Orange Book Companion®
Patent Expiration View
Products whose next patent expiration is in 2024

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.


TASIGNA (CAPSULE) (ORAL) NILOTINIB HYDROCHLORIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: NOVARTIS      NDA No.: 022068  Prod. No.: 001 RX (EQ 200MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 50MG BASE)
PatentsExpirationPatented Use
Pat. No. 7169791 DS* DP* Inhibitors of tyrosine kinases
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: None; 002: Sep 23, 2011; 003: Apr 12, 2018
Jan 4, 2024 *PEDU-836: A method for the treatment of leukemias
Pat. No. 8389537 Salts of 4-methyl N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyridin-3-yl- -pyrimidin-2-ylamino)-benzamide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 29, 2013; 002: None; 003: Apr 12, 2018
Jan 18, 2027 *PEDU-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
Pat. No. 8415363 DS* DP* Crystalline forms of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-3-(4-pyr- idin-3-yl-pyrimidin-2-ylamino)-benzamide
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 13, 2013; 002: None; 003: Apr 12, 2018
Jan 18, 2027 *PEDU-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
U-1407: Treatment of newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (PH + CML)
Pat. No. 8501760 DP* Pharmaceutical compositions comprising nilotinib or its salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2013; 002: Aug 9, 2013; 003: Apr 12, 2018
Jan 18, 2027 *PED 
Pat. No. 8293756 DP* Pharmaceutical compositions comprising nilotinib hydrochloride monohydrate
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Oct 8, 2014; 002: Oct 8, 2014; 003: Apr 12, 2018
Mar 25, 2028 *PED 
Pat. No. 8163904 DS* DP* Salts of 4-methyl-N-[3-(4-methyl-imidazol-1-yl)-5-trifluoromethyl-phenyl]-- 3-(4-pyridin-3-yl-pyrimidin-2-ylamino)-Benzamide
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: May 10, 2012; 002: None; 003: Apr 12, 2018
Feb 23, 2029 *PED 
Pat. No. 9061029 DS* Method of treating proliferative disorders and other pathological conditions mediated by Bcr-Abl, c-Kit, DDR1, DDR2 or PDGF-R kinase activity
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Dec 1, 2016; 002: Dec 1, 2016; 003: Apr 12, 2018
Oct 7, 2032 *PEDU-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
U-3231: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (PH+CML) by administering nilotinib dispersed in a fruit preparation
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 22, 2025 PEDODE-171: Treatment of pediatric patients greater than or equal to 1 year of age with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML) in chronic phase
Exclusivity Code: ODE - Orphan drug exclusivitySep 22, 2025 PEDODE-172: Treatment of pediatric patients greater than or equal to 1 year of age with chronic phase Philadelphia chromosome positive chronic myeloid leukemia with resistance or intolerance to prior tyrosine-kinase inhibitor therapy
Exclusivity Code: ODE - Orphan drug exclusivityMar 23, 2029 PEDODE-380: Treatment of pediatric patients greater than or equal to 1 year of age with accelerated phase Philadelphia chromosome positive chronic myeloid leukemia (PH+ CML) with resistance orintolerance to prior tyrosine-kinase inhibitor (TKI) therapy

LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.: 022569  Prod. No.: 001 DISC (EQ 0.1MG BASE); 002 DISC (EQ 0.4MG BASE)
PatentsExpirationPatented Use
Pat. No. 9078814 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Aug 11, 2015
Jan 8, 2024 
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): All strengths: Dec 13, 2017
Jan 8, 2024 
Pat. No. 8889176 Method of managing or treating pain
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Dec 12, 2014
Jan 16, 2024U-767: Management of breakthrough pain in patients with cancer
Pat. No. 8216604 Method of managing or treating pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 19, 2012; 002: None
Oct 3, 2024U-767: Management of breakthrough pain in patients with cancer
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): All strengths: Sep 1, 2017
Jan 26, 2032 

LAZANDA (SPRAY, METERED) (NASAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: BTCP PHARMA      NDA No.: 022569  Prod. No.: 003 DISC (EQ 0.3MG BASE)
PatentsExpirationPatented Use
Pat. No. 9814705 DP* Intranasal spray device containing pharmaceutical composition
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 13, 2017
Jan 8, 2024 
Pat. No. 9731869 DP* Container
Claim Types: Packaging or device material
Pat. Sub. Date(s): 003: Sep 1, 2017
Jan 26, 2032 

ATRIPLA (TABLET) (ORAL) EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: Antivirals:Anti-HIV Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == Antivirals:Anti-HIV Combinations == HIV-1 non-nucleoside reverse transcriptase inhibitor (NNRTI) == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES      NDA No.: 021937  Prod. No.: 001 RX (600MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-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. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9018192 Unitary pharmaceutical dosage form
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2015
Jun 13, 2026U-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, 2026U-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 

STRIBILD (TABLET) (ORAL) COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
Drug Classes: Antivirals:Anti-HIV Agents, Other == CYP3A inhibitor == Antivirals:Anti-HIV Combinations == HIV integrase strand transfer inhibitor (HIV-1 INSTI) == Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 203100  Prod. No.: 001 RX (150MG;150MG;200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 2, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 19, 2017
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 7176220 DS* DP* [Extended 1011 days (2.8 years)]
4-oxoquinoline compound and use thereof as pharmaceutical agent
Claim Types: Method of use; Compound; Composition
Pat. Sub. Date(s): 001: None
Feb 27, 2027 *PEDU-257: Treatment of HIV infection
Pat. No. 7635704 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Apr 26, 2027 *PEDU-257: Treatment of HIV infection
Pat. No. 8981103 DS* DP* Stable crystal of 4-oxoquinoline compound
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Apr 14, 2015
Apr 26, 2027 *PED 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: None
Mar 3, 2030 *PEDU-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
Pat. No. 9891239 DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Mar 6, 2018
Mar 3, 2030 *PEDU-257: Treatment of HIV infection
Pat. No. 8633219 DP* Combination therapy
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 24, 2014
Oct 30, 2030 *PEDU-257: Treatment of HIV infection
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 4, 2018
Apr 6, 2033 *PED 

TRUVADA (TABLET) (ORAL) EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes: Antivirals:Anti-HIV Agents, Nucleoside and Nucleotide Reverse Transcriptase Inhibitors (NRTI) == Antivirals:Anti-HIV Combinations == HIV nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis B (HBV) Agents == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI)
NDA Applicant: GILEAD      NDA No.: 021752  Prod. No.: 001 RX (200MG;300MG)
PatentsExpirationPatented Use
Pat. No. 8592397 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Jan 13, 2024U-1170: Treatment of HIV-1 infection in pediatric patients 12 years of age and older
U-248: Treatment of HIV
U-541: Method of treatment of adults infected with HIV-1
Pat. No. 8716264 DP* Compositions and methods for combination antiviral therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 30, 2014
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9457036 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 10, 2016
Jan 13, 2024U-257: Treatment of HIV infection
Pat. No. 9744181 DP* Compositions and methods for combination antiviral therapy
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 18, 2017
Jan 13, 2024U-257: Treatment of HIV infection

DIFICID (TABLET) (ORAL) FIDAXOMICIN
Drug Classes: Antibacterials:Macrolides == macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC      NDA No.: 201699  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Dec 6, 2013
Jan 15, 2024 *PED 
Pat. No. 7906489 18-membered macrocycles and analogs thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 29, 2011
Sep 4, 2027 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
U-319: Treatment of microbial infections
Pat. No. 7378508 DS* DP* Polymorphic crystalline forms of tiacumicin B
Claim Types: New polymorph, salt or hydrate; Formulation; Composition
Pat. Sub. Date(s): 001: Aug 29, 2011
Jan 31, 2028 *PED 
Pat. No. 7863249 DS* DP* Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Aug 29, 2011
Jan 31, 2028 *PED 
Pat. No. 8859510 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 5, 2014
Jan 31, 2028 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
U-319: Treatment of microbial infections
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationJul 24, 2023 PED 
Exclusivity Code: ODE - Orphan drug exclusivityJan 24, 2027ODE-367: Pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD)

PROLENSA (SOLUTION/DROPS) (OPHTHALMIC) BROMFENAC SODIUM
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-inflammatories == nonsteroidal anti-inflammatory drug
NDA Applicant: BAUSCH AND LOMB      NDA No.: 203168  Prod. No.: 001 RX (EQ 0.07% ACID)
PatentsExpirationPatented Use
Pat. No. 8669290 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 28, 2014
Jan 16, 2024 
Pat. No. 8754131 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 30, 2014
Jan 16, 2024 
Pat. No. 8871813 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 29, 2014
Jan 16, 2024 
Pat. No. 8927606 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenyl acetic acid
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 12, 2015
Jan 16, 2024U-100: Method of treating ocular inflammation
U-1095: Method of treating ocular inflammation
U-810: Method of treatment to alleviate inflammation of the eye
Pat. No. 9144609 DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 4, 2015
Jan 16, 2024 
Pat. No. 9561277 Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 7, 2017
Jan 16, 2024U-1933: Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery
Pat. No. 8129431 DS* DP* Aqueous liquid preparation containing 2-amino-3-(4-bromobenzoyl)phenylacetic acid
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 6, 2013
Sep 11, 2025 
Pat. No. 10085958 DP* Bromfenac bioavailability
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 15, 2018
Nov 19, 2032 
Pat. No. 9517220 Bromfenac bioavailability
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 11, 2017
Nov 11, 2033U-1933: Treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract surgery

HALAVEN (SOLUTION) (INTRAVENOUS) ERIBULIN MESYLATE
Drug Classes: microtubule inhibitor
NDA Applicant: EISAI INC      NDA No.: 201532  Prod. No.: 001 RX (1MG/2ML (0.5MG/ML))
PatentsExpirationPatented Use
Pat. No. 6214865 DS* [Extended 1495 days (4.1 years)]
Macrocyclic analogs and methods of their use and preparation
Claim Types: Compound; Process
Pat. Sub. Date(s): 001: Nov 30, 2010
Jan 20, 2024 *PED 
Pat. No. RE46965 DP* Intermediates for the preparation of analogs of Halichondrin B
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 7, 2018
Jul 8, 2027 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousMar 13, 2026 PEDM-280: Revisions to the pediatric use subsection of labeling to include the results from clinical studies E7389-G000-223 and E7389-G000-213, conducted to fulfill a pediatric written request
Exclusivity Code: ODE - Orphan drug exclusivityJan 28, 2023ODE-107: Treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracyclne-containing regimen

RHOFADE (CREAM) (TOPICAL) OXYMETAZOLINE HYDROCHLORIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: EPI HLTH      NDA No.: 208552  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 8815929 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 12, 2018
Jan 22, 2024U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 8420688 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 9, 2017
Aug 2, 2024U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 7812049 Method and therapeutic/cosmetic topical compositions for the treatment of rosacea and skin erythema using .alpha..sub.1-adrenoceptor agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 9, 2017
May 2, 2028U-1959: Topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 8883838 DP* Pharmaceutical cream compositions and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 9, 2017
Dec 1, 2031 
Pat. No. 9974773 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 22, 2018
Jun 11, 2035U-2306: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream
Pat. No. 10335391 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2019
Jun 11, 2035U-2567: Once daily topical treatment of persistent facial erythema associated with rosacea in adults with 1% oxymetazoline hydrochloride cream, where the patient experiences no rebound or worsening of facial erythema post-treatment
Pat. No. 10751325 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 26, 2020
Jun 11, 2035U-2921: Once daily topical treatment of persistent facial erythema associated with rosacea in adults
Pat. No. 11517560 Stabilized oxymetazoline formulations and their uses
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2022
Jun 11, 2035U-3494: Once daily topical treatment of persistent facial erythema associated with rosacea in female adults

EVOCLIN (AEROSOL, FOAM) (TOPICAL) CLINDAMYCIN PHOSPHATE [GENERIC AT]
Drug Classes: Antibacterials:Antibacterials, Other == Dermatological Agents:Acne and Rosacea Agents == Dermatological Agents:Topical Anti-infectives == lincosamide antibacterial
NDA Applicant: MYLAN      NDA No.: 050801  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 7374747 DP* Pharmaceutical foam
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Jan 23, 2024U-921: Treatment of acne vulgaris
Pat. No. 7141237 DP* Pharmaceutical foam
Claim Types: Drug in a container
Pat. Sub. Date(s): 001: None
Feb 3, 2024 

DIFICID (FOR SUSPENSION) (ORAL) FIDAXOMICIN
Drug Classes: Antibacterials:Macrolides == macrolide antibacterial
NDA Applicant: CUBIST PHARMS LLC      NDA No.: 213138  Prod. No.: 001 RX (40MG/ML)
PatentsExpirationPatented Use
Pat. No. 8586551 DS* DP* 18-membered macrocycles and analogs thereof
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 23, 2024 *PED 
Pat. No. 7906489 18-membered macrocycles and analogs thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2020
Sep 4, 2027 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
Pat. No. 7378508 DS* DP* Polymorphic crystalline forms of tiacumicin B
Claim Types: New polymorph, salt or hydrate; Formulation; Composition
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 31, 2028 *PED 
Pat. No. 7863249 DP* Macrolide polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 31, 2028 *PED 
Pat. No. 8859510 Macrocyclic polymorphs, compositions comprising such polymorphs, and methods of use and manufacture thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2020
Jan 31, 2028 *PEDU-2741: Treatment of clostridioides difficile-associated diarrhea (CDAD) in patients from 6 months of age and older
Pat. No. 9808530 DP* Composition of tiacumicin compounds
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 21, 2020
Nov 28, 2034 *PED 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJul 24, 2023 PED 
Exclusivity Code: ODE - Orphan drug exclusivityJan 24, 2027ODE-367: Pediatric patients aged 6 months and older for the treatment of C. difficile-associated diarrhea (CDAD)

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))
PatentsExpirationPatented Use
Pat. No. 8299116 DP* CCI-779 concentrate formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 20, 2012
Jan 25, 2024 *PED 
Pat. No. 8455539 DP* CCI-779 concentrate formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 18, 2013
Jan 25, 2024 *PED 
Pat. No. 8722700 DP* CCI-779 formulations for parenteral administration
Claim Types: Method of administration; Formulation; Process
Pat. Sub. Date(s): 001: Jun 5, 2014
Jan 25, 2024 *PED 
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 *PEDU-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.

LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN      NDA No.: 202811  Prod. No.: 001 RX (145MCG)
PatentsExpirationPatented Use
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024 
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 18, 2012
Jan 28, 2024U-1278: Method of treating irritable bowel syndrome with constipation in adults
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, 2026U-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, 2031U-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, 2033U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.

LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN      NDA No.: 202811  Prod. No.: 002 RX (290MCG)
PatentsExpirationPatented Use
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: None
Jan 28, 2024 
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: None
Jan 28, 2024U-1278: Method of treating irritable bowel syndrome with constipation in adults
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, 2026U-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, 2031U-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, 2033U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.

LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == guanylate cyclase-C agonist
NDA Applicant: ALLERGAN      NDA No.: 202811  Prod. No.: 003 RX (72MCG)
PatentsExpirationPatented Use
Pat. No. 7371727 DS* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 7704947 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 7745409 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 8080526 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024 
Pat. No. 8110553 Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Feb 24, 2017
Jan 28, 2024U-1516: Method of treating chronic idiopathic constipation in adult patients.
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, 2026U-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): 003: Feb 24, 2017
Feb 17, 2031U-1516: Method of treating chronic idiopathic constipation in adult patients.
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, 2031U-1516: Method of treating chronic idiopathic constipation in adult patients.
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, 2033U-1516: Method of treating chronic idiopathic constipation in adult patients.

MYFEMBREE (TABLET) (ORAL) ESTRADIOL; NORETHINDRONE ACETATE; RELUGOLIX
Drug Classes: Contraceptives:Oral Contraceptives Combinations == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Contraceptives:Oral Progestins == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES      NDA No.: 214846  Prod. No.: 001 RX (1MG;0.5MG;40MG)
PatentsExpirationPatented Use
Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 21, 2021
Jan 28, 2024 
Pat. No. 8058280 DS* 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, 2024 
Pat. No. 9346822 Thienopyrimidine compounds and use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 21, 2021
Feb 17, 2024U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women
Pat. No. 11033551 Methods of treating uterine fibroids
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 21, 2021
Sep 29, 2037U-3129: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationAug 5, 2025I-898: For the management of moderate to severe pain associated with endometriosis
Exclusivity Code: NCE - New chemical entityDec 18, 2025 
Exclusivity Code: NP - New productMay 26, 2024 

ORGOVYX (TABLET) (ORAL) RELUGOLIX
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: MYOVANT SCIENCES      NDA No.: 214621  Prod. No.: 001 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 7300935 DS* Thienopyrimidine compounds and use thereof
Claim Types: Compound
Pat. Sub. Date(s): 001: Jan 14, 2021
Jan 28, 2024 
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, 2024 
Pat. No. 8735401 Thienopyrimidine compounds and use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2021
Feb 4, 2024U-3019: Treatment of adult patients with advanced prostate cancer that is sex-hormone-dependent
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, 2037U-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, 2037U-3020: Treatment of adult patients with advanced prostate cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityDec 18, 2025 

OMIDRIA (SOLUTION) (IRRIGATION) KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor == Ophthalmic Agents:Ophthalmic Combinations == alpha-1 adrenergic receptor agonist
NDA Applicant: RAYNER SURGICAL      NDA No.: 205388  Prod. No.: 001 RX (EQ 0.3% BASE;EQ 1% BASE)
PatentsExpirationPatented Use
Pat. No. 8173707 Ophthalmologic irrigation solutions and method
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 13, 2014
Jan 30, 2024 *PEDU-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 8586633 DP* Ophthalmologic irrigation solutions and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 13, 2014
Jan 30, 2024 *PED 
Pat. No. 9278101 Ophthalmologic irrigation solutions and method
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 9, 2016
Jan 30, 2024 *PEDU-1518: Maintaining pupil size by preventing intraoperative miosis and reducing postoperative ocular pain
Pat. No. 9399040 DP* Ophthalmologic irrigation solutions and method
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 28, 2016
Jan 30, 2024 *PED 
Pat. No. 9855246 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 5, 2018
Oct 23, 2033 
Pat. No. 9066856 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 13, 2015
Apr 23, 2034 *PED 
Pat. No. 9486406 DP* Stable preservative-free mydriatic and anti-inflammatory solutions for injection
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 9, 2016
Apr 23, 2034 *PED 

NATESTO (GEL, METERED) (NASAL) TESTOSTERONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant: ACERUS      NDA No.: 205488  Prod. No.: 001 RX (5.5MG/0.122GM ACTUATION)
PatentsExpirationPatented Use
Pat. No. 8574622 DP* Controlled release delivery system for nasal applications
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 26, 2014
Feb 4, 2024 
Pat. No. 8784869 DP* Controlled release delivery system for nasal applications and methods of treatment
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014
Feb 4, 2024 
Pat. No. 8784882 DP* Controlled release delivery system for nasal applications and method of treatment
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 20, 2014
Feb 4, 2024U-1557: A method of testosterone replacement therapy comprising the step of nasally administering to a patient in need of such treatment an effective amount of testosterone gel formulation.
Pat. No. 8877230 Controlled release delivery system for nasal applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 3, 2014
Feb 4, 2024U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone
Pat. No. 11090312 Methods of treating hypogonadism with transnasal testerosterone bio-adhesive gel formulations in male with allergic rhinitis, and methods for preventing an allergic rhinitis event
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Sep 10, 2021
Mar 17, 2034U-1616: Nasal administration of a testosterone gel to a patient to treat the patient for a condition associated with a deficiency or absence of endogenous testosterone

ZMAX (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) AZITHROMYCIN
Drug Classes: Antibacterials:Macrolides == Ophthalmic Agents:Ophthalmic Anti-Infectives == macrolide antimicrobial
NDA Applicant: PF PRISM CV      NDA No.: 050797  Prod. No.: 001 DISC (EQ 2GM BASE/BOT)
PatentsExpirationPatented Use
Pat. No. 6984403 DP* Azithromycin dosage forms with reduced side effects
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: None
Feb 14, 2024U-282: Method of treating bacterial infections
Pat. No. 7887844 DP* Multiparticulate crystalline drug compositions having controlled release profiles
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Mar 15, 2011
Feb 14, 2024 

EXSERVAN (FILM) (ORAL) RILUZOLE
Drug Classes: Central Nervous System Agents:Central Nervous System, Other == benzothiazole
NDA Applicant: AQUESTIVE      NDA No.: 212640  Prod. No.: 001 RX (50MG)
PatentsExpirationPatented Use
Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Jun 2, 2020
Feb 20, 2024 
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 2, 2020
Apr 3, 2024 

LATUDA (TABLET) (ORAL) LURASIDONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant: SUNOVION PHARMS INC      NDA No.: 200603  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (20MG); 004 RX (120MG); 005 RX (60MG)
PatentsExpirationPatented Use
Pat. No. 9815827 Agent for treatment of schizophrenia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 12, 2017
Feb 20, 2024U-2166: Treatment of major depressive episodes associated with bipolar I disorder
U-543: Treatment of schizophrenia
Pat. No. 9174975 Remedy for integration dysfunction syndrome
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 23, 2015
Aug 20, 2024 *PEDU-1770: Treatment of schizophrenia with improvement in negative symptoms and/or cognitive dysfunction of schizophrenia
Pat. No. RE45573 DS* Process for producing imide compound
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jun 24, 2015
Dec 23, 2025 *PED 
Pat. No. 9555027 DP* Pharmaceutical composition
Claim Types: Formulation; Process; Method of use
Pat. Sub. Date(s): All strengths: Mar 1, 2017
May 26, 2026U-543: Treatment of schizophrenia
Pat. No. 9907794 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Mar 19, 2018
May 26, 2026 
Pat. No. 8729085 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 29, 2014
Nov 26, 2026 *PED 
Pat. No. 8883794 DP* Pharmaceutical composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 12, 2014
Nov 26, 2026 *PED 
Pat. No. 9827242 Method of treatment for mental disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 19, 2017
May 23, 2031U-2199: Treatment of schizophrenia with improvement in attention function in schizophrenia
U-2201: Treatment of bipolar depression with improvement in attention function in bipolar disorder
Pat. No. 9259423 Method of treatment for mental disorders
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 15, 2016
Nov 23, 2031 *PEDU-1822: Treatment of schizophrenia or bipolar depression with improvement in attention function in schizophrenia and/or bipolar disorder

SYMPAZAN (FILM) (ORAL) CLOBAZAM
Drug Classes: Anticonvulsants:Gamma-aminobutyric Acid (GABA) Augmenting Agents == benzodiazepine
NDA Applicant: OTTER PHARMS      NDA No.: 210833  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (20MG)
PatentsExpirationPatented Use
Pat. No. 8765167 DP* Uniform films for rapid-dissolve dosage form incorporating anti-tacking compositions
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: Nov 30, 2018
Feb 20, 2024 
Pat. No. 8603514 DP* Uniform films for rapid dissolve dosage form incorporating taste-masking compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 30, 2018
Apr 3, 2024 
Pat. No. 11541002 DP* Oral film compositions and dosage forms having precise active dissolution profiles
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 4, 2023
Sep 5, 2039U-724: Method of treating seizures

OFEV (CAPSULE) (ORAL) NINTEDANIB ESYLATE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Fibrosis Agents == kinase inhibitor
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 205832  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 7119093 DS* DP* 3-Z-[1-(4-(N-((4-Methyl-piperazin-1-yl)-methylcarbonyl)-N-methyl-amino)-an-ilino)-1-phenyl-methylene]-6-methoxycarbonyl-2-indolinone-monoethanesulpho- nate and the use thereof as a pharmaceutical composition
Claim Types: New polymorph, salt or hydrate; Composition; Intermediate
Pat. Sub. Date(s): All strengths: Oct 22, 2014
Feb 21, 2024 
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
Oct 1, 2025 
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
Dec 20, 2025U-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
Jun 4, 2029 
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
Jun 7, 2029 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationSep 6, 2022I-805: Slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease
Exclusivity Code: I - New IndicationMar 9, 2023I-825: Treatment for chronic fibrosing interstitial lung diseases with a progressive phenotype
Exclusivity Code: ODE - Orphan drug exclusivitySep 6, 2026ODE-261: Indicated to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSC-ILD)
Exclusivity Code: ODE - Orphan drug exclusivityOct 15, 2021ODE-77: Treatment of idiopathic pulmonary fibrosis

NASCOBAL (SPRAY, METERED) (NASAL) CYANOCOBALAMIN
Drug Classes: radioactive diagnostic agent
NDA Applicant: ENDO PHARMS INC      NDA No.: 021642  Prod. No.: 001 RX (0.5MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 8940714 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 5, 2015
Feb 26, 2024U-1152: Cyanocobalamin administration through nasal infusion
Pat. No. 7404489 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Kit
Pat. Sub. Date(s): 001: None
Mar 12, 2024 
Pat. No. 9415007 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 15, 2016
Jul 28, 2024U-1896: Supplement for vitamin B12 deficiencies
Pat. No. 7229636 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: None
Aug 1, 2024U-817: Nasal administration of cyanocobalamin
Pat. No. 7879349 DP* Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Formulation; Method of administration; Method of use
Pat. Sub. Date(s): 001: Jun 10, 2011
Aug 1, 2024U-1152: Cyanocobalamin administration through nasal infusion
Pat. No. 8003353 Cyanocobalamin low viscosity aqueous formulations for intranasal delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 9, 2014
Aug 1, 2024U-817: Nasal administration of cyanocobalamin

ULORIC (TABLET) (ORAL) FEBUXOSTAT [GENERIC AB]
Drug Classes: Antigout Agents
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021856  Prod. No.: 001 RX (40MG); 002 RX (80MG)
PatentsExpirationPatented Use
Pat. No. 7361676 DP* Solid preparation containing single crystal form
Claim Types: Formulation; Process
Pat. Sub. Date(s): All strengths: None
Mar 8, 2024 
Pat. No. 8372872 Methods for concomitant treatment of theophylline and febuxostat
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 26, 2013; 002: None
Sep 8, 2031U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline
Pat. No. 9107912 Methods for concomitant treatment of theophylline and febuxostat
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 3, 2015
Sep 8, 2031U-1346: Use of febuxostat for the management of hyperuricemia in patients suffering from gout and, when used with theophylline without the need for dose adjustment of theophylline

SINUVA (IMPLANT) (IMPLANTATION) MOMETASONE FUROATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: INTERSECT ENT INC      NDA No.: 209310  Prod. No.: 001 RX (1.35MG)
PatentsExpirationPatented Use
Pat. No. 7662141 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-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. 7713255 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-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. 7951130 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-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. 7951131 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-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. 7951133 Sinus delivery of sustained release therapeutics
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-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. 8109918 Sinus delivery of sustained release therapeutics
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Mar 12, 2024U-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. 9585681 Device and methods for treating paranasal sinus conditions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 26, 2018
Apr 4, 2026U-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, 2026U-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, 2027U-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, 2031U-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, 2034U-2272: Treatment of nasal polyps in patients >=18 years of age who have had ethmoid sinus surgery using a corticosteroid-eluting (mometasone furoate) implant

TIROSINT (CAPSULE) (ORAL) LEVOTHYROXINE SODIUM [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/Replacement/ Modifying (Thyroid) == L-thyroxine (T4)
NDA Applicant: INSTITUT BIOCHIMIQUE      NDA No.: 021924  Prod. No.: 002 RX (0.025MG); 003 RX (0.05MG); 004 RX (0.075MG); 005 RX (0.1MG); 006 RX (0.125MG); 007 RX (0.15MG); 008 RX (0.112MG); 009 RX (0.137MG); 010 RX (0.088MG); 011 RX (0.175MG); 012 RX (0.2MG); 013 RX (0.013MG)
PatentsExpirationPatented Use
Pat. No. 7691411 DP* Pharmaceutical formulae for thyroid hormones and procedures for obtaining them
Claim Types: Formulation
Pat. Sub. Date(s): 002: Sep 15, 2016; 003: Sep 15, 2016; 004: Sep 15, 2016; 005: Sep 15, 2016; 006: Sep 15, 2016; 007: Sep 15, 2016; 008: Sep 15, 2016; 009: Sep 15, 2016; 010: Sep 15, 2016; 011: Oct 17, 2019; 012: Oct 17, 2019; 013: Sep 15, 2016
Mar 14, 2024 
Pat. No. 7723390 DP* Pharmaceutical formulations for thyroid hormones
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 27, 2010; 003: May 27, 2010; 004: May 27, 2010; 005: May 27, 2010; 006: May 27, 2010; 007: May 27, 2010; 008: May 27, 2010; 009: May 27, 2010; 010: May 27, 2010; 011: Oct 17, 2019; 012: Oct 17, 2019; 013: May 27, 2010
Mar 14, 2024 

VELTASSA (POWDER) (ORAL) PATIROMER SORBITEX CALCIUM
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Potassium Binders
NDA Applicant: VIFOR PHARMA      NDA No.: 205739  Prod. No.: 001 RX (EQ 8.4GM BASE/PACKET); 002 RX (EQ 16.8GM BASE/PACKET); 003 RX (EQ 25.2GM BASE/PACKET)
PatentsExpirationPatented Use
Pat. No. 8287847 Ion binding polymers and uses thereof
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8475780 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8778324 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 8889115 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 10485821 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2019
Mar 30, 2024U-1766: Treatment of hyperkalemia
Pat. No. 7556799 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Feb 27, 2025U-1766: Treatment of hyperkalemia
Pat. No. 8216560 Ion binding polymers and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Mar 14, 2027U-1766: Treatment of hyperkalemia
Pat. No. 8282913 DP* Ion binding polymers and uses thereof
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Nov 18, 2015
May 29, 2027 
Pat. No. 8147873 DP* [Extended 832 days (2.3 years)]
Methods and compositions for treatment of ion imbalances
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 18, 2015
Jun 20, 2028 
Pat. No. 8337824 DS* Linear polyol stabilized polyfluoroacrylate compositions
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Nov 18, 2015
May 29, 2030U-1766: Treatment of hyperkalemia
Pat. No. 9492476 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 13, 2016
Oct 8, 2033U-1766: Treatment of hyperkalemia
Pat. No. 9925212 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 20, 2018
Oct 8, 2033U-1766: Treatment of hyperkalemia
Pat. No. 11123363 Potassium-binding agents for treating hypertension and hyperkalemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 21, 2021
Oct 8, 2033U-1766: Treatment of hyperkalemia

ARIKAYCE KIT (SUSPENSION, LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes: Antibacterials:Aminoglycosides == aminoglycoside antibacterial
NDA Applicant: INSMED INC      NDA No.: 207356  Prod. No.: 001 RX (EQ 590MG BASE/8.4ML)
PatentsExpirationPatented Use
Pat. No. 8802137 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 9827317 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Apr 8, 2024U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 7718189 DP* Sustained release of antiinfectives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jun 6, 2025U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8632804 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen
Pat. No. 8642075 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026 
Pat. No. 8679532 Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Dec 5, 2026U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 8226975 DP* Lipid-based compositions of antiinfectives for treating pulmonary infections and methods of use thereof
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Aug 15, 2028 
Pat. No. 9566234 DP* Systems for treating pulmonary infections
Claim Types: Kit; Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
Jan 18, 2034U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen
Pat. No. 9895385 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2018
May 15, 2035U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen
Pat. No. 10251900 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 2, 2019
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 10751355 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 24, 2020
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
Pat. No. 11446318 Methods for treating pulmonary non-tuberculous mycobacterial infections
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2022
May 15, 2035U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivitySep 28, 2030 GAINODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy

RELISTOR (SOLUTION) (SUBCUTANEOUS) METHYLNALTREXONE BROMIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == opioid antagonist
NDA Applicant: SALIX PHARMS      NDA No.: 021964  Prod. No.: 001 RX (12MG/0.6ML (12MG/0.6ML)); 002 RX (8MG/0.4ML (8MG/0.4ML)); 003 RX (12MG/0.6ML (12MG/0.6ML))
PatentsExpirationPatented Use
Pat. No. 8552025 DP* Stable methylnaltrexone preparation
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 22, 2013
Apr 8, 2024 
Pat. No. 9669096 DP* Stable pharmaceutical formulations of methylnaltrexone
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jun 9, 2017
Apr 8, 2024 
Pat. No. 10376584 DP* Stable pharmaceutical formulations of methylnaltrexone
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Sep 10, 2019
Apr 8, 2024U-1185: Treatment of opioid-induced constipation
Pat. No. 8420663 Peripheral opioid receptor antagonists and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 24, 2013; 002: None; 003: None
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 8822490 DP* Peripheral opioid receptor antagonists and uses thereof
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): All strengths: Sep 22, 2014
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 9180125 DP* Peripheral opioid receptor antagonists and uses thereof
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Nov 20, 2015
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 9492445 DP* Peripheral opioid receptor antagonists and uses thereof
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Aug 30, 2017
Sep 30, 2029U-1185: Treatment of opioid-induced constipation
Pat. No. 8247425 Peripheral opioid receptor antagonists and uses thereof
Claim Types: Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Sep 13, 2012; 002: None; 003: None
Dec 31, 2030U-1185: Treatment of opioid-induced constipation

MAVENCLAD (TABLET) (ORAL) CLADRIBINE
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents == purine antimetabolite
NDA Applicant: EMD SERONO INC      NDA No.: 022561  Prod. No.: 001 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 7888328 DP* Oral formulations of cladribine
Claim Types: Formulation; Product-by-process; Method of improving a treatment; Method of use; Process
Pat. Sub. Date(s): 001: May 28, 2019
Apr 11, 2024U-2521: Treatment of MS with a tablet with an admixture of (a) an amorphous inclusion complex of cladribine and hydroxypropyl-b-cyclodextrin and (b) amorphous free cladribine and cyclodextrin as a non-inclusion complex, cladribine/cyclodextrin 1:10-1:16 w/w
Pat. No. 8785415 DP* Oral formulations of cladribine
Claim Types: Formulation; Process; Product-by-process; Method of use
Pat. Sub. Date(s): 001: May 28, 2019
Apr 11, 2024U-2523: Treatment of MS with an admixture of (a) an amorphous inclusion complex of cladribine (2CDA) and cyclodextrin and (b) amorphous free 2CDA and cyclodextrin as a non-inclusion complex, formulated as a solid oral form, w/o sign. amounts of cryst. 2CDA
Pat. No. 8377903 Cladribine regimen for treating multiple sclerosis
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 28, 2019
May 31, 2026U-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, 2026U-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, 2038U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 29, 2022 

BOSULIF (TABLET) (ORAL) BOSUTINIB MONOHYDRATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == 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)
PatentsExpirationPatented Use
Pat. No. RE42376 DS* [Extended 1663 days (4.6 years)]
Substituted 3-cyanoquinolines
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Sep 25, 2012; 002: None; 003: Nov 15, 2017
Apr 13, 2024 
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
Dec 11, 2025U-1283: A method of treating chronic myelogenous leukemia
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
Dec 11, 2025 
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
Nov 23, 2026 
Pat. No. 11103497 Treatment of imatinib resistant leukemia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 29, 2021
Feb 28, 2034U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityDec 19, 2024ODE-163: Treatment of adult patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome-positive chronic myelogenous leukemia (Ph+ CML)

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 001 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Apr 15, 2024U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Jun 30, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
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): 001: Feb 5, 2014
Oct 4, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
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: Feb 5, 2014
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 5, 2014
Mar 21, 2028 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 5, 2014
Mar 21, 2028U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 2, 2014
Mar 21, 2028 
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 5, 2014
Aug 19, 2028 
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: Feb 5, 2014
Dec 16, 2029 
Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 15, 2017
Jan 18, 2030 
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: Jun 25, 2014
May 26, 2030U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 5, 2023I-834: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction
Exclusivity Code: I - New IndicationOct 18, 2022I-841: To reduce the risk of hospitalization for heart failure in adults with Type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors
Exclusivity Code: I - New IndicationApr 30, 2024I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Exclusivity Code: M - MiscellaneousFeb 22, 2022M-238: Information added to the prescribing information to reflect that no dose adjustment is needed for patients with an estimated glomerular filtration rate (EGFR) of 45 ml/min/1.73 m2 or greater as supported by clinical study report

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 002 RX (10MG)
PatentsExpirationPatented Use
Pat. No. 9238076 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 15, 2024U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8431685 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 8461105 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Apr 13, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Pat. No. 7456254 DP* Polymer-based sustained release device
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Jun 30, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
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): 002: Feb 5, 2014
Oct 4, 2025U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8329648 Methods for treating diabetes and reducing body weight
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Pat. No. 8906851 Method for treating diabetes
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 15, 2017
Aug 18, 2026U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
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): 002: Feb 5, 2014
Jun 20, 2027U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8221786 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 5, 2014
Mar 21, 2028 
Pat. No. 8361972 Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 5, 2014
Mar 21, 2028U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 8716251 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 2, 2014
Mar 21, 2028 
Pat. No. 7851502 DP* Pharmaceutical formulations containing an SGLT2 inhibitor
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 5, 2014
Aug 19, 2028 
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): 002: Feb 5, 2014
Dec 16, 2029 
Pat. No. 8721615 DP* DLR* Ampoule comprising an ampoule holder
Claim Types: Device
Pat. Sub. Date(s): 002: Nov 15, 2017
Jan 18, 2030 
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): 002: Jun 25, 2014
May 26, 2030U-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. 10973836 Methods of treating heart failure with reduced ejection fraction
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Apr 21, 2021
Mar 9, 2040U-3127: Reduction of the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction and without Type II diabetes
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationMay 5, 2023I-834: To reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure (NYHA class II-IV) with reduced ejection fraction
Exclusivity Code: I - New IndicationOct 18, 2022I-841: To reduce the risk of hospitalization for heart failure in adults with Type 2 diabetes mellitus and established cardiovascular disease or multiple cardiovascular risk factors
Exclusivity Code: I - New IndicationApr 30, 2024I-857: To reduce the risk of sustained EGFR decline, end-stage kidney disease, cardiovascular death, and hospitalization for heart failure in adults with chronic kidney disease at risk of progression
Exclusivity Code: M - MiscellaneousFeb 22, 2022M-238: Information added to the prescribing information to reflect that no dose adjustment is needed for patients with an estimated glomerular filtration rate (EGFR) of 45 ml/min/1.73 m2 or greater as supported by clinical study report

EVEKEO ODT (TABLET, ORALLY DISINTEGRATING) (ORAL) AMPHETAMINE SULFATE
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines == central nervous system stimulant
NDA Applicant: AZURITY      NDA No.: 209905  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG) NDA No.: 209905  Prod. No.: 005 DISC (2.5MG)
PatentsExpirationPatented Use
Pat. No. 10130580 DP* Taste-masked pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 31, 2019; 002: Jan 31, 2019; 003: Jan 31, 2019; 004: Jan 31, 2019; 005: Jul 7, 2021
Apr 19, 2024 
Pat. No. 10441554 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 15, 2019; 002: Oct 15, 2019; 003: Oct 15, 2019; 004: Oct 15, 2019; 005: Jul 7, 2021
Mar 10, 2037 
Pat. No. 11160772 DP* Oral amphetamine composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 9, 2021
Mar 10, 2037 

CONTRAVE (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants, Other == aminoketone == Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents == opioid antagonist
NDA Applicant: NALPROPION      NDA No.: 200063  Prod. No.: 001 RX (90MG;8MG)
PatentsExpirationPatented Use
Pat. No. 11278544 Compositions for affecting weight loss
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2022
Apr 21, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 7462626 Compositions for affecting weight loss
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Jul 20, 2024U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 8815889 Compositions and methods for increasing insulin sensitivity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Jul 20, 2024U-1586: For effect on blood glucose parameters in patients with insulin resistance
Pat. No. 7375111 DP* Compositions for affecting weight loss
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Mar 26, 2025 
Pat. No. 9107837 Sustained release formulation of naltrexone
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 3, 2015
Jun 4, 2027U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 8318788 Layered pharmaceutical formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Nov 8, 2027U-1584: Use of naltrexone and bupropion in a layered formulation for chronic weight management for affecting weight loss
Pat. No. 8722085 Methods for administering weight loss medications
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2014
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 9125868 Methods for administering weight loss medications
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 15, 2015
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 10307376 Methods for administering weight loss medications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 17, 2019
Nov 8, 2027U-1585: Use of naltrexone and bupropion based on an escalating dose schedule
Pat. No. 8088786 DP* Layered pharmaceutical formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 6, 2014
Feb 3, 2029 
Pat. No. 11324741 Methods for treating visceral fat conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 19, 2022
May 29, 2029U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 8916195 Sustained release formulation of naltrexone
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 20, 2015
Feb 2, 2030U-1639: Use of naltrexone and bupropion in extended-release form for chronic weight management for treating overweight or obesity
Pat. No. 11033543 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 22, 2021
Jan 10, 2031U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 9248123 Methods of providing weight loss therapy in patients with major depression
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 17, 2016
Jan 13, 2032U-1808: Use of naltrexone and bupropion for chronic weight management for treating overweight or obesity in patients with major depressive disorder
Pat. No. 10403170 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 11139056 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 5, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 9633575 Methods of treating overweight and obesity
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 29, 2021
Jun 25, 2033U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10231964 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2019
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10828294 Compositions and methods for weight loss in at risk patient populations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity
Pat. No. 10835527 Compositions and methods for reducing major adverse cardiovascular events
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 14, 2020
Jul 2, 2034U-1583: For chronic weight management for treating overweight or obesity

MEGACE ES (SUSPENSION) (ORAL) MEGESTROL ACETATE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
NDA Applicant: ENDO PHARMS INC      NDA No.: 021778  Prod. No.: 001 RX (125MG/ML)
PatentsExpirationPatented Use
Pat. No. 7101576 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9040088 Nanoparticulate megestrol formulations
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 11, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9101540 DP* Nanoparticulate megestrol formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 13, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9101549 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 13, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)
Pat. No. 9107827 Nanoparticulate megestrol formulations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 27, 2015
Apr 22, 2024U-755: Treatment of anorexia, cachexia, or an unexplained, significant weight loss in patients with a diagnosis of acquired immunodeficiency syndrome (aids)

SOOLANTRA (CREAM) (TOPICAL) IVERMECTIN [GENERIC AB]
Drug Classes: Antiparasitics:Anthelmintics == Dermatological Agents:Pediculicides/Scabicides
NDA Applicant: GALDERMA LABS LP      NDA No.: 206255  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 7550440 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8080530 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8093219 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8415311 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8470788 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 8815816 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Jan 20, 2015
Apr 22, 2024U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 11033565 DP* Topical application of ivermectin for the treatment of dermatological conditions/afflictions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 22, 2021
Apr 22, 2024 
Pat. No. 9089587 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2015
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233117 Treatment of inflammatory lesions of rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2016
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9233118 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 19, 2016
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 9782425 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 5, 2018
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.
Pat. No. 10206939 Treatment of papulopustular rosacea with ivermectin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 19, 2019
Mar 13, 2034U-1631: Treatment of inflammatory lesions of rosacea.

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == corticosteroid
NDA Applicant: HORIZON      NDA No.: 202020  Prod. No.: 001 RX (1MG)
PatentsExpirationPatented Use
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 13, 2012
Apr 23, 2024U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Mar 12, 2013
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == corticosteroid
NDA Applicant: HORIZON      NDA No.: 202020  Prod. No.: 002 RX (2MG)
PatentsExpirationPatented Use
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 002: None
Apr 23, 2024 
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 002: None
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet

RAYOS (TABLET, DELAYED RELEASE) (ORAL) PREDNISONE [GENERIC AB]
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == corticosteroid
NDA Applicant: HORIZON      NDA No.: 202020  Prod. No.: 003 RX (5MG)
PatentsExpirationPatented Use
Pat. No. 8309124 Delayed release tablet with defined core geometry
Claim Types: Method of administration
Pat. Sub. Date(s): 003: None
Apr 23, 2024U-1292: Treatment of diseases or conditions by the use of a delayed release 1, 2, or 5 mg prednisone tablet
Pat. No. 8394407 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 003: None
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9040085 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 003: Jun 25, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9186332 Delayed release tablet with defined core geometry
Claim Types: Method of use
Pat. Sub. Date(s): 003: Dec 4, 2015
Apr 23, 2024U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 9504699 Delayed-release glucocorticoid treatment of rheumatoid disease
Claim Types: Method of use
Pat. Sub. Date(s): 003: Dec 7, 2016
Aug 3, 2027U-1362: Treatment of diseases or conditions by the use of a delayed-release 1,2, or 5mg prednisone tablet
Pat. No. 8168218 DP* Delayed release tablet with defined core geometry
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Aug 22, 2012
Jan 7, 2028U-1269: Treatment of rheumatologic, allergic, pulmonary, gastrointestinal, dermatologic diseases or conditions by the use of a delayed release 5mg prednisone tablet

PROBUPHINE (IMPLANT) (IMPLANTATION) BUPRENORPHINE HYDROCHLORIDE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == partial opioid agonist
NDA Applicant: TITAN PHARMS      NDA No.: 204442  Prod. No.: 001 DISC (EQ 80MG BASE/IMPLANT)
PatentsExpirationPatented Use
Pat. No. 7736665 Implantable polymeric device for sustained release of buprenorphine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2016
Apr 25, 2024U-1878: For opioid dependence

DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents == prostaglandin analog
NDA Applicant: ALLERGAN INC      NDA No.: 211911  Prod. No.: 001 RX (10MCG)
PatentsExpirationPatented Use
Pat. No. 10398707 Hypotensive lipid-containing biodegradable intraocular implants and related implants
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Apr 30, 2024U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
Pat. No. 8673341 Intraocular pressure reduction with intracameral bimatoprost implants
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Feb 19, 2025U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
Pat. No. 9149428 DP* Processes for making cyclic lipid implants for intraocular use
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 24, 2020
Dec 19, 2026 
Pat. No. 10441543 DP* Processes for making cyclic lipid implants for intraocular use
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 24, 2020
Dec 19, 2026 
Pat. No. 8206737 Hypotensive lipid-containing biodegradable intraocular implants and related methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Apr 7, 2027U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
Pat. No. 7799336 DP* Hypotensive lipid-containing biodegradable intraocular implants and related methods
Claim Types: Device; Product-by-process
Pat. Sub. Date(s): 001: Mar 24, 2020
Apr 24, 2029 
Pat. No. 8629185 DS* DP* 7-[3,5-dihydroxy-2- (3-hydroxy-5-phenyl-pent-1-enyl)-cyclopentyl]-N-ethyl-hept-5-enamide (bimatoprost) in crystalline form II, methods for preparation, and methods for use thereof
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Mar 24, 2020
Jul 15, 2031 
Pat. No. 9492316 DP* Prostamide-containing intraocular implants and methods of use thereof
Claim Types: Device; Method of use; Process
Pat. Sub. Date(s): 001: Mar 24, 2020
Oct 31, 2034 
Pat. No. 9980974 Prostamide-containing intraocular implants and methods of use thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Oct 31, 2034U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productMar 4, 2023 

DUAVEE (TABLET) (ORAL) BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
Drug Classes: estrogen agonist/antagonist
NDA Applicant: WYETH PHARMS      NDA No.: 022247  Prod. No.: 001 RX (EQ 20MG BASE;0.45MG)
PatentsExpirationPatented Use
Pat. No. 6479535 DP* 2-phenyl-1-[4-(2-aminoethoxy)-benzyl]-indole and estrogen formulations
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 31, 2013
May 6, 2024U-594: Prevention of postmenopausal osteoporosis
U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause
Pat. No. 7683051 DS* DP* Crystalline polymorph of bazedoxifene acetate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process; Product-by-process
Pat. Sub. Date(s): 001: Oct 31, 2013
Mar 10, 2027U-594: Prevention of postmenopausal osteoporosis
U-904: Treatment of moderate to severe vasomotor symptoms associated with menopause

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))
PatentsExpirationPatented Use
Pat. No. 7084245 DS* DP* Peptides that bind to the erythropoietin receptor
Claim Types: Compound; 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
May 12, 2024U-1238: Treatment of anemia due to chronic kidney disease
Pat. No. 7414105 DS* DP* [Extended 684 days (1.9 years)]
Peptides that bind to the erythropoietin receptor
Claim Types: Compound; 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
May 12, 2024U-1238: Treatment of anemia due to chronic kidney disease
Pat. No. 7528104 DS* DP* Peptides that bind to the erythropoietin receptor
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
May 12, 2024 
Pat. No. 7919118 DS* DP* Spacer moiety for poly (ethylene glycol) modified peptide based compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Apr 25, 2012; 002: None; 003: None; 004: None; 005: None; 006: None; 007: None; 008: None
May 12, 2024 
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, 2026U-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, 2026U-1238: Treatment of anemia due to chronic kidney disease

ALIQOPA (POWDER) (INTRAVENOUS) COPANLISIB DIHYDROCHLORIDE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: BAYER HEALTHCARE      NDA No.: 209936  Prod. No.: 001 RX (60MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7511041 DS* DP* Fused azole-pyrimidine derivatives
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Oct 10, 2017
May 13, 2024 
Pat. No. RE46856 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating hyper-proliferative disorders and diseases associated with angiogenesis
Claim Types: Compound; Composition; Kit; Method of use
Pat. Sub. Date(s): 001: Jun 15, 2018
Oct 22, 2029U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 9636344 Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 10, 2017
Mar 29, 2032U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies
Pat. No. 10383876 DS* DP* Substituted 2,3-dihydroimidazo[1,2-c]quinazoline salts
Claim Types: Compound; New polymorph, salt or hydrate; Process; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 18, 2019
Mar 29, 2032 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entitySep 14, 2022 
Exclusivity Code: ODE - Orphan drug exclusivitySep 14, 2024ODE-155: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies

EQUETRO (CAPSULE, EXTENDED RELEASE) (ORAL) CARBAMAZEPINE [Has competitive generic]
Drug Classes: Anticonvulsants:Sodium Channel Agents == Bipolar Agents:Mood Stabilizers == Central Nervous System Agents:Central Nervous System, Other
NDA Applicant: VALIDUS PHARMS      NDA No.: 021710  Prod. No.: 001 RX (100MG); 002 RX (200MG); 003 RX (300MG)
PatentsExpirationPatented Use
Pat. No. 6977253 Methods for the treatment of bipolar disorder using carbamazepine
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 19, 2024U-693: The recommended initial dose of EQUETRO is 400mg/day given in divided doses, twice daily. The dose should be adjusted in 200mg daily increments to achieve optimal clinical response.

PREVYMIS (TABLET) (ORAL) LETERMOVIR
Drug Classes: Antivirals:Anti-cytomegalovirus (CMV) Agents == CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 209939  Prod. No.: 001 RX (240MG); 002 RX (480MG)
PatentsExpirationPatented Use
Pat. No. RE46791 DS* DP* Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 21, 2020
May 22, 2024 
Pat. No. 8513255 DS* DP* Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 7, 2017
May 22, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 8, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityNov 8, 2024ODE-165: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)

PREVYMIS (SOLUTION) (INTRAVENOUS) LETERMOVIR
Drug Classes: Antivirals:Anti-cytomegalovirus (CMV) Agents == CMV DNA terminase complex inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 209940  Prod. No.: 001 RX (240MG/12ML (20MG/ML)); 002 RX (480MG/24ML (20MG/ML))
PatentsExpirationPatented Use
Pat. No. RE46791 DS* DP* Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 29, 2020
May 22, 2024 
Pat. No. 8513255 DS* DP* Substituted dihydroquinazolines
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 7, 2017
May 22, 2024 
Pat. No. 10603384 DP* Pharmaceutical composition containing an antivirally active dihydroquinazoline derivative
Claim Types: Formulation; Product-by-process; Process; Method of use
Pat. Sub. Date(s): All strengths: Apr 29, 2020
Feb 28, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityNov 8, 2022 
Exclusivity Code: ODE - Orphan drug exclusivityNov 8, 2024ODE-165: Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (HSCT)

ORENITRAM (TABLET, EXTENDED RELEASE) (ORAL) TREPROSTINIL DIOLAMINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 203496  Prod. No.: 001 RX (EQ 0.125MG BASE); 005 RX (EQ 5MG BASE)
PatentsExpirationPatented Use
Pat. No. 8252839 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Jan 13, 2014; 005: Feb 9, 2017
May 24, 2024 
Pat. No. 9050311 DS* DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Jun 17, 2015; 005: Feb 9, 2017
May 24, 2024 
Pat. No. 9278901 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 8, 2016; 005: Feb 9, 2017
May 24, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
Pat. No. 9422223 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 23, 2016; 005: Feb 9, 2017
May 24, 2024 
Pat. No. 7544713 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 9, 2014; 005: Feb 9, 2017
Jul 14, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
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, 2026U-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* 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. 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, 2031U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 18, 2022I-820: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression
Exclusivity Code: ODE - Orphan drug exclusivityOct 18, 2026ODE-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: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == 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)
PatentsExpirationPatented Use
Pat. No. 8252839 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition; Formulation
Pat. Sub. Date(s): All strengths: Jan 13, 2014
May 24, 2024 
Pat. No. 9050311 DS* DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jun 17, 2015
May 24, 2024 
Pat. No. 9278901 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2016
May 24, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
Pat. No. 9422223 DP* Compounds and methods for delivery of prostacyclin analogs
Claim Types: Composition
Pat. Sub. Date(s): All strengths: Aug 23, 2016
May 24, 2024 
Pat. No. 7544713 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 9, 2014
Jul 14, 2024U-1475: Use of ORENITRAM for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1).
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, 2026U-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. 9604901 DS* 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. 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, 2031U-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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 18, 2022I-820: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression
Exclusivity Code: ODE - Orphan drug exclusivityOct 18, 2026ODE-272: Indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to delay disease progression

REMODULIN (INJECTABLE) (IV (INFUSION), SUBCUTANEOUS) TREPROSTINIL [GENERIC AP]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 021272  Prod. No.: 001 RX (1MG/ML); 002 RX (2.5MG/ML); 003 RX (5MG/ML); 004 RX (10MG/ML); 005 RX (20MG/ML)
PatentsExpirationPatented Use
Pat. No. 9199908 Compounds and methods for delivery of prostacyclin analogs
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 2, 2015; 002: Dec 2, 2015; 003: Dec 2, 2015; 004: Dec 2, 2015; 005: Aug 24, 2021
May 24, 2024U-1771: Administration of REMODULIN diluted for intravenous infusion with sterile water for injection or 0.9% sodium chloride injection prior to administration
Pat. No. 9713599 Parenteral formulations of treprostinil
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jul 25, 2017; 002: Jul 25, 2017; 003: Jul 25, 2017; 004: Jul 25, 2017; 005: Aug 24, 2021
Dec 16, 2024U-2036: A method of treating pulmonary hypertension comprising parenterally administering a formulation comprising a) 0.1 to 5% w/v of treprostinil or a pharmaceutically acceptable salt thereof and b) a citrate buffer
Pat. No. 10076505 DP* Inhalation formulations of Treprostinil
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 1, 2018; 002: Oct 1, 2018; 003: Oct 1, 2018; 004: Oct 1, 2018; 005: Aug 24, 2021
Dec 16, 2024 
Pat. No. 10695308 Inhalation formulations of treprostinil
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2020; 002: Jul 8, 2020; 003: Jul 8, 2020; 004: Jul 8, 2020; 005: Aug 24, 2021
Dec 16, 2024U-2845: A method of treating a human patient suffering from pulmonary hypertension
Pat. No. 8653137 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 18, 2014; 002: Feb 18, 2014; 003: Feb 18, 2014; 004: Feb 18, 2014; 005: Aug 24, 2021
Sep 5, 2028U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration
Pat. No. 8658694 Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 25, 2014; 002: Feb 25, 2014; 003: Feb 25, 2014; 004: Feb 25, 2014; 005: Aug 24, 2021
Sep 5, 2028U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration
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): 001: Mar 14, 2017; 002: Mar 14, 2017; 003: Mar 14, 2017; 004: Mar 14, 2017; 005: Aug 24, 2021
Dec 15, 2028 
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 28, 2017; 002: Mar 28, 2017; 003: Mar 28, 2017; 004: Mar 28, 2017; 005: Aug 24, 2021
Dec 15, 2028 
Pat. No. 7999007 DP* Buffer solutions having selective bactericidal activity against gram negative bacteria and methods of using same
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Aug 23, 2011; 002: None; 003: None; 004: None; 005: Aug 24, 2021
Mar 29, 2029U-1437: Administration of remodulin diluted for intravenous infusion with sterile diluent for flolan or sterile diluent for epoprostenol sodium prior to administration

ADVIL, CHILDREN'S FLAVORED (SUSPENSION) (ORAL) IBUPROFEN [GENERIC OTC]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 020589  Prod. No.: 002 OTC (100MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 002: Apr 24, 2019
May 25, 2024 

ADVIL ALLERGY SINUS, CHILDREN'S (SUSPENSION) (ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes: histamine-1 (H1) receptor antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs == alpha adrenergic agonist
NDA Applicant: GLAXOSMITHKLINE      NDA No.: 021587  Prod. No.: 001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
PatentsExpirationPatented Use
Pat. No. 10238640 DP* Pharmaceutical suspension composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 24, 2019
May 25, 2024 

MIRVASO (GEL) (TOPICAL) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations == alpha adrenergic agonist
NDA Applicant: GALDERMA LABS LP      NDA No.: 204708  Prod. No.: 001 RX (EQ 0.33% BASE)
PatentsExpirationPatented Use
Pat. No. 8859551 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 27, 2014
May 25, 2024U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8231885 DP* Compounds, formulations, and methods for ameliorating telangiectasis
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025 
Pat. No. 8410102 Methods and compositions for treating or preventing erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8426410 Compounds, formulations, and methods for treating or preventing inflammatory skin disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
May 24, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 7439241 Compounds, formulations, and methods for treating or preventing rosacea
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Aug 25, 2025U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513247 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8513249 DP* Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): 001: Sep 13, 2013
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861631 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 25, 2018
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 9861632 Methods and compositions for safe and effective treatment of erythema
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 25, 2018
Mar 25, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8053427 DP* Brimonidine gel composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Jun 13, 2031U-1428: Topical treatment of facial erythema of rosacea
Pat. No. 8163725 DP* Gel compositions and methods of use
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2013
Jun 13, 2031 
Pat. No. 10201517 DP* Brimonidine gel compositions and methods of use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 13, 2019
Jun 13, 2031 

ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN      NDA No.: 021528  Prod. No.: 001 RX (0.4%)
PatentsExpirationPatented Use
Pat. No. 8648107 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 4, 2014
May 28, 2024 
Pat. No. 8906950 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 8, 2015
May 28, 2024U-1626: A method of treating or preventing ocular pain and burning
Pat. No. 8946281 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Mar 4, 2015
May 28, 2024U-1662: A method of treating ocular pain
Pat. No. 9216167 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016
May 28, 2024U-1800: A method of treating ocular pain and/or enhancing ocular comfort
Pat. No. 8207215 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 23, 2012
Nov 28, 2024 *PEDU-1251: A method of controlling postoperative ocular pain and burning/stinging in a patient
Pat. No. 8377982 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 18, 2013
Nov 28, 2024 *PEDU-1363: A method of treating or preventing ocular pain and burning/stinging following corneal surgery
Pat. No. 8541463 Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013
Nov 28, 2024 *PEDU-1441: A method of treating or reducing ocular pain and burning/stinging
Pat. No. 8008338 DS* DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 23, 2011
Nov 24, 2027 *PEDU-1181: A method of treating or preventing ocular pain in a patient

NUVIGIL (TABLET) (ORAL) ARMODAFINIL [GENERIC AB]
Drug Classes: Sleep Disorder Agents:Wakefulness Promoting Agents
NDA Applicant: CEPHALON      NDA No.: 021875  Prod. No.: 001 RX (50MG); 003 RX (150MG); 004 RX (250MG); 005 RX (200MG) NDA No.: 021875  Prod. No.: 002 DISC (100MG**)
PatentsExpirationPatented Use
Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
May 29, 2024 *PED 
Pat. No. 7132570 DS* DP* Method for the production of crystalline forms and crystalline forms of optical enantiomers of modafinil
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: None
Jun 18, 2024 *PED 

PROVIGIL (TABLET) (ORAL) MODAFINIL [GENERIC AB]
NDA Applicant: CEPHALON      NDA No.: 020717  Prod. No.: 001 RX (100MG); 002 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 7297346 DP* Pharmaceutical formulations of modafinil
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
May 29, 2024 *PED 

ZONTIVITY (TABLET) (ORAL) VORAPAXAR SULFATE
Drug Classes: Blood Products and Modifiers:Anticoagulants == protease-activated receptor-1 (PAR-1) antagonist
NDA Applicant: XSPIRE PHARMA      NDA No.: 204886  Prod. No.: 001 RX (EQ 2.08MG BASE)
PatentsExpirationPatented Use
Pat. No. 7713999 DS* DP* Thrombin receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 14, 2018
May 30, 2024U-2291: Reduction of thrombotic cardiovascular events in patients with a history of myocardial infarction (MI) or with peripheral arterial disease (PAD)
Pat. No. 7304078 DS* DP* [Extended 1356 days (3.7 years)]
Thrombin receptor antagonists
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 5, 2014
Dec 23, 2027U-1512: Reduction of thrombotic cardiovascular events

ILEVRO (SUSPENSION/DROPS) (OPHTHALMIC) NEPAFENAC
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-inflammatories == nonsteroidal anti-inflammatory drug
NDA Applicant: NOVARTIS      NDA No.: 203491  Prod. No.: 001 RX (0.3%)
PatentsExpirationPatented Use
Pat. No. 7947295 DP* Ophthalmic compositions containing a synergistic combination of two polymers
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 15, 2013
Jun 8, 2024 
Pat. No. 9662398 DP* Carboxylvinyl polymer-containing nanoparticle suspensions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 2, 2017
Dec 1, 2030 
Pat. No. 8921337 DP* Carboxyvinyl polymer-containing nanoparticle suspensions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 8, 2015
Mar 31, 2032 

ABRAXANE (POWDER) (INTRAVENOUS) PACLITAXEL
Drug Classes: microtubule inhibitor
NDA Applicant: BRISTOL-MYERS      NDA No.: 021660  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7923536 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 15, 2011
Jun 9, 2024 *PEDU-1117: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8138229 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Drug in a container; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2012
Jun 9, 2024 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 8314156 Compositions and methods of delivery of pharmacological agents
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 28, 2012
Jun 9, 2024 *PEDU-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7820788 DP* Compositions and methods of delivery of pharmacological agents
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 12, 2010
Apr 27, 2025 *PEDU-1092: Treatment of breast cancer
U-1290: Treatment of lung cancer
U-1434: Treatment of pancreatic cancer
Pat. No. 7758891 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 8268348 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Aug 21, 2026 *PEDU-1290: Treatment of lung cancer
Pat. No. 9101543 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 18, 2015
Aug 21, 2026 *PEDU-1434: Treatment of pancreatic cancer
Pat. No. 8034375 Combinations and modes of administration of therapeutic agents and combination therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 24, 2012
Feb 13, 2027 *PEDU-1290: Treatment of lung cancer
Pat. No. 9393318 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 22, 2016
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9597409 Methods of treating cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2017
Sep 4, 2032 *PEDU-1290: Treatment of lung cancer
Pat. No. 9511046 Methods of treating pancreatic cancer
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 29, 2016
Jul 12, 2034 *PEDU-1434: Treatment of pancreatic cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: M - MiscellaneousJun 6, 2023 PEDM-14: Additional clinical trial information added to pediatric use subsection

TPOXX (CAPSULE) (ORAL) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES      NDA No.: 208627  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 8124643 DS* DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Composition; Compound
Pat. Sub. Date(s): 001: Aug 9, 2018
Jun 18, 2024 
Pat. No. 8530509 DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 9, 2018
Jun 18, 2024 
Pat. No. 8802714 Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 9, 2018
Jun 18, 2024U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg
Pat. No. 8039504 DP* Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 9, 2018
Jul 23, 2027 
Pat. No. 9339466 DS* DP* Polymorphic forms of ST-246 and methods of preparation
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): 001: Aug 9, 2018
Mar 23, 2031 
Pat. No. 7737168 [Extended 1585 days (4.3 years)]
Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 9, 2018
Sep 4, 2031U-2346: Treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 13, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJul 13, 2025ODE-200: Indicated for the treatment of human smallpox disease caused by variola virus in adults and pediatric patients weighing at least 13 kg

TPOXX (SOLUTION) (INTRAVENOUS) TECOVIRIMAT
Drug Classes: inhibitor of the orthopoxvirus VP37 envelope wrapping protein
NDA Applicant: SIGA TECHNOLOGIES      NDA No.: 214518  Prod. No.: 001 RX (200MG/20ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 8124643 DS* DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Composition; Compound
Pat. Sub. Date(s): 001: Jun 10, 2022
Jun 18, 2024 
Pat. No. 8530509 DP* Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Composition
Pat. Sub. Date(s): 001: Jun 10, 2022
Jun 18, 2024 
Pat. No. 8802714 Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2022
Jun 18, 2024U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
Pat. No. 8039504 DP* Chemicals, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2022
Jul 23, 2027 
Pat. No. 9233097 DP* ST-246 liquid formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2022
Aug 2, 2031 
Pat. No. 9907859 ST-246 liquid formulations and methods
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2022
Aug 2, 2031U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
Pat. No. 10576165 DP* ST-246 liquid formulations and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2022
Aug 2, 2031 
Pat. No. 7737168 [Extended 1585 days (4.3 years)]
Compounds, compositions, and methods for treatment and prevention of orthopoxvirus infections and associated diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 10, 2022
Sep 4, 2031U-3377: TPOXX is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 13, 2023 

XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: Antibacterials:Antibacterials, Other == Gastrointestinal Agents:Anti-Diarrheal Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other == rifamycin antibacterial
NDA Applicant: SALIX PHARMS      NDA No.: 021361  Prod. No.: 001 RX (200MG)
PatentsExpirationPatented Use
Pat. No. 7045620 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: None
Jun 19, 2024 
Pat. No. 7612199 DS* DP* Polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: None
Jun 19, 2024 
Pat. No. 7902206 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 001: Apr 7, 2011
Jun 19, 2024 
Pat. No. 8158644 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 8, 2012
Jun 19, 2024 
Pat. No. 8158781 DS* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 8, 2012
Jun 19, 2024 
Pat. No. 8835452 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Oct 1, 2014
Jun 19, 2024 
Pat. No. 8853231 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition
Pat. Sub. Date(s): 001: Nov 5, 2014
Jun 19, 2024 
Pat. No. 7906542 DS* DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Apr 7, 2011
Jun 1, 2025 
Pat. No. 8518949 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 001: Sep 16, 2013
Feb 27, 2026 
Pat. No. 8741904 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Jul 11, 2014
Feb 27, 2026U-1526: The treatment of patients with travelers' diarrhea (TD) or the reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9271968 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Jun 8, 2016
Feb 27, 2026 
Pat. No. 10703763 Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 14, 2020
Feb 27, 2026U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
U-2847: Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults
U-2848: Treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escheria coli in adult and pediatric patients 12 years of age and older
Pat. No. 8193196 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Formulation; Method of use; New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jun 18, 2012
Sep 2, 2027 
Pat. No. 7928115 Methods of treating travelers diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 21, 2011
Jul 24, 2029U-1121: Method of treating travelers' diarrhea

XIFAXAN (TABLET) (ORAL) RIFAXIMIN
Drug Classes: Antibacterials:Antibacterials, Other == Gastrointestinal Agents:Anti-Diarrheal Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other == rifamycin antibacterial
NDA Applicant: SALIX PHARMS      NDA No.: 021361  Prod. No.: 002 RX (550MG)
PatentsExpirationPatented Use
Pat. No. 7045620 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in medicinal preparations
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: None
Jun 19, 2024 
Pat. No. 7612199 DS* DP* Polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Apr 7, 2011
Jun 19, 2024 
Pat. No. 7902206 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 002: Apr 7, 2011
Jun 19, 2024 
Pat. No. 8158644 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: May 9, 2012
Jun 19, 2024 
Pat. No. 8158781 DS* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: May 8, 2012
Jun 19, 2024 
Pat. No. 8835452 DS* DP* Polymorphic forms .alpha., .beta. and .gamma. of rifaximin
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 002: Oct 1, 2014
Jun 19, 2024 
Pat. No. 8853231 DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition
Pat. Sub. Date(s): 002: Nov 5, 2014
Jun 19, 2024 
Pat. No. 7915275 Use of polymorphic forms of rifaximin for medical preparations
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 18, 2015
Feb 23, 2025U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 7906542 DS* DP* Pharmaceutical compositions comprising polymorphic forms .alpha., .beta., and .gamma. of rifaximin
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Apr 7, 2011
Jun 1, 2025 
Pat. No. 8518949 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Product-by-process; Composition; Formulation
Pat. Sub. Date(s): 002: Sep 16, 2013
Feb 27, 2026 
Pat. No. 8741904 DS* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 002: Jul 11, 2014
Feb 27, 2026U-1526: The treatment of patients with travelers' diarrhea (TD) or the reduction in risk of overt hepatic encephalopathy (HE) recurrence
U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 9271968 DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 002: Jun 8, 2016
Feb 27, 2026 
Pat. No. 10703763 Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 14, 2020
Feb 27, 2026U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
U-2847: Reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults
U-2848: Treatment of travelers' diarrhea (TD) caused by noninvasive strains of Escheria coli in adult and pediatric patients 12 years of age and older
Pat. No. 8193196 DS* DP* Polymorphous forms of rifaximin, processes for their production and use thereof in the medicinal preparations
Claim Types: Formulation; Method of use; New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: Jun 18, 2012
Sep 2, 2027U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 10456384 Methods for treating irritable bowel syndrome (IBS)
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 12, 2019
Feb 26, 2029U-2643: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older and symptoms thereof
U-2644: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older
Pat. No. 10765667 Methods for treating irritable bowel syndrome (IBS)
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 19, 2020
Feb 26, 2029U-2643: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older and symptoms thereof
U-2644: Treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults 65 years of age or older
Pat. No. 8309569 Methods for treating diarrhea-associated irritable bowel syndrome
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 18, 2015
Jul 18, 2029U-1707: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults and symptoms thereof.
U-1708: Treatment of irritable bowel syndrome with diarrhea (ibs-d) in adults.
Pat. No. 8829017 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 9, 2014
Jul 24, 2029U-1562: Treatment of patients with hepatic encephalopathy (he)
Pat. No. 8946252 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 3, 2015
Jul 24, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9421195 Methods of treating hepatic encephalopathy
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Oct 11, 2016
Jul 24, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 9629828 Methods of treating traveler's diarrhea and hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 27, 2017
Jul 24, 2029U-1994: Reduction in risk of overt hepatic encephalopathy (HE) in adults
Pat. No. 10314828 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 1, 2019
Jul 24, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 10335397 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 24, 2019
Jul 24, 2029U-2579: Reduction in a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode
Pat. No. 10709694 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 23, 2020
Jul 24, 2029U-2579: Reduction in a subject's risk of experiencing a breakthrough overt hepatic encephalopathy (HE) episode
Pat. No. 8642573 Methods of treating hepatic encephalopathy
Claim Types: Method of administration
Pat. Sub. Date(s): 002: None
Oct 2, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence
Pat. No. 8969398 Methods of treating hepatic encephalopathy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 4, 2015
Oct 2, 2029U-1481: Reduction in risk of overt hepatic encephalopathy (HE) recurrence

ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary) == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE INC      NDA No.: 213388  Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)
PatentsExpirationPatented Use
Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 29, 2020
Jul 6, 2024 
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 29, 2020
Sep 10, 2024 
Pat. No. 11459305 DP* Processes for the preparation of uracil derivatives
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 2, 2022
Nov 7, 2028U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
Pat. No. 10881659 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 3, 2021
Mar 14, 2034U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
Pat. No. 11045470 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 27, 2021
Mar 14, 2034U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 
Exclusivity Code: NP - New productMay 29, 2023 

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary) == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE INC      NDA No.: 210450  Prod. No.: 001 RX (EQ 150MG BASE)
PatentsExpirationPatented Use
Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 20, 2018
Sep 10, 2024 
Pat. No. 10537572 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 19, 2020
Sep 1, 2036U-2735: Management of moderate to severe pain associated with endometriosis using 150mg elagolix while co-administering rifampin
Pat. No. 10682351 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 15, 2020
Sep 1, 2036U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 

ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other == Hormonal Agents, Suppressant (Pituitary) == gonadotropin-releasing hormone (GnRH) receptor antagonist
NDA Applicant: ABBVIE INC      NDA No.: 210450  Prod. No.: 002 RX (EQ 200MG BASE)
PatentsExpirationPatented Use
Pat. No. 7176211 Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Method of use
Pat. Sub. Date(s): 002: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7419983 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods related thereto
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Aug 20, 2018
Jul 6, 2024U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 7056927 DS* DP* Gonadotropin-releasing hormone receptor antagonists and methods relating thereto
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Aug 20, 2018
Sep 10, 2024 
Pat. No. 11344551 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 27, 2022
Mar 14, 2034U-3388: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women to reduce dysmenorrhea and non-menstrual pelvic pain
U-3389: Use of elagolix 200 mg bid for 6 months to manage moderate to severe pain associated with endometriosis in premenopausal women having dyspareunia associated with endometriosis
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 23, 2023 

XEGLYZE (LOTION) (TOPICAL) ABAMETAPIR
Drug Classes: Dermatological Agents:Pediculicides/Scabicides
NDA Applicant: HATCHTECH      NDA No.: 206966  Prod. No.: 001 DISC (0.74%)
PatentsExpirationPatented Use
Pat. No. 8212038 DP* Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 9357783 DP* Methods and compositions for controlling ectoparasites
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024 
Pat. No. 9839631 DS* DP* Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Jul 16, 2024U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
Pat. No. 7812163 DP* Methods and compositions for controlling ectoparasites
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 31, 2020
Oct 28, 2026U-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, 2034U-2863: Topical treatment of head lice infestation in patients 6 months of age and older
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 24, 2025 

INVOKAMET (TABLET) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: JANSSEN PHARMS      NDA No.: 204353  Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
PatentsExpirationPatented Use
Pat. No. 8785403 DP* Glucopyranoside compound
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Jul 30, 2024 
Pat. No. 8222219 [Extended 255 days (0.7 years)]
Glucopyranoside compound
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Apr 11, 2025U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943788 DS* DP* Glucopyranoside compound
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Jul 14, 2027 
Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Dec 3, 2027U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): All strengths: Sep 4, 2014
Feb 26, 2029U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 29, 2021I-788: New indication for canagliflozin to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease (CVD)

INVOKAMET XR (TABLET, EXTENDED RELEASE) (ORAL) CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: Blood Glucose Regulators:Antidiabetic Agents == Blood Glucose Regulators:Antidiabetic Combinations == sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: JANSSEN PHARMS      NDA No.: 205879  Prod. No.: 001 RX (50MG;500MG); 002 RX (50MG;1GM); 003 RX (150MG;500MG); 004 RX (150MG;1GM)
PatentsExpirationPatented Use
Pat. No. 8785403 DP* Glucopyranoside compound
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Jul 30, 2024 
Pat. No. 8222219 [Extended 255 days (0.7 years)]
Glucopyranoside compound
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Apr 11, 2025U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943788 DS* DP* Glucopyranoside compound
Claim Types: Compound; Process; Composition
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Jul 14, 2027 
Pat. No. 8513202 DS* DP* Crystalline form of 1-(.beta.-D-glucopyranosyl)-4-methyl-3-[5-(4-fluorophenyl)-2-thienylmethy- l]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Dec 3, 2027U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
Pat. No. 7943582 DS* DP* Crystalline form of 1-(.beta.-D-glucopyransoyl)-4-methyl-3-[5-(4-fluorophenyl)-2- thienylmethyl]benzene hemihydrate
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Pat. Sub. Date(s): All strengths: Oct 14, 2016
Feb 26, 2029U-2441: Reduction of risk of major adverse cardiovascular events in the treatment of Type 2 diabetes mellitus patients
U-2632: Reduction of risk of end stage kidney disease, doubling of serum creatinine, cardiovascular death, and hospitalization for heart failure in the treatment of Type 2 diabetes mellitus patients
U-493: Treatment of Type 2 Diabetes Mellitus
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationOct 29, 2021I-788: New indication for canagliflozin to reduce the risk of major adverse cardiovascular events (cardiovascular death, nonfatal myocardial infarction and nonfatal stroke) in adults with Type 2 diabetes mellitus and established cardiovascular disease (CVD)

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 021372  Prod. No.: 001 DISC (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML)**)
PatentsExpirationPatented Use
Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 27, 2011
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 3, 2013
Jul 30, 2024 *PED 
Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8598219 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jul 30, 2024 *PED 
Pat. No. 8729094 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 21, 2014
Jul 30, 2024 *PEDU-528: Prevention of chemotherapy-induced nausea and vomiting
Pat. No. 9066980 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 22, 2015
Jul 30, 2024 *PEDU-528: Prevention of chemotherapy-induced nausea and vomiting
Pat. No. 9125905 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation; Process; Drug in a container
Pat. Sub. Date(s): 001: Sep 9, 2015
Jul 30, 2024 *PED 
Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Sep 27, 2016
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Oct 25, 2016
Jul 30, 2024 *PED 
Pat. No. 9457021 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 25, 2016
Jul 30, 2024 *PED 

ALOXI (INJECTABLE) (INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HELSINN HLTHCARE      NDA No.: 021372  Prod. No.: 002 DISC (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML)**)
PatentsExpirationPatented Use
Pat. No. 7947724 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7947725 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 7960424 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 8518981 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Sep 3, 2013
Jul 30, 2024 *PED 
Pat. No. 8598218 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: None
Jul 30, 2024 *PED 
Pat. No. 9173942 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 5, 2015
Jul 30, 2024 *PED 
Pat. No. 9439854 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Sep 27, 2016
Jul 30, 2024 *PED 
Pat. No. 9457020 DP* Liquid pharmaceutical formulations of palonosetron
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 002: Oct 25, 2016
Jul 30, 2024 *PED 

LIVALO (TABLET) (ORAL) PITAVASTATIN CALCIUM [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, HMG CoA Reductase Inhibitors == HMG CoA-reductase inhibitor
NDA Applicant: KOWA CO      NDA No.: 022363  Prod. No.: 001 RX (EQ 1MG BASE); 002 RX (EQ 2MG BASE); 003 RX (EQ 4MG BASE)
PatentsExpirationPatented Use
Pat. No. 8557993 DP* Crystalline forms of pitavastatin calcium
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): All strengths: Nov 12, 2013
Aug 2, 2024 *PED 
Pat. No. 7022713 Hyperlipemia therapeutic agent
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Aug 19, 2024 *PEDU-998: Adjuncitve [sic, "Adjunctive"] therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase HDL-C in adult patients with primary hyperlipidemia or mixed dyslipidemia
ExclusivityExpirationExclusivity Description
Exclusivity Code: NPP - New patient populationNov 16, 2022 PED 

ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant: ALLERGAN      NDA No.: 022427  Prod. No.: 001 RX (0.45%)
PatentsExpirationPatented Use
Pat. No. 8992952 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 10, 2015
Aug 5, 2024 
Pat. No. 8512717 DP* Compositions for delivery of therapeutics into the eyes and methods for making and using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 19, 2013
Mar 7, 2028 
Pat. No. 9192571 DP* Ketorolac tromethamine compositions for treating or preventing ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015
Mar 7, 2028 
Pat. No. 7842714 DS* DP* Ketorolac tromethamine compositions for treating ocular pain
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 30, 2010
Aug 15, 2029 

NINLARO (CAPSULE) (ORAL) IXAZOMIB CITRATE
Drug Classes: Antineoplastics:Antineoplastics, Other == proteasome inhibitor
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 208462  Prod. No.: 001 RX (EQ 2.3MG BASE); 002 RX (EQ 3MG BASE); 003 RX (EQ 4MG BASE)
PatentsExpirationPatented Use
Pat. No. 8546608 DS* Proteasome inhibitors and methods of using the same
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Aug 12, 2024 
Pat. No. 9233115 Proteasome inhibitors and methods of using the same
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 8, 2016
Aug 12, 2024U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
Pat. No. 7687662 DS* DP* Proteasome inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Aug 6, 2027 
Pat. No. 8003819 DS* DP* Proteasome inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Aug 6, 2027U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
Pat. No. 8530694 DS* DP* Proteasome inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Aug 6, 2027U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
Pat. No. 8871745 Proteasome inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Aug 6, 2027U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
Pat. No. 8859504 DS* DP* Boronate ester compounds and pharmaceutical compositions thereof
Claim Types: Compound; New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Jun 16, 2029 
Pat. No. 9175017 Boronate ester compounds and pharmaceutical compositions thereof
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Jun 16, 2029U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
Pat. No. 7442830 DS* DP* Proteasome inhibitors
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Dec 14, 2015
Nov 20, 2029U-2434: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityNov 20, 2022ODE-103: Use in combination with lenalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy

PREZCOBIX (TABLET) (ORAL) COBICISTAT; DARUNAVIR
Drug Classes: Antivirals:Anti-HIV Agents, Other == CYP3A inhibitor == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations == HIV protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.: 205395  Prod. No.: 001 RX (150MG;800MG)
PatentsExpirationPatented Use
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Feb 26, 2015
Aug 16, 2024 *PED 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Feb 26, 2015
Jun 26, 2027 *PED 
Pat. No. 8148374 DS* DP* Modulators of pharmacokinetic properties of therapeutics
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Feb 26, 2015
Sep 3, 2029U-1279: Treatment of HIV infection using a composition containing a pharmacokinetic enhancer that inhibits cytochrome p450 monooxygenase
U-2939: Treatment of HIV infection in adults and pediatric patients weighing at least 40kg using a composition containing a pharmacokinetic enhancer that inhibits cytochrome P450 monooxygenase
Pat. No. 10039718 DP* Use of solid carrier particles to improve the processability of a pharmaceutical agent
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Sep 5, 2018
Oct 6, 2032 

PREZISTA (TABLET) (ORAL) DARUNAVIR [GENERIC AB]
Drug Classes: Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations == HIV protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.: 021976  Prod. No.: 002 RX (600MG); 004 RX (75MG); 005 RX (150MG); 006 RX (800MG) NDA No.: 021976  Prod. No.: 001 DISC (300MG**); 003 DISC (400MG**)
PatentsExpirationPatented Use
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): All strengths: Sep 19, 2013
Aug 16, 2024 *PED 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): All strengths: None
Jun 26, 2027 *PED 

PREZISTA (SUSPENSION) (ORAL) DARUNAVIR
Drug Classes: Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == Antivirals:Anti-HIV Combinations == HIV protease inhibitor
NDA Applicant: JANSSEN PRODS      NDA No.: 202895  Prod. No.: 001 RX (100MG/ML)
PatentsExpirationPatented Use
Pat. No. 8518987 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition; Formulation
Pat. Sub. Date(s): 001: Sep 18, 2013
Aug 16, 2024 *PED 
Pat. No. 7700645 DS* DP* Pseudopolymorphic forms of a HIV protease inhibitor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Jan 13, 2012
Jun 26, 2027 *PED 

VIEKIRA PAK (COPACKAGED) (TABLET) (ORAL) DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 206619  Prod. No.: 001 DISC (EQ 250MG BASE;12.5MG, 75MG, 50MG)
PatentsExpirationPatented Use
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 15, 2015
Aug 25, 2024 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 15, 2015
Aug 25, 2024 
Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 21, 2015
Nov 9, 2028U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 8501238 DS* DP* [Extended 93 days (0.3 years)]
Anti-infective agents and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Jan 15, 2015
Dec 19, 2028U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
May 17, 2029U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 10, 2029U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 6, 2015
Jun 10, 2030U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Apr 10, 2031 
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 1, 2015
Apr 10, 2031U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 15, 2015
Jun 9, 2031 
Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jan 15, 2015
Apr 13, 2032 
Pat. No. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 4, 2032U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8492386 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8680106 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 4, 2032U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8685984 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 9629841 DP* Formulations of pyrimidinedione derivative compounds
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Jun 16, 2017
Oct 18, 2033U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 10201542 DP* Formulations of pyrimidinedione derivative compounds
Claim Types: Formulation; Method of use; Process; Method of improving a treatment
Pat. Sub. Date(s): 001: Mar 14, 2019
Oct 18, 2033U-1753: Treatment of HCV infection using dasabuvir

VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == hepatitis C virus non-nucleoside NS5B palm polymerase inhibitor == hepatitis C virus (HCV) NS5A inhibitor == hepatitis C virus (HCV) NS3/4A protease inhibitor == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI) == CYP3A inhibitor == HIV protease inhibitor
NDA Applicant: ABBVIE INC      NDA No.: 208624  Prod. No.: 001 DISC (EQ 200MG BASE;8.33MG;50MG;33.33MG**)
PatentsExpirationPatented Use
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2016
Aug 25, 2024 
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2016
Aug 25, 2024 
Pat. No. 8501238 DS* DP* [Extended 93 days (0.3 years)]
Anti-infective agents and uses thereof
Claim Types: New polymorph, salt or hydrate; Composition; Method of use; Process
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 17, 2028U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Nov 9, 2028U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 8188104 DS* DP* Anti-infective agents and uses thereof
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
May 17, 2029U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 10, 2029U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Jun 10, 2030U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 17, 2016
Apr 10, 2031 
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Apr 10, 2031U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 17, 2016
Jun 9, 2031 
Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 17, 2016
Apr 13, 2032 
Pat. No. 10201541 DP* Compositions and methods for treating HCV
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 14, 2019
May 17, 2032 
Pat. No. 10201584 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2019
May 17, 2032U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
Pat. No. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 4, 2032U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8492386 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 8680106 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 4, 2032U-1637: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir with ribavirin.
Pat. No. 8685984 Methods for treating HCV
Claim Types: Method of administration; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 4, 2032U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
Pat. No. 9333204 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Jan 2, 2035U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
Pat. No. 9744170 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Sep 27, 2017
Jan 2, 2035U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
Pat. No. 10105365 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Jan 2, 2035U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination

COMBIVENT RESPIMAT (SPRAY, METERED) (INHALATION) ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2 adrenergic agonist == Respiratory Tract/ Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: BOEHRINGER INGELHEIM      NDA No.: 021747  Prod. No.: 001 RX (EQ 0.1MG BASE/INH;0.02MG/INH)
PatentsExpirationPatented Use
Pat. No. 7284474 DP* Piston-pumping system having o-ring seal properties
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 2, 2011
Aug 26, 2024 
Pat. No. 7896264 DP* Microstructured high pressure nozzle with built-in filter function
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Nov 2, 2011
May 26, 2025 
Pat. No. 7396341 DP* Blocking device for a locking stressing mechanism having a spring-actuated output drive device
Claim Types: Device; Method of use; Method of administration
Pat. Sub. Date(s): 001: Nov 2, 2011
Oct 10, 2026 
Pat. No. 9027967 DP* Device for clamping a fluidic component
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Sep 4, 2015
Mar 31, 2027 
Pat. No. 7837235 DP* Device for clamping a fluidic component
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 2, 2011
Mar 13, 2028 
Pat. No. 8733341 DP* Atomizer and method of atomizing fluid with a nozzle rinsing mechanism
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Sep 4, 2015
Oct 16, 2030 

FOSRENOL (TABLET, CHEWABLE) (ORAL) LANTHANUM CARBONATE [GENERIC AB]
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 021468  Prod. No.: 002 RX (EQ 500MG BASE); 003 RX (EQ 750MG BASE); 004 RX (EQ 1GM BASE) NDA No.: 021468  Prod. No.: 001 DISC (EQ 250MG BASE)
PatentsExpirationPatented Use
Pat. No. 7381428 Stabilized lanthanum carbonate compositions
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: None
Aug 26, 2024U-890: Reduction of serum phosphate in patients with end stage renal disease
Pat. No. 7465465 DP* Pharmaceutical formulation comprising lanthanum compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Aug 26, 2024 

FOSRENOL (POWDER) (ORAL) LANTHANUM CARBONATE
Drug Classes: Electrolytes/ Minerals/ Metals/ Vitamins:Phosphate Binders
NDA Applicant: TAKEDA PHARMS USA      NDA No.: 204734  Prod. No.: 001 RX (EQ 750MG BASE); 002 RX (EQ 1GM BASE)
PatentsExpirationPatented Use
Pat. No. 7465465 DP* Pharmaceutical formulation comprising lanthanum compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 20, 2014
Aug 26, 2024 
Pat. No. 8980327 DP* Capsule and powder formulations containing lanthanum compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Apr 2, 2015
Dec 1, 2030 
Pat. No. 9023397 DP* Capsule and powder formulations containing lanthanum compounds
Claim Types: Drug in a container
Pat. Sub. Date(s): All strengths: Dec 16, 2015
Dec 1, 2030 

RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE [Has competitive generic]
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other == calcineurin inhibitor immunosuppressant
NDA Applicant: ALLERGAN      NDA No.: 050790  Prod. No.: 002 RX (0.05%)
PatentsExpirationPatented Use
Pat. No. 8629111 DP* Methods of providing therapeutic effects using cyclosporin components
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 18, 2016
Aug 27, 2024 
Pat. No. 8633162 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 18, 2016
Aug 27, 2024U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).
Pat. No. 8642556 DP* Methods of providing therapeutic effects using cyclosporin components
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 18, 2016
Aug 27, 2024 
Pat. No. 8648048 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 18, 2016
Aug 27, 2024U-1483: Increase tear production in patients with keratoconjunctivitis sicca (dry eye).
Pat. No. 8685930 DP* Methods of providing therapeutic effects using cyclosporin components
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 18, 2016
Aug 27, 2024 
Pat. No. 9248191 Methods of providing therapeutic effects using cyclosporin components
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 18, 2016
Aug 27, 2024U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).
Pat. No. 8292129 DP* Dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 25, 2031 
Pat. No. 8561859 DP* Dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017
Apr 16, 2032 
Pat. No. 9676525 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017
Feb 7, 2034 
Pat. No. 9669974 DP* Protective cap for a dispenser, and discharge device for discharging pharmaceutical and/or cosmetical liquids
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 26, 2017
May 11, 2034 

XARELTO (FOR SUSPENSION) (ORAL) RIVAROXABAN
Drug Classes: Blood Products and Modifiers:Anticoagulants == factor Xa inhibitor
NDA Applicant: JANSSEN PHARMS      NDA No.: 215859  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationPatented Use
Pat. No. 7157456 DS* DP* [Extended 1356 days (3.7 years)]
Substituted oxazolidinones and their use in the field of blood coagulation
Claim Types: Compound; Process; Composition; Method of use
Pat. Sub. Date(s): 001: Jan 18, 2022
Aug 28, 2024 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NP - New productJun 20, 2025 PED 

ALTABAX (OINTMENT) (TOPICAL) RETAPAMULIN
Drug Classes: Dermatological Agents:Topical Anti-infectives == pleuromutilin antibacterial
NDA Applicant: ALMIRALL      NDA No.: 022055  Prod. No.: 001 RX (1%)
PatentsExpirationPatented Use
Pat. No. 8207191 Process, salts, composition and use
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 13, 2016
Aug 30, 2024U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes
Pat. No. 7875630 DS* Process salts compositions and use
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 001: Feb 10, 2011
Feb 14, 2027 

ENVARSUS XR (TABLET, EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Immunological Agents:Immunosuppressants == calcineurin inhibitor immunosuppressant
NDA Applicant: VELOXIS PHARMS INC      NDA No.: 206406  Prod. No.: 001 RX (EQ 0.75MG BASE); 002 RX (EQ 1MG BASE); 003 RX (EQ 4MG BASE)
PatentsExpirationPatented Use
Pat. No. 7994214 DP* Solid dispersions comprising tacrolimus
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024 
Pat. No. 8486993 DP* Solid dispersions comprising tacrolimus
Claim Types: Formulation; Product-by-process; Method of use
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024U-1752: Prophylaxis of organ rejection
Pat. No. 8586084 Modified release compositions comprising tacrolimus
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024U-1752: Prophylaxis of organ rejection
Pat. No. 8591946 DP* Modified release compositions comprising tacrolimus
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024 
Pat. No. 8617599 DP* Modified release compositions comprising tacrolimus
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024 
Pat. No. 8623410 DP* Modified release compositions comprising tacrolimus
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024 
Pat. No. 8623411 Modified release compositions comprising tacrolimus
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024U-1752: Prophylaxis of organ rejection
Pat. No. 8889185 Modified release compositions comprising tacrolimus
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024U-1752: Prophylaxis of organ rejection
Pat. No. 8889186 Modified release compositions comprising tacrolimus
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2024U-1752: Prophylaxis of organ rejection
Pat. No. 9161907 DP* Modified release compositions comprising tacrolimus
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Nov 13, 2015
Aug 30, 2024U-1752: Prophylaxis of organ rejection
Pat. No. 9757362 DP* Modified release compositions comprising tacrolimus
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Dec 20, 2017
Aug 30, 2024 
Pat. No. 9763920 DP* Solid dispersions comprising tacrolimus
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): All strengths: Dec 20, 2017
Aug 30, 2024 
Pat. No. 10548880 Solid dispersions comprising tacrolimus
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 28, 2020
Aug 30, 2024U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations
U-2678: Prophylaxis of organ rejection in de novo transplant patient
Pat. No. 11077096 DP* Modified release compositions comprising tacrolimus
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: Jul 8, 2022
Aug 30, 2024 
Pat. No. 9549918 DP* Stabilized tacrolimus composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 2, 2017
May 30, 2028 
Pat. No. 10166190 DP* Stabilized tacrolimus composition
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 14, 2019
May 30, 2028 
Pat. No. 10864199 Tacrolimus for improved treatment of transplant patients
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 6, 2021
May 30, 2028U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations
U-2678: Prophylaxis of organ rejection in de novo transplant patient
Pat. No. 11110081 Tacrolimus for improved treatment of transplant patients
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Sep 16, 2021
May 30, 2028U-2678: Prophylaxis of organ rejection in de novo transplant patient
Pat. No. 11123331 Tacrolimus for improved treatment of transplant patients
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Sep 28, 2021
May 30, 2028U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations
Pat. No. 11419823 DP* Stabilized tacrolimus composition
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Aug 24, 2022
May 30, 2028 
Pat. No. 8664239 Tacrolimus for improved treatment of transplant patients
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2028U-1752: Prophylaxis of organ rejection
U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations
U-2678: Prophylaxis of organ rejection in de novo transplant patient
Pat. No. 8685998 DP* Tacrolimus for improved treatment of transplant patients
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Aug 24, 2015
Aug 30, 2028U-1752: Prophylaxis of organ rejection
U-2677: Prophylaxis of organ rejection in patients converted from tacrolimus immediate-release formulations
U-2678: Prophylaxis of organ rejection in de novo transplant patient
ExclusivityExpirationExclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivityJul 10, 2022ODE-94: Prophylaxis of organ rejection in kidney transplant patients converted from tacrolimus immediate-release formulations in combination with other immunosuppressants

MOVIPREP (FOR SOLUTION) (ORAL) ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE [GENERIC AA]
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents == Gastrointestinal Agents:Gastrointestinal Agents, Other == osmotic laxative
NDA Applicant: SALIX PHARMS      NDA No.: 021881  Prod. No.: 001 RX (4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM)
PatentsExpirationPatented Use
Pat. No. 7169381 DS* DP* Colon cleansing compositions and methods
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Sep 1, 2024 
Pat. No. 7658914 DS* DP* Colon cleansing compositions
Claim Types: Kit; Formulation
Pat. Sub. Date(s): 001: None
Sep 1, 2024 

MULPLETA (TABLET) (ORAL) LUSUTROMBOPAG
Drug Classes: Blood Products and Modifiers:Blood Products and Modifiers, Other
NDA Applicant: SHIONOGI INC      NDA No.: 210923  Prod. No.: 001 RX (3MG)
PatentsExpirationPatented Use
Pat. No. 7601746 DS* DP* Compounds exhibiting thrombopoietin receptor agonism
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 7, 2018
Sep 5, 2024U-2344: Treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure
Pat. No. 8889722 DS* DP* Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
Claim Types: Composition; New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Aug 7, 2018
Jul 29, 2028 
Pat. No. 8530668 DS* DP* Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
Claim Types: New polymorph, salt or hydrate; Composition
Pat. Sub. Date(s): 001: Aug 7, 2018
Jan 21, 2030 
Pat. No. 9427402 DP* Preparation for improving solubility of poorly soluble drug
Claim Types: Formulation; Process
Pat. Sub. Date(s): 001: Aug 7, 2018
Sep 29, 2031 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 31, 2023 

DEXTENZA (INSERT) (OPHTHALMIC) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories == corticosteroid
NDA Applicant: OCULAR THERAPEUTIX      NDA No.: 208742  Prod. No.: 001 RX (0.4MG)
PatentsExpirationPatented Use
Pat. No. 9254267 DP* Composite hydrogel drug delivery systems
Claim Types: Process
Pat. Sub. Date(s): 001: Jan 30, 2019
Sep 11, 2024 
Pat. No. 8563027 Drug delivery through hydrogel plugs
Claim Types: Method of use; Process
Pat. Sub. Date(s): 001: Jan 30, 2019
Feb 12, 2030U-2487: DEXTENZA is approved for the treatment of ocular pain following ophthalmic surgery
Pat. No. 8409606 DP* Drug delivery through hydrogel plugs
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 30, 2019
May 14, 2030 
Pat. No. 11458041 Punctal plug and bioadhesives
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 20, 2022
Nov 16, 2037U-1680: Treatment of ocular itching associated with allergic conjunctivitis
U-3455: Treatment of ocular inflammation and pain following ophthalmic surgery
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJun 20, 2022I-800: Treatment of ocular inflammation following ophthalmic surgery
Exclusivity Code: I - New IndicationOct 7, 2024I-876: Treatment of ocular itching associated with allergic conjunctivitis
Exclusivity Code: NP - New productNov 30, 2021 

VANDAZOLE (GEL) (VAGINAL) METRONIDAZOLE [Has competitive generic]
Drug Classes: Antibacterials:Antibacterials, Other == nitroimidazole antimicrobial
NDA Applicant: TEVA PHARMS      NDA No.: 021806  Prod. No.: 001 RX (0.75%)
PatentsExpirationPatented Use
Pat. No. 7456207 DP* Vaginal pharmaceutical compositions and methods for preparing them
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Jan 20, 2011
Sep 22, 2024 

CABOMETYX (TABLET) (ORAL) CABOZANTINIB S-MALATE
Drug Classes: Antineoplastics:Molecular Target Inhibitors == 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)
PatentsExpirationPatented Use
Pat. No. 8497284 C-met modulators and method of use
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 24, 2016
Sep 24, 2024U-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
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, 2030U-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, 2030U-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, 2031U-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, 2031U-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. 9724342 DP* C-met modulator pharmaceutical compositions
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Aug 25, 2017
Jul 9, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationJan 14, 2022I-792: Treatment of patients with hepatocellular carcinoma who have been previously treated with sorafenib
Exclusivity Code: I - New IndicationJan 22, 2024I-854: For the treatment of patients with advanced renal cell carcinoma, as a first-line treatment in combination with nivolumab
Exclusivity Code: I - New IndicationSep 17, 2024I-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 exclusivityJan 14, 2026ODE-227: Indicated for treatment of patients with hepatocellular carcinoma (HCC) who have been previously treated with sorafenib
Exclusivity Code: ODE - Orphan drug exclusivitySep 17, 2028ODE-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

NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary) == factor VIII activator
NDA Applicant: ACERUS PHARMS      NDA No.: 201656  Prod. No.: 001 DISC (0.00083MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 7799761 DP* Pharmaceutical compositions including low dosages of desmopressin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 31, 2017
Sep 26, 2024 
Pat. No. 9539302 DP* Safe desmopressin administration
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 31, 2017
Jun 15, 2030 
Pat. No. 11419914 Safe desmopressin administration
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 20, 2022
Jun 15, 2030U-3431: Treatment of nocturia due to nocturnal polyuria in adults who awaken at least 2 times per night to void by inducing an antidiuretic effect by intranasally administering a plume of droplets comprising a dose of about 0.05-5 mcg desmopressin

SUSTOL (INJECTION, EXTENDED RELEASE) (SUBCUTANEOUS) GRANISETRON
Drug Classes: Antiemetics:Emetogenic Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant: HERON THERAPS INC      NDA No.: 022445  Prod. No.: 001 RX (10MG/0.4ML (10MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. 8252304 DP* Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 31, 2016
Sep 28, 2024 
Pat. No. 8252305 Methods of treating emesis utilizing semi-solid delivery pharmaceutical compositions comprising granisetron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 31, 2016
Sep 28, 2024U-1891: Treatment or prevention of nausea and vomiting
Pat. No. 8715710 DP* Semi-solid delivery vehicle and pharmaceutical compositions for delivery of granisetron
Claim Types: Composition
Pat. Sub. Date(s): 001: Aug 30, 2016
Sep 28, 2024 
Pat. No. 9913910 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 28, 2018
Sep 28, 2024U-2253: Prophylactic treatment of nausea and vomiting, including prevention of acute and delayed nausea and vomiting associated chemotherapy
Pat. No. 10357570 Methods of treating nausea utilizing semi-solid delivery vehicle compositions comprising granisetron
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Sep 28, 2024U-2253: Prophylactic treatment of nausea and vomiting, including prevention of acute and delayed nausea and vomiting associated chemotherapy

FENOGLIDE (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant: SALIX      NDA No.: 022118  Prod. No.: 001 RX (40MG); 002 RX (120MG)
PatentsExpirationPatented Use
Pat. No. 8124125 DP* Solid dosage form comprising a fibrate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 19, 2012; 002: None
Oct 1, 2024U-1234: For reducing total cholesterol (total-c), ldl-c, apo-lipoprotein b, or total triglycerides, and treating hypertriglyceridemia
Pat. No. 8481078 DP* Solid dosage form comprising a fibrate
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: None
Oct 1, 2024U-1416: Use of fenofibrate for reducing elevated total cholesterol (total-C), LDL-C, Apo-lipoprotein B, or total triglycerides
Pat. No. 9173847 DP* Tablet comprising a fibrate
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Nov 13, 2015
Oct 1, 2024 
Pat. No. 7658944 DP* Solid dosage form comprising a fibrate
Claim Types: Formulation;Process
Pat. Sub. Date(s): All strengths: None
Dec 9, 2024 

PRIALT (INJECTABLE) (INTRATHECAL) ZICONOTIDE ACETATE
Drug Classes: N-type calcium channel antagonist
NDA Applicant: TERSERA      NDA No.: 021060  Prod. No.: 001 RX (500MCG/20ML (25MCG/ML)); 002 RX (100MCG/1ML (100MCG/ML)); 004 RX (500MCG/5ML (100MCG/ML)) NDA No.: 021060  Prod. No.: 003 DISC (200MCG/2ML (100MCG/ML))
PatentsExpirationPatented Use
Pat. No. 8653033 Method for administering omega-conopeptide
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 19, 2014
Oct 1, 2024U-48: Analgesia
U-55: Treatment of pain
Pat. No. 8765680 Method for administering omega-conopeptide
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 2, 2014
Oct 1, 2024U-48: Analgesia
U-55: Treatment of pain
Pat. No. 9707270 Method for administering .omega.-conopeptide
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Aug 16, 2017
Oct 1, 2024U-2084: Treatment of severe chronic pain via intrathecal infusion of ziconotide in patients also receiving morphine

ALDARA (CREAM) (TOPICAL) IMIQUIMOD [GENERIC AB]
Drug Classes: Dermatological Agents:Dermatological Agents, Other
NDA Applicant: BAUSCH      NDA No.: 020723  Prod. No.: 001 RX (5%)
PatentsExpirationPatented Use
Pat. No. 7696159 DS* Treatment for basal cell carcinoma
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 12, 2010
Oct 1, 2024 *PEDU-1047: Treatment of biopsy-confirmed, primary superficial basal cell carcinoma (SBCC)
U-1048: Works through the induction of interferon and other cytokines

METHYLIN (SOLUTION) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [GENERIC AA]
Drug Classes: Central Nervous System Agents:Attention Deficit Hyperactivity Disorder Agents, Non-amphetamines == central nervous system stimulant
NDA Applicant: SPECGX LLC      NDA No.: 021419  Prod. No.: 001 RX (5MG/5ML); 002 RX (10MG/5ML)
PatentsExpirationPatented Use
Pat. No. 7691880 DP* Methylphenidate solution and associated methods of administration and production
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Oct 7, 2024 

OMEGAVEN (EMULSION) (INTRAVENOUS) FISH OIL TRIGLYCERIDES
NDA Applicant: FRESENIUS KABI USA      NDA No.: 210589  Prod. No.: 001 RX (5GM/50ML (0.1GM/ML)); 002 RX (10GM/100ML (0.1GM/ML))
PatentsExpirationPatented Use
Pat. No. 10350186 Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 2, 2019
Nov 5, 2024U-2585: Treatment of parenteral nutrition-associated cholestasis in patients under the age of 12
Pat. No. 9566260 DP* Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 27, 2018
Jul 11, 2025U-2366: Treatment of liver disease through nutrition for patients under the age of 12
Pat. No. 9629821 DP* Treatment and prevention of liver disease associated with parenteral nutrition (PN)
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 27, 2018
Jul 11, 2025U-2367: Use for patients with parenteral nutrition associated cholestasis or parenteral nutrition associated liver disease
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 27, 2023 
Exclusivity Code: ODE - Orphan drug exclusivityJul 27, 2025ODE-202: Indicated as a source of calories and fatty acids in pediatric patients with parenteral nutrition-associated cholestasis (PNAC)

XIIDRA (SOLUTION/DROPS) (OPHTHALMIC) LIFITEGRAST
Drug Classes: Ophthalmic Agents:Ophthalmic Agents, Other == lymphocyte function-associated antigen-1 (LFA-1) antagonist
NDA Applicant: NOVARTIS      NDA No.: 208073  Prod. No.: 001 RX (5%)
PatentsExpirationPatented Use
Pat. No. 7745460 DS* DP* Modulators of cellular adhesion
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 3, 2016
Nov 5, 2024U-1880: Treatment of signs and symptoms of dry eye disease (DED)
Pat. No. 7790743 Modulators of cellular adhesion
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 3, 2016
Nov 5, 2024U-1880: Treatment of signs and symptoms of dry eye disease (DED)
Pat. No. 7928122 DS* DP* Modulators of cellular adhesion
Claim Types: Compound; Composition; Method of use; Formulation
Pat. Sub. Date(s): 001: Aug 3, 2016
Nov 5, 2024 
Pat. No. 9216174 DP* Modulators of cellular adhesion
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Aug 3, 2016
Nov 5, 2024 
Pat. No. 10124000 Modulators of cellular adhesion
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 6, 2018
Nov 5, 2024U-1900: Treatment of the signs and symptoms of dry eye disease (DED)
Pat. No. 7314938 DS* DP* Modulators of cellular adhesion
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 3, 2016
Mar 10, 2025 
Pat. No. 8084047 DS* DP* Compositions and methods for treatment of eye disorders
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Aug 3, 2016
May 17, 2026 
Pat. No. 8592450 Compositions and methods for treatment of eye disorders
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 3, 2016
May 17, 2026U-1880: Treatment of signs and symptoms of dry eye disease (DED)
Pat. No. 8367701 DP* Crystalline pharmaceutical and methods of preparation and use thereof
Claim Types: Composition; New polymorph, salt or hydrate; Process; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 3, 2016
Apr 15, 2029U-1880: Treatment of signs and symptoms of dry eye disease (DED)
Pat. No. 9447077 Crystalline pharmaceutical and methods of preparation and use thereof
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Oct 6, 2016
Apr 15, 2029U-1900: Treatment of the signs and symptoms of dry eye disease (DED)
Pat. No. 8168655 Compositions and methods for treatment of eye disorders
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 3, 2016
May 9, 2029U-1880: Treatment of signs and symptoms of dry eye disease (DED)
Pat. No. 9353088 DP* Crystalline pharmaceutical and methods of preparation and use thereof
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Aug 3, 2016
Oct 21, 2030 
Pat. No. 9890141 DS* Crystalline pharmaceutical and methods of preparation and use thereof
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 5, 2018
Oct 21, 2030 
Pat. No. 8927574 DP* Crystalline pharmaceutical and methods of preparation and use thereof
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Aug 3, 2016
Nov 12, 2030 
Pat. No. 9085553 DP* LFA-1 inhibitor and methods of preparation and polymorph thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Aug 3, 2016
Jul 25, 2033 
Pat. No. 11058677 DP* LFA-1 inhibitor formulations
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Jul 23, 2021
Dec 18, 2033 
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJul 11, 2021 

FLONASE SENSIMIST ALLERGY RELIEF (SPRAY, METERED) (NASAL) FLUTICASONE FUROATE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Respiratory Tract/ Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant: GLAXOSMITHKLINE CONS      NDA No.: 022051  Prod. No.: 002 OTC (0.0275MG/SPRAY)
PatentsExpirationPatented Use
Pat. No. 9320862 DP* Fluid dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 31, 2016
Nov 6, 2024 
Pat. No. 8062264 DP* Fluid dispensing device
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 31, 2016
Apr 5, 2026 
Pat. No. 8752543 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 

PONVORY (TABLET) (ORAL) PONESIMOD
Drug Classes: sphingosine 1-phosphate receptor modulator
NDA Applicant: JANSSEN PHARMS      NDA No.: 213498  Prod. No.: 001 RX (2MG); 002 RX (3MG); 003 RX (4MG); 004 RX (5MG); 005 RX (6MG); 006 RX (7MG); 007 RX (8MG); 008 RX (9MG); 009 RX (10MG); 010 RX (20MG)
PatentsExpirationPatented Use
Pat. No. RE43728 DS* DP* Thiazolidin-4-one derivatives
Claim Types: Composition; Compound; Process
Pat. Sub. Date(s): All strengths: Apr 14, 2021
Nov 16, 2024 
Pat. No. 9000018 Thiazolidin-4-one-derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 14, 2021
Nov 16, 2024U-3102: Reduction of circulating lymphocytes in treating relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
Pat. No. 8273779 Thiazolidin 4-one derivatives
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 14, 2021
Dec 17, 2025U-2774: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
Pat. No. 9062014 DS* DP* Crystalline forms of (R)-5-[3-chloro-4-(2,3-dihydroxy-propoxy)-benz[Z]ylidene]-2-([Z]-propylim- ino)-3-0-tolyl-thiazolidin-4-one
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): All strengths: Apr 14, 2021
May 6, 2032U-2774: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults
Pat. No. 10220023 Dosing regimen for a selective S1P.sub.1 receptor agonist
Claim Types: Dosaage regimen
Pat. Sub. Date(s): All strengths: Apr 14, 2021
Dec 10, 2035U-3103: Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults using a dose titration schedule followed by a maintenance dose
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityMar 18, 2026 

TUKYSA (TABLET) (ORAL) TUCATINIB
Drug Classes: Antineoplastics:Molecular Target Inhibitors == kinase inhibitor
NDA Applicant: SEAGEN      NDA No.: 213411  Prod. No.: 001 RX (50MG); 002 RX (150MG)
PatentsExpirationPatented Use
Pat. No. 7452895 DS* DP* Quinazoline analogs as receptor tyrosine kinase inhibitors
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): All strengths: Apr 29, 2020
Nov 16, 2024U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer
Pat. No. 9693989 DP* N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Claim Types: Composition; Method of use
Pat. Sub. Date(s): All strengths: Apr 29, 2020
May 9, 2027U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer
Pat. No. 8648087 DS* DP* N4-phenyl-quinazoline-4-amine derivatives and related compounds as ErbB type I receptor tyrosine kinase inhibitors for the treatment of hyperproliferative diseases
Claim Types: Compound; Process
Pat. Sub. Date(s): All strengths: Apr 29, 2020
Apr 12, 2031 
Pat. No. 9457093 DP* Solid dispersions of a ERB2 (HER2) inhibitor
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): All strengths: Apr 29, 2020
Oct 12, 2032U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer
Pat. No. 11504370 Treatment of brain cancer
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 5, 2022
Mar 25, 2033U-2788: Treatment of breast cancer including HER2 (ERBB2)-positive or -overexpressing breast cancer
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityApr 17, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityApr 17, 2027ODE-309: Indicated for use in combination with trastuzumab and capecitabine for treatment of adult patients with metastatic HER2-positive breast cancer and brain metastases, who have received one or more prior anti-HER2-based regimens in the metastic setting

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 001 RX (EQ 0.3MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Dec 20, 2012
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2013
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 15, 2014
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 29, 2015
Nov 23, 2024 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 16, 2015
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 25, 2020
Nov 23, 2024 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Jan 15, 2025 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 21, 2025 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2019
Apr 30, 2025 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 23, 2016
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 11, 2016
Feb 1, 2026 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 5, 2015
Mar 31, 2026 
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Jun 1, 2026 
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 22, 2021
Jun 25, 2026 
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 18, 2016
Feb 20, 2027 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 21, 2013
Feb 27, 2027 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Mar 12, 2028 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 22, 2013
Oct 30, 2028 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 21, 2012
Nov 25, 2028 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Aug 21, 2012
Apr 10, 2029 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 26, 2013
Nov 2, 2029 

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 002 RX (EQ 0.15MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 15, 2014
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jan 29, 2015
Nov 23, 2024 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 16, 2015
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Aug 25, 2020
Nov 23, 2024 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Jan 15, 2025 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 21, 2025 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 2, 2019
Apr 30, 2025 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Nov 6, 2015
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Mar 23, 2016
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Apr 11, 2016
Feb 1, 2026 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Feb 5, 2015
Mar 31, 2026 
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Jun 1, 2026 
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: Apr 22, 2021
Jun 25, 2026 
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: Feb 18, 2016
Feb 20, 2027 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Feb 27, 2027 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 002: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Mar 12, 2028 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 002: None
Oct 30, 2028 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 002: None
Nov 25, 2028 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 002: None
Apr 10, 2029 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 002: Jul 26, 2013
Nov 2, 2029 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 002: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector

AUVI-Q (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant: KALEO INC      NDA No.: 201739  Prod. No.: 003 RX (EQ 0.1MG/DELIVERY)
PatentsExpirationPatented Use
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 8920377 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024 
Pat. No. 9833573 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 23, 2024U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs)
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Aug 25, 2020
Nov 23, 2024 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jan 15, 2025 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 21, 2025 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Jul 2, 2019
Apr 30, 2025 
Pat. No. 9149579 Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Jul 19, 2025U-1758: Method of treating allergic reaction via injection
Pat. No. 9259539 DP* Devices, systems and methods for medicament delivery
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 1, 2026 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 1, 2026 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 31, 2026 
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Jun 1, 2026 
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Apr 22, 2021
Jun 25, 2026 
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 20, 2027 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Feb 27, 2027 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 003: Dec 15, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Mar 12, 2028 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Oct 30, 2028 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 25, 2028 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 003: Dec 15, 2017
Apr 10, 2029 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 003: Dec 15, 2017
Nov 2, 2029 
Pat. No. 10688244 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Nov 4, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector
Pat. No. 10842938 DP* Medicament delivery device and methods for delivering drugs to infants and children
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 003: Dec 10, 2020
Dec 21, 2037U-2980: Method of treating an allergic reaction using an auto-injector

EVZIO (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: KALEO INC      NDA No.: 205787  Prod. No.: 001 DISC (0.4MG/0.4ML (0.4MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Nov 23, 2024 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2014
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Nov 23, 2024 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2015
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 23, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 25, 2020
Nov 23, 2024 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Jan 15, 2025 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Mar 21, 2025 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2019
Apr 30, 2025 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 11, 2016
Feb 1, 2026 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 16, 2015
Mar 31, 2026 
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Jun 10, 2026 
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 22, 2021
Jun 25, 2026 
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Feb 5, 2016
Feb 20, 2027 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Feb 27, 2027 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Mar 12, 2028 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Oct 30, 2028 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Nov 25, 2028 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: May 23, 2014
Apr 10, 2029 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Nov 2, 2029 
Pat. No. 8939943 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 27, 2015
Feb 28, 2031 
Pat. No. 9022022 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: May 15, 2015
Feb 28, 2031 
Pat. No. 9474869 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxo
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Nov 2, 2016
Feb 28, 2031U-1907: Use of a delivery device to administer a dose of naloxone
Pat. No. 10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 001: Jun 19, 2019
Feb 28, 2031U-1907: Use of a delivery device to administer a dose of naloxone
Pat. No. 10143972 Ultrafiltration membrane and a preparation method thereof
Claim Types: Process
Pat. Sub. Date(s): 001: Jan 2, 2019
Comments: Typo in the patent number. Likely should be 10,143,792.
May 24, 2031U-2476: Use of a delivery device to deliver a dose of naloxone
Pat. No. 8627816 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: May 23, 2014
Feb 4, 2032 
Pat. No. 9517307 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Dec 19, 2016
Jul 18, 2034U-1925: Use of an auto injector to administer naloxone HCl
Pat. No. 10220158 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2019
Mar 20, 2035U-2500: Use of a delivery device to deliver a bioequivalent dose of a naloxone composition via a needle

EVZIO (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: KALEO INC      NDA No.: 209862  Prod. No.: 001 DISC (2MG/0.4ML (2MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 23, 2024 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 23, 2024 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 30, 2017
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jun 11, 2019
Nov 23, 2024 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Aug 25, 2020
Nov 23, 2024 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Jan 15, 2025 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Mar 21, 2025 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 2, 2019
Apr 30, 2025 
Pat. No. 9278182 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Feb 1, 2026 
Pat. No. 8926594 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Mar 31, 2026 
Pat. No. 7731686 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Jun 1, 2026 
Pat. No. 10960155 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Apr 22, 2021
Jun 25, 2026 
Pat. No. 9238108 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Feb 20, 2027 
Pat. No. 8206360 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Feb 27, 2027 
Pat. No. 9724471 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Aug 23, 2017
May 23, 2027U-2092: Method for confirming dose delivery
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Mar 12, 2028 
Pat. No. 7749194 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Oct 30, 2028 
Pat. No. 8231573 DP* Medicament delivery device having an electronic circuit system
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 25, 2028 
Pat. No. 8226610 DP* Medical injector with compliance tracking and monitoring
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Nov 7, 2016
Apr 10, 2029 
Pat. No. 8021344 DP* Medicament delivery device configured to produce an audible output
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Nov 2, 2029 
Pat. No. 8939943 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Feb 28, 2031 
Pat. No. 9022022 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Feb 28, 2031 
Pat. No. 9474869 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxo
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Nov 7, 2016
Feb 28, 2031U-1907: Use of a delivery device to administer a dose of naloxone
Pat. No. 10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 001: Jun 19, 2019
Feb 28, 2031U-1907: Use of a delivery device to administer a dose of naloxone
Pat. No. 10143792 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 2, 2019
May 24, 2031U-2476: Use of a delivery device to deliver a dose of naloxone
Pat. No. 8627816 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 7, 2016
Feb 4, 2032 
Pat. No. 9517307 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Dec 19, 2016
Jul 18, 2034U-1925: Use of an auto injector to administer naloxone HCl
Pat. No. 10220158 DP* Devices and methods for delivering opioid antagonists including formulations for naloxone
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Mar 27, 2019
Mar 20, 2035U-2500: Use of a delivery device to deliver a bioequivalent dose of a naloxone composition via a needle

NALOXONE HYDROCHLORIDE (AUTOINJECTOR) (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents == opioid antagonist
NDA Applicant: KALEO INC      NDA No.: 215457  Prod. No.: 001 DISC (10MG/0.4ML (10MG/0.4ML))
PatentsExpirationPatented Use
Pat. No. 7918823 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 8313466 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 8361029 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 8425462 DP* Devices, systems, and methods for medicament delivery
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 8608698 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 9056170 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 9737669 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 10314977 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 10737028 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Nov 23, 2024 
Pat. No. 7731690 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Jan 15, 2025 
Pat. No. 8016788 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Mar 21, 2025 
Pat. No. 10335549 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Apr 30, 2025 
Pat. No. 7947017 DP* Devices, systems and methods for medicament delivery
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Mar 12, 2028 
Pat. No. 8939943 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Feb 28, 2031 
Pat. No. 9022022 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Feb 28, 2031 
Pat. No. 9474869 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxo
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Mar 25, 2022
Feb 28, 2031U-1907: Use of a delivery device to administer a dose of naloxone
Pat. No. 9814838 DP* Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Feb 28, 2031 
Pat. No. 10322239 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Method of administration; Device
Pat. Sub. Date(s): 001: Mar 25, 2022
Feb 28, 2031U-1907: Use of a delivery device to administer a dose of naloxone
Pat. No. 10143792 Medicament delivery device for administration of opioid antagonists including formulations for naloxone
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 25, 2022
May 24, 2031U-2476: Use of a delivery device to deliver a dose of naloxone

HYCAMTIN (CAPSULE) (ORAL) TOPOTECAN HYDROCHLORIDE
Drug Classes: Antineoplastics:Enzyme Inhibitors
NDA Applicant: NOVARTIS      NDA No.: 020981  Prod. No.: 001 RX (EQ 0.25MG BASE); 002 RX (EQ 1MG BASE)
PatentsExpirationPatented Use
Pat. No. 8158645 DP* Compound, corresponding compositions, preparation and/or treatment methods
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: May 11, 2012; 002: None
Dec 10, 2024 

ZEPZELCA (POWDER) (INTRAVENOUS) LURBINECTEDIN
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: JAZZ      NDA No.: 213702  Prod. No.: 001 RX (4MG/VIAL)
PatentsExpirationPatented Use
Pat. No. 7763615 DS* DP* Ecteinascidin analogs for use as antitumour agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jun 23, 2020
Dec 13, 2024U-2836: Treatment of adult patients with small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.
ExclusivityExpirationExclusivity Description
Exclusivity Code: NCE - New chemical entityJun 15, 2025 
Exclusivity Code: ODE - Orphan drug exclusivityJun 15, 2027ODE-304: Indicated for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy

REMODULIN (SOLUTION) (INTRAVENOUS, SUBCUTANEOUS) TREPROSTINIL
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives == prostacycline vasodilator
NDA Applicant: UNITED THERAP      NDA No.: 208276  Prod. No.: 001 DISC (20MG/20ML (1MG/ML)); 002 DISC (50MG/20ML (2.5MG/ML)); 003 DISC (100MG/20ML (5MG/ML)); 004 DISC (200MG/20ML (10MG/ML))
PatentsExpirationPatented Use
Pat. No. 9713599 Parenteral formulations of treprostinil
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018
Dec 16, 2024U-2036: A method of treating pulmonary hypertension comprising parenterally administering a formulation comprising a) 0.1 to 5% w/v of treprostinil or a pharmaceutically acceptable salt thereof and b) a citrate buffer
Pat. No. 10076505 DP* Inhalation formulations of Treprostinil
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018
Dec 16, 2024 
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): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018
Dec 15, 2028 
Pat. No. 9604901 DS* Process to prepare treprostinil, the active ingredient in Remodulin.RTM.
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Nov 2, 2018; 002: Nov 2, 2018; 003: Nov 2, 2018; 004: Oct 1, 2018
Dec 15, 2028 

VICTRELIS (CAPSULE) (ORAL) BOCEPREVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.: 202258  Prod. No.: 001 DISC (200MG)
PatentsExpirationPatented Use
Pat. No. RE43298 DS* DP* [Extended 1034 days (2.8 years)]
Peptides as NS3-serine protease inhibitors of hepatitis C virus
Claim Types: Compound; Intermediate; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: None
Dec 22, 2024U-1128: Treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin in adult patients (>=18 years of age) with compensated liver disease
Pat. No. 8119602 Administration of HCV protease inhibitors in combination with food to improve bioavailability
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 21, 2012
Mar 17, 2027U-1233: Treatment of chronic hepatitis C (CHC) genotype 1 infection, administered with food
Pat. No. 7772178 DP* Pharmaceutical formulations and methods of treatment using the same
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jun 10, 2011
Nov 11, 2027U-1128: Treatment of chronic hepatitis C (CHC) genotype 1 infection in combination with peginterferon alfa and ribavirin in adult patients (>=18 years of age) with compensated liver disease

FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 001 RX (EQ 0.1MG BASE)
PatentsExpirationPatented Use
Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 13, 2012
Dec 30, 2024 
Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 25, 2011
Jun 15, 2028 
Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 25, 2011
Jun 15, 2028 

FENTORA (TABLET) (BUCCAL, SUBLINGUAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting == opioid agonist
NDA Applicant: CEPHALON      NDA No.: 021947  Prod. No.: 002 RX (EQ 0.2MG BASE); 003 RX (EQ 0.4MG BASE); 004 RX (EQ 0.6MG BASE); 005 RX (EQ 0.8MG BASE)
PatentsExpirationPatented Use
Pat. No. 8092832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Dec 30, 2024 
Pat. No. 8119158 DP* Effervescent oral fentanyl dosage form and methods of administering fentanyl
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 002: Feb 23, 2012; 003: None; 004: None; 005: None
Dec 30, 2024 
Pat. No. 7862832 DP* Generally linear effervescent oral fentanyl dosage form and methods of administering
Claim Types: Formulation
Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011
Jun 15, 2028 
Pat. No. 7862833 DP* Effervescent oral opiate dosage forms and methods of administering opiates
Claim Types: Formulation
Pat. Sub. Date(s): 002: None; 003: None; 004: None; 005: Apr 25, 2011
Jun 15, 2028 


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
DLR* NDA holder has requested delisting of the patent. However, FDA will not delist if doing so would adversely affect an ANDA applicant's eligibility for 180-day generic exclusivity. ANDA applicants must provide a patent certification for the patent, but 505(b)(2) applicants do not need to do so.
Last edited: 17 January 2023
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