Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11752199 Methods of modulating pericytes Pat. Sub. Date(s): 003: Jul 31, 2024; 004: Jul 31, 2024; 008: Sep 21, 2023 Claim Types: Method of use Use Code: U-3686: Treatment of exacerbations of multiple sclerosis in adults with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering Use Code: U-3687: Treatment of infantile spasms with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering Use Code: U-3688: Treatment of ophthalmic diseases with corticotropin by promoting new vessel formation wherein VCAM-1 expression and angiopoetin-2 expression is increased after the administering | Jul 18, 2041 | New expiration date. Was previously Feb 25, 2041 |
AIRDUO RESPICLICK; AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM NDA No.: 208799 Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH) NDA No.: 208799 Prod. No.: 004 DISC (0.055MG/INH;EQ 0.014MG BASE/INH); 005 DISC (0.113MG/INH;EQ 0.014MG BASE/INH); 006 DISC (0.232MG/INH;EQ 0.014MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): None Claim Types: Part of a dosage form | Jul 1, 2032 *PED | This patent is no longer listed for this product |
ARBLI (SUSPENSION) (ORAL) LOSARTAN POTASSIUM
Drug Classes: angiotensin II receptor blocker (ARB)
NDA Applicant: SCIENTURE NDA No.: 218772 Prod. No.: 001 RX (10MG/ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11890273 DP* Losartan liquid formulations and methods of use Pat. Sub. Date(s): 001: Apr 4, 2025 Claim Types: Formulation | Oct 7, 2041 | New product in Orange Book |
| Pat. No. 12156869 DP* Losartan liquid formulations and methods of use Pat. Sub. Date(s): 001: Apr 4, 2025 Claim Types: Formulation; Method of use Use Code: U-4158: A method of using losartan for the reduction of the risk of stroke in patients with hypertension and left ventricular hypertrophy Use Code: U-4159: A method of using losartan for the treatment of hypertension Use Code: U-4160: A method of using losartan for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria in patients with type 2 diabetes and a history of hypertension | Oct 7, 2041 | New product in Orange Book |
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 002 RX (662MG/2.4ML (275.83MG/ML)); 003 RX (882MG/3.2ML (275.63MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12251381 Aripiprazole dosing strategy Pat. Sub. Date(s): All strengths: Apr 8, 2025 Claim Types: Method of use Use Code: U-543: Treatment of schizophrenia | Apr 9, 2039 | New patent for this product |
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 207533 Prod. No.: 004 RX (1064MG/3.9ML (272.82MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12251381 Aripiprazole dosing strategy Pat. Sub. Date(s): 004: Apr 8, 2025 Claim Types: Method of use Use Code: U-543: Treatment of schizophrenia | Apr 6, 2039 | New patent for this product |
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: atypical antipsychotic
NDA Applicant: ALKERMES INC NDA No.: 209830 Prod. No.: 001 RX (675MG/2.4ML (281.25MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12251381 Aripiprazole dosing strategy Pat. Sub. Date(s): 001: Apr 8, 2025 Claim Types: Method of use Use Code: U-543: Treatment of schizophrenia | Apr 6, 2039 | New patent for this product |
ARMONAIR RESPICLICK; ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM NDA No.: 208798 Prod. No.: 001 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH); 004 DISC (0.055MG/INH); 005 DISC (0.113MG/INH); 006 DISC (0.232MG/INH); 007 DISC (0.03MG/INH); 008 DISC (0.03MG/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10561808 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): 001: Mar 19, 2020; 002: Mar 19, 2020; 003: Mar 19, 2020; 004: Mar 19, 2020; 005: Mar 19, 2020; 006: Mar 19, 2020; 007: Aug 5, 2021; 008: May 5, 2022 Claim Types: Part of a dosage form | Jul 1, 2032 *PED | New Delisting Request flag |
ATROVENT HFA (AEROSOL, METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021527 Prod. No.: 001 RX (0.021MG/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8474447 DP* DLR* Inhaler device Pat. Sub. Date(s): 001: May 28, 2015 Claim Types: Device | Jan 17, 2030 | New Delisting Request flag |
COMBIVENT RESPIMAT (SPRAY, METERED) (INHALATION) ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021747 Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7396341 DP* DLR* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Pat. Sub. Date(s): 001: Nov 2, 2011 Claim Types: Device; Method of use; Method of administration | Oct 10, 2026 | New Delisting Request flag |
| Pat. No. 7837235 DP* DLR* Device for clamping a fluidic component Pat. Sub. Date(s): 001: Nov 2, 2011 Claim Types: Device | Mar 13, 2028 | New Delisting Request flag |
| Pat. No. 8733341 DP* DLR* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Pat. Sub. Date(s): 001: Sep 4, 2015 Claim Types: Device; Method of administration | Oct 16, 2030 | New Delisting Request flag |
| Pat. No. 9027967 DP* DLR* Device for clamping a fluidic component Pat. Sub. Date(s): 001: Sep 4, 2015 Claim Types: Device; Process | Mar 31, 2027 | New Delisting Request flag |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Pat. Sub. Date(s): None Claim Types: Device; Process | May 26, 2025 | This patent is no longer listed for this product |
CTEXLI (TABLET) (ORAL) CHENODIOL [Has competitive generic]
NDA Applicant: MIRUM NDA No.: 219488 Prod. No.: 001 RX (250MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NP - New product | Feb 21, 2028 | New exclusivity for this product |
EMBLAVEO (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; AZTREONAM
Drug Classes: beta lactamase inhibitor == monobactam antibacterial
NDA Applicant: ABBVIE NDA No.: 217906 Prod. No.: 001 RX (EQ 0.5GM BASE/VIAL;1.5GM/VIAL)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NP - New product | Feb 7, 2033 GAIN | New exclusivity for this product |
EPINEPHRINE (SOLUTION) (INTRAVENOUS, INTRAOCULAR, INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: FRESENIUS KABI USA NDA No.: 213708 Prod. No.: 001 RX (1MG/ML (1MG/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: PC - Patent challenge | Jun 3, 2025 | New exclusivity for this product |
EPINEPHRINE (SOLUTION) (INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: GLAND NDA No.: 219239 Prod. No.: 001 RX (10MG/10ML (1MG/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Sep 3, 2025 | New exclusivity for this product |
EXPAREL (INJECTABLE, LIPOSOMAL) (INJECTION) BUPIVACAINE [GENERIC AP]
Drug Classes: amide local anesthetic
NDA Applicant: PACIRA PHARMS INC NDA No.: 022496 Prod. No.: 001 RX (133MG/10ML (13.3MG/ML)); 002 RX (266MG/20ML (13.3MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12226610 Treatment of pain associated with total knee arthroplasty with sustained-release liposomal anesthetic compositions Pat. Sub. Date(s): All strengths: Mar 14, 2025 Claim Types: Method of administration Use Code: U-4148: Method of administering bupivacaine to produce postsurgical regional analgesia via an adductor canal block in adults Use Code: U-4149: Method of increasing the amount of time before postsurgical opioid medication is administered to a patient by administering bupivacaine to produce postsurgical regional analgesia Use Code: U-4150: Method of reducing postsurgical opioid consumption by administering bupivacaine to produce postsurgical regional analgesia | Feb 2, 2043 | New patent for this product |
| Pat. No. 12251468 DP* Manufacturing of bupivacaine multivesicular liposomes Pat. Sub. Date(s): All strengths: Mar 21, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use Use Code: U-4152: Method of treating pain, for example, via infiltration for local analgesia; or via interscalene brachial plexus nerve block, sciatic nerve block in the popliteal fossa, or adductor canal block for regional analgesia | Jul 2, 2044 | New patent for this product |
GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: influenza A M2 protein inhibitor
NDA Applicant: SUPERNUS PHARMS NDA No.: 208944 Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12233033 Amantadine compositions, preparations thereof, and methods of use Pat. Sub. Date(s): All strengths: Mar 25, 2025 Claim Types: Use Code: U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications Use Code: U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications Use Code: U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications | Aug 23, 2038 | New patent for this product |
GOMEKLI (TABLET, FOR SUSPENSION) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS NDA No.: 219379 Prod. No.: 001 RX (1MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12257215 Mirdametinib treatment Pat. Sub. Date(s): 001: Apr 3, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection | Mar 16, 2043 | New patent for this product |
| Pat. No. 12263146 Non-linear Dosing Of Mirdametinib Pat. Sub. Date(s): 001: Apr 3, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection | Feb 17, 2041 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-488: Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotropic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy | Feb 11, 2032 | New exclusivity for this product |
GOMEKLI (CAPSULE) (ORAL) MIRDAMETINIB
NDA Applicant: SPRINGWORKS NDA No.: 219389 Prod. No.: 001 RX (1MG); 002 RX (2MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12257215 Mirdametinib treatment Pat. Sub. Date(s): All strengths: Apr 3, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection | Mar 16, 2043 | New patent for this product |
| Pat. No. 12263146 Non-linear Dosing Of Mirdametinib Pat. Sub. Date(s): All strengths: Apr 3, 2025 Claim Types: Method of use Use Code: U-4130: Treatment of adult and pediatric patients 2 years of age and older with neurofibromatosis type 1 (NF1) who have symptomatic plexiform neurofibromas (PN) not amenable to complete resection | Feb 17, 2041 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-488: Treatment of adult and pediatric patients 12 years of age and older with solid tumors that have a neurotropic tyrosine receptor kinase (NTRK) gene fusion, are locally advanced or metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy | Feb 11, 2032 | New exclusivity for this product |
GOZELLIX (POWDER) (INTRAVENOUS) GALLIUM GA-68 GOZETOTIDE
NDA Applicant: TELIX INNOVATIONS NDA No.: 219592 Prod. No.: 001 RX (N/A)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11027031 Kit for radiolabelling Pat. Sub. Date(s): 001: Apr 4, 2025 Claim Types: Diagnostic or surgical method; Process Use Code: U-3317: Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer | Jul 28, 2035 | New product in Orange Book |
ILUVIEN (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
NDA Applicant: ALIMERA SCIENCES INC NDA No.: 201923 Prod. No.: 001 RX (0.19MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9849027 DP* Ocular implantation device Pat. Sub. Date(s): 001: Apr 3, 2025 Claim Types: Device; Method of administration Use Code: U-4157: The treatment of diabetic macular edema (dme) in patients who have been previously treated with a course of corticosteroids and did have a clinically significant rise in intraocular pressure Use Code: U-708: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye | Nov 7, 2028 | New patent for this product |
IMCIVREE (SOLUTION) (SUBCUTANEOUS) SETMELANOTIDE ACETATE
Drug Classes: melanocortin 4 (MC4) receptor agonist
NDA Applicant: RHYTHM NDA No.: 213793 Prod. No.: 001 RX (EQ 10MG BASE/ML (EQ 10MG BASE/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8039435 DS* DP* [Extended 1774 days (4.9 years)] Melanocortin receptor ligands Pat. Sub. Date(s): 001: Dec 22, 2020 Claim Types: Compound; Composition | Aug 21, 2032 | New expiration date. Was previously Oct 13, 2027 |
| Exclusivity | Expiration | Change |
| Exclusivity Code: ODE - Orphan drug exclusivity ODE-508: (Code description not yet released by FDA) | Dec 20, 2031 | New exclusivity for this product |
| Exclusivity Code: ODE - Orphan drug exclusivity ODE-509: (Code description not yet released by FDA) | Dec 20, 2031 | New exclusivity for this product |
INQOVI (TABLET) (ORAL) CEDAZURIDINE; DECITABINE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: TAIHO ONCOLOGY NDA No.: 212576 Prod. No.: 001 RX (100MG;35MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12239653 Combination decitabine and cedazuridine solid oral dosage forms Pat. Sub. Date(s): 001: Mar 27, 2025 Claim Types: Method of use Use Code: U-2865: Treatment of myelodysplastic syndrome Use Code: U-2866: Treatment of chronic myelomonocytic leukemia | Feb 24, 2041 | New patent for this product |
KOSELUGO (CAPSULE) (ORAL) SELUMETINIB SULFATE
Drug Classes: kinase inhibitor
NDA Applicant: ASTRAZENECA NDA No.: 213756 Prod. No.: 001 RX (EQ 10MG BASE); 002 RX (EQ 25MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8178693 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Pat. Sub. Date(s): All strengths: May 6, 2020 Claim Types: Compound; Composition | Mar 13, 2026 | New expiration date. Was previously Mar 13, 2025 |
LACTULOSE (FOR SOLUTION) (ORAL) LACTULOSE [GENERIC AA]
Drug Classes: osmotic laxative
NDA Applicant: PAI HOLDINGS NDA No.: 217914 Prod. No.: 001 RX (10GM/PACKET); 002 RX (20GM/PACKET)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: CGT - Competitive generic therapy | Sep 13, 2025 | New product in Orange Book |
LEQSELVI (TABLET) (ORAL) DEURUXOLITINIB PHOSPHATE
NDA Applicant: SUN PHARM INDS INC NDA No.: 217900 Prod. No.: 001 RX (EQ 8MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12247034 DS* DP* Crystalline form of deuruxolitinib phosphate Pat. Sub. Date(s): 001: Apr 8, 2025 Claim Types: New polymorph, salt or hydrate | May 10, 2044 | New patent for this product |
LUMAKRAS (TABLET) (ORAL) SOTORASIB
NDA Applicant: AMGEN INC NDA No.: 214665 Prod. No.: 001 RX (120MG); 002 RX (320MG); 003 RX (240MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: ODE - Orphan drug exclusivity: ODE-507: Treatment of adult patients with KRAS G12C-mutated metastatic colorectal cancer (MCRC), as determined by an FDA-approved test, who have received prior fluoropyrimidine-, oxaliplatin-and irinotecan-based chemotherapy | Jan 16, 2032 | New exclusivity for this product |
MAYZENT (TABLET) (ORAL) SIPONIMOD
Drug Classes: sphingosine 1-phosphate (S1P) receptor modulator
NDA Applicant: NOVARTIS NDA No.: 209884 Prod. No.: 001 RX (EQ 0.25MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 1MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11944602 Treatment of autoimmune disease in a patient receiving additionally a beta-blocker Pat. Sub. Date(s): All strengths: Apr 30, 2024 Claim Types: Method of use Use Code: U-3889: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults receiving or who may receive a beta-blocker treatment | Apr 23, 2036 | New expiration date. Was previously Jul 24, 2036 |
MEKTOVI (TABLET) (ORAL) BINIMETINIB
NDA Applicant: ARRAY BIOPHARMA INC NDA No.: 210498 Prod. No.: 001 RX (15MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7777050 DS* DP* N3 alkylated benzimidazole derivatives as MEK inhibitors Pat. Sub. Date(s): 001: Jul 25, 2018 Claim Types: Compound; Composition | Mar 13, 2026 | New expiration date. Was previously Mar 13, 2025 |
MIUDELLA (SYSTEM) (INTRAUTERINE) COPPER
Drug Classes: copper-containing intrauterine device (IUD)
NDA Applicant: SEBELA WOMENS HLTH NDA No.: 218201 Prod. No.: 001 RX (N/A)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9089418 DP* Intrauterine contraceptive device Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Apr 9, 2033 | New patent for this product |
| Pat. No. 9265652 Intrauterine contraceptive device Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Method of use Use Code: U-4155: U-2224 treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications | Apr 28, 2034 | New patent for this product |
| Pat. No. 9427351 DP* Intrauterine contraceptive device Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Aug 14, 2032 | New patent for this product |
| Pat. No. 9610191 Intrauterine device with retrieval thread Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Method of administration Use Code: U-4155: U-2224 treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications | Feb 24, 2034 | New patent for this product |
| Pat. No. 10022264 DP* Intrauterine device with retrieval thread Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Mar 22, 2034 | New patent for this product |
| Pat. No. 10159596 DP* Intrauterine contraceptive device Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Aug 14, 2032 | New patent for this product |
| Pat. No. 10166141 DP* Intrauterine contraceptive device Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Jun 13, 2034 | New patent for this product |
| Pat. No. 10188546 DP* Intrauterine device with controlled copper ion elution Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Aug 14, 2032 | New patent for this product |
| Pat. No. 10398588 DP* Intrauterine device with retrieval thread Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device; Method of administration Use Code: U-4155: U-2224 treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications | Feb 24, 2034 | New patent for this product |
| Pat. No. 10918516 DP* Intrauterine device with controlled copper ion elution Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Process | Jan 23, 2037 | New patent for this product |
| Pat. No. 11207209 DP* Intrauterine device with retrieval thread Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Aug 16, 2034 | New patent for this product |
| Pat. No. 11850181 DP* Intrauterine contraceptive device Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Aug 14, 2032 | New patent for this product |
| Pat. No. 12138199 DP* Intrauterine device with retrieval thread Pat. Sub. Date(s): 001: Mar 19, 2025 Claim Types: Device | Oct 18, 2033 | New patent for this product |
| Exclusivity | Expiration | Change |
| Exclusivity Code: NP - New product | Feb 24, 2028 | New exclusivity for this product |
MOXIDECTIN (TABLET) (ORAL) MOXIDECTIN
NDA Applicant: MDGH NDA No.: 210867 Prod. No.: 001 RX (2MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: NPP - New patient population | Feb 7, 2028 | New exclusivity for this product |
MYCAPSSA (CAPSULE, DELAYED RELEASE) (ORAL) OCTREOTIDE ACETATE
Drug Classes: somatostatin analog
NDA Applicant: CHIESI NDA No.: 208232 Prod. No.: 001 RX (EQ 20MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12246054 Method of treating diseases Pat. Sub. Date(s): 001: Apr 3, 2025 Claim Types: Method of use Use Code: U-2857: Use of oral octreotide for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide | Feb 3, 2036 | New patent for this product |
| Pat. No. 12251418 Method of treating diseases Pat. Sub. Date(s): 001: Apr 3, 2025 Claim Types: Method of use Use Code: U-2857: Use of oral octreotide for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide | Feb 3, 2036 | New patent for this product |
NEFFY (SPRAY) (NASAL) EPINEPHRINE
Drug Classes: alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: ARS PHARMS OPERATION NDA No.: 214697 Prod. No.: 002 RX (1MG/SPRAY)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10576156 DP* Compositions for drug administration Pat. Sub. Date(s): 002: Apr 3, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics | Feb 6, 2038 | New strength or variation of this product |
| Pat. No. 10682414 Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 002: Apr 3, 2025 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis | Feb 6, 2039 | New strength or variation of this product |
| Pat. No. 11173209 Compositions for drug administration Pat. Sub. Date(s): 002: Apr 3, 2025 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis | Feb 6, 2038 | New strength or variation of this product |
| Pat. No. 11191838 DP* Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 002: Apr 3, 2025 Claim Types: Method of use; Formulation Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis | Feb 6, 2039 | New strength or variation of this product |
| Pat. No. 11717571 Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 002: Apr 3, 2025 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis | Feb 6, 2039 | New strength or variation of this product |
| Pat. No. 11744895 Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 002: Apr 3, 2025 Claim Types: Method of use Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis | Feb 6, 2039 | New strength or variation of this product |
| Pat. No. 11918655 Intranasal epinephrine formulations and methods for the treatment of disease Pat. Sub. Date(s): 002: Apr 3, 2025 Claim Types: Method of use; Formulation Use Code: U-3979: Nasal administration of epinephrine for the treatment of allergic reactions (type I), including anaphylaxis | Feb 6, 2039 | New strength or variation of this product |
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) NOREPINEPHRINE BITARTRATE
Drug Classes: catecholamine
NDA Applicant: LONG GROVE PHARMS NDA No.: 214628 Prod. No.: 001 RX (EQ 4MG BASE/250 ML (EQ 16MCG BASE/ML)); 002 RX (EQ 8MG BASE/250ML (EQ 32MCG BASE/ML)); 003 RX (EQ 16MG BASE/250ML (EQ 64MCG BASE/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12245996 DP* Norepinephrine compositions and methods therefor Pat. Sub. Date(s): All strengths: Mar 26, 2025 Claim Types: Formulation; Product-by-process | Jan 30, 2038 | New patent for this product |
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) NOREPINEPHRINE BITARTRATE
Drug Classes: catecholamine
NDA Applicant: INFORLIFE NDA No.: 215700 Prod. No.: 001 RX (EQ 4MG BASE/250ML (EQ 16MCG BASE/ML)); 002 RX (EQ 8MG BASE/250ML (EQ 32MCG BASE/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE49422 DP* Process for producing a stable low concentration, injectable solution of noradrenaline Pat. Sub. Date(s): All strengths: Mar 3, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Product-by-process | Feb 26, 2035 | New patent for this product |
NOREPINEPHRINE BITARTRATE IN 0.9% SODIUM CHLORIDE (SOLUTION) (INTRAVENOUS) NOREPINEPHRINE BITARTRATE
Drug Classes: catecholamine
NDA Applicant: INFORLIFE NDA No.: 215700 Prod. No.: 003 RX (EQ 16MG BASE/250ML (EQ 64MCG BASE/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE49422 DP* Process for producing a stable low concentration, injectable solution of noradrenaline Pat. Sub. Date(s): 003: Mar 3, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Product-by-process | Feb 26, 2035 | New patent for this product |
| Pat. No. RE49443 DP* Process for producing a stable low concentration, injectable solution of noradrenaline Pat. Sub. Date(s): 003: Mar 3, 2025 Claim Types: Formulation; Product-by-process; Formulation claimed by its inherent performace characteristics | Feb 26, 2035 | New patent for this product |
| Pat. No. 10251848 DP* Process for producing a stable low concentration, injectable solution of noradrenaline Pat. Sub. Date(s): 003: Mar 14, 2025 Claim Types: Formulation; Product-by-process | Feb 26, 2035 | New patent for this product |
OGSIVEO (TABLET) (ORAL) NIROGACESTAT HYDROBROMIDE
NDA Applicant: SPRINGWORKS NDA No.: 217677 Prod. No.: 001 RX (EQ 50MG BASE); 002 RX (EQ 100MG BASE); 003 RX (EQ 150MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7951958 DS* Imidazole compounds for the treatment of neurodegenerative disorders Pat. Sub. Date(s): 001: Dec 1, 2023; 002: Apr 12, 2024; 003: Apr 12, 2024 Claim Types: Compound; Composition | Mar 11, 2026 | New expiration date. Was previously Mar 11, 2025 |
| Pat. No. 12234210 DP* Synthesis of nirogacestat Pat. Sub. Date(s): All strengths: Mar 14, 2025 Claim Types: Product-by-process | Jul 8, 2042 | New patent for this product |
| Pat. No. 12247012 DP* Synthesis of nirogacestat Pat. Sub. Date(s): All strengths: Mar 14, 2025 Claim Types: Process; Product-by-process | Jul 8, 2042 | New patent for this product |
OHTUVAYRE (SUSPENSION) (INHALATION) ENSIFENTRINE
NDA Applicant: VERONA PHARMA NDA No.: 217389 Prod. No.: 001 RX (3MG/2.5ML)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12251384 DP* Particulate composition Pat. Sub. Date(s): 001: Mar 26, 2025 Claim Types: Formulation | Jun 25, 2044 | New patent for this product |
OPFOLDA (CAPSULE) (ORAL) MIGLUSTAT
Drug Classes: enzyme stabilizer == glucosylceramide synthase inhibitor
NDA Applicant: AMICUS THERAP US NDA No.: 215211 Prod. No.: 001 RX (65MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12246062 Recombinant human acid alpha-glucosidase Pat. Sub. Date(s): 001: Mar 18, 2025 Claim Types: Method of use Use Code: U-3726: The treatment of pompe patients | Sep 16, 2038 | New patent for this product |
OPSUMIT (TABLET) (ORAL) MACITENTAN
Drug Classes: endothelin receptor antagonist
NDA Applicant: ACTELION NDA No.: 204410 Prod. No.: 001 RX (10MG)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-187: Addition of clinical information obtained from a pediatric trial to section 8.4 of the labeling | Feb 28, 2028 | New exclusivity for this product |
OPZELURA (CREAM) (TOPICAL) RUXOLITINIB PHOSPHATE
Drug Classes: Janus kinase (JAK) inhibitor == kinase inhibitor
NDA Applicant: INCYTE CORP NDA No.: 215309 Prod. No.: 001 RX (EQ 1.5% BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12226419 DP* Topical formulation for a JAK inhibitor Pat. Sub. Date(s): 001: Mar 17, 2025 Claim Types: Formulation | May 20, 2031 | New patent for this product |
| Pat. No. 12233067 Topical treatment of vitiligo by a JAK inhibitor Pat. Sub. Date(s): 001: Mar 17, 2025 Claim Types: Method of use Use Code: U-4151: For the topical treatment of nonsegmental vitiligo in adult and pediatric patients 12 years of age and older, wherein the depigmented area is ‚>= 0.5% BSA on the face, ‚>= 3% BSA on non-facial areas, and not >10% BSA on total body area | Jul 28, 2040 | New patent for this product |
OXYCONTIN (TABLET, EXTENDED RELEASE) (ORAL) OXYCODONE HYDROCHLORIDE
Drug Classes: opioid agonist
NDA Applicant: PURDUE PHARMA LP NDA No.: 022272 Prod. No.: 001 RX (10MG); 002 RX (15MG); 003 RX (20MG); 004 RX (30MG); 005 RX (40MG); 006 RX (60MG); 007 RX (80MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12246094 DP* Tamper resistant dosage forms Pat. Sub. Date(s): All strengths: Mar 14, 2025 Claim Types: Formulation; Formulation claimed by its inherent performace characteristics | Aug 24, 2027 | New patent for this product |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 001 RX (2MG/1.5ML (1.34MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE46363 DP* DLR* Dial-down mechanism for wind-up pen Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device; Method of use | Aug 3, 2026 | New Delisting Request flag |
| Pat. No. 8684969 DP* DLR* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device | Oct 20, 2025 | New Delisting Request flag |
| Pat. No. 8920383 DP* DLR* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 9108002 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 9132239 DP* DLR* Dial-down mechanism for wind-up pen Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device | Feb 1, 2032 | New Delisting Request flag |
| Pat. No. 9457154 DP* DLR* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Sep 27, 2027 | New Delisting Request flag |
| Pat. No. 9616180 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 001: Aug 17, 2018 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 9687611 DP* DLR* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device | Feb 27, 2027 | New Delisting Request flag |
| Pat. No. 9775953 DP* DLR* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Pat. Sub. Date(s): 001: Dec 20, 2017 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 9861757 DP* DLR* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): 001: Aug 17, 2018 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 10220155 DP* DLR* Syringe device with a dose limiting mechanism and an additional safety mechanism Pat. Sub. Date(s): 001: Apr 4, 2019 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 10357616 DP* DLR* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): 001: Aug 8, 2019 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 10376652 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 001: Sep 13, 2019 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 11097063 DP* DLR* Syringe device with a dose limiting mechanism and an additional safety mechanism Pat. Sub. Date(s): 001: Sep 21, 2021 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 11311679 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 001: May 20, 2022 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 11446443 DP* DLR* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): 001: Oct 7, 2022 Claim Types: Device | Oct 20, 2025 | New Delisting Request flag |
OZEMPIC (SOLUTION) (SUBCUTANEOUS) SEMAGLUTIDE
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 209637 Prod. No.: 002 RX (4MG/3ML (1.34MG/ML)); 003 RX (8MG/3ML (2.68MG/ML)); 004 RX (2MG/3ML (0.68MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE46363 DP* DLR* Dial-down mechanism for wind-up pen Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device; Method of use | Aug 3, 2026 | New Delisting Request flag |
| Pat. No. 8684969 DP* DLR* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Oct 20, 2025 | New Delisting Request flag |
| Pat. No. 8920383 DP* DLR* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 9108002 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 9132239 DP* DLR* Dial-down mechanism for wind-up pen Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Feb 1, 2032 | New Delisting Request flag |
| Pat. No. 9457154 DP* DLR* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Sep 29, 2027 | New Delisting Request flag |
| Pat. No. 9616180 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 9687611 DP* DLR* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Feb 27, 2027 | New Delisting Request flag |
| Pat. No. 9775953 DP* DLR* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 9861757 DP* DLR* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 10220155 DP* DLR* Syringe device with a dose limiting mechanism and an additional safety mechanism Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 10357616 DP* DLR* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 10376652 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 002: Dec 21, 2020; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 11097063 DP* DLR* Syringe device with a dose limiting mechanism and an additional safety mechanism Pat. Sub. Date(s): 002: Sep 21, 2021; 003: Apr 29, 2022; 004: Nov 14, 2022 Claim Types: Device | Jul 17, 2026 | New Delisting Request flag |
| Pat. No. 11311679 DP* DLR* Automatic injection device with a top release mechanism Pat. Sub. Date(s): 002: May 20, 2022; 003: May 20, 2022; 004: Nov 14, 2022 Claim Types: Device | Jan 20, 2026 | New Delisting Request flag |
| Pat. No. 11446443 DP* DLR* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): 002: Oct 7, 2022; 003: Oct 7, 2022; 004: Nov 14, 2022 Claim Types: Device | Oct 20, 2025 | New Delisting Request flag |
PROAIR HFA (AEROSOL, METERED) (INHALATION) ALBUTEROL SULFATE [GENERIC AB2]
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 021457 Prod. No.: 001 RX (EQ 0.09MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8132712 DP* DLR* Metered-dose inhaler Pat. Sub. Date(s): 001: Mar 27, 2012 Claim Types: Device; Method of use | Sep 7, 2028 | New Delisting Request flag |
| Pat. No. 9463289 DP* DLR* Dose counters for inhalers, inhalers and methods of assembly thereof Pat. Sub. Date(s): 001: Nov 8, 2016 Claim Types: Device | May 18, 2031 | New Delisting Request flag |
| Pat. No. 9808587 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): 001: Nov 16, 2017 Claim Types: Device | May 18, 2031 | New Delisting Request flag |
| Pat. No. 10561808 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): 001: Mar 19, 2020 Claim Types: Part of a dosage form | Jan 1, 2032 | New Delisting Request flag |
| Pat. No. 11395889 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): 001: Aug 19, 2022 Claim Types: Part of a dosage form | May 18, 2031 | New Delisting Request flag |
PROAIR RESPICLICK; PROAIR DIGIHALER (POWDER, METERED) (INHALATION) ALBUTEROL SULFATE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: TEVA BRANDED PHARM NDA No.: 205636 Prod. No.: 001 RX (EQ 0.09MG BASE/INH) NDA No.: 205636 Prod. No.: 002 DISC (EQ 0.09MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 10561808 DP* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): None Claim Types: Part of a dosage form | Jan 1, 2032 | This patent is no longer listed for this product |
PYRIDOSTIGMINE BROMIDE (TABLET, EXTENDED RELEASE) (ORAL) PYRIDOSTIGMINE BROMIDE
Drug Classes: cholinesterase inhibitor
NDA Applicant: AMNEAL NDA No.: 217604 Prod. No.: 001 DISC (105MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12233166 DP* Extended release compositions comprising pyridostigmine Pat. Sub. Date(s): 001: Mar 17, 2025 Claim Types: Formulation | Jun 18, 2038 | New patent for this product |
QVAR 80; QVAR 40 (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA BRANDED PHARM NDA No.: 020911 Prod. No.: 001 DISC (0.08MG/INH**); 002 DISC (0.04MG/INH**)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 9463289 DP* DLR* Dose counters for inhalers, inhalers and methods of assembly thereof Pat. Sub. Date(s): All strengths: Nov 8, 2016 Claim Types: Device | May 18, 2031 | New Delisting Request flag |
| Pat. No. 9808587 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): All strengths: Nov 30, 2017 Claim Types: Device | May 18, 2031 | New Delisting Request flag |
| Pat. No. 10561808 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): All strengths: Mar 19, 2020 Claim Types: Part of a dosage form | Jan 1, 2032 | New Delisting Request flag |
| Pat. No. 11395889 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): All strengths: Aug 19, 2022 Claim Types: Part of a dosage form | May 18, 2031 | New Delisting Request flag |
QVAR REDIHALER (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: corticosteroid
NDA Applicant: NORTON WATERFORD NDA No.: 207921 Prod. No.: 001 RX (0.04MG/INH); 002 RX (0.08MG/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8132712 DP* DLR* Metered-dose inhaler Pat. Sub. Date(s): All strengths: Aug 28, 2017 Claim Types: Device; Method of use | Sep 7, 2028 | New Delisting Request flag |
| Pat. No. 10561808 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): All strengths: Mar 19, 2020 Claim Types: Part of a dosage form | Jan 1, 2032 | New Delisting Request flag |
| Pat. No. 11395889 DP* DLR* Dose counter for inhaler having an anti-reverse rotation actuator Pat. Sub. Date(s): All strengths: Aug 19, 2022 Claim Types: Part of a dosage form | May 18, 2031 | New Delisting Request flag |
SAXENDA (SOLUTION) (SUBCUTANEOUS) LIRAGLUTIDE [Has competitive generic]
Drug Classes: glucagon-like peptide-1 (GLP-1) receptor agonist
NDA Applicant: NOVO NDA No.: 206321 Prod. No.: 001 RX (18MG/3ML (6MG/ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. RE46363 DP* Dial-down mechanism for wind-up pen Pat. Sub. Date(s): None Claim Types: Device; Method of use | Feb 3, 2027 *PED | This patent is no longer listed for this product |
| Pat. No. 8684969 DP* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): None Claim Types: Device | Apr 20, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 8920383 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Pat. Sub. Date(s): None Claim Types: Device | Jan 17, 2027 *PED | This patent is no longer listed for this product |
| Pat. No. 9108002 DP* Automatic injection device with a top release mechanism Pat. Sub. Date(s): None Claim Types: Device | Jul 26, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 9132239 DP* Dial-down mechanism for wind-up pen Pat. Sub. Date(s): None Claim Types: Device | Aug 1, 2032 *PED | This patent is no longer listed for this product |
| Pat. No. 9457154 DP* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): None Claim Types: Device Comments: Expiration date of this patent for OZEMPIC Prod. No. 001 is actually Sept. 29, 2027. This patent has a Certificate of Correction that states that the PTA of the patent is actually 617 days rather than the 615 days found on the first page of the patent. The expiration date of this patent for OZEMPIC Prod. Nos. 002, 003 and 004 is accurate. | Mar 27, 2028 *PED | This patent is no longer listed for this product |
| Pat. No. 9616180 DP* Automatic injection device with a top release mechanism Pat. Sub. Date(s): None Claim Types: Device | Jul 20, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 9687611 DP* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): None Claim Types: Device | Aug 27, 2027 *PED | This patent is no longer listed for this product |
| Pat. No. 9775953 DP* Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left Pat. Sub. Date(s): None Claim Types: Device | Jan 17, 2027 *PED | This patent is no longer listed for this product |
| Pat. No. 9861757 DP* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): None Claim Types: Device | Jul 20, 2026 *PED | This patent is no longer listed for this product |
| Pat. No. 10220155 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Pat. Sub. Date(s): None Claim Types: Device | Jan 17, 2027 *PED | This patent is no longer listed for this product |
| Pat. No. 10357616 DP* Injection device with an end of dose feedback mechanism Pat. Sub. Date(s): None Claim Types: Device | Jan 20, 2026 | This patent is no longer listed for this product |
| Pat. No. 10376652 DP* Automatic injection device with a top release mechanism Pat. Sub. Date(s): None Claim Types: Device | Jan 20, 2026 | This patent is no longer listed for this product |
| Pat. No. 11097063 DP* Syringe device with a dose limiting mechanism and an additional safety mechanism Pat. Sub. Date(s): None Claim Types: Device | Jul 17, 2026 | This patent is no longer listed for this product |
| Pat. No. 11311679 DP* Automatic injection device with a top release mechanism Pat. Sub. Date(s): None Claim Types: Device | Jan 20, 2026 | This patent is no longer listed for this product |
| Pat. No. 11446443 DP* Injection device with torsion spring and rotatable display Pat. Sub. Date(s): None Claim Types: Device | Oct 20, 2025 | This patent is no longer listed for this product |
SCEMBLIX (TABLET) (ORAL) ASCIMINIB HYDROCHLORIDE
NDA Applicant: NOVARTIS NDA No.: 215358 Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 100MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12252478 DP* Crystalline forms of N-[4-(chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide Pat. Sub. Date(s): All strengths: Apr 4, 2025 Claim Types: New polymorph, salt or hydrate | May 14, 2040 | New patent for this product |
| Pat. No. 12252479 Crystalline forms OF N-[4-(chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(1H-pyrazol-5-yl)pyridine-3-carboxamide Pat. Sub. Date(s): All strengths: Apr 4, 2025 Claim Types: Method of use; New polymorph, salt or hydrate Use Code: U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) | May 17, 2040 | New patent for this product |
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 | Change |
|---|---|---|
| Pat. No. 7694676 DP* Dry powder inhaler Pat. Sub. Date(s): None Claim Types: Device | Sep 12, 2027 *PED | This patent is no longer listed for this product |
| Pat. No. 9010323 DP* Inhaler and sieve for an inhaler Pat. Sub. Date(s): None Claim Types: Device | Apr 19, 2030 | This patent is no longer listed for this product |
SPIRIVA RESPIMAT (SPRAY, METERED) (INHALATION) TIOTROPIUM BROMIDE
Drug Classes: anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 021936 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH); 002 RX (EQ 0.00125MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7396341 DP* DLR* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 Claim Types: Device; Method of use; Method of administration | Apr 10, 2027 *PED | New Delisting Request flag |
| Pat. No. 7837235 DP* DLR* Device for clamping a fluidic component Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 Claim Types: Device | Sep 13, 2028 *PED | New Delisting Request flag |
| Pat. No. 7896264 DP* DLR* Microstructured high pressure nozzle with built-in filter function Pat. Sub. Date(s): 001: Oct 20, 2014; 002: Oct 5, 2015 Claim Types: Device; Process | Nov 26, 2025 *PED | New Delisting Request flag |
| Pat. No. 8733341 DP* DLR* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015 Claim Types: Device; Method of administration | Apr 16, 2031 *PED | New Delisting Request flag |
| Pat. No. 9027967 DP* DLR* Device for clamping a fluidic component Pat. Sub. Date(s): 001: Sep 15, 2015; 002: Oct 5, 2015 Claim Types: Device; Process | Sep 30, 2027 *PED | New Delisting Request flag |
STIOLTO RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE; TIOTROPIUM BROMIDE
Drug Classes: beta-2 adrenergic agonist == anticholinergic
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 206756 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH;EQ 0.0025MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7396341 DP* DLR* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Pat. Sub. Date(s): 001: Jun 10, 2015 Claim Types: Device; Method of use; Method of administration | Apr 10, 2027 *PED | New Delisting Request flag |
| Pat. No. 7837235 DP* DLR* Device for clamping a fluidic component Pat. Sub. Date(s): 001: Jun 10, 2015 Claim Types: Device | Sep 13, 2028 *PED | New Delisting Request flag |
| Pat. No. 8733341 DP* DLR* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Pat. Sub. Date(s): 001: Jun 10, 2015 Claim Types: Device; Method of administration | Oct 16, 2030 | New Delisting Request flag |
| Pat. No. 9027967 DP* DLR* Device for clamping a fluidic component Pat. Sub. Date(s): 001: Jun 10, 2015 Claim Types: Device; Process | Mar 31, 2027 | New Delisting Request flag |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Pat. Sub. Date(s): None Claim Types: Device; Process | May 26, 2025 | This patent is no longer listed for this product |
STRIVERDI RESPIMAT (SPRAY, METERED) (INHALATION) OLODATEROL HYDROCHLORIDE
Drug Classes: beta-2 adrenergic agonist
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 203108 Prod. No.: 001 RX (EQ 0.0025MG BASE/INH)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device Pat. Sub. Date(s): None Claim Types: Device; Method of use; Method of administration Use Code: U-1547: Treatment of chronic obstructive pulmonary disease (COPD), chronic bronchitis or emphysema | Oct 10, 2026 | This patent is no longer listed for this product |
| Pat. No. 7837235 DP* Device for clamping a fluidic component Pat. Sub. Date(s): None Claim Types: Device | Mar 13, 2028 | This patent is no longer listed for this product |
| Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function Pat. Sub. Date(s): None Claim Types: Device; Process | May 26, 2025 | This patent is no longer listed for this product |
| Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism Pat. Sub. Date(s): None Claim Types: Device; Method of administration | Oct 16, 2030 | This patent is no longer listed for this product |
| Pat. No. 9027967 DP* Device for clamping a fluidic component Pat. Sub. Date(s): None Claim Types: Device; Process | Mar 31, 2027 | This patent is no longer listed for this product |
SUBLOCADE (SOLUTION, EXTENDED RELEASE) (SUBCUTANEOUS) BUPRENORPHINE
Drug Classes: partial opioid agonist
NDA Applicant: INDIVIOR NDA No.: 209819 Prod. No.: 001 RX (100MG/0.5ML (100MG/0.5ML)); 002 RX (300MG/1.5ML (200MG/ML))
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous M-314: (Code description not yet released by FDA) | Feb 21, 2028 | New exclusivity for this product |
SYNJARDY (TABLET) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 206111 Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (12.5MG;500MG); 004 RX (12.5MG;1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11666590 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Mar 28, 2025 Claim Types: Method of use Use Code: U-4154: U-2106 treatment of dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications | Apr 3, 2034 | New patent for this product |
SYNJARDY XR (TABLET, EXTENDED RELEASE) (ORAL) EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: BOEHRINGER INGELHEIM NDA No.: 208658 Prod. No.: 001 RX (5MG;1GM); 002 RX (10MG;1GM); 003 RX (12.5MG;1GM); 004 RX (25MG;1GM)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 11666590 Pharmaceutical composition, methods for treating and uses thereof Pat. Sub. Date(s): All strengths: Mar 28, 2025 Claim Types: Method of use Use Code: U-4154: U-2106 treatment of dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications | Apr 3, 2034 | New patent for this product |
TRUQAP (TABLET) (ORAL) CAPIVASERTIB
NDA Applicant: ASTRAZENECA NDA No.: 218197 Prod. No.: 001 RX (160MG); 002 RX (200MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12252495 Protein kinase B inhibitors Pat. Sub. Date(s): All strengths: Mar 28, 2025 Claim Types: Method of use Use Code: U-3762: Treatment with fulvestrant of hr-pos. her2-neg. locally advanced or metastatic breast cancer with PIK3CA/AKT1/PTEN-alteration(s) following progression on endocrine therapy in the metastatic setting or recurrence on or within 12 months of adjuvant therapy | Oct 10, 2028 | New patent for this product |
TUKYSA (TABLET) (ORAL) TUCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: SEAGEN NDA No.: 213411 Prod. No.: 001 RX (50MG); 002 RX (150MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7452895 DS* DP* Quinazoline analogs as receptor tyrosine kinase inhibitors Pat. Sub. Date(s): All strengths: Apr 29, 2020 Claim Types: Compound; Method of use; Composition Use Code: U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer Use Code: U-4153: Treating ras wild-type HER2-positive unresectable or metastatic colorectal cancer that has progressed following prior treatment | Nov 16, 2025 | New patent for this product |
UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE NDA No.: 211765 Prod. No.: 001 RX (50MG); 002 RX (100MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12220408 DP* Treatment of migraine Pat. Sub. Date(s): All strengths: Mar 12, 2025 Claim Types: Formulation | Jan 30, 2035 | New patent for this product |
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 | Change |
|---|---|---|
| Pat. No. 9265893 DP* Injection button Pat. Sub. Date(s): None Claim Types: Device | Mar 23, 2033 *PED | This patent is no longer listed for this product |
VIZIMPRO (TABLET) (ORAL) DACOMITINIB
NDA Applicant: PFIZER NDA No.: 211288 Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 7772243 DS* DP* 4-phenylamino-quinazolin-6-yl-amides Pat. Sub. Date(s): All strengths: Oct 25, 2018 Claim Types: Compound; Composition | May 5, 2028 | New expiration date. Was previously Aug 26, 2028 |
VOXZOGO (POWDER) (SUBCUTANEOUS) VOSORITIDE
Drug Classes: C type natriuretic peptide (CNP) analog
NDA Applicant: BIOMARIN PHARM NDA No.: 214938 Prod. No.: 001 RX (0.4MG/VIAL); 002 RX (0.56MG/VIAL); 003 RX (1.2MG/VIAL)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12233106 C-type natriuretic peptide variants to treat skeletal dysplasia in children Pat. Sub. Date(s): All strengths: Mar 21, 2025 Claim Types: Method of use Use Code: U-3927: Use to increase linear growth in pediatric patients with achondroplasia with open epiphyses | Jul 11, 2042 | New patent for this product |
VUMERITY (CAPSULE, DELAYED RELEASE) (ORAL) DIROXIMEL FUMARATE
NDA Applicant: BIOGEN INC NDA No.: 211855 Prod. No.: 001 RX (231MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8669281 DS* DP* [Extended 39 days (0.1 years)] Prodrugs of fumarates and their use in treating various diseases Pat. Sub. Date(s): 001: Nov 22, 2019 Claim Types: Compound; Composition | Oct 29, 2033 | New expiration date. Was previously Sep 20, 2033 |
WAINUA (AUTOINJECTOR) (SOLUTION) (SUBCUTANEOUS) EPLONTERSEN SODIUM
NDA Applicant: ASTRAZENECA AB NDA No.: 217388 Prod. No.: 001 RX (EQ 45MG BASE/0.8ML (EQ 45MG BASE/0.8ML))
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8101743 DS* DP* Modulation of transthyretin expression Pat. Sub. Date(s): 001: Jan 18, 2024 Claim Types: Compound | Apr 1, 2026 | New expiration date. Was previously Apr 1, 2025 |
XELJANZ (TABLET) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PF PRISM CV NDA No.: 203214 Prod. No.: 001 RX (EQ 5MG BASE)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection | Aug 21, 2028 PED | New exclusivity for this product |
XELJANZ (SOLUTION) (ORAL) TOFACITINIB CITRATE
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: PFIZER NDA No.: 213082 Prod. No.: 001 RX (EQ 1MG BASE/ML)
| Exclusivity | Expiration | Change |
|---|---|---|
| Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsection | Aug 21, 2028 PED | New exclusivity for this product |
XPOVIO (TABLET) (ORAL) SELINEXOR
Drug Classes: nuclear export inhibitor
NDA Applicant: KARYOPHARM THERAPS NDA No.: 212306 Prod. No.: 005 RX (10MG)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8999996 DS* DP* [Extended 342 days (0.9 years)] Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: Compound; Composition | Jul 3, 2033 | New strength or variation of this product |
| Pat. No. 9079865 Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: Method of use; Process Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-2855: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Jul 26, 2032 | New strength or variation of this product |
| Pat. No. 9714226 DS* DP* Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: Compound; Composition | Jul 26, 2032 | New strength or variation of this product |
| Pat. No. 10519139 DS* DP* Polymorphs of Selinexor Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-2855: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Aug 14, 2035 | New strength or variation of this product |
| Pat. No. 10544108 Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Jul 26, 2032 | New strength or variation of this product |
| Pat. No. 11034660 Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Jul 26, 2032 | New strength or variation of this product |
| Pat. No. 11746102 Polymorphs of selinexor Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-2855: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Aug 14, 2035 | New strength or variation of this product |
| Pat. No. 11753401 DP* Polymorphs of Selinexor Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: New polymorph, salt or hydrate; Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-2855: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Aug 14, 2035 | New strength or variation of this product |
| Pat. No. 11787771 Hydrazide containing nuclear transport modulators and uses thereof Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: Method of use Use Code: U-2584: XPOVIO is indicated in combination with dexamethasone to treat relapsed or refractory multiple myeloma (refractory to at least an anti-CD38 mab, 2 proteasome inhibitors and 2 immunomodulatory agents) in adults who received at least 4 prior therapies Use Code: U-2855: XPOVIO is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy Use Code: U-3018: XPOVIO is indicated in combination with bortezomib and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy | Jul 26, 2032 | New strength or variation of this product |
| Pat. No. 11807629 DS* Polymorphs of Selinexor Pat. Sub. Date(s): 005: Apr 8, 2025 Claim Types: New polymorph, salt or hydrate | Aug 14, 2035 | New strength or variation of this product |
YCANTH (SOLUTION) (TOPICAL) CANTHARIDIN
NDA Applicant: VERRICA PHARMS NDA No.: 212905 Prod. No.: 001 RX (0.7%)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 12233042 DP* Treatment of cutaneous disorders Pat. Sub. Date(s): 001: Mar 26, 2025 Claim Types: Formulation Use Code: U-3663: Topical treatment of molluscum contagiosum in adult and pediatric patients 2 years of age and older | Aug 22, 2038 | New patent for this product |
ZEPOSIA (CAPSULE) (ORAL) OZANIMOD HYDROCHLORIDE
Drug Classes: sphingosine 1-phosphate (S1P) receptor modulator
NDA Applicant: BRISTOL NDA No.: 209899 Prod. No.: 001 RX (EQ 0.23MG BASE); 002 RX (EQ 0.46MG BASE); 003 RX (EQ 0.92MG BASE)
| Patents | Expiration | Change |
|---|---|---|
| Pat. No. 8481573 DS* DP* Modulators of sphingosine phosphate receptors Pat. Sub. Date(s): All strengths: Apr 16, 2020 Claim Types: Compound; Method of use; Composition Use Code: U-2774: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults | Mar 24, 2033 | New expiration date. Was previously May 14, 2029 |
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 | Change |
|---|---|---|
| Pat. No. 8021335 DP* Prefilled syringe jet injector Pat. Sub. Date(s): None Claim Types: Device | Oct 4, 2026 | This patent is no longer listed for this product |
| Pat. No. 8496619 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): None Claim Types: Device | Aug 21, 2031 | This patent is no longer listed for this product |
| Pat. No. 8562564 DP* Prefilled syringe jet injector Pat. Sub. Date(s): None Claim Types: Device | Jan 24, 2026 | This patent is no longer listed for this product |
| Pat. No. 9180259 DP* Prefilled syringe jet injector Pat. Sub. Date(s): None Claim Types: Device | Jan 24, 2026 | This patent is no longer listed for this product |
| Pat. No. 9364610 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): None Claim Types: Device | Aug 21, 2031 | This patent is no longer listed for this product |
| Pat. No. 9364611 DP* Needle assisted jet injection device having reduced trigger force Pat. Sub. Date(s): None Claim Types: Device | Aug 21, 2031 | This patent is no longer listed for this product |
| Pat. No. 9446195 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): None Claim Types: Device | Aug 21, 2031 | This patent is no longer listed for this product |
| Pat. No. 9533102 DP* Prefilled syringe jet injector Pat. Sub. Date(s): None Claim Types: Device | Jan 24, 2026 | This patent is no longer listed for this product |
| Pat. No. 9629959 DP* Prefilled syringe jet injector Pat. Sub. Date(s): None Claim Types: Device | Jan 24, 2026 | This patent is no longer listed for this product |
| Pat. No. 10279131 DP* Injection device with cammed RAM assembly Pat. Sub. Date(s): None Claim Types: Device | Jul 31, 2031 | This patent is no longer listed for this product |
| Pat. No. 10357609 DP* Needle assisted jet injection device having reduced trigger force Pat. Sub. Date(s): None Claim Types: Device | Aug 21, 2031 | This patent is no longer listed for this product |
| Pat. No. 10478560 DP* Prefilled syringe injector Pat. Sub. Date(s): None Claim Types: Device | Jan 24, 2026 | This patent is no longer listed for this product |
| Pat. No. 10881798 DP* Needle assisted injection device having reduced trigger force Pat. Sub. Date(s): None Claim Types: Device | Feb 11, 2034 | This patent is no longer listed for this product |
| Pat. No. 10905827 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): None Claim Types: Device | Aug 21, 2031 | This patent is no longer listed for this product |
| Pat. No. 11185642 DP* Injection device with cammed ram assembly Pat. Sub. Date(s): None Claim Types: Device; Method of administration | Aug 28, 2031 | This patent is no longer listed for this product |
| Pat. No. 11191908 DP* Syringe shock absorber for use in an injection device Pat. Sub. Date(s): None Claim Types: Device | Oct 18, 2035 | This patent is no longer listed for this product |
| Pat. No. 11446440 DP* Needle assisted injection device having reduced trigger force Pat. Sub. Date(s): None Claim Types: Device | Aug 21, 2031 | This patent is no longer listed for this product |
| Pat. No. 11446441 DP* Prefilled syringe injector Pat. Sub. Date(s): None Claim Types: Device | Jan 24, 2026 | This patent is no longer listed for this product |
| Pat. No. 11813435 DP* Needle assisted injection device having reduced trigger force Pat. Sub. Date(s): None Claim Types: Device | Feb 25, 2035 | This patent is no longer listed for this product |