. No. 8404724 DP* Unit dose formulations and methods of treating thrombosis with an oral factor Xa inhibitor Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 21, 2017 | Mar 29, 2031 | U-2034: Inhibiting coagulation |
ORKAMBI (TABLET) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC NDA No.: 206038 Prod. No.: 001 RX (125MG;200MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7973038 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2016 | Nov 8, 2026 | U-1973: Method of treating cystic fibrosis using n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and 3-(6-(1-2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
| Pat. No. 8741933 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 22, 2015 | Nov 8, 2026 | U-1717: Method of treating cystic fibrosis in patients who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene U-1909: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and lumacaftor |
| Pat. No. 9216969 DS* DP* Modulators of ATP-binding cassette transporters Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 15, 2016 | Nov 8, 2026 | |
| Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Composition; Compound Pat. Sub. Date(s): 001: Jul 22, 2015 | Dec 28, 2026 | |
| Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 22, 2015 | Dec 28, 2026 | |
| Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Method of use; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Jul 5, 2017 | Dec 28, 2026 | U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor |
| Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: May 2, 2018 | Dec 28, 2026 | U-2276: Method of treating cystic fibrosis in a patient age 6 or older homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor |
| Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jul 22, 2015 | May 20, 2027 | |
| Pat. No. 8324242 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 22, 2015 | Aug 5, 2027 | U-1311: Method of treating cystic fibrosis U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor |
| Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition Pat. Sub. Date(s): 001: Jul 22, 2015 | Dec 4, 2028 | |
| Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 21, 2016 | Dec 4, 2028 | U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor |
| Pat. No. 10076513 DP* Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Oct 18, 2018 | Dec 4, 2028 | U-2411: Treatment of cystic fibrosis in a patient age 12 years or older who is homozygous for the F508DEL mutation in the CFTR gene using the tablet comprising lumacaftor as recited in claim 1, 19, or 21 of U.S. Patent No. 10,076,513 and ivacaftor |
| Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: Apr 23, 2020 | Dec 4, 2028 | U-2777: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor |
| Pat. No. 11052075 DP* Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 4, 2021 | Dec 4, 2028 | U-3181: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using the tablet according to claim 1 of U.S. Patent No. 11,052,075, where the tablet further comprises ivacaftor |
| Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2024 | Dec 4, 2028 | U-3984: Treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432 |
| Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 22, 2015 | Jul 2, 2029 | U-1717: Method of treating cystic fibrosis in patients who are homozygous for the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor |
| Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 11, 2020 | Aug 13, 2029 | |
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 28, 2023 | Aug 13, 2029 | U-3529: Treatment of CF in a patient age 6 years and older who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916 |
| Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition; Method of use; Kit Pat. Sub. Date(s): 001: Oct 21, 2016 | Sep 29, 2029 | U-1912: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using a dosage unit as defined in claim 1 of U.S. Patent no. 9,192,606 |
| Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jul 22, 2015 | Sep 20, 2030 | |
| Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2015 | Sep 20, 2030 | U-1718: Method of treating cystic fibrosis in patients who have the F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene. U-1910: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using the dosage unit of claim 1 of U.S. patent no. 8,716,338 |
| Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Claim Types: Composition Pat. Sub. Date(s): 001: Jul 22, 2015 | Dec 11, 2030 |
ORKAMBI (TABLET) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC NDA No.: 206038 Prod. No.: 002 RX (125MG;100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7973038 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 21, 2016 | Nov 8, 2026 | U-1973: Method of treating cystic fibrosis using n-(5-hydroxy-2,4-ditert-butyl-phenyl)-4-oxo-1h-quinoline-3-carboxamide and 3-(6-(1-2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid |
| Pat. No. 8741933 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 21, 2016 | Nov 8, 2026 | U-1909: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and lumacaftor |
| Pat. No. 9216969 DP* Modulators of ATP-binding cassette transporters Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 21, 2016 | Nov 8, 2026 | |
| Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Composition; Compound Pat. Sub. Date(s): 002: Oct 21, 2016 | Dec 28, 2026 | |
| Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 21, 2016 | Dec 28, 2026 | |
| Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Method of use; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): 002: Jul 5, 2017 | Dec 28, 2026 | U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor |
| Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Claim Types: Method of use; Formulation Pat. Sub. Date(s): 002: May 2, 2018 | Dec 28, 2026 | U-2276: Method of treating cystic fibrosis in a patient age 6 or older homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous (less than about 30% crystalline) ivacaftor |
| Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Claim Types: Compound; Composition Pat. Sub. Date(s): 002: Oct 21, 2016 | May 20, 2027 | |
| Pat. No. 8324242 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 21, 2016 | Aug 5, 2027 | U-1911: Method of treating a patient having cystic fibrosis using ivacaftor and lumacaftor |
| Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition Pat. Sub. Date(s): 002: Oct 21, 2016 | Dec 4, 2028 | |
| Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 21, 2016 | Dec 4, 2028 | U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor |
| Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 002: Apr 23, 2020 | Dec 4, 2028 | U-2777: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor |
| Pat. No. 11052075 DP* Pharmaceutical compositions of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid and administration thereof Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Aug 4, 2021 | Dec 4, 2028 | U-3181: Treatment of cystic fibrosis in patients 6 years and older who are homozygous for the F508DEL mutation in the CFTR gene using the tablet according to claim 1 of U.S. Patent No. 11,052,075, where the tablet further comprises ivacaftor |
| Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 18, 2024 | Dec 4, 2028 | U-3984: Treatment of cystic fibrosis in patients aged 6 years and older who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432 |
| Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 21, 2016 | Jul 2, 2029 | U-1908: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using ivacaftor and form i lumacaftor |
| Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Jun 11, 2020 | Aug 13, 2029 | |
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Feb 28, 2023 | Aug 13, 2029 | U-3529: Treatment of CF in a patient age 6 years and older who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916 |
| Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition; Method of use; Kit Pat. Sub. Date(s): 002: Oct 21, 2016 | Sep 29, 2029 | U-1912: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using a dosage unit as defined in claim 1 of U.S. Patent no. 9,192,606 |
| Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 002: Oct 21, 2016 | Sep 20, 2030 | |
| Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Pat. Sub. Date(s): 002: Oct 21, 2016 | Sep 20, 2030 | U-1910: Method of treating cystic fibrosis in a patient, the patient having the F508del mutation in CFTR, using the dosage unit of claim 1 of U.S. patent no. 8,716,338 |
| Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Claim Types: Composition Pat. Sub. Date(s): 002: Oct 21, 2016 | Dec 11, 2030 |
ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC NDA No.: 211358 Prod. No.: 001 RX (125MG/PACKET;100MG/PACKET); 002 RX (188MG/PACKET;150MG/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7973038 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Nov 8, 2026 | U-2374: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and ivacaftor |
| Pat. No. 8741933 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Nov 8, 2026 | U-2374: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and ivacaftor |
| Pat. No. 9216969 DP* Modulators of ATP-binding cassette transporters Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Nov 8, 2026 | |
| Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Composition; Compound Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Dec 28, 2026 | |
| Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Dec 28, 2026 | |
| Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Method of use; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Dec 28, 2026 | U-2376: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor |
| Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Dec 28, 2026 | U-2376: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor |
| Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Sep 6, 2018 | May 20, 2027 | |
| Pat. No. 8324242 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Aug 5, 2027 | U-2374: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor and ivacaftor |
| Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Dec 4, 2028 | |
| Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Dec 4, 2028 | U-2375: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor Form I and ivacaftor |
| Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 23, 2020 | Dec 4, 2028 | U-2778: Treatment of cystic fibrosis in patients 2 to 5 years old who are homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor |
| Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 18, 2024 | Dec 4, 2028 | U-3983: Treatment of cystic fibrosis in patients aged 1 year to 5 years who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432 |
| Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Claim Types: Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Jul 2, 2029 | U-2375: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508del mutation in the CFTR gene using lumacaftor Form I and ivacaftor |
| Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 11, 2020 | Aug 13, 2029 | |
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Feb 28, 2023 | Aug 13, 2029 | U-3526: Treatment of CF in a patient age 1 to <6 years and weighing 7 kg or more who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916 |
| Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition; Method of use; Kit Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Sep 29, 2029 | U-2397: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor and ivacaftor as recited in claim 1 of us patent 9192606 |
| Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Sep 20, 2030 | |
| Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Sep 20, 2030 | U-2396: Treatment of cystic fibrosis in a patient age 2-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor as recited in claim 1 of us patent 8716338 and ivacaftor |
| Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Claim Types: Composition Pat. Sub. Date(s): All strengths: Sep 6, 2018 | Dec 11, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 13, 2028 PED | M-14: Additional clinical trial information added to pediatric use subsection |
| Exclusivity Code: NPP - New patient population | Sep 2, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 7, 2025 | ODE-195: For the treatment of cystic fibrosis (CF) in patients age 2 through 5 years old who are homozygous for the F508del mutation in the CFTR gene |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 2, 2029 | ODE-408: Treatment of cystic fibrosis (CF) in patients aged 1 year to less than 2 years who are homozygous for the F508DEL mutation in the CFTR gene |
ORKAMBI (GRANULE) (ORAL) IVACAFTOR; LUMACAFTOR
Drug Classes: cystic fibrosis transmembrane conductance regulator (CFTR)
NDA Applicant: VERTEX PHARMS INC NDA No.: 211358 Prod. No.: 003 RX (94MG/PACKET;75MG/PACKET)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7973038 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 26, 2022 | Nov 8, 2026 | U-3424: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and ivacaftor |
| Pat. No. 8741933 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 26, 2022 | Nov 8, 2026 | U-3424: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and ivacaftor |
| Pat. No. 9216969 DP* Modulators of ATP-binding cassette transporters Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 26, 2022 | Nov 8, 2026 | |
| Pat. No. 8410274 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Composition; Compound Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 28, 2026 | |
| Pat. No. 8754224 DS* DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 28, 2026 | |
| Pat. No. 9670163 DP* Solid forms of N-[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline- -3-carboxamide Claim Types: Method of use; Process; New polymorph, salt or hydrate Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 28, 2026 | U-3429: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor |
| Pat. No. 9931334 DP* Solid forms of N[2,4-bis(1,1-dimethylethyl)-5-hydroxyphenyl]-1,4-dihydro-4-oxoquinoline-3-carboxamide Claim Types: Method of use; Formulation Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 28, 2026 | U-3429: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and a solid composition comprising amorphous and less than about 30% crystalline ivacaftor |
| Pat. No. 7495103 DS* DP* Modulators of ATP-binding cassette transporters Claim Types: Compound; Composition Pat. Sub. Date(s): 003: Sep 26, 2022 | May 20, 2027 | |
| Pat. No. 8324242 Modulators of ATP-binding cassette transporters Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 26, 2022 | Aug 5, 2027 | U-3424: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor and ivacaftor |
| Pat. No. 8653103 DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 4, 2028 | |
| Pat. No. 9150552 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 4, 2028 | U-3427: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor form I and ivacaftor |
| Pat. No. 10597384 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[D][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-- methylpyridin-2-yl) benzoic acid Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 4, 2028 | U-3430: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using a pharmaceutical composition according to claim 2 of U.S. Patent No. 10,597,384, further comprising ivacaftor |
| Pat. No. 12065432 Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl)cyclopropanecarboxamido)-3-methylpyridin-2-yl) benzoic acid Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 18, 2024 | Dec 4, 2028 | U-3983: Treatment of cystic fibrosis in patients aged 1 year to 5 years who are homozygous for the F508DEL CFTR gene mutation comprising administering an effective amount of IVA and form I LUM as recited in, e.g., claim 1 of US 12065432 |
| Pat. No. 8846718 [Extended 210 days (0.6 years)] Solid forms of 3-(6-(1-(2,2-difluoro Claim Types: Method of use Pat. Sub. Date(s): 003: Sep 26, 2022 | Jul 2, 2029 | U-3427: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using lumacaftor form I and ivacaftor |
| Pat. No. 10646481 DP* Pharmaceutical composition and administrations thereof Claim Types: Formulation Pat. Sub. Date(s): 003: Sep 26, 2022 | Aug 13, 2029 | |
| Pat. No. 11564916 Pharmaceutical composition and administrations thereof Claim Types: Method of use Pat. Sub. Date(s): 003: Feb 28, 2023 | Aug 13, 2029 | U-3526: Treatment of CF in a patient age 1 to <6 years and weighing 7 kg or more who is homozygous for the F508DEL mutation in the CFTR gene using the composition recited in claim 1 of US 11564916 |
| Pat. No. 9192606 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[d] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: Composition; Method of use; Kit Pat. Sub. Date(s): 003: Sep 26, 2022 | Sep 29, 2029 | U-3428: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor and ivacaftor as recited in claim 1 of US patent 9192606 |
| Pat. No. 8507534 DS* DP* Solid forms of 3-(6-(1-(2,2-difluorobenzo[d][1,3]dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 003: Sep 26, 2022 | Sep 20, 2030 | |
| Pat. No. 8716338 DP* Dosage units of 3-(6-(1-(2,2-difluorobenzo[D] [1,3] dioxol-5-yl) cyclopropanecarboxamido)-3-methylpyridin-2-yl)benzoic acid Claim Types: New polymorph, salt or hydrate; Formulation; Method of use Pat. Sub. Date(s): 003: Sep 26, 2022 | Sep 20, 2030 | U-3426: Treatment of cystic fibrosis in a patient age 1-5 years who is homozygous for the F508DEL mutation in the CFTR gene using the dosage unit comprising lumacaftor as recited in claim 1 of US patent 8716338 and ivacaftor |
| Pat. No. 8993600 DP* Modulators of ATP-binding cassette transporte Claim Types: Composition Pat. Sub. Date(s): 003: Sep 26, 2022 | Dec 11, 2030 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 13, 2028 PED | M-14: Additional clinical trial information added to pediatric use subsection |
| Exclusivity Code: NS - New strength | Sep 2, 2025 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Sep 2, 2029 | ODE-408: Treatment of cystic fibrosis (CF) in patients aged 1 year to less than 2 years who are homozygous for the F508DEL mutation in the CFTR gene |
EOHILIA (SUSPENSION) (ORAL) BUDESONIDE
Drug Classes: corticosteroid
NDA Applicant: TAKEDA PHARMS USA NDA No.: 213976 Prod. No.: 001 RX (2MG/10ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8497258 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 9, 2026 | U-3820: Treatment of eosinophilic esophagitis |
| Pat. No. 8679545 DP* Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 9, 2026 | |
| Pat. No. 8975243 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 9, 2026 | U-3820: Treatment of eosinophilic esophagitis |
| Pat. No. 9119863 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Claim Types: Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 9, 2026 | U-3820: Treatment of eosinophilic esophagitis |
| Pat. No. 11197822 DP* Topical corticosteroids for the treatment of inflammatory diseases of the gastrointestinal tract Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 9, 2026 | |
| Pat. No. 11413296 DP* Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 9, 2026 | |
| Pat. No. 11357859 Compositions for the treatment of gastrointestinal inflammation Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 12, 2028 | U-3820: Treatment of eosinophilic esophagitis |
| Pat. No. 10293052 DP* Compositions for the treatment of gastrointestinal inflammation Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 4, 2024 | Nov 22, 2028 | |
| Pat. No. 9050368 DP* Corticosteroid compositions Claim Types: Formulation; Kit; Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 4, 2024 | Aug 1, 2029 | |
| Pat. No. 8324192 Viscous budesonide for the treatment of inflammatory diseases of the gastrointestinal tract Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 4, 2024 | Aug 3, 2029 | U-3820: Treatment of eosinophilic esophagitis |
| Pat. No. 11260064 DP* Stable corticosteroid compositions Claim Types: Formulation; Kit Pat. Sub. Date(s): 001: Mar 4, 2024 | Jan 10, 2039 | |
| Pat. No. 11564934 Stable corticosteroid compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 4, 2024 | Jan 10, 2039 | U-3820: Treatment of eosinophilic esophagitis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 9, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 9, 2031 | ODE-466: Treatment of adult and pediatric patients 11 years of age and older with eosinophilic esophagitis (EOE) |
SOFDRA (GEL, METERED) (TOPICAL) SOFPIRONIUM BROMIDE
NDA Applicant: BOTANIX SB NDA No.: 217347 Prod. No.: 001 RX (EQ 12.45% BASE (EQ 72MG BASE/ACTUATION))
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8628759 Soft anticholinergic esters Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | Nov 13, 2026 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 8147809 DS* DP* Soft anticholinergic esters Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 26, 2024 | Mar 26, 2027 | |
| Pat. No. 9220707 Method of dosing and use of soft anticholinergic esters Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 26, 2024 | Mar 14, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 9492429 DP* Method of dosing and use of soft anticholinergic esters Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | Mar 14, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 9895350 Method of dosing and use of soft anticholinergic esters Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | Mar 14, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 10383846 Method of dosing and use of soft anticholinergic esters Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Sep 26, 2024 | Mar 14, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 10947192 Formulation for soft anticholinergic analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 10952990 Formulation for soft anticholinergic analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 10959983 Formulation for soft anticholinergic analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 10961191 Formulation for soft anticholinergic analogs Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 11026919 DP* Formulation for soft anticholinergic analogs Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 11034652 DP* Formulation for soft anticholinergic analogs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 11052067 DP* Formulation for soft anticholinergic analogs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 11084788 DP* Formulation for soft anticholinergic analogs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2034 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 11123325 DP* Formulation for soft anticholinergic analogs Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 26, 2024 | Jul 20, 2037 | U-2398: Topical treatment of primary axillary hyperhidrosis in adults and pediatric patients 9 years of age and older |
| Pat. No. 11566000 DS* DP* Crystalline form of sofpironium bromide and preparation method thereof Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2040 | |
| Pat. No. 11584715 DS* DP* Crystalline form of sofpironium bromide and preparation method thereof Claim Types: Formulation; New polymorph, salt or hydrate; Product-by-process Pat. Sub. Date(s): 001: Sep 26, 2024 | May 22, 2040 | |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 20, 2029 |
ELIQUIS (TABLET) (ORAL) APIXABAN [GENERIC AB]
Drug Classes: factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 202155 Prod. No.: 001 RX (2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)] Lactam-containing compounds and derivatives thereof as factor Xa inhibitors Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 001: Jan 25, 2013 | Nov 21, 2026 | U-1167: Prophylaxis of deep vein thrombosis (DVT) U-1200: Reducing the risk of stroke and systemic embolism U-1301: Treatment of deep vein thrombosis (DVT) U-1302: Treatment of pulmonary embolism (PE) U-1323: Reducing the risk of stroke U-1501: Prophylaxis of deep vein thrombosis and pulmonary embolism U-1502: Prophylaxis of pulmonary embolism U-1729: Reduce the risk of recurrent deep vein thrombosis (DVT) U-1730: Reduce the risk of recurrent pulmonary embolism |
| Pat. No. 9326945 DP* Apixaban formulations Claim Types: Formulation Pat. Sub. Date(s): 001: May 26, 2016 | Feb 24, 2031 |
ELIQUIS (TABLET) (ORAL) APIXABAN [GENERIC AB]
Drug Classes: factor Xa inhibitor
NDA Applicant: BRISTOL MYERS SQUIBB NDA No.: 202155 Prod. No.: 002 RX (5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 6967208 DS* DP* [Extended 1526 days (4.2 years)] Lactam-containing compounds and derivatives thereof as factor Xa inhibitors Claim Types: Composition; Method of use; Compound Pat. Sub. Date(s): 002: Jan 25, 2013 | Nov 21, 2026 | U-1200: Reducing the risk of stroke and systemic embolism U-1301: Treatment of deep vein thrombosis (DVT) U-1302: Treatment of pulmonary embolism (PE) U-1323: Reducing the risk of stroke |
| Pat. No. 9326945 DP* Apixaban formulations Claim Types: Formulation Pat. Sub. Date(s): 002: May 26, 2016 | Feb 24, 2031 |
CALQUENCE (CAPSULE) (ORAL) ACALABRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 210259 Prod. No.: 001 RX (100MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Apr 13, 2018 | Nov 24, 2026 | |
| Pat. No. 9290504 DS* DP* 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Nov 28, 2017 | Jul 11, 2032 | |
| Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2017 | Jul 11, 2032 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy |
| Pat. No. 10239883 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 12, 2019 | Jul 11, 2032 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab |
| Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: May 22, 2019 | Jan 21, 2035 | U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily U-4109: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation by administering 100 mg of acalabrutinib twice daily in combination with bendamustine and rituximab |
| Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 30, 2023 | Jan 21, 2035 | U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab |
| Pat. No. 9796721 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1- yl)-N-(pyridin-2-yl)benzamide Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Nov 28, 2017 | Jul 1, 2036 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2667: Treatment of adult patients with small lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab U-4108: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation in combination with bendamustine and rituximab |
| Pat. No. 10167291 DP* Pharmaceutical composition comprising a crystal form of (S)-4-(8-amino-3-(1-(but-2-ynoyl) pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-yl)-N-(pyridin-2-yl)benzamide Claim Types: Composition; Method of use Pat. Sub. Date(s): 001: Jan 24, 2019 | Jul 1, 2036 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2667: Treatment of adult patients with small lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: ODE - Orphan drug exclusivity | Oct 31, 2024 | ODE-175: Treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Nov 21, 2026 | ODE-274: Indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) |
CALQUENCE (TABLET) (ORAL) ACALABRUTINIB MALEATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 216387 Prod. No.: 001 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7459554 DS* Imidazopyrazine tyrosine kinase inhibitors Claim Types: Compound Pat. Sub. Date(s): 001: Sep 1, 2022 | Nov 24, 2026 | |
| Pat. No. 9290504 DS* DP* 4-imidazopyridazin-1-yl-benzamides and 4-imidazotriazin-1-yl-benzamides as BTK inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 11, 2032 | |
| Pat. No. 9758524 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 11, 2032 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy |
| Pat. No. 10239883 4-imidazopyridazin-1-yl-benzamides as BTK inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 11, 2032 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab |
| Pat. No. 10272083 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jan 21, 2035 | U-2519: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy by administering 100 mg of acalabrutinib twice daily U-2682: Treatment of adult patients with chronic lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2683: Treatment of adult patients with small lymphocytic leukemia by administering 100mg of acalabrutinib twice daily U-2684: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2685: Treatment of adult patients with previously untreated small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily in combination with obinutuzumab U-2686: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia by administering 100 mg of acalabrutinib twice daily U-2687: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab by administering 100 mg of acalabrutinib twice daily U-4109: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation by administering 100 mg of acalabrutinib twice daily in combination with bendamustine and rituximab |
| Pat. No. 11771696 Methods of treating chronic lymphocytic leukemia and small lymphocytic leukemia using a BTK inhibitor Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 30, 2023 | Jan 21, 2035 | U-3710: Treatment of adult patients with previously untreated chronic lymphocytic leukemia by orally administering 100 mg of acalabrutinib twice daily in combination with intravenous administration of obinutuzumab |
| Pat. No. 11059829 DS* DP* Crystal forms of (S)-4-(8-amino-3-(1-(but-2-ynoyl)pyrrolidin-2-yl)imidazo[1,5-a]pyrazin-1-- yl)-N-(pyridin-2-yl)benzamide maleate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: Sep 1, 2022 | Jul 1, 2036 | U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2667: Treatment of adult patients with small lymphocytic leukemia U-2668: Treatment of adult patients with previously untreated chronic lymphocytic leukemia in combination with obinutuzumab U-2669: Treatment of adult patients with previously untreated small lymphocytic leukemia in combination with obinutuzumab U-2670: Treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia U-2671: Treatment of adult patients with previously untreated chronic lymphocytic leukemia or small lymphocytic leukemia in combination with obinutuzumab U-4108: Treatment of adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic stem cell transplantation in combination with bendamustine and rituximab |
AXUMIN (SOLUTION) (INTRAVENOUS) FLUCICLOVINE F-18
NDA Applicant: BLUE EARTH NDA No.: 208054 Prod. No.: 001 RX (9-221mCi/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9387266 Precursor compound of radioactive halogen-labeled organic compound Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Jul 28, 2016 | Nov 28, 2026 | U-1879: Method of diagnosing tumors using positron emission tomography |
| Pat. No. 10010632 DP* Precursor compound of radioactive halogen-labeled organic compound Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 27, 2018 | Nov 28, 2026 | |
| Pat. No. 10953112 Precursor compound of radioactive halogen-labeled organic compound Claim Types: Product-by-process Pat. Sub. Date(s): 001: Apr 20, 2021 | Nov 28, 2026 | U-1879: Method of diagnosing tumors using positron emission tomography |
| Pat. No. 10124079 Imaging of metastatic or recurrent cancer Claim Types: Method of administration; Diagnostic or surgical method Pat. Sub. Date(s): 001: Dec 12, 2018 | Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
| Pat. No. 10716868 Imaging of metastatic or recurrent cancer Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 22, 2020 | Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
| Pat. No. 10933147 Imaging of metastatic or recurrent cancer Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 9, 2021 | Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
| Pat. No. 10967077 Imaging of metastatic or recurrent cancer Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Apr 20, 2021 | Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
| Pat. No. 11980674 Imaging of metastatic or recurrent cancer Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Jun 10, 2024 | Apr 23, 2042 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
ZTALMY (SUSPENSION) (ORAL) GANAXOLONE
Drug Classes: neuroactive steroid gamma-aminobutyric acid (GABA) A receptor
NDA Applicant: MARINUS NDA No.: 215904 Prod. No.: 001 RX (50MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7858609 DP* Solid ganaxolone formulations and methods for the making and use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2022 | Nov 28, 2026 | |
| Pat. No. 8022054 DP* Liquid ganaxolone formulations and methods for the making and use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2022 | Nov 28, 2026 | |
| Pat. No. 8318714 DP* Liquid ganaxolone formulations and methods for the making and use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2022 | Nov 28, 2026 | |
| Pat. No. 8367651 DP* Solid ganaxolone formulations and methods for the making and use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2022 | Nov 28, 2026 | |
| Pat. No. 8618087 Solid ganaxolone formulations and methods for the making and use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 2, 2022 | Nov 28, 2026 | U-3374: Treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older |
| Pat. No. 9029355 DP* Solid ganaxolone compositions and methods for the making and use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 2, 2022 | Nov 28, 2026 | |
| Pat. No. 9056116 Liquid ganaxolone formulations and methods for the making and use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 2, 2022 | Nov 28, 2026 | U-3374: Treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older |
| Pat. No. 10603308 Methods and compositions for treatment of epileptic disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 2, 2022 | Aug 10, 2037 | U-3374: Treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older |
| Pat. No. 12144801 Methods and compositions for treatment of epileptic disorders Claim Types: Method of use; Dosaage regimen; Method of Use claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 21, 2024 | Aug 10, 2037 | U-4034: Treatment of seizures associated with cyclin-dependent kinase-like-5 (CDLK5) deficiency disorder (CDD) in patients 2 years of age and older |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Jun 1, 2027 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Jun 1, 2029 | ODE-395: Treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older |
SIRTURO (TABLET) (ORAL) BEDAQUILINE FUMARATE
Drug Classes: diarylquinoline antimycobacterial
NDA Applicant: JANSSEN THERAP NDA No.: 204384 Prod. No.: 001 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7498343 DS* DP* [Extended 790 days (2.2 years)] Mycobacterial inhibitors Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: Jan 24, 2013 | Dec 1, 2026 | U-1321: Treatment of pulmonary multi-drug resistant tuberculosis |
| Pat. No. 8546428 DS* DP* Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-- beta-phenyl-3-quinolineethanol Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Mar 14, 2014 | Mar 19, 2029 | U-1321: Treatment of pulmonary multi-drug resistant tuberculosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 21, 2027 | M-306: Revisions to the labeling to reflect the results of a clinical study to fulfill post marketing requirement 1988-001 |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 9, 2026 | ODE-251: Indicated as part of combination therapy in the treatment of pediatric patients (12 to less than 18 years of age and weighing at least 30 kg) with pulmonary multi-drug resistant tuberculosis |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 27, 2027 | ODE-307: Indicated as part of combination therapy in the treatment of pediatric patients 5 years and older to less than 12 years of age and weighing at least 15 kg with pulmonary multi-drug resistant tuberculosis (MDR-TB) |
SIRTURO (TABLET) (ORAL) BEDAQUILINE FUMARATE
Drug Classes: diarylquinoline antimycobacterial
NDA Applicant: JANSSEN THERAP NDA No.: 204384 Prod. No.: 002 RX (EQ 20MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7498343 DS* DP* [Extended 790 days (2.2 years)] Mycobacterial inhibitors Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 002: Jun 24, 2020 | Dec 1, 2026 | U-1321: Treatment of pulmonary multi-drug resistant tuberculosis |
| Pat. No. 8546428 DS* DP* Fumarate salt of (alpha S, beta R)-6-bromo-alpha-[2-(dimethylamino)ethyl]-2-methoxy-alpha-1-naphthalenyl-- beta-phenyl-3-quinolineethanol Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 002: Jun 24, 2020 | Mar 19, 2029 | U-1321: Treatment of pulmonary multi-drug resistant tuberculosis |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Jun 21, 2027 | M-306: Revisions to the labeling to reflect the results of a clinical study to fulfill post marketing requirement 1988-001 |
| Exclusivity Code: ODE - Orphan drug exclusivity | May 27, 2027 | ODE-307: Indicated as part of combination therapy in the treatment of pediatric patients 5 years and older to less than 12 years of age and weighing at least 15 kg with pulmonary multi-drug resistant tuberculosis (MDR-TB) |
ZUNVEYL (TABLET, DELAYED RELEASE) (ORAL) BENZGALANTAMINE GLUCONATE
NDA Applicant: ALPHA COGNITION NDA No.: 218549 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 15MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9763953 Cholinergic enhancers with improved blood-brain barrier permeability for the treatment of diseases accompanied by cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 22, 2024 | Dec 1, 2026 | U-713: Treatment of mild to moderate dementia of the Alzheimer's type |
| Pat. No. 11795176 DS* Solid forms of Alpha-1062 gluconate Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Aug 22, 2024 | Jan 13, 2042 | U-713: Treatment of mild to moderate dementia of the Alzheimer's type |
CLINDESSE (CREAM) (VAGINAL) CLINDAMYCIN PHOSPHATE [Has competitive generic]
Drug Classes: lincosamide antibacterial
NDA Applicant: PADAGIS US NDA No.: 050793 Prod. No.: 001 RX (EQ 2% BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9789057 DP* Pharmaceutical delivery system Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Jan 9, 2018 | Dec 2, 2026 | U-137: Method of treating bacterial vaginosis |
ADEMPAS (TABLET) (ORAL) RIOCIGUAT [GENERIC AB]
Drug Classes: soluble guanylate cyclase (sGC) stimulator
NDA Applicant: BAYER HLTHCARE NDA No.: 204819 Prod. No.: 001 RX (0.5MG); 002 RX (1MG); 003 RX (1.5MG); 004 RX (2MG); 005 RX (2.5MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7173037 DS* DP* [Extended 1319 days (3.6 years)] Carbamate-substituted pyrazolopyridines Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 6, 2013 | Dec 4, 2026 | |
| Pat. No. 10662188 DS* DP* Forms of methyl {4,6-diamino-2-[1 (2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl} methyl carbamate Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Jun 23, 2020 | Feb 18, 2034 | U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening |
| Pat. No. 11203593 DS* DP* Forms of methyl {4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimid- ino-5-yl}methyl carbamate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Jan 14, 2022 | Feb 18, 2034 | U-2834: Treatment of adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment, or inoperable CTEPH, to improve exercise capacity and WHO functional class U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening |
AZILECT (TABLET) (ORAL) RASAGILINE MESYLATE [GENERIC AB]
Drug Classes: monoamine oxidase inhibitor (MAOI)
NDA Applicant: TEVA NDA No.: 021641 Prod. No.: 001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7572834 DP* Rasagiline formulations and processes for their preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: None | Dec 5, 2026 | |
| Pat. No. 7815942 DS* DP* Rasagiline formulations of improved content uniformity Claim Types: Formulation; Composition; Method of use; Process Pat. Sub. Date(s): 001: Nov 8, 2010; 002: None | Aug 27, 2027 | U-219: Treatment of Parkinson's disease |
MOXATAG (TABLET, EXTENDED RELEASE) (ORAL) AMOXICILLIN
Drug Classes: penicillin class antibacterial
NDA Applicant: PRAGMA NDA No.: 050813 Prod. No.: 001 DISC (775MG)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8357394 DP* Compositions and methods for improved efficacy of penicillin-type antibiotics Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 30, 2013 | Dec 8, 2026 | |
| Pat. No. 8778924 DS* DP* Modified release amoxicillin products Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 17, 2015 | Dec 8, 2026 | U-897: Method of treating tonsillitis and/or pharyngitis secondary to streptococcus pyogenes in a once-a-day amoxicillin product |
| Pat. No. 8299052 Pharmaceutical compositions and methods for improved bacterial eradication Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2012 | May 7, 2027 | U-1304: Use of once-a-day amoxicillin product to treat tonsillitis and/or pharyngitis secondary to streptococcus pyogenes |
INREBIC (CAPSULE) (ORAL) FEDRATINIB HYDROCHLORIDE
NDA Applicant: BRISTOL-MYERS NDA No.: 212327 Prod. No.: 001 RX (EQ 100MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7825246 DS* Bi-aryl meta-pyrimidine inhibitors of kinases Claim Types: Compound Pat. Sub. Date(s): 001: Aug 27, 2019 | Dec 16, 2026 | |
| Pat. No. 8138199 Use of bi-aryl meta-pyrimidine inhibitors of kinases Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 27, 2019 | Jun 30, 2028 | U-2607: Treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis |
| Pat. No. 7528143 DS* DP* [Extended 1796 days (4.9 years)] Bi-aryl meta-pyrimidine inhibitors of kinases Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Aug 27, 2019 | Nov 16, 2031 | |
| Pat. No. 10391094 DP* Compositions and methods for treating myelofibrosis Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): 001: Sep 4, 2019 | Jun 4, 2032 | U-2607: Treatment of adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis |
| Pat. No. 11400092 Methods of treating myeloproliferative disorders Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 30, 2022 | Sep 24, 2039 | U-3409: Treating adult patients with intermediate-2 or high-risk primary or secondary myelofibrosis, monitoring thiamine levels and administering thiamine or a thiamine equivalent |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NCE - New chemical entity | Aug 16, 2024 | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Aug 16, 2026 | ODE-259: Indicated for the treatment of adult patients with intermediate-2 or high-risk primary or secondary (post-polycythemia vera or post-essential thrombocythemia) myelofibrosis (MF) |
TRINTELLIX (TABLET) (ORAL) VORTIOXETINE HYDROBROMIDE
NDA Applicant: TAKEDA PHARMS USA NDA No.: 204447 Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 004 RX (EQ 20MG BASE) NDA No.: 204447 Prod. No.: 003 DISC (EQ 15MG BASE**)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 7144884 DS* DP* Phenyl-piperazine derivatives as serotonin reuptake inhibitors Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Oct 16, 2013 | Dec 17, 2026 *PED | U-1439: Method of treating an affective disorder such as depression |
| Pat. No. 8969355 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 19, 2015 | Dec 15, 2027 *PED | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 9125908 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Dec 15, 2027 *PED | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9125909 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Dec 15, 2027 *PED | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9125910 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 24, 2018 | Dec 15, 2027 *PED | U-2309: Use in the treatment of major depressive disorder to improve processing speed, an aspect of cognitive function |
| Pat. No. 9227946 1-[2-(2,4 dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1a activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 21, 2016 | Dec 15, 2027 *PED | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 9861630 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT.sub.3 and 5-HT.sub.1A activity for the treatment of cognitive impairment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 18, 2018 | Dec 15, 2027 *PED | U-1668: Method of treating depression or major depressive disorder |
| Pat. No. 11458134 DP* 1-[2-(2,4-dimeihylphenylsulfanyl)-phenyl]piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 2, 2022 | Dec 15, 2027 *PED | U-3463: Use of TRINTELLIX for the treatment of major depressive disorder (MDD) in adults |
| Pat. No. 8722684 DS* DP* 1-[2-(2,4-dimethylphenylsulfanyl)-phenyl] piperazine as a compound with combined serotonin reuptake, 5-HT3 and 5-HT1A activity for the treatment of cognitive impairment Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process; Formulation Pat. Sub. Date(s): All strengths: Jun 9, 2014 | Dec 30, 2031 *PED | |
| Pat. No. 9278096 Therapeutic uses of compounds having combined SERT, 5-HT.sub.3 and 5-HT.sub.1A activity Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 13, 2018 | Sep 21, 2032 *PED | U-2436: Use in the treatment of major depressive disorder to improve treatment emergent sexual dysfunction (TESD) induced by prior serotonin reuptake inhibitor treatment |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: M - Miscellaneous | Feb 23, 2027 PED | M-232: Information added to section 8.4 of the labeling to describe the results from pediatric studies |
PICATO (GEL) (TOPICAL) INGENOL MEBUTATE
NDA Applicant: LEO LABS NDA No.: 202833 Prod. No.: 001 DISC (0.015%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8372827 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 8, 2013 | Dec 18, 2026 | |
| Pat. No. 8372828 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 8, 2013 | Dec 18, 2026 | |
| Pat. No. 8377919 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 8, 2013 | Dec 18, 2026 | |
| Pat. No. 8536163 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 15, 2013 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 8716271 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2014 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 8735375 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 26, 2014 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 9820959 DP* Therapeutic compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 22, 2017 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 9833428 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2017 | Dec 18, 2026 | |
| Pat. No. 9833429 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2017 | Dec 18, 2026 | |
| Pat. No. 9861603 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 16, 2018 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 8278292 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 23, 2012 | Jul 6, 2027 | |
| Pat. No. 9789078 Method of topically treating actinic keratosis with ingenol mebutate cycle therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2017 | May 15, 2033 | U-2138: Topical treatment of actinic keratosis of the face or scalp using more than one treatment course of ingenol mebutate |
PICATO (GEL) (TOPICAL) INGENOL MEBUTATE
NDA Applicant: LEO LABS NDA No.: 202833 Prod. No.: 002 DISC (0.05%)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8372827 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 002: None | Dec 18, 2026 | |
| Pat. No. 8372828 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 002: None | Dec 18, 2026 | |
| Pat. No. 8377919 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 002: None | Dec 18, 2026 | |
| Pat. No. 8536163 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 002: Oct 15, 2013 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 8716271 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 002: May 28, 2014 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 8735375 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 26, 2014 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 9820959 DP* Therapeutic compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: Nov 22, 2017 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 9833428 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 6, 2017 | Dec 18, 2026 | |
| Pat. No. 9833429 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 6, 2017 | Dec 18, 2026 | |
| Pat. No. 9861603 Therapeutic compositions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 16, 2018 | Dec 18, 2026 | U-1440: Use of ingenol mebutate to treat actinic keratosis |
| Pat. No. 8278292 DP* Therapeutic compositions Claim Types: Formulation Pat. Sub. Date(s): 002: None | Jul 6, 2027 |
ICLUSIG (TABLET) (ORAL) PONATINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: TAKEDA PHARMS USA NDA No.: 203469 Prod. No.: 001 RX (EQ 15MG BASE); 002 RX (EQ 45MG BASE); 003 RX (EQ 30MG BASE); 004 RX (EQ 10MG BASE)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 9029533 Substituted acetylenic imidazo[1,2-A]pyridazines as kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 9, 2015; 002: Jun 9, 2015; 003: Jun 9, 2015; 004: Jan 14, 2021 | Dec 22, 2026 | U-1283: A method of treating chronic myelogenous leukemia U-1699: A method for treating acute lymphoblastic leukemia U-1700: A method for treating philadelphia chromosome positive acute lymphoblastic leukemia U-1701: A method for treating leukemia resulting from a mutation in the bcr-abl kinase domain U-836: A method for the treatment of leukemias |
| Pat. No. 8114874 DS* DP* Substituted acetylenic imidazo[1,2-B]pyridazine compounds as kinase inhibitors Claim Types: Compound; New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: None; 002: None; 003: Jun 9, 2015; 004: Jan 14, 2021 | Jan 24, 2027 | |
| Pat. No. 9493470 DS* DP* Crystalline forms of 3-(imidazo[1,2-B] pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin-1-yl) methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): 001: Nov 29, 2016; 002: Nov 29, 2016; 003: Nov 29, 2016; 004: Jan 14, 2021 | Dec 12, 2033 | U-1700: A method for treating philadelphia chromosome positive acute lymphoblastic leukemia U-1948: A method for treating chronic myeloid leukemia |
| Pat. No. 11192895 Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 6, 2022 | Dec 12, 2033 | U-1700: A method for treating philadelphia chromosome positive acute lymphoblastic leukemia U-1701: A method for treating leukemia resulting from a mutation in the bcr-abl kinase domain U-1948: A method for treating chronic myeloid leukemia |
| Pat. No. 11192897 DS* Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-{4-[(4-methylpiperazin- -1-yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt Claim Types: New polymorph, salt or hydrate; Method of use Pat. Sub. Date(s): All strengths: Jan 6, 2022 | Dec 12, 2033 | U-1700: A method for treating philadelphia chromosome positive acute lymphoblastic leukemia U-1701: A method for treating leukemia resulting from a mutation in the bcr-abl kinase domain U-1948: A method for treating chronic myeloid leukemia |
| Pat. No. 11384086 DS* DP* Crystalline forms of 3-(imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-n-{4-[(4-methylpiperazin- -1- yl)methyl]-3-(trifluoromethyl)phenyl}benzamide and its mono hydrochloride salt Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Aug 3, 2022 | Dec 12, 2033 | U-1700: A method for treating philadelphia chromosome positive acute lymphoblastic leukemia U-1701: A method for treating leukemia resulting from a mutation in the bcr-abl kinase domain U-1948: A method for treating chronic myeloid leukemia |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Mar 19, 2027 | I-934: Treatment of adult patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (PH+ ALL) in combination with chemotherapy |
| Exclusivity Code: ODE - Orphan drug exclusivity | Mar 19, 2031 | ODE-472: Treatment of adult patients with newly diagnosed philadelphia chromosome-positive acute lymphoblastic leukemia (PH+ ALL) |
IMBRUVICA (SUSPENSION) (ORAL) IBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: PHARMACYCLICS LLC NDA No.: 217003 Prod. No.: 001 RX (70MG/ML)
| Patents | Expiration | Patented Use |
|---|---|---|
| Pat. No. 8476284 Inhibitors of Bruton's tyrosine kinase Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Dec 28, 2026 | U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM) |
| Pat. No. 8703780 Inhibitors of Bruton's tyrosine kinase Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Dec 28, 2026 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion |
| Pat. No. 8952015 Inhibitors of Bruton's tyrosine kinase Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Dec 28, 2026 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM) |
| Pat. No. 8563563 Inhibitors of bruton's tyrosine kinase Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Apr 26, 2027 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM) |
| Pat. No. 7514444 DS* DP* Inhibitors of bruton's tyrosine kinase Claim Types: Compound Pat. Sub. Date(s): 001: Sep 21, 2022 | Jun 28, 2027 *PED | |
| Pat. No. 8497277 Inhibitors of Bruton's tyrosine kinase Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2022 | Jun 28, 2027 *PED | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy U-3422: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM) |
| Pat. No. 8697711 DS* DP* Inhibitors of Bruton'S tyrosine kinase Claim Types: Compound; Composition; Process Pat. Sub. Date(s): 001: Sep 21, 2022 | Jun 28, 2027 *PED | |
| Pat. No. 8735403 DS* DP* Inhibitors of Bruton's tyrosine kinase Claim Types: Compound Pat. Sub. Date(s): 001: Sep 21, 2022 | Jun 28, 2027 *PED | |
| Pat. No. 8754091 DP* Inhibitors of bruton's tyrosine kinase Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2022 | Jun 28, 2027 *PED | |
| Pat. No. 8957079 DS* DP* Inhibitors of Bruton's tyrosine kinase Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Sep 21, 2022 | Jun 28, 2027 *PED | |
| Pat. No. 9181257 DS* Inhibitors of Bruton's tyrosine kinase Claim Types: Composition Pat. Sub. Date(s): 001: Sep 21, 2022 | Jun 28, 2027 *PED | |
| Pat. No. 8008309 DS* DP* [Extended 320 days (0.9 years)] Inhibitors of bruton's tyrosine kinase Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Sep 21, 2022 | May 13, 2028 *PED | |
| Pat. No. 8999999 Use of inhibitors of Bruton's tyrosine kinase (Btk) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion |
| Pat. No. 9125889 Use of inhibitors of Bruton's tyrosine kinase (Btk) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM) |
| Pat. No. 9801881 Use of inhibitors of bruton's tyrosine kinase (BTK) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-3846: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia U-3847: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion |
| Pat. No. 9801883 Use of inhibitors of bruton's tyrosine kinase (BTK) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion |
| Pat. No. 10004746 Use of inhibitors of Bruton's tyrosine kinase (BTK) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-3846: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia U-3847: Treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia with 17p deletion U-3848: Treatment of adult patients with relapsed or refractory small lymphocytic lymphoma (SLL) with 17p deletion U-3849: Treatment of adult patients with relapsed or refractory small lymphocytic lymphoma (SLL) |
| Pat. No. 10016435 Use of inhibitors of Bruton's tyrosine kinase (BTK) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM) |
| Pat. No. 10751342 Use of inhibitors of Bruton's tyrosine kinase (Btk) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion |
| Pat. No. 11672803 Use of inhibitors of Brutons tyrosine kinase (Btk) Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Jun 3, 2031 | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion |
| Pat. No. 10478439 Use of inhibitors of bruton's tyrosine kinase (Btk) Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2022 | Dec 3, 2031 *PED | U-2666: Treatment of adult patients with chronic lymphocytic leukemia U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy U-3422: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy U-3842: Treatment of adult patients with chronic lymphocytic leukemia (CLL) with 17p deletion U-3843: Treatment of adult patients with small lymphocytic lymphoma (SLL) U-3844: Treatment of adult patients with small lymphocytic lymphoma (SLL) with 17p deletion U-3845: Treatment of adult patients with Waldenstrom's macroglobulinemia (WM) |
| Pat. No. 9725455 DS* Crystalline forms of a bruton's tyrosine kinase inhibitor Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Sep 21, 2022 | Dec 3, 2033 *PED | |
| Pat. No. 10106548 DS* DP* Crystalline forms of a Bruton's tyrosine kinase inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Sep 21, 2022 | Dec 3, 2033 *PED | |
| Pat. No. 10125140 DS* DP* Crystalline forms of a Bruton's tyrosine kinase inhibitor Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Sep 21, 2022 | Dec 3, 2033 *PED | |
| Pat. No. 10961251 DP* Crystalline forms of a Bruton's tyrosine kinase inhibitor Claim Types: Compositon of a new polymorph, salt or hydrate as a product-by-process Pat. Sub. Date(s): 001: Sep 21, 2022 | Dec 3, 2033 *PED | |
| Pat. No. 9296753 DS* Crystalline forms of a Bruton's tyrosine kinase inhibitor Claim Types: New polymorph, salt or hydrate; Formulation Pat. Sub. Date(s): 001: Sep 21, 2022 | Apr 30, 2034 *PED | |
| Pat. No. 10463668 Methods of treating and preventing graft versus host disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Oct 24, 2034 | U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy |
| Pat. No. 10695350 Methods of treating and preventing graft versus host disease Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 19, 2024 | Oct 24, 2034 | U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy |
| Pat. No. 9795604 Methods of treating and preventing graft versus host disease Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 21, 2022 | Apr 24, 2035 *PED | U-2970: Treatment of adult patients with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy U-3422: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: NP - New product | Feb 24, 2026 PED | |
| Exclusivity Code: ODE - Orphan drug exclusivity | Feb 24, 2030 PED | ODE-405: Treatment of pediatric patients age 1 year and older with chronic graft-versus-host disease (CGVHD) after failure of one or more lines of systemic therapy |