Orange Book Companion (R)
What's New for Vol. 44, Supp. 05
Changes to patent and exclusivity information

In the What's New that logged-in subscribers see, the tradename of each drug is a link to the full patent/exclusivity portfolio of the drug. If you would like that have that very useful feature, please subscribe! It is only $295/year for your whole company or organization! Click the link at the top of this page for more info.

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.


ACETAMINOPHEN AND IBUPROFEN (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN [GENERIC OTC]
Drug Classes: nonsteroidal anti-inflammatory drug
NDA Applicant: GLENMARK PHARMS LTD      NDA No.:
218311  Prod. No.: 001 OTC (250MG;125MG)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Nov 3, 2024New exclusivity for this product

AIRDUO RESPICLICK; AIRDUO DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes: corticosteroid == beta-2 adrenergic agonist
NDA Applicant: TEVA PHARM      NDA No.:
208799  Prod. No.: 001 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX (0.232MG/INH;EQ 0.014MG BASE/INH); 004 RX (0.055MG/INH;EQ 0.014MG BASE/INH); 005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX (0.232MG/INH;EQ 0.014MG BASE/INH)
PatentsExpirationChange
Pat. No. 11969544 DP*
Inhalers and airflow adaptors therefor
Pat. Sub. Date(s): All strengths: May 29, 2024
Claim Types: Device
Aug 20, 2039New patent for this product

ALECENSA (CAPSULE) (ORAL) ALECTINIB HYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: HOFFMANN-LA ROCHE      NDA No.:
208434  Prod. No.: 001 RX (EQ 150MG BASE)
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-947: For adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors >/= 4 cm or node positive), as detected by an FDA-approved testApr 18, 2027New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-477: Adjuvant treatment in adult patients following tumor resection of anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) (tumors greater than or equal to 4 cm or node positive), as detected by an FDA-approved testApr 18, 2031New exclusivity for this product

ALVAIZ (TABLET) (ORAL) ELTROMBOPAG CHOLINE
Drug Classes: thrombopoietin receptor agonist
NDA Applicant: TEVA PHARMS INC      NDA No.:
216774  Prod. No.: 001 RX (EQ 9MG BASE); 002 RX (EQ 18MG BASE); 003 RX (EQ 36MG BASE); 004 RX (EQ 54MG BASE)
PatentsExpirationChange
Pat. No. 11072586 DS* DP*
Solid state forms of eltrombopag choline
Pat. Sub. Date(s): All strengths: May 22, 2024
Claim Types: New polymorph, salt or hydrate; Method of use
Use Code: U-3936: Treatment of adult patients with severe aplastic anemia who have had an insufficient response to immunosuppressive therapy
Use Code: U-3937: Treatment of thrombocytopenia in adult patients with chronic hepatitis c to allow the initiation and maintenance of interferon-based therapy
Use Code: U-3938: Treatment of thrombocytopenia in adult and pediatric patients 6 years and older with persistent or chronic immune thrombocytopenia (ITP)
Nov 5, 2038New patent for this product

ANGIOMAX RTU (SOLUTION) (INTRAVENOUS) BIVALIRUDIN
Drug Classes: anticoagulant == direct thrombin inhibitor
NDA Applicant: MAIA PHARMS INC      NDA No.:
211215  Prod. No.: 001 RX (250MG/50ML (5MG/ML))
PatentsExpirationChange
Pat. No. 11992514 DP*
Ready-to-use bivalirudin compositions
Pat. Sub. Date(s): 001: May 30, 2024
Claim Types: Formulation
May 20, 2039New patent for this product

ARMONAIR RESPICLICK; ARMONAIR DIGIHALER (POWDER) (INHALATION) FLUTICASONE PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: TEVA PHARM      NDA No.:
208798  Prod. No.: 004 RX (0.055MG/INH); 005 RX (0.113MG/INH); 006 RX (0.232MG/INH) NDA No.: 208798  Prod. No.: 001 DISC (0.055MG/INH); 002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH); 007 DISC (0.03MG/INH); 008 DISC (0.03MG/INH)
PatentsExpirationChange
Pat. No. 11969544 DP*
Inhalers and airflow adaptors therefor
Pat. Sub. Date(s): All strengths: May 29, 2024
Claim Types: Device
Aug 20, 2039New patent for this product

ATROPINE SULFATE (SOLUTION/DROPS) (OPHTHALMIC) ATROPINE SULFATE [GENERIC AT2]
Drug Classes: anticholinergic == muscarinic antagonist
NDA Applicant: SOMERSET      NDA No.:
217791  Prod. No.: 001 RX (1%)
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Dec 4, 2024New exclusivity for this product

AUVELITY (TABLET, EXTENDED RELEASE) (ORAL) BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Drug Classes: aminoketone == sigma-1 agonist == uncompetitive NMDA receptor antagonist
NDA Applicant: AXSOME      NDA No.:
215430  Prod. No.: 001 RX (105MG;45MG)
PatentsExpirationChange
Pat. No. 11986444
Treatment of poor metabolizers of dextromethorphan with a combination of bupropion and dextromethorphan
Pat. Sub. Date(s): 001: May 31, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-3419: Dextromethorphan and bupropion in combination to treat major depressive disorder
Feb 15, 2043New patent for this product

AXUMIN (SOLUTION) (INTRAVENOUS) FLUCICLOVINE F-18
NDA Applicant: BLUE EARTH      NDA No.:
208054  Prod. No.: 001 RX (9-221mCi/ML)
PatentsExpirationChange
Pat. No. 11980674
Imaging of metastatic or recurrent cancer
Pat. Sub. Date(s): 001: Jun 10, 2024
Claim Types: Diagnostic or surgical method
Use Code: U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment
Apr 23, 2042New patent for this product

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.:
212608  Prod. No.: 001 RX (100MG); 002 RX (200MG)
PatentsExpirationChange
Pat. No. 11999744
Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making
Pat. Sub. Date(s): All strengths: Jun 5, 2024
Claim Types: Method of use
Use Code: U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Apr 10, 2040New patent for this product

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 004 RX (25MG)
PatentsExpirationChange
Pat. No. 11999744
Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making
Pat. Sub. Date(s): 004: Jun 5, 2024
Claim Types: Method of use
Use Code: U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Use Code: U-3506: Treatment of indolent systemic mastocytosis (ISM)
Apr 10, 2040New patent for this product

AYVAKIT (TABLET) (ORAL) AVAPRITINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.: 212608  Prod. No.: 005 RX (50MG)
PatentsExpirationChange
Pat. No. 11999744
Crystalline forms of (S)-1-(4-fluorophenyl)-1-(2-(4-(6-(1-methyl-1H-pyrazol-4-yl)pyrrolo[2,1-f][1,2,4]triazin-4-yl)piperazinyl)-pyrimidin-5-yl)ethan-1-amine and methods of making
Pat. Sub. Date(s): 005: Jun 5, 2024
Claim Types: Method of use
Use Code: U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL)
Apr 10, 2040New patent for this product

BALVERSA (TABLET) (ORAL) ERDAFITINIB
Drug Classes: kinase inhibitor
NDA Applicant: JANSSEN BIOTECH      NDA No.:
212018  Prod. No.: 001 RX (3MG); 002 RX (4MG); 003 RX (5MG)
PatentsExpirationChange
Pat. No. 10478494
FGFR/PD-1 combination therapy for the treatment of cancer
Pat. Sub. Date(s): All strengths: May 10, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-3902: Treatment of adults with locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations whose disease has progressed on or after prior PD-1 or PD-L1 inhibitor therapy
Aug 13, 2036New patent for this product

BELSOMRA (TABLET) (ORAL) SUVOREXANT
Drug Classes: orexin receptor antagonist
NDA Applicant: MERCK SHARP DOHME      NDA No.:
204569  Prod. No.: 001 RX (5MG); 002 RX (10MG); 003 RX (15MG); 004 RX (20MG)
PatentsExpirationChange
Pat. No. 11980623 DP*
Solid dosage formulations of an orexin receptor antagonist
Pat. Sub. Date(s): All strengths: May 20, 2024
Claim Types: Formulation; Product-by-process
May 29, 2033New patent for this product

BRUKINSA (CAPSULE) (ORAL) ZANUBRUTINIB
Drug Classes: kinase inhibitor
NDA Applicant: BEIGENE      NDA No.:
213217  Prod. No.: 001 RX (80MG)
PatentsExpirationChange
Pat. No. 11970500
Crystalline form of (s)-7-(1-acryloylpiperidin-4-yl)- 2-(4-phenoxyphenyl)-4,5,6,7-tetra- hydropyrazolo[1,5-a]pyrimidine-3-carboxamide, preparation, and uses thereof
Pat. Sub. Date(s): 001: May 9, 2024
Claim Types: Method of use
Use Code: U-1745: For the treatment of patients with Waldenstrom's macroglobulinemia
Use Code: U-2145: Treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy
Use Code: U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Use Code: U-2666: Treatment of adult patients with chronic lymphocytic leukemia
Use Code: U-3063: Relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-cd20-based regimen
Use Code: U-3486: Treatment of adult patients with small lymphocytic lymphoma
Use Code: U-3860: Treatment of adult patients with relapsed or refractory follicular lymphoma (FL), in combination with obinutuzumab, after two or more lines of systemic therapy
Aug 15, 2037New patent for this product

BRYHALI (LOTION) (TOPICAL) HALOBETASOL PROPIONATE
Drug Classes: corticosteroid
NDA Applicant: BAUSCH      NDA No.:
209355  Prod. No.: 001 RX (0.01%)
PatentsExpirationChange
Pat. No. 11957753 DP*
Pharmaceutical formulations containing corticosteroids for topical administration
Pat. Sub. Date(s): 001: May 10, 2024
Claim Types: Formulation
Nov 2, 2031New patent for this product
Pat. No. 11986527
Pharmaceutical formulations containing corticosteroids for topical administration
Pat. Sub. Date(s): 001: Jun 13, 2024
Claim Types: Method of use
Use Code: U-2625: Topical treatment of plaque psoriasis in adults
Nov 2, 2031New patent for this product

BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA      NDA No.:
212295  Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
PatentsExpirationChange
Pat. No. 9827251 [Extended 798 days (2.2 years)]
Dosing regimen for sedation with CNS 7056 (remimazolam)
Pat. Sub. Date(s): 001: Oct 23, 2020
Claim Types: Method of use
Use Code: U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Jan 13, 2034New expiration date. Was previously Nov 7, 2031

CAPLYTA (CAPSULE) (ORAL) LUMATEPERONE TOSYLATE
Drug Classes: atypical antipsychotic
NDA Applicant: INTRA-CELLULAR      NDA No.:
209500  Prod. No.: 001 RX (EQ 42MG BASE); 002 RX (EQ 10.5MG BASE); 003 RX (EQ 21MG BASE)
PatentsExpirationChange
Pat. No. 11980617
Methods of treating acute depression and/or acute anxiety
Pat. Sub. Date(s): All strengths: Jun 11, 2024
Claim Types: Method of use
Use Code: U-3940: Treatment of bipolar disorder or bipolar depression, including associated depressive episodes
Oct 27, 2039New patent for this product

DOVATO (TABLET) (ORAL) DOLUTEGRAVIR SODIUM; LAMIVUDINE
Drug Classes: HIV integrase strand transfer inhibitor (HIV-1 INSTI) == HBV nucleoside analog reverse transcriptase inhibitor (HBV-NRTI) == nucleoside analogue human immunodeficiency virus (HIV-1) reverse tr
NDA Applicant: VIIV HLTHCARE      NDA No.:
211994  Prod. No.: 001 RX (EQ 50MG BASE;300MG)
ExclusivityExpirationChange
Exclusivity Code: NPP - New patient population Apr 5, 2027New exclusivity for this product

DUOBRII (LOTION) (TOPICAL) HALOBETASOL PROPIONATE; TAZAROTENE
Drug Classes: corticosteroid == retinoid
NDA Applicant: BAUSCH      NDA No.:
209354  Prod. No.: 001 RX (0.01%;0.045%)
PatentsExpirationChange
Pat. No. 11957753 DP*
Pharmaceutical formulations containing corticosteroids for topical administration
Pat. Sub. Date(s): 001: May 10, 2024
Claim Types: Formulation
Nov 2, 2031New patent for this product

ELCYS (SOLUTION) (INTRAVENOUS) CYSTEINE HYDROCHLORIDE
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: EXELA PHARMA      NDA No.:
210660  Prod. No.: 001 RX (500MG/10ML (50MG/ML))
PatentsExpirationChange
Pat. No. 11969439
Stable, highly pure L-cysteine compositions for injection and methods of use
Pat. Sub. Date(s): 001: May 29, 2024
Claim Types: Method of use
Use Code: U-2752: Method of using L-cysteine in an admixture for treating patients needing parenteral nutrition
Jan 15, 2039New patent for this product

EPIDIOLEX (SOLUTION) (ORAL) CANNABIDIOL
NDA Applicant: JAZZ PHARMS RES      NDA No.:
210365  Prod. No.: 001 RX (100MG/ML)
PatentsExpirationChange
Pat. No. 11963937
Use of cannabinoids in the treatment of epilepsy
Pat. Sub. Date(s): 001: May 21, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-2780: Use for the treatment of seizures in patients with Lennox-Gastaut syndrome
Use Code: U-2781: Use for the treatment of seizures in patients with Dravet syndrome
Jun 17, 2035New patent for this product

ERLEADA (TABLET) (ORAL) APALUTAMIDE
NDA Applicant: JANSSEN BIOTECH      NDA No.:
210951  Prod. No.: 001 RX (60MG); 002 RX (240MG)
PatentsExpirationChange
Pat. No. 11963952
Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer
Pat. Sub. Date(s): All strengths: Apr 26, 2024
Claim Types: Method of use
Use Code: U-3901: Treatment of metastatic castration sensitive prostate cancer
Jan 30, 2040New Use Code

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.:
202293  Prod. No.: 001 RX (5MG)
PatentsExpirationChange
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Pat. Sub. Date(s): 001: Feb 5, 2014
Claim Types: Compound; Composition; Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Apr 4, 2026 *PEDNew expiration date. Was previously Oct 4, 2025
Pat. No. 7456254
Polymer-based sustained release device
Pat. Sub. Date(s): 001: Nov 15, 2017
Claim Types: Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Dec 30, 2025 *PEDNew expiration date. Was previously Jun 30, 2025
Pat. No. 7851502 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 001: Feb 5, 2014
Claim Types: Formulation
Feb 19, 2029 *PEDNew expiration date. Was previously Aug 19, 2028
Pat. No. 7919598 DS*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 001: Feb 5, 2014
Claim Types: New polymorph, salt or hydrate; Process
Jun 16, 2030 *PEDNew expiration date. Was previously Dec 16, 2029
Pat. No. 8221786 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 001: Feb 5, 2014
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8329648
Methods for treating diabetes and reducing body weight
Pat. Sub. Date(s): 001: Nov 15, 2017
Claim Types: Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Use Code: U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
Use Code: U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Feb 18, 2027 *PEDNew expiration date. Was previously Aug 18, 2026
Pat. No. 8361972
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 001: Feb 5, 2014
Claim Types: Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8431685
Polymer-based sustained release device
Pat. Sub. Date(s): 001: Nov 15, 2017
Claim Types: Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Oct 13, 2025 *PEDNew expiration date. Was previously Apr 13, 2025
Pat. No. 8461105
Polymer-based sustained release device
Pat. Sub. Date(s): 001: Nov 15, 2017
Claim Types: Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Oct 13, 2025 *PEDNew expiration date. Was previously Apr 13, 2025
Pat. No. 8501698 DP*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 001: Feb 5, 2014
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Dec 20, 2027 *PEDNew expiration date. Was previously Jun 20, 2027
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
Pat. Sub. Date(s): 001: Jun 25, 2014
Claim Types: Method of use
Use Code: U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Nov 26, 2030 *PEDNew expiration date. Was previously May 26, 2030
Pat. No. 8716251 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 001: Jun 2, 2014
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8721615 DP* DLR*
Ampoule comprising an ampoule holder
Pat. Sub. Date(s): 001: Nov 15, 2017
Claim Types: Device
Jul 18, 2030 *PEDNew expiration date. Was previously Jan 18, 2030
Pat. No. 8906851
Method for treating diabetes
Pat. Sub. Date(s): 001: Nov 15, 2017
Claim Types: Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Feb 18, 2027 *PEDNew expiration date. Was previously Aug 18, 2026
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-298: Labeling revisions related to study D1699CC00001Nov 8, 2026 PEDNew expiration date. Was previously May 8, 2026

FARXIGA (TABLET) (ORAL) DAPAGLIFLOZIN
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor
NDA Applicant: ASTRAZENECA AB      NDA No.: 202293  Prod. No.: 002 RX (10MG)
PatentsExpirationChange
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Pat. Sub. Date(s): 002: Feb 5, 2014
Claim Types: Compound; Composition; Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Apr 4, 2026 *PEDNew expiration date. Was previously Oct 4, 2025
Pat. No. 7456254
Polymer-based sustained release device
Pat. Sub. Date(s): 002: Nov 15, 2017
Claim Types: Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Dec 30, 2025 *PEDNew expiration date. Was previously Jun 30, 2025
Pat. No. 7851502 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 002: Feb 5, 2014
Claim Types: Formulation
Feb 19, 2029 *PEDNew expiration date. Was previously Aug 19, 2028
Pat. No. 7919598 DS*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 002: Feb 5, 2014
Claim Types: New polymorph, salt or hydrate; Process
Jun 16, 2030 *PEDNew expiration date. Was previously Dec 16, 2029
Pat. No. 8221786 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 002: Feb 5, 2014
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8329648
Methods for treating diabetes and reducing body weight
Pat. Sub. Date(s): 002: Nov 15, 2017
Claim Types: Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Use Code: U-2212: Reducing fasting plasma glucose in a human in need thereof in combination with a sustained-release composition containing exendin-4
Use Code: U-2213: Reducing HBA1C in a human in need thereof in combination with a sustained-release composition containing exendin-4
Feb 18, 2027 *PEDNew expiration date. Was previously Aug 18, 2026
Pat. No. 8361972
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 002: Feb 5, 2014
Claim Types: Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8431685
Polymer-based sustained release device
Pat. Sub. Date(s): 002: Nov 15, 2017
Claim Types: Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Oct 13, 2025 *PEDNew expiration date. Was previously Apr 13, 2025
Pat. No. 8461105
Polymer-based sustained release device
Pat. Sub. Date(s): 002: Nov 15, 2017
Claim Types: Formulation; Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Oct 13, 2025 *PEDNew expiration date. Was previously Apr 13, 2025
Pat. No. 8501698 DP*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 002: Feb 5, 2014
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Dec 20, 2027 *PEDNew expiration date. Was previously Jun 20, 2027
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
Pat. Sub. Date(s): 002: Jun 25, 2014
Claim Types: Method of use
Use Code: U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Nov 26, 2030 *PEDNew expiration date. Was previously May 26, 2030
Pat. No. 8716251 DP*
Pharmaceutical formulations containing an SGLT2 inhibitor
Pat. Sub. Date(s): 002: Jun 2, 2014
Claim Types: Formulation
Sep 21, 2028 *PEDNew expiration date. Was previously Mar 21, 2028
Pat. No. 8721615 DP* DLR*
Ampoule comprising an ampoule holder
Pat. Sub. Date(s): 002: Nov 15, 2017
Claim Types: Device
Jul 18, 2030 *PEDNew expiration date. Was previously Jan 18, 2030
Pat. No. 8906851
Method for treating diabetes
Pat. Sub. Date(s): 002: Nov 15, 2017
Claim Types: Method of use
Use Code: U-2139: Treatment of Type 2 diabetes mellitus in combination with exenatide
Feb 18, 2027 *PEDNew expiration date. Was previously Aug 18, 2026
Pat. No. 10973836
Methods of treating heart failure with reduced ejection fraction
Pat. Sub. Date(s): 002: Apr 21, 2021
Claim Types: Method of improving a treatment
Use Code: U-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
Sep 9, 2040 *PEDNew expiration date. Was previously Mar 9, 2040
Pat. No. 11826376
Methods of treating heart failure with preserved ejection fraction employing dapagliflozin and compositions comprising the same
Pat. Sub. Date(s): 002: Dec 19, 2023
Claim Types: Method of use
Use Code: U-3766: Reduce the risk of cardiovascular death and hospitalization for heart failure and urgent heart failure visits in adults with heart failure with preserved ejection fraction and without Type II diabetes
Jan 18, 2040 *PEDNew expiration date. Was previously Jul 18, 2039
Pat. No. 11903955
Methods of treating heart failure with reduced ejection fraction
Pat. Sub. Date(s): 002: Mar 13, 2024
Claim Types: Method of use
Use Code: U-3825: Reduce the risk of cardiovascular death and worsening heart failure in adults with heart failure with reduced ejection fraction, without type ii diabetes, and having an HBA1C of < 5.7%
Sep 9, 2040 *PEDNew expiration date. Was previously Mar 9, 2040
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-298: Labeling revisions related to study D1699CC00001Nov 8, 2026 PEDNew expiration date. Was previously May 8, 2026

GALAFOLD (CAPSULE) (ORAL) MIGALASTAT HYDROCHLORIDE
NDA Applicant: AMICUS THERAP US      NDA No.:
208623  Prod. No.: 001 RX (EQ 123MG BASE)
PatentsExpirationChange
Pat. No. RE48608 [Extended 980 days (2.7 years)]
Method to predict response to pharmacological chaperone treatment of diseases
Pat. Sub. Date(s): 001: Jul 22, 2021
Claim Types: Method of use
Use Code: U-2371: The treatment of Fabry patients
Oct 20, 2031New expiration date. Was previously Feb 12, 2029

GAVRETO (CAPSULE) (ORAL) PRALSETINIB
Drug Classes: kinase inhibitor
NDA Applicant: BLUEPRINT MEDICINES      NDA No.:
213721  Prod. No.: 001 RX (100MG)
PatentsExpirationChange
Pat. No. 11963958
RET inhibitor for use in treating cancer having a RET alteration
Pat. Sub. Date(s): 001: May 13, 2024
Claim Types: Method of use
Use Code: U-2828: Treatment of adult and pediatric patients 12 years of age and older with advanced or metastatic ret fusion-positive thyroid cancer who require systemic therapy and who are radioactive iodine refractory (if radioactive iodine is appropriate)
Apr 3, 2039New patent for this product

HYDROMORPHONE HYDROCHLORIDE (INJECTABLE) (INJECTION) HYDROMORPHONE HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist
NDA Applicant: HIKMA      NDA No.:
216899  Prod. No.: 002 RX (0.5MG/0.5ML)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Nov 11, 2024New exclusivity for this product

HYDROMORPHONE HYDROCHLORIDE (INJECTABLE) (INJECTION) HYDROMORPHONE HYDROCHLORIDE [GENERIC AP]
Drug Classes: opioid agonist
NDA Applicant: HIKMA      NDA No.: 216899  Prod. No.: 003 RX (1MG/ML)
ExclusivityExpirationChange
Exclusivity Code: PC - Patent challenge Dec 2, 2024New exclusivity for this product

IGALMI (FILM) (BUCCAL, SUBLINGUAL) DEXMEDETOMIDINE HYDROCHLORIDE
Drug Classes: central alpha-2 adrenergic agonist
NDA Applicant: BIOXCEL      NDA No.:
215390  Prod. No.: 001 RX (EQ 0.12MG BASE); 002 RX (EQ 0.18MG BASE)
PatentsExpirationChange
Pat. No. 11998529
Non-sedating dexmedetomidine treatment regimens
Pat. Sub. Date(s): All strengths: Jun 5, 2024
Claim Types: Method of use
Use Code: U-3935: Acute treatment of agitation associated with schizophrenia or bipolar I or II disorder by sublingual or buccal administration
Jul 17, 2040New patent for this product

INGREZZA SPRINKLE (CAPSULE) (ORAL) VALBENAZINE TOSYLATE [Has competitive generic]
Drug Classes: vesicular monoamine transporter 2 (VMAT2) inhibitor
NDA Applicant: NEUROCRINE      NDA No.:
218390  Prod. No.: 001 RX (EQ 40MG BASE); 002 RX (EQ 60MG BASE); 003 RX (EQ 80MG BASE)
PatentsExpirationChange
Pat. No. 8039627 DS* DP* [Extended 552 days (1.5 years)]
Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquin- olin-2-ol compounds and meth
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Compound; Composition
Apr 11, 2031New patent for this product
Pat. No. 8357697
Substituted 3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-A]isoquin- olin-2-ol compounds and methods relating thereto
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Nov 8, 2027New patent for this product
Pat. No. 10065952 DS* DP*
Valbenazine salts and polymorphs thereof
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Oct 28, 2036New patent for this product
Pat. No. 10844058 DS* DP*
Valbenazine salts and polymorphs thereof
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Oct 28, 2036New patent for this product
Pat. No. 10851103 DS* DP*
Valbenazine salts and polymorphs thereof
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Oct 28, 2036New patent for this product
Pat. No. 10851104 DS*
Valbenazine salts and polymorphs thereof
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: New polymorph, salt or hydrate; Process; Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Oct 28, 2036New patent for this product
Pat. No. 10857137
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Oct 10, 2037New patent for this product
Pat. No. 10857148
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Oct 10, 2037New patent for this product
Pat. No. 10874648
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of administration
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3046: Method of administering valbenazine while avoiding concomitant use of a strong CYP3A4 inducer
Use Code: U-3055: A method of treating Huntington's chorea
Oct 10, 2037New patent for this product
Pat. No. 10906902 DS* DP*
Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1,-a]isoquinolin-2-2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Product-by-process; Composition
Dec 22, 2036New patent for this product
Pat. No. 10906903 DS* DP*
Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1,-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: New polymorph, salt or hydrate; Formulation
Dec 22, 2036New patent for this product
Pat. No. 10912771
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Use Code: U-3076: Method of treating tardive dyskinesia while avoiding concomitant use of a strong CYP3A4 inducer
Oct 10, 2037New patent for this product
Pat. No. 10919892 DS* DP*
Synthetic methods for preparation of (S)-(2R,3R,11bR)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1H-pyr- ido[2,1-a]isoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate)
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Formulation
Dec 22, 2036New patent for this product
Pat. No. 10940141
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Aug 10, 2040New patent for this product
Pat. No. 10952997
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Oct 10, 2037New patent for this product
Pat. No. 10993941
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Oct 10, 2037New patent for this product
Pat. No. 11026931
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Aug 14, 2039New patent for this product
Pat. No. 11026939 DP*
High dosage valbenazine formulation and compositions, methods, and kits related thereto
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Formulation; Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Sep 18, 2038New patent for this product
Pat. No. 11040029
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Oct 10, 2037New patent for this product
Pat. No. 11311532 DP*
High dosage valbenazine formulation and compositions, methods, and kits related thereto
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Formulation; Method of use
Use Code: U-1995: Treatment of tardive dyskinesia
Use Code: U-3055: A method of treating Huntington's chorea
Sep 18, 2038New patent for this product
Pat. No. 11439629
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-3055: A method of treating Huntington's chorea
Oct 10, 2037New patent for this product
Pat. No. 11654142
Methods for the administration of certain VMAT2 inhibitors
Pat. Sub. Date(s): All strengths: May 13, 2024
Claim Types: Method of use
Use Code: U-3055: A method of treating Huntington's chorea
Nov 14, 2038New patent for this product
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-925: Treatment of adults with chorea associated with Huntington's diseaseAug 18, 2026New exclusivity for this product

INOMAX (GAS) (INHALATION) NITRIC OXIDE [GENERIC AA]
NDA Applicant: MALLINCKRODT HOSP      NDA No.:
020845  Prod. No.: 003 RX (800PPM)
PatentsExpirationChange
Pat. No. 11931377 DS* DP*
Methods of administering inhaled nitric oxide gas
Pat. Sub. Date(s): 003: May 6, 2024
Claim Types: Method of use
Use Code: U-3903: A method for treating a pediatric patient who is experiencing idiopathic pulmonary arterial hypertension resulting in oxygen desaturation, wherein the patient is not dependent on right-to-left shunting of blood
Dec 3, 2029 *PEDNew patent for this product

INOMAX (GAS) (INHALATION) NITRIC OXIDE
NDA Applicant: MALLINCKRODT HOSP      NDA No.: 020845  Prod. No.: 004 RX (4880PPM)
PatentsExpirationChange
Pat. No. 11931377 DS* DP*
Methods of administering inhaled nitric oxide gas
Pat. Sub. Date(s): 004: May 6, 2024
Claim Types: Method of use
Use Code: U-3903: A method for treating a pediatric patient who is experiencing idiopathic pulmonary arterial hypertension resulting in oxygen desaturation, wherein the patient is not dependent on right-to-left shunting of blood
Jun 3, 2029New strength or variation of this product

INQOVI (TABLET) (ORAL) CEDAZURIDINE; DECITABINE
Drug Classes: nucleoside metabolic inhibitor
NDA Applicant: OTSUKA      NDA No.:
212576  Prod. No.: 001 RX (100MG;35MG)
PatentsExpirationChange
Pat. No. 11963971 DP*
Combination decitabine and cedazuridine solid oral dosage forms
Pat. Sub. Date(s): 001: May 10, 2024
Claim Types: Formulation
Feb 24, 2041New patent for this product

KORLYM (TABLET) (ORAL) MIFEPRISTONE [GENERIC AB]
Drug Classes: progestin antagonist
NDA Applicant: CORCEPT THERAP      NDA No.:
202107  Prod. No.: 001 RX (300MG)
PatentsExpirationChange
Pat. No. 11969435
Concomitant administration of glucocorticoid receptor modulators and CYP3A inhibitors
Pat. Sub. Date(s): 001: May 29, 2024
Claim Types: Method of use
Use Code: U-1643: Treating Cushing's syndrome
Jun 19, 2037New patent for this product

LANSOPRAZOLE (TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE) (ORAL) LANSOPRAZOLE [Has competitive generic]
Drug Classes: proton pump inhibitor (PPI)
NDA Applicant: DEXCEL      NDA No.:
208025  Prod. No.: 001 OTC (15MG)
PatentsExpirationChange
Pat. No. 11986554 DP*
Orally disintegrating compositions
Pat. Sub. Date(s): 001: May 21, 2024
Claim Types: Formulation
Apr 21, 2036New patent for this product

LEGUBETI (FOR SOLUTION) (ORAL) ACETYLCYSTEINE LYSINE
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: GALEPHAR      NDA No.:
215040  Prod. No.: 001 RX (EQ 500MG BASE/PACKET); 002 RX (EQ 2.5GM BASE/PACKET)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Feb 13, 2027New exclusivity for this product

LIBERVANT (FILM) (BUCCAL) DIAZEPAM
Drug Classes: benzodiazepine
NDA Applicant: AQUESTIVE      NDA No.:
218623  Prod. No.: 001 RX (5MG); 002 RX (7.5MG); 003 RX (10MG); 004 RX (12.5MG); 005 RX (15MG)
PatentsExpirationChange
Pat. No. 11273131 DP*
Pharmaceutical compositions with enhanced permeation
Pat. Sub. Date(s): All strengths: May 14, 2024
Claim Types: Formulation
Jun 18, 2038New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NP - New product Apr 26, 2027New exclusivity for this product

LUMIFY PRESERVATIVE FREE (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC OTC]
Drug Classes: alpha-adrenergic receptor agonist
NDA Applicant: BAUSCH AND LOMB INC      NDA No.:
218424  Prod. No.: 001 OTC (0.025%)
PatentsExpirationChange
Pat. No. 8293742
Preferential vasoconstriction compositions and methods of use
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Method of use
Use Code: U-2222: Relieves redness of the eye due to minor eye irritations
Jul 14, 2030New patent for this product
Pat. No. 9259425
Compositions and methods for eye whitening
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Method of use
Use Code: U-2222: Relieves redness of the eye due to minor eye irritations
Jul 14, 2030New patent for this product
Pat. No. 11596600
Vasoconstriction compositions and methods of use
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Method of use
Use Code: U-2222: Relieves redness of the eye due to minor eye irritations
Jul 27, 2029New patent for this product

LUMISIGHT (POWDER) (INTRAVENOUS) PEGULICIANINE ACETATE
NDA Applicant: LUMICELL      NDA No.:
214511  Prod. No.: 001 RX (EQ 40MG BASE/VIAL)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Apr 17, 2029New exclusivity for this product

LUMRYZ (FOR SUSPENSION, EXTENDED RELEASE) (ORAL) SODIUM OXYBATE
Drug Classes: central nervous system depressant
NDA Applicant: AVADEL CNS      NDA No.:
214755  Prod. No.: 001 RX (4.5GM/PACKET); 002 RX (6GM/PACKET); 003 RX (7.5GM/PACKET); 004 RX (9GM/PACKET)
PatentsExpirationChange
Pat. No. 11986451
Modified release gamma-hydroxybutyrate formulations having improved pharmacokinetics
Pat. Sub. Date(s): All strengths: May 29, 2024
Claim Types: Method of use
Use Code: U-3934: Treatment of narcolepsy-related cataplexy or eds in a human patient with a once-nightly GHB formulation by initiating treatment with a dose equivalent to 4.5 g of sodium oxybate and uptitrating in increments equivalent to 1.5 g of sodium oxybate
Jul 21, 2037New patent for this product

LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM LU 177 DOTATATE
NDA Applicant: AAA USA INC      NDA No.:
208700  Prod. No.: 001 RX (10mCi/ML)
ExclusivityExpirationChange
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-479: Treatment of pediatric patients 12 years and older with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS), including foregut, midgut, and hindgut neuroendocrine tumorsOct 23, 2031 PEDNew exclusivity for this product

LYNPARZA (TABLET) (ORAL) OLAPARIB
Drug Classes: poly (ADP-ribose) polymerase (PARP) inhibitor
NDA Applicant: ASTRAZENECA      NDA No.:
208558  Prod. No.: 001 RX (100MG); 002 RX (150MG)
PatentsExpirationChange
Pat. No. 11970530
Methods of treating homologous recombination deficient cancer
Pat. Sub. Date(s): All strengths: May 28, 2024
Claim Types: Method of use
Use Code: U-3929: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of advanced epithelial ovarian cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status
Use Code: U-3930: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of fallopian tube cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status
Use Code: U-3931: Maintenance treatment with 15 mg/kg of body weight bevacizumab every three weeks of primary peritoneal cancer in complete or partial response to first-line platinum-based chemotherapy and associated with hrd-positive status
Oct 25, 2041New patent for this product
Pat. No. 11975001 DP*
Immediate release pharmaceutical formulation of 4-[3-(4-cyclopropanecarbonyl-piperazine-1-carbonyl)-4-fluoro-benzyl]-2H-phthalazin-1-one
Pat. Sub. Date(s): All strengths: Jun 3, 2024
Claim Types: Formulation
Oct 7, 2029New patent for this product

MYHIBBIN (SUSPENSION) (ORAL) MYCOPHENOLATE MOFETIL
NDA Applicant: AZURITY      NDA No.:
216482  Prod. No.: 001 RX (200MG/ML)
PatentsExpirationChange
Pat. No. 11931455 DP*
Pharmaceutical suspension for oral dosage
Pat. Sub. Date(s): 001: May 15, 2024
Claim Types: Formulation; Method of use
Use Code: U-1752: Prophylaxis of organ rejection
Aug 16, 2039New product in Orange Book

NEXLETOL (TABLET) (ORAL) BEMPEDOIC ACID
NDA Applicant: ESPERION THERAPS INC      NDA No.:
211616  Prod. No.: 001 RX (180MG)
PatentsExpirationChange
Pat. No. 7335799 DS* [Extended 5 years]
Hydroxyl compounds and compositions for cholesterol management and related uses
Pat. Sub. Date(s): 001: Mar 6, 2020
Claim Types: Compound; Composition
Dec 3, 2030New expiration date. Was previously Dec 3, 2025
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-943: To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established cardiovascular disease (CVD), or at high risk for a CVD event but without established CVDMar 22, 2027New exclusivity for this product
Exclusivity Code: I - New Indication: I-944: Expanded indication for use as an adjunct to diet, in combination with other low-density lipoprotein cholesterol (LDL-C) lowering therapies, or alone when concomitant LDL-C lowering therapy is not possible, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH)Mar 22, 2027New exclusivity for this product

NEXLIZET (TABLET) (ORAL) BEMPEDOIC ACID; EZETIMIBE
Drug Classes: dietary cholesterol absorption inhibitor
NDA Applicant: ESPERION THERAPS INC      NDA No.:
211617  Prod. No.: 001 RX (180MG;10MG)
PatentsExpirationChange
Pat. No. 7335799 DS* [Extended 5 years]
Hydroxyl compounds and compositions for cholesterol management and related uses
Pat. Sub. Date(s): 001: Mar 6, 2020
Claim Types: Compound; Composition
Dec 3, 2030New expiration date. Was previously Dec 3, 2025
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-943: To reduce the risk of myocardial infarction and coronary revascularization in adults who are unable to take recommended statin therapy (including those not taking a statin) with established cardiovascular disease (CVD), or at high risk for a CVD event but without established CVDMar 22, 2027New exclusivity for this product
Exclusivity Code: I - New Indication: I-945: Expanded indication for use as an adjunct to diet, alone or in combination with other LDL-C lowering therapies, to reduce LDL-C in adults with primary hyperlipidemia, including heterozygous familial hypercholesterolemia (HEFH)Mar 22, 2027New exclusivity for this product

NOCDURNA (TABLET) (SUBLINGUAL) DESMOPRESSIN ACETATE
Drug Classes: factor VIII activator == vasopressin analog
NDA Applicant: FERRING PHARMS INC      NDA No.:
022517  Prod. No.: 001 DISC (0.0277MG); 002 DISC (0.0553MG)
PatentsExpirationChange
Pat. No. 11963995
Methods comprising desmopressin
Pat. Sub. Date(s): All strengths: May 21, 2024
Claim Types: Method of use
Use Code: U-2327: Treatment of nocturia due to nocturnal polyuria in adults, comprising monitoring a patient's serum sodium concentration
May 21, 2029New patent for this product

NOURESS (SOLUTION) (INTRAVENOUS) CYSTEINE HYDROCHLORIDE
Drug Classes: antidote == antidote for acetaminophen overdose == mucolytic
NDA Applicant: BAXTER HLTHCARE CORP      NDA No.:
212535  Prod. No.: 001 DISC (500MG/10ML (50MG/ML))
PatentsExpirationChange
Pat. No. 11642370 DP*
Stable, highly pure L-cysteine compositions for injection and methods of use
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process
Jan 15, 2039New patent for this product
Pat. No. 11648262 DP*
Stable, highly pure L-cysteine compositions for injection and methods of use
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Process
Jan 15, 2039New patent for this product
Pat. No. 11679125 DP*
Stable, highly pure L-cysteine compositions for injection and methods of use
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Formulation claimed by its inherent performace characteristics; Process
Jan 15, 2039New patent for this product
Pat. No. 11684636 DP*
Stable, highly pure l-cysteine compositions for injection and methods of use
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Formulation claimed by its inherent performace characteristics; Process
Jan 15, 2039New patent for this product
Pat. No. 11826383 DP*
Stable, highly pure L-cysteine compositions for injection and methods of use
Pat. Sub. Date(s): 001: May 17, 2024
Claim Types: Formulation
Jan 15, 2039New patent for this product

NUZYRA (TABLET) (ORAL) OMADACYCLINE TOSYLATE
Drug Classes: tetracycline class antibacterial
NDA Applicant: PARATEK PHARMS INC      NDA No.:
209816  Prod. No.: 001 RX (EQ 150MG BASE)
PatentsExpirationChange
Pat. No. 7553828 DS*
9-aminomethyl substituted minocycline compounds
Pat. Sub. Date(s): 001: Jul 23, 2019
Claim Types: Compound; Composition
Jun 2, 2025New expiration date. Was previously Jun 2, 2024

NUZYRA (POWDER) (INTRAVENOUS) OMADACYCLINE TOSYLATE
Drug Classes: tetracycline class antibacterial
NDA Applicant: PARATEK PHARMS INC      NDA No.: 209817  Prod. No.: 001 RX (EQ 100MG BASE/VIAL)
PatentsExpirationChange
Pat. No. 7553828 DS*
9-aminomethyl substituted minocycline compounds
Pat. Sub. Date(s): 001: Jul 23, 2019
Claim Types: Compound; Composition
Jun 2, 2025New expiration date. Was previously Jun 2, 2024

OJEMDA (TABLET) (ORAL) TOVORAFENIB
NDA Applicant: DAY ONE BIOPHARMS      NDA No.:
217700  Prod. No.: 001 RX (100MG)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Apr 23, 2029New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-478: Treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a braf fusion or rearrangement, or BRAF V600 mutationApr 23, 2031New exclusivity for this product

OJEMDA (FOR SUSPENSION) (ORAL) TOVORAFENIB
NDA Applicant: DAY ONE BIOPHARMS      NDA No.: 218033  Prod. No.: 001 RX (25MG/ML)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Apr 23, 2029New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-478: Treatment of patients 6 months of age and older with relapsed or refractory pediatric low-grade glioma (LGG) harboring a braf fusion or rearrangement, or BRAF V600 mutationApr 23, 2031New exclusivity for this product

OJJAARA (TABLET) (ORAL) MOMELOTINIB DIHYDROCHLORIDE
Drug Classes: kinase inhibitor
NDA Applicant: GLAXOSMITHKLINE      NDA No.:
216873  Prod. No.: 001 RX (EQ 100MG BASE); 002 RX (EQ 150MG BASE); 003 RX (EQ 200MG BASE)
PatentsExpirationChange
Pat. No. 11963962
Platelet count-agnostic methods of treating myelofibrosis
Pat. Sub. Date(s): All strengths: May 21, 2024
Claim Types: Method of use
Use Code: U-3928: For the treatment of intermediate or high-risk myelofibrosis in subjects having a baseline platelet count of less than 50 billion/l
Dec 2, 2040New patent for this product

ONYDA XR (SUSPENSION, EXTENDED RELEASE) (ORAL) CLONIDINE HYDROCHLORIDE
Drug Classes: alpha adrenergic agonist == central alpha-2 adrenergic agonist
NDA Applicant: TRIS PHARMA INC      NDA No.:
217645  Prod. No.: 001 RX (0.1MG/ML)
PatentsExpirationChange
Pat. No. 8062667 DP*
Modified release formulations containing drug-ion exchange resin complexes
Pat. Sub. Date(s): 001: Jun 12, 2024
Claim Types: Formulation
Mar 29, 2029New product in Orange Book
Pat. No. 11918689 DP*
Liquid clonidine extended release composition
Pat. Sub. Date(s): 001: Jun 12, 2024
Claim Types: Formulation; ; Formulation claimed by its inherent performace characteristics
Use Code: U-3944: Method for delivering an effective amount of clonidine for a 24-hour period using a single oral clonidine composition according to claim 1 prior to bed time
Jul 28, 2041New product in Orange Book

OTEZLA (TABLET) (ORAL) APREMILAST [GENERIC AB]
Drug Classes: phosphodiesterase 4 inhibitor
NDA Applicant: AMGEN INC      NDA No.:
205437  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (30MG)
ExclusivityExpirationChange
Exclusivity Code: M - Miscellaneous: M-299: Clinical study information added to the label about the treatment of moderate to severe genital psoriasisJan 20, 2027 PEDNew expiration date. Was previously Jul 20, 2026
Exclusivity Code: NPP - New patient population Oct 25, 2027 PEDNew exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-248: Treatment of adult patients with oral ulcers associated with Behcets diseaseJan 19, 2027 PEDNew expiration date. Was previously Jul 19, 2026

PARSABIV (SOLUTION) (INTRAVENOUS) ETELCALCETIDE
Drug Classes: calcium-sensing receptor agonist
NDA Applicant: KAI PHARMS INC      NDA No.:
208325  Prod. No.: 001 RX (2.5MG/0.5ML (2.5MG/0.5ML)); 002 RX (5MG/ML (5MG/ML)); 003 RX (10MG/2ML (5MG/ML))
PatentsExpirationChange
Pat. No. 11959486 DP*
Stable liquid formulation of AMG 416 (etelcalcetide)
Pat. Sub. Date(s): All strengths: May 10, 2024
Claim Types: Formulation; Method of use
Use Code: U-2014: A method of treating secondary hyperparathyroidism (SHPT); a method of decreasing parathyroid hormone levels
Jun 27, 2034New patent for this product

PLUVICTO (SOLUTION) (INTRAVENOUS) LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
NDA Applicant: NOVARTIS      NDA No.:
215833  Prod. No.: 001 RX (27mCi/ML)
PatentsExpirationChange
Pat. No. 11951190
Use of labeled inhibitors of prostate specific membrane antigen (PSMA), as agents for the treatment of prostate cancer
Pat. Sub. Date(s): 001: May 7, 2024
Claim Types: Method of use
Use Code: U-3345: For treatment of adult patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (MCRPC) who have been treated with androgen receptor (AR) pathway inhibition and taxane-based chemotherapy
Nov 12, 2035New patent for this product

PURIFIED CORTROPHIN GEL (INJECTABLE) (INJECTION) CORTICOTROPIN
Drug Classes: adrenocorticotropic hormone
NDA Applicant: ANI PHARMS      NDA No.:
008975  Prod. No.: 002 RX (80 UNITS/ML)
PatentsExpirationChange
Pat. No. 11975047
Methods for storing and warming purified corticotropin compositions
Pat. Sub. Date(s): 002: May 17, 2024
Claim Types: Process
Use Code: U-3904: Acute exacerbations of multiple sclerosis
Use Code: U-3905: Allergic conjunctivitis
Use Code: U-3906: Anterior segment inflammation
Use Code: U-3907: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: acute gouty arthritis
Use Code: U-3908: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: ankylosing spondylitis
Use Code: U-3909: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: juvenile rheumatoid arthritis
Use Code: U-3910: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: psoriatic arthritis
Use Code: U-3911: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in: rheumatoid arthritis
Use Code: U-3912: Atopic dermatitis
Use Code: U-3913: Chorioretinitis
Use Code: U-3914: Diffuse posterior uveitis and choroiditis
Use Code: U-3915: During an exacerbation or as maintenance therapy in selected cases of: systemic dermatomyositis (polymyositis)
Use Code: U-3916: During an exacerbation or as maintenance therapy in selected cases of: systemic lupus erythematosus
Use Code: U-3917: Iridocyclitis
Use Code: U-3918: Iritis
Use Code: U-3919: Keratitis
Use Code: U-3920: Optic neuritis
Use Code: U-3921: Serum sickness
Use Code: U-3922: Severe acute and chronic allergic and inflammatory processes involving the eye and its adnexa
Use Code: U-3923: Severe erythema multiforme (stevens-johnson syndrome)
Use Code: U-3924: Severe psoriasis
Use Code: U-3925: Symptomatic sarcoidosis
Use Code: U-3926: To induce a diuresis or a remission of proteinuria in the nephrotic syndrome without uremia of the idiopathic type or that due to lupus erythematosus
Oct 27, 2043New patent for this product

QVAR REDIHALER (AEROSOL, METERED) (INHALATION) BECLOMETHASONE DIPROPIONATE
Drug Classes: corticosteroid
NDA Applicant: NORTON WATERFORD      NDA No.:
207921  Prod. No.: 001 RX (0.04MG/INH); 002 RX (0.08MG/INH)
PatentsExpirationChange
Pat. No. 11957832 DP*
Breath actuated inhaler
Pat. Sub. Date(s): All strengths: May 7, 2024
Claim Types: Part of a dosage form; Device
May 5, 2041New patent for this product

RECARBRIO (POWDER) (INTRAVENOUS) CILASTATIN SODIUM; IMIPENEM; RELEBACTAM
Drug Classes: renal dehydropeptidase inhibitor == penem antibacterial
NDA Applicant: MSD MERCK CO      NDA No.:
212819  Prod. No.: 001 RX (EQ 500MG BASE/VIAL;500MG/VIAL;250MG/VIAL)
PatentsExpirationChange
Pat. No. 8487093 DS* DP* [Extended 1218 days (3.3 years)]
.beta.-lactamase inhibitors
Pat. Sub. Date(s): 001: Aug 13, 2019
Claim Types: Compound; Composition; Method of use
Use Code: U-2586: Treatment of complicated urinary tract infections, including pyelonephritis (CUTI)
Use Code: U-2587: Treatment of complicated intra-abdominal infections (CIAI)
Use Code: U-2840: Treatment of hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP)
Mar 21, 2033New expiration date. Was previously Nov 19, 2029

RETEVMO (TABLET) (ORAL) SELPERCATINIB
Drug Classes: kinase inhibitor
NDA Applicant: LOXO ONCOL ELI LILLY      NDA No.:
218160  Prod. No.: 001 RX (40MG); 002 RX (80MG); 003 RX (120MG); 004 RX (160MG)
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity May 8, 2025New exclusivity for this product

REXULTI (TABLET) (ORAL) BREXPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.:
205422  Prod. No.: 001 RX (0.25MG); 002 RX (0.5MG); 003 RX (1MG); 004 RX (2MG); 005 RX (3MG)
PatentsExpirationChange
Pat. No. RE48059 DS* [Extended 986 days (2.7 years)]
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): All strengths: Jul 20, 2020
Claim Types: Compound; Process
Jun 23, 2029 *PEDNew expiration date. Was previously Dec 23, 2028
Pat. No. 7888362 DS* DLR*
Piperazine-substituted benzothiophenes for treat
Pat. Sub. Date(s): 001: Jul 17, 2015; 002: Jul 17, 2015; 003: Jul 23, 2015; 004: Jul 23, 2015; 005: Jul 23, 2015
Claim Types: Compound; Process
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
Pat. No. 8349840 DP*
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): 001: Jul 17, 2015; 002: Jul 17, 2015; 003: Jul 23, 2015; 004: Jul 23, 2015; 005: Jul 23, 2015
Claim Types: Composition; Method of use
Use Code: U-1529: Adjunctive treatment of major depressive disorder (MDD)
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
Pat. No. 8618109
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): 001: Jul 17, 2015; 002: Jul 17, 2015; 003: Jul 23, 2015; 004: Jul 23, 2015; 005: Jul 23, 2015
Claim Types: Method of use
Use Code: U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older
Use Code: U-543: Treatment of schizophrenia
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
Pat. No. 9839637 DP*
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): All strengths: Jan 9, 2018
Claim Types: Composition; Formulation; Method of use
Use Code: U-1529: Adjunctive treatment of major depressive disorder (MDD)
Use Code: U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older
Use Code: U-543: Treatment of schizophrenia
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
Pat. No. 10307419 DP*
Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof
Pat. Sub. Date(s): All strengths: Jun 14, 2019
Claim Types: Formulation; Process
Apr 12, 2033 *PEDNew expiration date. Was previously Oct 12, 2032
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-913: Treatment of agitation associated with dementia due to Alzheimer’s diseaseNov 10, 2026 PEDNew expiration date. Was previously May 10, 2026
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsectionNov 8, 2027 PEDNew exclusivity for this product

REXULTI (TABLET) (ORAL) BREXPIPRAZOLE [GENERIC AB]
Drug Classes: atypical antipsychotic
NDA Applicant: OTSUKA      NDA No.: 205422  Prod. No.: 006 RX (4MG)
PatentsExpirationChange
Pat. No. RE48059 DS* [Extended 986 days (2.7 years)]
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): 006: Jul 20, 2020
Claim Types: Compound; Process
Jun 23, 2029 *PEDNew expiration date. Was previously Dec 23, 2028
Pat. No. 7888362 DS* DLR*
Piperazine-substituted benzothiophenes for treat
Pat. Sub. Date(s): 006: Jul 23, 2015
Claim Types: Compound; Process
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
Pat. No. 8349840 DP*
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): 006: Jul 23, 2015
Claim Types: Composition; Method of use
Use Code: U-1529: Adjunctive treatment of major depressive disorder (MDD)
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
Pat. No. 8618109
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): 006: Jul 23, 2015
Claim Types: Method of use
Use Code: U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older
Use Code: U-543: Treatment of schizophrenia
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
Pat. No. 9839637 DP*
Piperazine-substituted benzothiophenes for treatment of mental disorders
Pat. Sub. Date(s): 006: Jan 9, 2018
Claim Types: Composition; Formulation; Method of use
Use Code: U-1529: Adjunctive treatment of major depressive disorder (MDD)
Use Code: U-3281: Treatment of schizophrenia in adults and pediatric patients ages 13 years and older
Use Code: U-543: Treatment of schizophrenia
Oct 12, 2026 *PEDNew expiration date. Was previously Apr 12, 2026
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-913: Treatment of agitation associated with dementia due to Alzheimer’s diseaseNov 10, 2026 PEDNew expiration date. Was previously May 10, 2026
Exclusivity Code: M - Miscellaneous: M-14: Additional clinical trial information added to pediatric use subsectionNov 8, 2027 PEDNew exclusivity for this product

REZDIFFRA (TABLET) (ORAL) RESMETIROM
NDA Applicant: MADRIGAL      NDA No.:
217785  Prod. No.: 001 RX (60MG); 002 RX (80MG); 003 RX (100MG)
PatentsExpirationChange
Pat. No. 11986481
Method of synthesizing thyroid hormone analogs and polymorphs thereof
Pat. Sub. Date(s): All strengths: Jun 5, 2024
Claim Types: Method of use
Use Code: U-3861: Treatment of adults with noncirrhotic nonalcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis)
Sep 17, 2033New patent for this product

REZENOPY (SPRAY) (NASAL) NALOXONE HYDROCHLORIDE
Drug Classes: opioid antagonist
NDA Applicant: SUMMIT BIOSCI      NDA No.:
215487  Prod. No.: 001 RX (10MG/SPRAY)
ExclusivityExpirationChange
Exclusivity Code: NP - New product Apr 19, 2027New exclusivity for this product

RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 001 RX (15MG); 002 RX (30MG); 003 RX (45MG)
PatentsExpirationChange
Pat. No. RE47221 DS* [Extended 989 days (2.7 years)]
Tricyclic compounds
Pat. Sub. Date(s): 001: Sep 13, 2019; 002: Feb 10, 2022; 003: Apr 14, 2022
Claim Types: Compound
Aug 16, 2033New expiration date. Was previously Dec 1, 2030
ExclusivityExpirationChange
Exclusivity Code: I - New Indication: I-946: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) who have had an inadequate response or intolerance to one of more tumor necrosis factor (TNF) blockersApr 26, 2027New exclusivity for this product
Exclusivity Code: NPP - New patient population Apr 24, 2027New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-481: Treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockersApr 26, 2031New exclusivity for this product

RINVOQ LQ (SOLUTION) (ORAL) UPADACITINIB
Drug Classes: Janus kinase (JAK) inhibitor
NDA Applicant: ABBVIE      NDA No.:
218347  Prod. No.: 001 RX (1MG/ML)
PatentsExpirationChange
Pat. No. RE47221 DS* [Extended 989 days (2.7 years)]
Tricyclic compounds
Pat. Sub. Date(s): 001: Jun 12, 2024
Claim Types: Compound
Aug 16, 2033New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Aug 16, 2024New exclusivity for this product
Exclusivity Code: NP - New product Apr 26, 2027New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-481: Treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockersApr 26, 2031New exclusivity for this product

RISVAN (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) RISPERIDONE
Drug Classes: atypical antipsychotic
NDA Applicant: LABS FARMS ROVI SA      NDA No.:
214835  Prod. No.: 001 RX (75MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 10058504 DP*
Methods for the preparation of injectable depot compositions
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Formulation; Kit
May 31, 2031New patent for this product
Pat. No. 10085936 DP*
Antipsychotic injectable depot composition
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Formulation; Kit
May 31, 2031New patent for this product
Pat. No. 10182982
Antipsychotic injectable depot composition
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-3943: Treatment of schizophrenia in adults by administration of extended release injectable composition
May 31, 2031New patent for this product
Pat. No. 10195138
Methods for the preparation of injectable depot compositions
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-3943: Treatment of schizophrenia in adults by administration of extended release injectable composition
May 31, 2031New patent for this product
Pat. No. 10335366 DP*
Risperidone or paliperidone implant formulation
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Kit
May 31, 2031New patent for this product
Pat. No. 10463607 DP*
Antipsychotic Injectable Depot Composition
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
May 31, 2031New patent for this product
Pat. No. 10881605 DP*
Methods for the preparation of injectable depot compositions
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
May 31, 2031New patent for this product
Pat. No. 11007139
Risperidone or paliperidone implant formulation
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-3942: Treatment of schizophrenia in adults by intramuscular administration of extended release injectable composition
May 31, 2031New patent for this product
Pat. No. 11173110
Risperidone or paliperidone implant formulation
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Method of administration; Method of Use claimed by its inherent performace characteristics
Use Code: U-3941: Administration of risperidone in extended release injectable suspension for treatment of schizophrenia in adults
May 31, 2031New patent for this product
Pat. No. 11241377
Antipsychotic injectable depot composition
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Method of administration; Method of Use claimed by its inherent performace characteristics
Use Code: U-3939: Intramuscular administration of risperidone in extended release injectable suspension for treatment of schizophrenia in adults
May 31, 2031New patent for this product
Pat. No. 11752092
Methods for the preparation of injectable depot compositions
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Method of administration; Method of Use claimed by its inherent performace characteristics; Kit
Use Code: U-3941: Administration of risperidone in extended release injectable suspension for treatment of schizophrenia in adults
May 31, 2031New patent for this product
Pat. No. 11752093 DP*
Antipsychotic injectable depot composition
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Kit
May 31, 2031New patent for this product
Pat. No. 11759416
Antipsychotic injectable depot composition
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Method of administration; Method of Use claimed by its inherent performace characteristics
Use Code: U-3939: Intramuscular administration of risperidone in extended release injectable suspension for treatment of schizophrenia in adults
May 31, 2031New patent for this product

SCEMBLIX (TABLET) (ORAL) ASCIMINIB HYDROCHLORIDE
NDA Applicant: NOVARTIS      NDA No.:
215358  Prod. No.: 003 RX (EQ 100MG BASE)
PatentsExpirationChange
Pat. No. 8829195 DS*
Compounds and compositions for inhibiting the activity of ABL1, ABL2 and BCR-ABL1
Pat. Sub. Date(s): 003: May 10, 2024
Claim Types: Compound; Method of use
Use Code: U-1374: Treatment of Philadelphia chromosome positive chronic myeloid leukemia (Ph+CML)
May 13, 2033New patent for this product
Pat. No. 11407735 DS*
Crystalline forms of N-[4-(Chlorodifluoromethoxy)phenyl]-6-[(3R)-3-hydroxypyrrolidin-1-yl]-5-(- 1H-pyrazol-5-yl)pyridine-3-carboxamide
Pat. Sub. Date(s): 003: May 10, 2024
Claim Types: New polymorph, salt or hydrate
May 14, 2040New patent for this product

SELENIOUS ACID (SOLUTION) (INTRAVENOUS) SELENIOUS ACID
NDA Applicant: AM REGENT      NDA No.:
209379  Prod. No.: 001 RX (EQ 600MCG SELENIUM/10ML (EQ 60MCG SELENIUM/ML)); 002 RX (EQ 60MCG SELENIUM/ML (EQ 60MCG SELENIUM/ML)); 003 RX (EQ 12MCG SELENIUM/2ML (EQ 6MCG SELENIUM/ML))
PatentsExpirationChange
Pat. No. 11998565 DP*
Trace element compositions, methods of making and use
Pat. Sub. Date(s): All strengths: Jun 7, 2024
Claim Types: Formulation
Jul 1, 2041New patent for this product

SODIUM ACETATE (SOLUTION) (INTRAVENOUS) SODIUM ACETATE [GENERIC AP]
NDA Applicant: HIKMA      NDA No.:
216920  Prod. No.: 001 RX (40MEQ/20ML (2MEQ/ML))
ExclusivityExpirationChange
Exclusivity Code: CGT - Competitive generic therapy Nov 16, 2024New exclusivity for this product

SUNOSI (TABLET) (ORAL) SOLRIAMFETOL HYDROCHLORIDE
Drug Classes: dopamine and norepinephrine reuptake inhibitor (DNRI)
NDA Applicant: AXSOME MALTA      NDA No.:
211230  Prod. No.: 001 RX (EQ 75MG BASE); 002 RX (EQ 150MG BASE)
PatentsExpirationChange
Pat. No. 11986454
Methods of providing solriamfetol therapy to subjects with impaired renal function
Pat. Sub. Date(s): All strengths: May 31, 2024
Claim Types: Method of use
Use Code: U-3775: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having no, mild, moderate, or severe renal impairment
Mar 19, 2040New patent for this product
Pat. No. 11986455
Methods of providing solriamfetol therapy to subjects with impaired renal function
Pat. Sub. Date(s): All strengths: May 31, 2024
Claim Types: Method of use
Use Code: U-3521: Treatment of excessive daytime sleepiness by administering solriamfetol to a subject having mild, moderate, or severe renal impairment
Mar 19, 2040New patent for this product
Pat. No. 11998639 DP*
Formulations of (R)-2-amino-3-phenylpropyl carbamate
Pat. Sub. Date(s): All strengths: Jun 10, 2024
Claim Types: Formulation; Method of use
Use Code: U-2548: To improve wakefulness in adult patients with excessive daytime sleepiness associated with narcolepsy or obstructive sleep apnea (OSA)
Sep 5, 2037New patent for this product

TADLIQ (SUSPENSION) (ORAL) TADALAFIL
Drug Classes: phosphodiesterase-5 (PDE-5) inhibitor
NDA Applicant: CMP DEV LLC      NDA No.:
214522  Prod. No.: 001 RX (20MG/5ML)
PatentsExpirationChange
Pat. No. 11975006 DP*
Liquid oral formulations for tadalafil
Pat. Sub. Date(s): 001: May 16, 2024
Claim Types: Formulation; Method of use
Use Code: U-3397: TADLIQ is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO group 1) to improve exercise ability
Dec 24, 2038New patent for this product

TRALEMENT; MULTRYS (SOLUTION) (INTRAVENOUS) CUPRIC SULFATE; MANGANESE SULFATE; SELENIOUS ACID; ZINC SULFATE
NDA Applicant: AM REGENT      NDA No.:
209376  Prod. No.: 001 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (1ML)); 002 RX (EQ 0.3MG COPPER/ML;EQ 55MCG BASE/ML;EQ 60MCG SELENIUM/ML;EQ 3MG BASE/ML (5ML)); 003 RX (EQ 60MCG COPPER/ML;EQ 3MCG BASE/ML;EQ 6MCG SELENIUM/ML;EQ 1000MCG BASE/ML (1ML))
PatentsExpirationChange
Pat. No. 11998565 DP*
Trace element compositions, methods of making and use
Pat. Sub. Date(s): All strengths: Jun 7, 2024
Claim Types: Formulation
Jul 1, 2041New patent for this product

TYMLOS (SOLUTION) (SUBCUTANEOUS) ABALOPARATIDE
Drug Classes: parathyroid hormone related peptide [PTHrP(1-34)] analog
NDA Applicant: RADIUS      NDA No.:
208743  Prod. No.: 001 RX (3.12MG/1.56ML (2MG/ML))
PatentsExpirationChange
Pat. No. 11977067 DP*
Abaloparatide formulations and methods of testing, storing, modifying, and using same
Pat. Sub. Date(s): 001: May 16, 2024
Claim Types: Compound; Composition; Formulation
Apr 30, 2038New patent for this product

VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.:
202057  Prod. No.: 001 RX (1GM); 002 RX (500MG)
PatentsExpirationChange
Pat. No. 8293727
Methods of treating hypertriglyceridemia
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Feb 9, 2030This patent is no longer listed for this product
Pat. No. 8293728
Methods of treating hypertriglyceridemia
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Feb 9, 2030This patent is no longer listed for this product
Pat. No. 8314086
Methods of treating hypertriglyceridemia
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Feb 9, 2030This patent is no longer listed for this product
Pat. No. 8318715
Methods of treating hypertriglyceridemia
Pat. Sub. Date(s): None
Claim Types: Method of use
Use Code: U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Feb 9, 2030This patent is no longer listed for this product

VEKLURY (POWDER) (INTRAVENOUS) REMDESIVIR
Drug Classes: SARS-CoV-2 nucleotide analog RNA polymerase inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.:
214787  Prod. No.: 001 RX (100MG/VIAL)
PatentsExpirationChange
Pat. No. 11975012
Remdesivir treatment methods
Pat. Sub. Date(s): 001: Jun 5, 2024
Claim Types: Method of use
Use Code: U-3835: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) requiring hospitalization and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended
Use Code: U-3836: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (birth to < 18 years of age weighing > 1.5 kg) and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended
May 28, 2041New patent for this product
Pat. No. 11975017 DP*
Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections
Pat. Sub. Date(s): 001: Jun 5, 2024
Claim Types: Formulation claimed by its inherent performace characteristics
Jul 10, 2038New patent for this product

VEKLURY (SOLUTION) (INTRAVENOUS) REMDESIVIR
Drug Classes: SARS-CoV-2 nucleotide analog RNA polymerase inhibitor
NDA Applicant: GILEAD SCIENCES INC      NDA No.: 214787  Prod. No.: 002 RX (100MG/20ML (5MG/ML))
PatentsExpirationChange
Pat. No. 11975012
Remdesivir treatment methods
Pat. Sub. Date(s): 002: Jun 5, 2024
Claim Types: Method of use
Use Code: U-3833: Treatment of coronavirus disease 2019 (COVID-19) in adults and pediatric patients (weighing at least 40 kg) requiring hospitalization and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended
Use Code: U-3834: Treatment of coronavirus disease 2019 (COVID-19) in non-hospitalized adults and pediatric patients (weighing at least 40 kg) and for whom concomitant use of chloroquine, or an analog or salt thereof, is not recommended
May 28, 2041New patent for this product

VIJOICE (GRANULES) (ORAL) ALPELISIB
NDA Applicant: NOVARTIS      NDA No.:
218466  Prod. No.: 001 RX (50MG/PACKET)
PatentsExpirationChange
Pat. No. 8227462 DS* DP* [Extended 1327 days (3.6 years)]
Pyrrolidine-1,2-dicarboxamide derivatives
Pat. Sub. Date(s): 001: May 15, 2024
Claim Types: Compound; Method of use; Composition; Formulation
Apr 29, 2033New patent for this product
Pat. No. 8476268 DS* DP*
Pyrrolidine-1,2-dicarboxamide derivatives
Pat. Sub. Date(s): 001: May 15, 2024
Claim Types: Compound; Method of use; Composition
Sep 10, 2029New patent for this product

VOXZOGO (POWDER) (SUBCUTANEOUS) VOSORITIDE
Drug Classes: C type natriuretic peptide (CNP) analog
NDA Applicant: BIOMARIN PHARM      NDA No.:
214938  Prod. No.: 001 RX (0.4MG/VIAL); 002 RX (0.56MG/VIAL); 003 RX (1.2MG/VIAL)
PatentsExpirationChange
Pat. No. RE48267
Variants of C-type natriuretic peptide
Pat. Sub. Date(s): All strengths: Dec 17, 2021
Claim Types: Compound; Formulation; Method of use
Use Code: U-3927: Use to increase linear growth in pediatric patients with achondroplasia with open epiphyses
May 20, 2030New Use Code
Pat. No. 8198242 DS* DP*
Variants of C-type natriuretic peptide
Pat. Sub. Date(s): All strengths: Dec 17, 2021
Claim Types: Compound; Composition; Method of use; Process; Product-by-process
Use Code: U-3927: Use to increase linear growth in pediatric patients with achondroplasia with open epiphyses
Jun 11, 2030New Use Code
Pat. No. 10646550 DP*
Use of C-type natriuretic peptide variants to treat skeletal dysplasia
Pat. Sub. Date(s): All strengths: Dec 17, 2021
Claim Types: Method of use
Use Code: U-3927: Use to increase linear growth in pediatric patients with achondroplasia with open epiphyses
Aug 1, 2036New Use Code
Pat. No. 11590204 DP*
Use of C-type natriuretic peptide variants to treat skeletal dysplasia
Pat. Sub. Date(s): All strengths: May 20, 2024
Claim Types: Formulation; Method of use
Use Code: U-3927: Use to increase linear growth in pediatric patients with achondroplasia with open epiphyses
Aug 1, 2036New patent for this product
Pat. No. 11911446
Use of C-type natriuretic peptide variants to treat skeletal dysplasia
Pat. Sub. Date(s): All strengths: May 20, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-3927: Use to increase linear growth in pediatric patients with achondroplasia with open epiphyses
Aug 1, 2036New patent for this product

VOYDEYA (TABLET) (ORAL) DANICOPAN
NDA Applicant: ALEXION PHARMS INC      NDA No.:
218037  Prod. No.: 001 RX (50MG); 002 RX (100MG)
PatentsExpirationChange
Pat. No. 9796741 DS*
Aryl, heteroaryl, and heterocyclic compounds for treatment of complement mediated disorders
Pat. Sub. Date(s): All strengths: May 23, 2024
Claim Types: Compound; Method of use
Use Code: U-3933: Treatment of extravascular hemolysis (evh) in adults with paroxysmal nocturnal hemoglobinuria (PNH) as add-on therapy to ravulizumab or eculizumab
Feb 25, 2035New patent for this product

VYONDYS 53 (SOLUTION) (INTRAVENOUS) GOLODIRSEN
Drug Classes: antisense oligonucleotide
NDA Applicant: SAREPTA THERAPS INC      NDA No.:
211970  Prod. No.: 001 RX (100MG/2ML (50MG/ML))
PatentsExpirationChange
Pat. No. RE47691 DP*
Antisense oligonucleotides for inducing exon skipping and methods of use thereof
Pat. Sub. Date(s): 001: Dec 18, 2019
Claim Types: Formulation
Jun 28, 2028New expiration date. Was previously Jun 28, 2025

WELIREG (TABLET) (ORAL) BELZUTIFAN
Drug Classes: hypoxia-inducible factor inhibitor
NDA Applicant: MERCK SHARP DOHME      NDA No.:
215383  Prod. No.: 001 RX (40MG)
PatentsExpirationChange
Pat. No. RE49948 DS* DP*
Aryl ethers and uses thereof
Pat. Sub. Date(s): 001: May 28, 2024
Claim Types: Compound; Composition; Method of use
Use Code: U-3201: Treatment of adult patients with Von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery
Use Code: U-3780: Treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor
Sep 5, 2034New patent for this product
Pat. No. 9969689 DS* DP*
Aryl ethers and uses thereof
Pat. Sub. Date(s): None
Claim Types: Compound; Composition; Method of use
Use Code: U-3201: Treatment of adult patients with Von Hippel-Lindau disease who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors, not requiring immediate surgery
Use Code: U-3780: Treatment of adult patients with advanced renal cell carcinoma following a programmed death receptor-1 or programmed death-ligand inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor
Sep 5, 2034This patent is no longer listed for this product

WINLEVI (CREAM) (TOPICAL) CLASCOTERONE
Drug Classes: androgen receptor inhibitor
NDA Applicant: SUN PHARM      NDA No.:
213433  Prod. No.: 001 RX (1%)
PatentsExpirationChange
Pat. No. 8865690
17alfa, 21-dihydroxypregnene esters as antiandrogenic agents
Pat. Sub. Date(s): 001: Sep 4, 2020
Claim Types: Method of use
Use Code: U-2942: Method of treating acne vulgaris with topically applied cortexolone 17a-propionate
Jul 24, 2025New expiration date. Was previously Jul 24, 2024
Pat. No. 9211295 DP*
17 alpha, 21-dihydroxypregnene esters as antiandrogenic agents
Pat. Sub. Date(s): 001: Sep 4, 2020
Claim Types: Composition; Formulation; Method of use
May 31, 2025New expiration date. Was previously Jul 24, 2024
Pat. No. 11938141 DP*
Enzymatic process for obtaining 17 alpha-monoesters of cortexolone and/or its 9,11-dehydroderivatives
Pat. Sub. Date(s): 001: May 30, 2024
Claim Types: Formulation
Jul 24, 2028New patent for this product

XATMEP (SOLUTION) (ORAL) METHOTREXATE SODIUM
Drug Classes: folate analog metabolic inhibitor
NDA Applicant: AZURITY      NDA No.:
208400  Prod. No.: 001 RX (EQ 2.5MG BASE/ML)
PatentsExpirationChange
Pat. No. 11969503 DP*
Methotrexate composition
Pat. Sub. Date(s): 001: May 15, 2024
Claim Types: Formulation
Jan 2, 2033New patent for this product

XIGDUO XR (TABLET, EXTENDED RELEASE) (ORAL) DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
Drug Classes: sodium-glucose co-transporter 2 (SGLT2) inhibitor == biguanide
NDA Applicant: ASTRAZENECA AB      NDA No.:
205649  Prod. No.: 001 RX (5MG;500MG); 002 RX (5MG;1GM); 003 RX (10MG;500MG); 004 RX (10MG;1GM); 005 RX (2.5MG;1GM)
PatentsExpirationChange
Pat. No. 6515117 DS* DP* [Extended 5 years]
C-aryl glucoside SGLT2 inhibitors and method
Pat. Sub. Date(s): All strengths: Nov 24, 2014
Claim Types: Compound; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Apr 4, 2026 *PEDNew expiration date. Was previously Oct 4, 2025
Pat. No. 7919598 DS*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Claim Types: New polymorph, salt or hydrate; Process
Jun 16, 2030 *PEDNew expiration date. Was previously Dec 16, 2029
Pat. No. 8501698 DP*
Crystal structures of SGLT2 inhibitors and processes for preparing same
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Use Code: U-493: Treatment of Type 2 Diabetes Mellitus
Dec 20, 2027 *PEDNew expiration date. Was previously Jun 20, 2027
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
Pat. Sub. Date(s): 001: Nov 24, 2014; 002: Nov 24, 2014; 003: Nov 24, 2014; 004: Nov 24, 2014; 005: Aug 30, 2017
Claim Types: Method of use
Use Code: U-1522: Treatment of Type 2 diabetes mellitus in a patient, wherein glycemic control (HBA1C < 7.0%) is not achievable using one or more of insulin, metformin, pioglitazone, or rosiglitazone
Nov 26, 2030 *PEDNew expiration date. Was previously May 26, 2030
Pat. No. 9616028 DP*
Bilayer tablet formulations
Pat. Sub. Date(s): All strengths: Aug 30, 2017
Claim Types: Formulation
May 12, 2031 *PEDNew expiration date. Was previously Nov 12, 2030

XOLREMDI (CAPSULE) (ORAL) MAVORIXAFOR
NDA Applicant: X4 PHARMS      NDA No.:
218709  Prod. No.: 001 RX (100MG)
PatentsExpirationChange
Pat. No. 10548889 DP*
Compositions of CXCR4 inhibitors and methods of preparation and use
Pat. Sub. Date(s): 001: May 24, 2024
Claim Types: Formulation
Dec 11, 2038New patent for this product
Pat. No. 10610527
Methods for treating immunodeficiency disease
Pat. Sub. Date(s): 001: May 24, 2024
Claim Types: Method of use
Use Code: U-3932: Treatment of patients 12 years and older with warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome
Dec 22, 2036New patent for this product
Pat. No. 10953003 DP*
Methods for treating cancer
Pat. Sub. Date(s): 001: May 24, 2024
Claim Types: Formulation
Dec 14, 2036New patent for this product
Pat. No. 11045461 DP*
Compositions of CXCR4 inhibitors and methods of preparation and use
Pat. Sub. Date(s): 001: May 24, 2024
Claim Types: Composition; Formulation; Compound
Dec 11, 2038New patent for this product
Pat. No. 11219621
Methods for treating immunodeficiency disease
Pat. Sub. Date(s): 001: May 24, 2024
Claim Types: Method of use; Method of Use claimed by its inherent performace characteristics
Use Code: U-3932: Treatment of patients 12 years and older with warts, hypogammaglobulinemia, infections, and myelokathexis (WHIM) syndrome
Dec 22, 2036New patent for this product
ExclusivityExpirationChange
Exclusivity Code: NCE - New chemical entity Apr 26, 2029New exclusivity for this product
Exclusivity Code: ODE - Orphan drug exclusivity: ODE-480: To increase the number of circulating mature neutrophils and lymphocytes in patients 12 years of age and older with WHIM syndrome (warts, hypogammaglobulinemia, infections and myelokathexis)Apr 26, 2031New exclusivity for this product

ZILBRYSQ (SOLUTION) (SUBCUTANEOUS) ZILUCOPLAN SODIUM
Drug Classes: complement inhibitor
NDA Applicant: UCB INC      NDA No.:
216834  Prod. No.: 001 RX (EQ 16.6MG BASE/0.416ML (EQ 16.6MG BASE/0.416ML)); 002 RX (EQ 23MG BASE/0.574ML (EQ 23MG BASE/0.574ML)); 003 RX (EQ 32.4MG BASE/0.81ML (EQ 32.4 BASE/0.81ML))
PatentsExpirationChange
Pat. No. 11965040 DP*
Modulation of complement activity
Pat. Sub. Date(s): All strengths: May 17, 2024
Claim Types: Composition
Jun 12, 2035New patent for this product


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
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 June 2024
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