Orange Book Companion®
Company names starting with "A"

Patents whose numbers are in italics have been extended under 35 USC 156. Unless otherwise noted, 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.


AAA USA INC
LUTATHERA (SOLUTION) (INTRAVENOUS) LUTETIUM LU 177 DOTATATE
NDA Applicant: AAA USA INC      NDA No.:
208700  Prod. No.: 001 RX (10mCi/ML)
Patents Expiration Patented Use
Pat. No. 10596276 DP* Stable, concentrated radionuclide complex solutions
Claim Types: Product-by-proces; Process
Pat. Sub. Date(s): 001: Apr 13, 2020
Jul 25, 2038  
Pat. No. 10596278 DP* Stable, concentrated radionuclide complex solutions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Apr 13, 2020
Jul 25, 2038  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Jan 26, 2023  
Exclusivity Code: ODE - Orphan drug exclusivity Jan 26, 2025 ODE-166: Treatment of somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors (GEP-NETS) including foregut, midgut, and hindgut neuroendocrine tumors in adults

AAA USA INC
NETSPOT (POWDER) (INTRAVENOUS) GALLIUM DOTATATE GA-68
NDA Applicant: AAA USA INC      NDA No.:
208547  Prod. No.: 001 RX (2.1-5.5mCi/ML)
Patents Expiration Patented Use
Pat. No. 9375498 DP* Process for the preparation of complexes of .sup.68Ga
Claim Types: Kit; Product-by-process; Drug in a container; Process
Pat. Sub. Date(s): 001: Jul 9, 2018
Aug 10, 2032  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Jun 1, 2023 ODE-120: For use after radiolabeling with Ga 68, with positron emission tomography (PET) for localization of somatostatin receptor positive neuroendocrine tumors (NETs) in adult and pediatric patients.

AAA USA NOVARTIS
LOCAMETZ (POWDER) (INTRAVENOUS) GALLIUM GA-68 GOZETOTIDE
NDA Applicant: AAA USA NOVARTIS      NDA No.:
215841  Prod. No.: 001 RX (N/A)
Patents Expiration Patented Use
Pat. No. 11369590 DS* DP* PSMA binding ligand-linker conjugates and methods for using
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 28, 2022
Aug 15, 2028 U-3400: For use after radiolabeling with gallium-68, for positron emission tomography of prostate-specific membrane antigen (PSMA)-positive lesions in men with prostate cancer
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NP - New product Mar 23, 2025  

AAA USA NOVARTIS
PLUVICTO (SOLUTION) (INTRAVENOUS) LUTETIUM LU-177 VIPIVOTIDE TETRAXETAN
NDA Applicant: AAA USA NOVARTIS      NDA No.:
215833  Prod. No.: 001 RX (27mCi/ML)
Patents Expiration Patented Use
Pat. No. 10398791 DS* DP* Labeled inhibitors of prostate specific membrane antigen (PSMA), their use as imaging agents and pharmaceutical agents for the treatment of prostate cancer
Claim Types: Compound; Composition; Formulation
Pat. Sub. Date(s): 001: Apr 20, 2022
Oct 17, 2034  
Pat. No. 10406240 DS* DP* PSMA binding ligand-linker conjugates and methods for using
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Apr 20, 2022
Aug 15, 2028 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
Pat. No. 11318121 DS* DP* PSMA binding ligand-linker conjugates and methods for using
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: May 31, 2022
Aug 15, 2028 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
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Mar 23, 2027  

AADI
FYARRO (POWDER) (INTRAVENOUS) SIROLIMUS
Drug Classes: Immunological Agents:Immunosuppressants
NDA Applicant: AADI      NDA No.:
213312  Prod. No.: 001 RX (100MG/VIAL)
Patents Expiration Patented Use
Pat. No. 8911786 DP* Nanoparticle comprising rapamycin and albumin as anticancer agent
Claim Types: Method of use; Formulation; Kit
Pat. Sub. Date(s): 001: Dec 17, 2021
Feb 14, 2029 U-3259: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA)
Pat. No. 10206887 DP* Prion free nanoparticle compositions and methods of making thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2021
Apr 15, 2030  
Pat. No. 10705070 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
Claim Types: Process
Pat. Sub. Date(s): 001: Dec 17, 2021
Mar 5, 2036  
Pat. No. 10973806 Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2021
Jun 29, 2036 U-3258: Treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA) with a dose between about 56 mg/m2 and about 100 mg/m2 administered on days 1 and 8 of a 21-day cycle
Pat. No. 11497737 DP* Pharmaceutical compositions of albumin and rapamycin
Claim Types: Drug in a container
Pat. Sub. Date(s): 001: Nov 23, 2022
Oct 28, 2040  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NP - New product Nov 22, 2024  
Exclusivity Code: ODE - Orphan drug exclusivity Nov 22, 2028 ODE-386: For the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PECOMA)

ABBVIE
ACULAR LS (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE [GENERIC AT]
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ABBVIE      NDA No.:
021528  Prod. No.: 001 RX (0.4%)
Patents Expiration Patented Use
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 *PED U-1181: A method of treating or preventing ocular pain in a patient
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 *PED U-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 *PED U-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 *PED U-1441: A method of treating or reducing ocular pain and burning/stinging
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, 2024 U-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, 2024 U-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, 2024 U-1800: A method of treating ocular pain and/or enhancing ocular comfort

ABBVIE
ACUVAIL (SOLUTION/DROPS) (OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ABBVIE      NDA No.:
022427  Prod. No.: 001 RX (0.45%)
Patents Expiration Patented Use
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  
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. 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. 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  

ABBVIE
ALPHAGAN P (SOLUTION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC AB]
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: ABBVIE      NDA No.:
021770  Prod. No.: 001 RX (0.1%)
Patents Expiration Patented Use
Pat. No. 8858961 DP* Compositions containing alpha-2-adrenergic agonist components
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 13, 2014
Mar 2, 2024 *PED  

ABBVIE
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN [Has competitive generic]
Drug Classes: Cardiovascular Agents:Beta-adrenergic Blocking Agents == Cardiovascular Agents:Angiotensin II Receptor Antagonists == Cardiovascular Agents:Cardiovascular Combinations
NDA Applicant: ABBVIE      NDA No.:
206302  Prod. No.: 001 DISC (EQ 5MG BASE;80MG)
Patents Expiration Patented Use
Pat. No. 7803838 DP* Compositions comprising nebivolol
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 5, 2016
Aug 29, 2026  
Pat. No. 7838552 Compositions comprising nebivolol
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 5, 2016
Oct 4, 2027 U-185: Method of treating hypertension

ABBVIE
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: Inflammatory Bowel Disease Agents:Aminosalicylates and/ or Prodrugs
NDA Applicant: ABBVIE      NDA No.:
021252  Prod. No.: 002 RX (1GM)
Patents Expiration Patented Use
Pat. No. 8217083 DP* Mesalamine suppository
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2013
Jun 6, 2028  
Pat. No. 8436051 DP* Mesalamine suppository
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: May 24, 2013
Jun 6, 2028  

ABBVIE
DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents
NDA Applicant: ABBVIE      NDA No.:
211911  Prod. No.: 001 RX (10MCG)
Patents Expiration Patented Use
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. 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, 2027 U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
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. 8673341 Intraocular pressure reduction with intracameral bimatoprost implants
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 24, 2020
Feb 19, 2025 U-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. 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, 2034 U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
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, 2024 U-2759: Reduction of intraocular pressure (IOP) in patients with open angle glaucoma(OAG) or ocular hypertension (OHT) with a biodegradable bimatoprost implant
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  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NP - New product Mar 4, 2023  

ABBVIE
FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE [Has competitive generic]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
NDA Applicant: ABBVIE      NDA No.:
204168  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 80MG BASE); 004 RX (EQ 120MG BASE)
Patents Expiration Patented Use
Pat. No. RE43879 [Extended 953 days (2.6 years)]
Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 15, 2013
Jan 11, 2026 U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8481598 Stable dosage forms of levomilnacipran
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): All strengths: Aug 15, 2013
Mar 2, 2031 U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): All strengths: Nov 20, 2014
May 23, 2032  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: M - Miscellaneous Oct 7, 2022 M-249: Information added to the labeling to describe study LVM-MD-15 to fulfill postmarketing commitment 1943-4

ABBVIE
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE
Drug Classes: Genitourinary Agents:Antispasmodics, Urinary
NDA Applicant: ABBVIE      NDA No.:
022204  Prod. No.: 001 RX (10% (100MG/PACKET))
Patents Expiration Patented Use
Pat. No. 8920392 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Drug in a container; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 27, 2015
Mar 26, 2031 U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin
Pat. No. 9259388 Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Mar 16, 2016
Nov 6, 2029 U-1644: Treatment of overactive bladder by application of oxybutynin chloride gel to skin
Pat. No. 10449173 DP* Method for treating overactive bladders and a device for storage and administration of topical oxybutynin compositions
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 30, 2019
Nov 6, 2029 U-2637: Treatment of patients with an overactive bladder with symptoms of urinary frequency, urgency, or urge incontinence with a single unit dose of 10% oxybutynin chloride gel

ABBVIE
LASTACAFT (SOLUTION/DROPS) (OPHTHALMIC) ALCAFTADINE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents
NDA Applicant: ABBVIE      NDA No.:
022134  Prod. No.: 001 OTC (0.25%)
Patents Expiration Patented Use
Pat. No. 8664215 Ocular allergy treatments with alcaftadine
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2014
Dec 23, 2027 U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander
Pat. No. 10617695 DP* Ophthalmic compositions containing alcaftadine
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: May 12, 2020
Mar 19, 2027 U-3267: Use of LASTACAFT to temporary relieve itchy eyes due to pollen, ragweed, grass, animal hair and dander

ABBVIE
LATISSE (SOLUTION/DROPS) (TOPICAL) BIMATOPROST [GENERIC AT]
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents
NDA Applicant: ABBVIE      NDA No.:
022369  Prod. No.: 001 RX (0.03%)
Patents Expiration Patented Use
Pat. No. 8038988 DS* DP* Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 31, 2011
Aug 25, 2023 U-1208: Treatment of hypotrichosis of the eyelashes by increasing their growth including length, thickness and darkness
Pat. No. 8101161 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 10, 2012
May 25, 2024 U-1217: Method of increasing hair growth
U-1218: Method of stimulating hair growth
Pat. No. 8263054 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 17, 2012
Jan 15, 2023 U-1277: Method of increasing eyelash growth including length, thickness, darkness and/or number of eyelashes by administering bimatoprost to an eyelid margin
Pat. No. 8632760 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 21, 2014
Jan 15, 2023 U-1487: Method of increasing eyelash growth
Pat. No. 8758733 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 16, 2014
Jan 15, 2023 U-1487: Method of increasing eyelash growth
Pat. No. 8986715 Method of enhancing hair growth
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 1, 2015
Jan 15, 2023 U-1217: Method of increasing hair growth
Pat. No. 9216183 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016
Jan 15, 2023 U-1487: Method of increasing eyelash growth
Pat. No. 9226931 Topical treatment for chemotherapy induced eyelash loss or hypotrichosis using prostamide F2 alpha agonists
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 20, 2016
Jan 15, 2023 U-1799: Method of increasing growth of hair including eyelashes

ABBVIE
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors) == Anxiolytics:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
NDA Applicant: ABBVIE      NDA No.:
021323  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)
Patents Expiration Patented Use
Pat. No. 6916941 DS* DP* Crystalline composition containing escitalopram
Claim Types: New polymorph, salt or hydrate; Process; Composition; Formulation
Pat. Sub. Date(s): All strengths: None
Feb 12, 2023 *PED  
Pat. No. 7420069 DP* Crystalline composition containing escitalopram
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): All strengths: None
Feb 12, 2023 *PED  

ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents
NDA Applicant: ABBVIE      NDA No.:
202811  Prod. No.: 001 RX (145MCG)
Patents Expiration Patented Use
Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 18, 2012
Aug 30, 2026 U-1278: Method of treating irritable bowel syndrome with constipation in adults
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 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, 2024 U-1278: Method of treating irritable bowel syndrome with constipation in adults
Pat. No. 8748573 Formulations comprising linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 11, 2014
Oct 30, 2031 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 19, 2014
Oct 30, 2031  
Pat. No. 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. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 10, 2017
Aug 16, 2033 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.

ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents
NDA Applicant: ABBVIE      NDA No.:
202811  Prod. No.: 002 RX (290MCG)
Patents Expiration Patented Use
Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 002: None
Aug 30, 2026 U-1278: Method of treating irritable bowel syndrome with constipation in adults
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 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, 2024 U-1278: Method of treating irritable bowel syndrome with constipation in adults
Pat. No. 8748573 Formulations comprising linaclotide
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 11, 2014
Oct 30, 2031 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.
U-1516: Method of treating chronic idiopathic constipation in adult patients.
Pat. No. 8802628 DP* Stable solid formulation of a GC-C receptor agonist polypeptide suitable for oral administration
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 19, 2014
Oct 30, 2031  
Pat. No. 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. 9708371 DP* Treatments for gastrointestinal disorders
Claim Types: Compound; Composition; Formulation; Method of use
Pat. Sub. Date(s): 002: Aug 10, 2017
Aug 16, 2033 U-1515: Method of treating irritable bowel syndrome with constipation in adult patients.

ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: Gastrointestinal Agents:Anti-Constipation Agents
NDA Applicant: ABBVIE      NDA No.:
202811  Prod. No.: 003 RX (72MCG)
Patents Expiration Patented Use
Pat. No. 7304036 DS* DP* [Extended 945 days (2.6 years)]
Methods and compositions for the treatment of gastrointestinal disorders
Claim Types: Compound; Method of use; Composition
Pat. Sub. Date(s): 003: Feb 24, 2017
Aug 30, 2026 U-1516: Method of treating chronic idiopathic constipation in adult patients.
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, 2024 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): 003: Feb 24, 2017
Feb 17, 2031 U-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, 2033 U-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, 2031 U-1516: Method of treating chronic idiopathic constipation in adult patients.

ABBVIE
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents
NDA Applicant: ABBVIE      NDA No.:
209394  Prod. No.: 001 RX (100MG;40MG)
Patents Expiration Patented Use
Pat. No. RE48923 DS* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 8, 2022
Nov 8, 2035 *PED  
Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 29, 2017
Jul 19, 2032 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 8937150 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 29, 2017
Nov 18, 2032 *PED  
Pat. No. 9321807 DS* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Aug 29, 2017
Dec 5, 2035 *PED  
Pat. No. 9586978 [Extended 149 days (0.4 years)]
Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 29, 2017
May 6, 2031 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 10028937 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 24, 2018
Dec 10, 2030 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 10039754 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 6, 2018
Dec 10, 2030 *PED U-2141: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6
U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 10286029 Method for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 31, 2019
Sep 14, 2034 *PED U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Pat. No. 11246866 DP* Solid pharmaceutical compositions for treating HCV
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Mar 8, 2022
Dec 24, 2036 *PED  
Pat. No. 11484534 Methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 30, 2022
Sep 14, 2034 *PED U-3237: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in adult and pediatric patients 12 years and older or weighing at least 45 kg
Exclusivity Expiration Exclusivity Description
Exclusivity Code: D - New Dosing Schedule Mar 26, 2023 PED D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study
Exclusivity Code: M - Miscellaneous Oct 10, 2023 PED M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection
Exclusivity Code: NCE - New chemical entity Feb 3, 2023 PED  
Exclusivity Code: ODE - Orphan drug exclusivity Oct 30, 2026 PED ODE-232: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1,2,3,4,5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Exclusivity Code: ODE - Orphan drug exclusivity Oct 30, 2026 PED ODE-233: Treatment of pediatric patients 12 years and older or weighing at least 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both
Exclusivity Code: ODE - Orphan drug exclusivity Dec 10, 2028 PED ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

ABBVIE
MAVYRET (PELLETS) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents
NDA Applicant: ABBVIE      NDA No.:
215110  Prod. No.: 001 RX (50MG;20MG/PACKET)
Patents Expiration Patented Use
Pat. No. RE48923 DS* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Mar 8, 2022
Nov 8, 2035 *PED  
Pat. No. 8648037 DS* DP* Macrocyclic proline derived HCV serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021
Jul 19, 2032 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 8937150 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jul 8, 2021
Nov 18, 2032 *PED  
Pat. No. 9321807 DS* DP* Crystal forms
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Jul 8, 2021
Dec 5, 2035 *PED  
Pat. No. 9586978 [Extended 149 days (0.4 years)]
Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021
May 6, 2031 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 10028937 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021
Dec 10, 2030 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 10039754 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021
Dec 10, 2030 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Pat. No. 10286029 Method for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 8, 2021
Sep 14, 2034 *PED U-3238: Treatment of chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 in pediatric patients 3 to less than 12 years of age or weighing less than 45 kg
Exclusivity Expiration Exclusivity Description
Exclusivity Code: D - New Dosing Schedule Mar 26, 2023 PED D-175: Eight-week dosing regimen for the treatment of genotypes 1, 2, 3, 4, 5, and 6, chronic hepatitis C virus infection in treatment-naive subjects with compensated cirrhosis based on the results from the EXPEDITION-8 study
Exclusivity Code: M - Miscellaneous Oct 10, 2023 PED M-259: Information added to the labeling regarding safety and efficacy in subjects with HCV subtype 3b infection
Exclusivity Code: NCE - New chemical entity Feb 3, 2023 PED  
Exclusivity Code: ODE - Orphan drug exclusivity Dec 10, 2028 PED ODE-372: For treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A); and treatment of pediatric patients 3 years of age to less than 12 years of age weighing less than 45 kg with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

ABBVIE
NAMENDA XR (CAPSULE, EXTENDED RELEASE) (ORAL) MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidementia Agents:N-methyl-D-aspartate (NMDA) Receptor Antagonist == Antidementia Agents:Antidementia Agents, Other
NDA Applicant: ABBVIE      NDA No.:
022525  Prod. No.: 001 RX (7MG); 002 RX (14MG); 003 RX (21MG); 004 RX (28MG)
Patents Expiration Patented Use
Pat. No. 8039009 Modified release formulations of memantine oral dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2011; 002: None; 003: None; 004: None
Sep 24, 2029 *PED U-539: Treatment of moderate to severe dementia of the Alzheimer's type

ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: Antidementia Agents:Cholinesterase Inhibitors == Antidementia Agents:N-methyl-D-aspartate (NMDA) Receptor Antagonist == Antidementia Agents:Antidementia Agents, Other
NDA Applicant: ABBVIE      NDA No.:
206439  Prod. No.: 001 RX (10MG;14MG); 002 RX (10MG;28MG); 003 RX (10MG;7MG); 004 RX (10MG;21MG)
Patents Expiration Patented Use
Pat. No. 8039009 Modified release formulations of memantine oral dosage forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: None; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Sep 24, 2029 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8058291 Methods and compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Dec 5, 2029 U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8168209 DP* Method and composition for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED  
Pat. No. 8173708 Method and composition for administering an NMDA receptor antagonist to a subject
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8283379 Methods and compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 22, 2015; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025  
Pat. No. 8329752 DP* Composition for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED  
Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025  
Pat. No. 8338486 Methods for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025 U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8362085 Method for administering an NMDA receptor antagonist to a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8580858 Compositions for the treatment of CNS-related conditions
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
Nov 22, 2025 U-1641: Memantine HCl/donepezil HCl combination for the treatment of moderate to severe dementia of the Alzheimer's type
Pat. No. 8598233 DP* Method for administering an NMDA receptor antagonist to a subject
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 16, 2016; 002: Jan 22, 2015; 003: Aug 16, 2016; 004: Aug 16, 2016
May 22, 2026 *PED  

ABBVIE
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)
NDA Applicant: ABBVIE      NDA No.:
213388  Prod. No.: 001 RX (EQ 300MG BASE,1MG,0.5MG; EQ 300MG BASE)
Patents Expiration Patented Use
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. 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. 10881659 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 3, 2021
Mar 14, 2034 U-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, 2034 U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
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, 2028 U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Feb 6, 2023
Jul 23, 2039  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Jul 23, 2023  
Exclusivity Code: NP - New product May 29, 2023  

ABBVIE
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)
NDA Applicant: ABBVIE      NDA No.:
210450  Prod. No.: 001 RX (EQ 150MG BASE)
Patents Expiration Patented Use
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. 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, 2024 U-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, 2024 U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 10537572 Methods of administering elagolix
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 19, 2020
Sep 1, 2036 U-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, 2036 U-2850: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix while co-administering ketoconazole
Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 001: Feb 6, 2023
Jul 23, 2039  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Jul 23, 2023  

ABBVIE
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)
NDA Applicant: ABBVIE      NDA No.:
210450  Prod. No.: 002 RX (EQ 200MG BASE)
Patents Expiration Patented Use
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. 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, 2024 U-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, 2024 U-2360: Management of moderate to severe pain associated with endometriosis
Pat. No. 11344551 Methods of treating heavy menstrual bleeding
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 27, 2022
Mar 14, 2034 U-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
Pat. No. 11542239 DS* DP* Elagolix sodium compositions and processes
Claim Types: Composition; Product-by-process
Pat. Sub. Date(s): 002: Feb 6, 2023
Jul 23, 2039  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Jul 23, 2023  

ABBVIE
OZURDEX (IMPLANT) (INTRAVITREAL) DEXAMETHASONE
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Adrenal) == Inflammatory Bowel Disease Agents:Glucocorticoids == Ophthalmic Agents:Ophthalmic Anti-inflammatories
NDA Applicant: ABBVIE      NDA No.:
022315  Prod. No.: 001 RX (0.7MG)
Patents Expiration Patented Use
Pat. No. 6899717 Methods and apparatus for delivery of ocular implants
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Nov 1, 2023 U-1206: Delivering an ocular implant as described in the dosage and administration section of the approved labeling of OZURDEX
Pat. No. 8034366 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 23, 2011
Jan 9, 2023 U-1204: Treatment of uveitis
U-1205: Treatment of macular edema
Pat. No. 8034370 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 23, 2011
Jan 9, 2023  
Pat. No. 8506987 Ocular implant made by a double extrusion process
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 11, 2013
Jan 9, 2023 U-1204: Treatment of uveitis
U-1205: Treatment of macular edema
Pat. No. 9192511 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 21, 2015
Jan 9, 2023  
Pat. No. 10076526 DP* Ocular implant made by a double extrusion process
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 17, 2018
Jan 9, 2023  
Pat. No. 10702539 Ocular implant made by a double extrusion process
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 7, 2020
Jan 9, 2023 U-1597: Treatment of diabetic macular edema
U-2868: Treatment of non-infectious uveitis affecting the posterior segment of the eye
U-985: Treatment of macular edema following branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)

ABBVIE
QULIPTA (TABLET) (ORAL) ATOGEPANT
NDA Applicant: ABBVIE      NDA No.:
215206  Prod. No.: 001 RX (10MG); 002 RX (30MG); 003 RX (60MG)
Patents Expiration Patented Use
Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Jul 19, 2032 U-3142: Preventive treatment of episodic migraine in adults
Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Nov 10, 2031 U-3142: Preventive treatment of episodic migraine in adults
Pat. No. 9850246 DS* Process for making CGRP receptor antagonists
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Mar 13, 2033  
Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Oct 26, 2021
Jan 30, 2035  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Sep 28, 2026  

ABBVIE
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE [Has competitive generic]
Drug Classes: Immunological Agents:Immunosuppressants == Ophthalmic Agents:Ophthalmic Agents, Other
NDA Applicant: ABBVIE      NDA No.:
050790  Prod. No.: 002 RX (0.05%)
Patents Expiration Patented Use
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. 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, 2024 U-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, 2024 U-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, 2024 U-1479: Increase tear production to treat patients with keratoconjunctivitis sicca (dry eye).
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  
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  

ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 001 RX (15MG)
Patents Expiration Patented Use
Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 001: Sep 13, 2019
Dec 1, 2030  
Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Sep 13, 2019
Jan 15, 2031 U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers
U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 001: Sep 13, 2019
Oct 17, 2036  
Pat. No. 9963459 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpla]pyrrolo[2,3-e]-pyrazin-8-YL)-N-(2- ,2,2-Trifluoroethyl)pyrrol and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 13, 2019
Oct 17, 2036  
Pat. No. 10519164 DP* Processes for the preparation of (3S,4R)-3,ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 29, 2020
Oct 17, 2036  
Pat. No. 10597400 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2020
Oct 17, 2036 U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 001: May 18, 2021
Oct 17, 2036  
Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 18, 2021
Oct 17, 2036  
Pat. No. 10995095 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carb oxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 10, 2022
Oct 17, 2036 U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable
Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Dec 17, 2021
Oct 17, 2036  
Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 17, 2021
Oct 17, 2036  
Pat. No. 11365198 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 20, 2022
Oct 17, 2036 U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers
Pat. No. 11512092 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 16, 2022
Oct 17, 2036 U-3275: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more tnf blockers
U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers
U-3487: Treatment of adults with active non-radiographic axial spondyloarthritis with objective signs of inflammation who have had an inadequate response or intolerance to one or more tnf blockers
Pat. No. 11524964 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 12, 2023
Oct 17, 2036 U-3371: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 11535624 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-α]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 26, 2023
Oct 17, 2036 U-3255: Treatment of adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 11535625 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]-pyrazin-8-yl)-N-(2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 26, 2023
Oct 17, 2036 U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable
Pat. No. 11607411 Methods of treating Crohn's disease and ulcerative colitis
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 18, 2023
Mar 9, 2038 U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Expiration Exclusivity Description
Exclusivity Code: I - New Indication Dec 14, 2024 I-880: Treatment of adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: I - New Indication Jan 14, 2025 I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable
Exclusivity Code: I - New Indication Mar 16, 2025 I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: I - New Indication Apr 29, 2025 I-888: Treatment of adults with active ankylosing spondylitis who have had an inadequate response or intolerance to one or more tnf blockers
Exclusivity Code: NCE - New chemical entity Aug 16, 2024  

ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 002 RX (30MG)
Patents Expiration Patented Use
Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 002: Feb 10, 2022
Dec 1, 2030  
Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Feb 10, 2022
Jan 15, 2031 U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036  
Pat. No. 10344036 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-#a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,- 2-trifluoroethyl)pyrrolidine-1-#carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036  
Pat. No. 10550126 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-A]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036 U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable
Pat. No. 10730883 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation claimed by its inherent performace characteristics; Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036  
Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036  
Pat. No. 10981924 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036  
Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036  
Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 10, 2022
Oct 17, 2036  
Pat. No. 11535626 Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2-trifluoroethyl)pyrrolidine-1 carboxamide and solid state forms thereof
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 26, 2023
Oct 17, 2036 U-3298: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate to severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, or when use of those therapies are inadvisable
Exclusivity Expiration Exclusivity Description
Exclusivity Code: I - New Indication Jan 14, 2025 I-883: Treatment of adults and pediatric patients 12 years of age and older with refractory, moderate-to-severe atopic dermatitis whose disease is not adequately controlled with other systemic drug products, including biologics, or when use of those therapies are inadvisable
Exclusivity Code: I - New Indication Mar 16, 2025 I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: NCE - New chemical entity Aug 16, 2024  

ABBVIE
RINVOQ (TABLET, EXTENDED RELEASE) (ORAL) UPADACITINIB
Drug Classes: Immunological Agents:Immunological Agents, Other
NDA Applicant: ABBVIE      NDA No.:
211675  Prod. No.: 003 RX (45MG)
Patents Expiration Patented Use
Pat. No. RE47221 DS* Tricyclic compounds
Claim Types: Compound
Pat. Sub. Date(s): 003: Apr 14, 2022
Dec 1, 2030  
Pat. No. 8962629 DS* Tricyclic compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Apr 14, 2022
Jan 15, 2031 U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 9951080 DS* DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-alpha]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2- ,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process
Pat. Sub. Date(s): 003: Apr 14, 2022
Oct 17, 2036  
Pat. No. 10202393 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-.alpha.]pyrrolo[2,3-e]-pyrazin-8-yl)-N-- (2,2,2-trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 003: Apr 14, 2022
Oct 17, 2036  
Pat. No. 10981923 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[l,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process; Composition
Pat. Sub. Date(s): 003: Apr 14, 2022
Oct 17, 2036  
Pat. No. 11186584 DS* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-n-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 003: Apr 14, 2022
Oct 17, 2036  
Pat. No. 11198697 DP* Processes for the preparation of (3S,4R)-3-ethyl-4-(3H-imidazo[1,2-a]pyrrolo[2,3-e]-pyrazin-8-yl)-N-(2,2,2- -trifluoroethyl)pyrrolidine-1-carboxamide and solid state forms thereof
Claim Types: Formulation
Pat. Sub. Date(s): 003: Apr 14, 2022
Oct 17, 2036  
Pat. No. 11607411 Methods of treating Crohn's disease and ulcerative colitis
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 18, 2023
Mar 9, 2038 U-3341: Treatment of adults with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Expiration Exclusivity Description
Exclusivity Code: I - New Indication Mar 16, 2025 I-886: Treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: NCE - New chemical entity Aug 16, 2024  

ABBVIE
SAVELLA (TABLET) (ORAL) MILNACIPRAN HYDROCHLORIDE
Drug Classes: Central Nervous System Agents:Fibromyalgia Agents
NDA Applicant: ABBVIE      NDA No.:
022256  Prod. No.: 001 RX (12.5MG); 002 RX (25MG); 003 RX (50MG); 004 RX (100MG)
Patents Expiration Patented Use
Pat. No. 6602911 [Extended 435 days (1.2 years)]
Methods of treating fibromyalgia
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Jan 14, 2023 U-882: Management of fibromyalgia (FM)
Pat. No. 7994220 Milnacipran for the long-term treatment of fibromyalgia syndrome
Claim Types: Method of use
Pat. Sub. Date(s): 001: Sep 1, 2011; 002: None; 003: None; 004: None
Sep 19, 2029 U-819: Management of fibromyalgia

ABBVIE
TECHNIVIE (TABLET) (ORAL) OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: Antivirals:Anti-HIV Agents, Protease Inhibitors (PI)
NDA Applicant: ABBVIE      NDA No.:
207931  Prod. No.: 001 DISC (12.5MG;75MG;50MG**)
Patents Expiration Patented Use
Pat. No. 8268349 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 25, 2025 *PED  
Pat. No. 8399015 DP* Solid pharmaceutical dosage form
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Feb 25, 2025 *PED  
Pat. No. 8420596 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Oct 10, 2031 *PED  
Pat. No. 8642538 DS* DP* Macrocyclic hepatitis C serine protease inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Sep 10, 2029 U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 8686026 DP* Solid compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 6, 2015
Jun 9, 2031  
Pat. No. 8691938 DS* DP* Anti-viral compounds
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Aug 6, 2015
Apr 13, 2032  
Pat. No. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Jun 10, 2030 U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2015
Apr 10, 2031 U-1638: Treatment of HCV infection using paritaprevir

ABBVIE
TRICOR (TABLET) (ORAL) FENOFIBRATE [GENERIC AB]
Drug Classes: Cardiovascular Agents:Dyslipidemics, Fibric Acid Derivatives
NDA Applicant: ABBVIE      NDA No.:
021656  Prod. No.: 001 RX (48MG); 002 RX (145MG)
Patents Expiration Patented Use
Pat. No. 7276249 DP* Nanoparticulate fibrate formulations
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: None
Feb 21, 2023  
Pat. No. 7320802 Methods of treatment using nanoparticulate fenofibrate compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
Feb 21, 2023 U-847: Adjunctive therapy to diet in adults to reduce LDL-c, triglycerides and Apo b, and increase HDL-c in patients with primary hypercholesterolemia or mixed dyslipidemia (types IIa, IIb) and to treat hypertriglyceridemia (types IV, V)

ABBVIE
TRILIPIX (CAPSULE, DELAYED RELEASE) (ORAL) CHOLINE FENOFIBRATE [GENERIC AB]
NDA Applicant: ABBVIE      NDA No.:
022224  Prod. No.: 001 RX (EQ 45MG FENOFIBRIC ACID); 002 RX (EQ 135MG FENOFIBRIC ACID)
Patents Expiration Patented Use
Pat. No. 7259186 DS* Salts of fenofibric acid and pharmaceutical formulations thereof
Claim Types: Formulation; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Jan 7, 2025  

ABBVIE
UBRELVY (TABLET) (ORAL) UBROGEPANT
Drug Classes: Antimigraine Agents:Calcitonin Gene-Related Peptide (CGRP) Receptor Antagonist
NDA Applicant: ABBVIE      NDA No.:
211765  Prod. No.: 001 RX (50MG); 002 RX (100MG)
Patents Expiration Patented Use
Pat. No. 8754096 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2020
Jul 19, 2032 U-2717: Acute treatment of migraine with headache, with or without aura in adults
Pat. No. 8912210 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Jan 21, 2020
Nov 10, 2031  
Pat. No. 9499545 DS* DP* Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2020
Nov 10, 2031 U-2718: Acute treatment of migraine with or without aura in adults
Pat. No. 9833448 Piperidinone carboxamide azaindane CGRP receptor antagonists
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 21, 2020
Nov 10, 2031 U-2718: Acute treatment of migraine with or without aura in adults
Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 21, 2020
Jan 30, 2035  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Dec 23, 2024  

ABBVIE
VENCLEXTA (TABLET) (ORAL) VENETOCLAX
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: ABBVIE      NDA No.:
208573  Prod. No.: 001 RX (10MG); 002 RX (50MG); 003 RX (100MG)
Patents Expiration Patented Use
Pat. No. 8546399 DS* DP* Apoptosis inducing agents for the treatment of cancer and immune and autoimmune diseases
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: May 4, 2016
Jun 27, 2031  
Pat. No. 8722657 DS* Salts and crystalline forms of an apoptosis-inducing agent
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Feb 13, 2020
Jan 29, 2032  
Pat. No. 9174982 Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: May 4, 2016
May 26, 2030 U-2323: Treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
U-2445: Treatment in combination with azacitidine or decitabine or low-dose cytarabine of newly-diagnosed acute myeloid leukemia (AML) in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
U-2446: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
U-2537: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
Pat. No. 9539251 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 13, 2019
Sep 6, 2033 U-2538: Treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic leukemia (Sll) in combination with a GA101 antibody such as obinutuzumab for one or more dosing periods, wherein the CLL or SLL is a CD20-expressing cancer
Pat. No. 10730873 DS* Salts and crystalline forms of an apoptosis-inducing agent
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Aug 17, 2020
Nov 21, 2031  
Pat. No. 10993942 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Claim Types: Method of use; Dosaage regimen
Pat. Sub. Date(s): All strengths: May 24, 2021
Sep 6, 2033 U-3114: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up that includes a dose of 50 mg per day for 1 week followed by 100 mg per day for 1 week
Pat. No. 11110087 Combination therapy of a type II anti-CD20 antibody with a selective Bcl-2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Oct 7, 2021
Sep 6, 2033 U-3222: Treatment of acute myeloid leukemia (AML) by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine in adults 75 years or older or having certain comorbidities according to a dose ramp-up including a 100 mg per day dose
U-3223: Treatment of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) by orally administering venetoclax to an adult according to a dose ramp-up including a 100 mg per day dose
Pat. No. 11369599 DP* Melt-extruded solid dispersions containing an apoptosis-inducing agent
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jul 20, 2022
May 23, 2032  
Pat. No. 11413282 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Sep 12, 2022
Sep 6, 2033 U-3412: Treatment of adults with relapsed, refractory or previously untreated chronic lymphocytic leukemia including a dose ramp-up and in combination with obinutuzumab in multiple 28-day dosing cycles followed by administration in absence of obinutuzumab
Pat. No. 11590128 Combination therapy of a type II anti-CD20 antibody with a selective BCL-2 inhibitor
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 24, 2023
Sep 6, 2033 U-3548: Treatment of aml by orally administering venetoclax with azacitidine or decitabine or low-dose cytarabine to adults 75 years or older or having certain comorbidities per a dose ramp-up including an initial 100 mg or a final 400 mg per day dose
Exclusivity Expiration Exclusivity Description
Exclusivity Code: M - Miscellaneous Oct 16, 2023 M-265: Revisions to the labeling to include results from clinical study M15-656 (VIALE-A) and M16-043 (VIALE-C) to support PMR 3545-1 and PMR 3545-2
Exclusivity Code: ODE - Orphan drug exclusivity Apr 11, 2023 ODE-114: Treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA approved test, who have received at least one prior therapy
Exclusivity Code: ODE - Orphan drug exclusivity Jun 8, 2025 ODE-185: Indicated for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
Exclusivity Code: ODE - Orphan drug exclusivity Nov 21, 2025 ODE-211: Indicated in combo with azacitidine, or decitabine, or low-dose cytarabine for the tx of newly-diagnosed acute myeloid leukemia in adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy
Exclusivity Code: ODE - Orphan drug exclusivity May 15, 2026 ODE-239: Treatment of previously untreated adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)

ABBVIE
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents
NDA Applicant: ABBVIE      NDA No.:
206940  Prod. No.: 001 RX (75MG)
Patents Expiration Patented Use
Pat. No. 7741356 DS* DP* [Extended 1068 days (2.9 years)]
Compounds as opioid receptor modulators
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 26, 2015
May 27, 2029  
Pat. No. 7786158 DS* Compounds as opioid receptor modulators
Claim Types: Compound
Pat. Sub. Date(s): 001: Jun 26, 2015
Mar 14, 2025  
Pat. No. 8344011 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 26, 2015
Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 8609709 DS* Compounds as opioid receptor modulators
Claim Types: Compound; New polymorph, salt, or hydrate
Pat. Sub. Date(s): 001: Jun 26, 2015
Mar 14, 2025  
Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl
Claim Types: New polymorph, salt, or hydrate; Method of use
Pat. Sub. Date(s): 001: Jun 26, 2015
Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 8772325 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 16, 2017
Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Sep 23, 2015
Jul 7, 2028 U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline)
Pat. No. 9205076 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 30, 2015
Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 14, 2016
Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 7, 2017
Mar 14, 2033  
Pat. No. 9700542 DP* Compounds as opioid receptor modulators
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Aug 7, 2017
Mar 14, 2025  
Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): 001: Nov 1, 2017
Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 28, 2019
Mar 14, 2033  
Pat. No. 10213415 DS* Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 21, 2019
Mar 14, 2025 U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 3, 2021
Mar 14, 2033  
Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 7, 2021
Mar 14, 2033  
Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 24, 2021
Mar 14, 2033  
Pat. No. 11229627 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 15, 2022
Mar 14, 2033  
Pat. No. 11311516 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 19, 2022
Mar 14, 2033  

ABBVIE
VIBERZI (TABLET) (ORAL) ELUXADOLINE
Drug Classes: Gastrointestinal Agents:Anti-Diarrheal Agents
NDA Applicant: ABBVIE      NDA No.:
206940  Prod. No.: 002 RX (100MG)
Patents Expiration Patented Use
Pat. No. 7741356 DS* DP* [Extended 1068 days (2.9 years)]
Compounds as opioid receptor modulators
Claim Types: Compound; Composition
Pat. Sub. Date(s): 002: Jun 26, 2015
May 27, 2029  
Pat. No. 7786158 DS* Compounds as opioid receptor modulators
Claim Types: Compound
Pat. Sub. Date(s): 002: Jun 26, 2015
Mar 14, 2025  
Pat. No. 8344011 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jun 26, 2015
Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 8609709 DS* Compounds as opioid receptor modulators
Claim Types: Compound; New polymorph, salt, or hydrate
Pat. Sub. Date(s): 002: Jun 26, 2015
Mar 14, 2025  
Pat. No. 8691860 DS* Crystals and process of making 5-({(2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(-4-phenyl
Claim Types: New polymorph, salt, or hydrate; Method of use
Pat. Sub. Date(s): 002: Jun 26, 2015
Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 8772325 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Feb 16, 2017
Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9115091 DS* DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- -1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 002: Sep 23, 2015
Jul 7, 2028 U-1738: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline)
Pat. No. 9205076 Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Dec 30, 2015
Mar 14, 2025 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9364489 Crystals and process of making 5-({[2-amino-3-(4-Carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1h-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 14, 2016
Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
Pat. No. 9675587 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Aug 7, 2017
Mar 14, 2033  
Pat. No. 9700542 DP* Compounds as opioid receptor modulators
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Aug 7, 2017
Mar 14, 2025  
Pat. No. 9789125 DP* Crystals and process of making 5-({[2-amino-3-(4-carbamoyl-2,6-dimethyl-phenyl)-propionyl]-[1-(4-phenyl-- 1H-imidazol-2-yl)-ethyl]-amino}-methyl)-2-methoxy-benzoic acid
Claim Types: New polymorph, salt or hydrate; Method of use
Pat. Sub. Date(s): 002: Nov 1, 2017
Jul 7, 2028 U-1709: Treatment of irritable bowel syndrome with diarrhea (ibs-d) with VIBERZI (eluxadoline).
U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 10188632 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 28, 2019
Mar 14, 2033  
Pat. No. 10213415 DS* Compounds as opioid receptor modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Mar 21, 2019
Mar 14, 2025 U-2152: Treatment of pain associated with irritable bowel syndrome with diarrhea (IBS-D) with VIBERZI (eluxadoline)
Pat. No. 11007179 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Jun 3, 2021
Mar 14, 2033  
Pat. No. 11090291 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Sep 7, 2021
Mar 14, 2033  
Pat. No. 11160792 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Nov 24, 2021
Mar 14, 2033  
Pat. No. 11229627 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: Feb 15, 2022
Mar 14, 2033  
Pat. No. 11311516 DP* Opioid receptor modulator dosage formulations
Claim Types: Formulation
Pat. Sub. Date(s): 002: May 19, 2022
Mar 14, 2033  
Pat. No. 11484527 Opioid receptor modulator dosage formulations
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 22, 2022
Mar 14, 2033 U-3475: Reduction of the frequency of abdominal pain and diarrhea, in an inflammatory bowel disease with diarrhea (IBS-D) patient, with eluxadoline twice daily with food

ABBVIE
VIEKIRA PAK (COPACKAGED) (TABLET) (ORAL) DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents
NDA Applicant: ABBVIE      NDA No.:
206619  Prod. No.: 001 DISC (EQ 250MG BASE;12.5MG, 75MG, 50MG)
Patents Expiration Patented Use
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, 2029 U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
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. 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. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 15, 2015
Sep 4, 2032 U-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, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
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, 2028 U-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, 2029 U-1638: Treatment of HCV infection using paritaprevir
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, 2032 U-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, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
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. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 6, 2015
Jun 10, 2030 U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 1, 2015
Apr 10, 2031 U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 21, 2015
Nov 9, 2028 U-1753: Treatment of HCV infection using dasabuvir
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, 2033 U-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, 2033 U-1753: Treatment of HCV infection using dasabuvir

ABBVIE
VIEKIRA XR (TABLET, EXTENDED RELEASE) (ORAL) DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR
Drug Classes: Antivirals:Anti-hepatitis C (HCV) Agents == Antivirals:Anti-HIV Agents, Protease Inhibitors (PI)
NDA Applicant: ABBVIE      NDA No.:
208624  Prod. No.: 001 DISC (EQ 200MG BASE;8.33MG;50MG;33.33MG**)
Patents Expiration Patented Use
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, 2029 U-1636: Use of dasabuvir to inhibit viral replication for the treatment of HCV infection.
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. 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. 8466159 Methods for treating HCV
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Aug 17, 2016
Sep 4, 2032 U-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, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
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, 2028 U-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, 2029 U-1638: Treatment of HCV infection using paritaprevir
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, 2032 U-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, 2032 U-1840: Treatment of HCV infection using paritaprevir, ombitasvir, ritonavir, and dasabuvir, without ribavirin
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. 9006387 Anti-viral compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Jun 10, 2030 U-1687: Treatment of HCV infection using ombitasvir
Pat. No. 9044480 Compositions and methods for treating HCV
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Apr 10, 2031 U-1638: Treatment of HCV infection using paritaprevir
Pat. No. 9139536 Anti-infective agents and uses thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Nov 9, 2028 U-1753: Treatment of HCV infection using dasabuvir
Pat. No. 9333204 DP* Solid antiviral dosage forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Aug 17, 2016
Jan 2, 2035 U-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, 2035 U-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, 2035 U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination
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, 2032 U-1889: Treatment of HCV infection using dasabuvir/ombitasvir/paritaprevir/ritonavir fixed dose combination

ABBVIE
VIIBRYD (TABLET) (ORAL) VILAZODONE HYDROCHLORIDE [GENERIC AB]
Drug Classes: Antidepressants:SSRIs/SNRIs (Selective Serotonin Reuptake Inhibitors/ Serotonin and Norepinephrine Reuptake Inhibitors)
NDA Applicant: ABBVIE      NDA No.:
022567  Prod. No.: 001 RX (10MG); 002 RX (20MG); 003 RX (40MG)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: M - Miscellaneous Jul 31, 2023 PED M-254: Information added to the labeling regarding pediatric patients ages 7 to 17 years of age with major depressive disorder

ABBVIE
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: Antipsychotics:2nd Generation/Atypical
NDA Applicant: ABBVIE      NDA No.:
204370  Prod. No.: 001 RX (EQ 1.5MG BASE)
Patents Expiration Patented Use
Pat. No. RE47350 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 15, 2019
Jul 16, 2029 U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. RE49110 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 21, 2022
Jul 16, 2029 U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. RE49302 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 13, 2023
Jul 16, 2029 U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. 7737142 DS* DP* [Extended 905 days (2.5 years)]
(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Claim Types: Compound; Process; Method of use; Composition
Pat. Sub. Date(s): 001: Oct 16, 2015
Sep 17, 2029 U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): 001: Oct 16, 2015
Dec 16, 2028  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: I - New Indication Dec 16, 2025 I-904: Adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults

ABBVIE
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: Antipsychotics:2nd Generation/Atypical
NDA Applicant: ABBVIE      NDA No.:
204370  Prod. No.: 002 RX (EQ 3MG BASE)
Patents Expiration Patented Use
Pat. No. RE49110 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 21, 2022
Jul 16, 2029 U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. RE49302 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 13, 2023
Jul 16, 2029 U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. 7737142 DS* DP* [Extended 905 days (2.5 years)]
(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Claim Types: Compound; Process; Method of use; Composition
Pat. Sub. Date(s): 002: Oct 16, 2015
Sep 17, 2029 U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): 002: Oct 16, 2015
Dec 16, 2028  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: I - New Indication Dec 16, 2025 I-904: Adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults

ABBVIE
VRAYLAR (CAPSULE) (ORAL) CARIPRAZINE HYDROCHLORIDE
Drug Classes: Antipsychotics:2nd Generation/Atypical
NDA Applicant: ABBVIE      NDA No.:
204370  Prod. No.: 003 RX (EQ 4.5MG BASE); 004 RX (EQ 6MG BASE)
Patents Expiration Patented Use
Pat. No. RE49110 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 21, 2022
Jul 16, 2029 U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
Pat. No. RE49302 Pharmaceutical formulations containing dopamine receptor ligands
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 13, 2023
Jul 16, 2029 U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2545: Treatment of depressive episodes associated with bipolar I disorder (bipolar depression) with cariprazine
U-3503: Adjunctive therapy to antidepressants for the treatment of major depressive disorder
Pat. No. 7737142 DS* DP* [Extended 905 days (2.5 years)]
(Thio) carbamoyl-cyclohexane derivatives as D3/D2 receptor antagonists
Claim Types: Compound; Process; Method of use; Composition
Pat. Sub. Date(s): All strengths: Oct 16, 2015
Sep 17, 2029 U-1750: Treatment of schizophrenia and/or acute manic or mixed episodes associated with bipolar I disorder with cariprazine
U-2543: Treatment of schizophrenia with cariprazine
U-2544: Treatment of acute manic or mixed episodes associated with bipolar I disorder with cariprazine
Pat. No. 7943621 DS* DP* Salts of piperazine compounds as D.sub.3/D.sub.2 antagonists
Claim Types: Compound; New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Oct 16, 2015
Dec 16, 2028  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: I - New Indication Dec 16, 2025 I-904: Adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults

ABBVIE
VUITY (SOLUTION) (OPHTHALMIC) PILOCARPINE HYDROCHLORIDE
Drug Classes: Dental and Oral Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents
NDA Applicant: ABBVIE      NDA No.:
214028  Prod. No.: 001 RX (1.25%)
Patents Expiration Patented Use
Pat. No. 10610518 Presbyopia treatments
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 24, 2021
Apr 24, 2039 U-3252: Use of VUITY for the treatment of presbyopia in adults
U-3561: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation once daily
U-3562: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation twice daily
Pat. No. 11285134 Presbyopia treatments
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 28, 2022
Apr 24, 2039 U-3252: Use of VUITY for the treatment of presbyopia in adults
U-3561: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation once daily
U-3562: Treatment of presbyopia in adults by administration of pilocarpine HCl formulation twice daily
Exclusivity Expiration Exclusivity Description
Exclusivity Code: D - New Dosing Schedule Mar 28, 2026 D-187: Addition of second dose for treatment of presbyopia in adults
Exclusivity Code: NP - New product Oct 28, 2024  

ABBVIE
ZEMPLAR (SOLUTION) (INTRAVENOUS) PARICALCITOL [GENERIC AP]
Drug Classes: Metabolic Bone Disease Agents
NDA Applicant: ABBVIE      NDA No.:
020819  Prod. No.: 001 RX (0.005MG/ML (0.005MG/ML)); 002 RX (0.002MG/ML (0.002MG/ML)); 003 RX (0.01MG/2ML (0.005MG/ML))
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) Oct 18, 2023  

ABBVIE
ZEMPLAR (CAPSULE) (ORAL) PARICALCITOL [GENERIC AB]
Drug Classes: Metabolic Bone Disease Agents
NDA Applicant: ABBVIE      NDA No.:
021606  Prod. No.: 001 RX (1MCG); 002 RX (2MCG) NDA No.: 021606  Prod. No.: 003 DISC (4MCG**)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Oct 18, 2023 ODE-125: Indicated in pediatric patients 10 years and older for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease (CKD) stages 3 and 4 and ckd stage 5 in patients on hemodialysis or peritoneal dialysis

ABBVIE ENDOCRINE INC
LUPRON DEPOT (INJECTABLE) (INJECTION) LEUPROLIDE ACETATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary)
NDA Applicant: ABBVIE ENDOCRINE INC      NDA No.:
020517  Prod. No.: 003 RX (45MG/VIAL)
Patents Expiration Patented Use
Pat. No. 8921326 DP* Sustained-release composition and method for producing the same
Claim Types: Formulation
Pat. Sub. Date(s): 003: Mar 13, 2015
Feb 5, 2031 U-1666: Palliative treatment of prostate cancer

ACACIA
BARHEMSYS (SOLUTION) (INTRAVENOUS) AMISULPRIDE
Drug Classes: Antiemetics:Antiemetics, Other
NDA Applicant: ACACIA      NDA No.:
209510  Prod. No.: 001 RX (5MG/2ML (2.5MG/ML)); 002 RX (10MG/4ML (2.5MG/ML))
Patents Expiration Patented Use
Pat. No. 9084765 [Extended 1084 days (3 years)]
Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Feb 26, 2034 U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting
U-3467: Prevention and treatment of post-operative nausea and vomiting
Pat. No. 9545426 Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Mar 10, 2031 U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 9889118 Use of amisulpride as an anti-emetic
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Mar 10, 2031 U-1744: Prevention of post-operative nausea and vomiting
U-2754: Treatment of post-operative nausea and vomiting
Pat. No. 10525033 DP* Use of amisulpride as an anti-emetic
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Mar 16, 2020; 002: Feb 9, 2022
Mar 10, 2031  
Pat. No. 11357753 Rescue treatment of post operative nausea and vomiting
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 8, 2022
Feb 9, 2038 U-2754: Treatment of post-operative nausea and vomiting
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Feb 26, 2025  

ACACIA
BYFAVO (POWDER) (INTRAVENOUS) REMIMAZOLAM BESYLATE
NDA Applicant: ACACIA      NDA No.:
212295  Prod. No.: 001 RX (EQ 20MG BASE/VIAL)
Patents Expiration Patented Use
Pat. No. 9561236 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Apr 30, 2033 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 9737547 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 9777007 DP* Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Composition
Pat. Sub. Date(s): 001: Oct 23, 2020
Jul 10, 2027  
Pat. No. 9827251 Dosing regimen for sedation with CNS 7056 (remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 9914738 DP* Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Oct 23, 2020
Jul 10, 2027  
Pat. No. 10052334 Dosing regimen for sedation with CNS 7056 (remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10195210 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Diagnostic or surgical method
Pat. Sub. Date(s): 001: Oct 23, 2020
Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10342800 Dosing regimen for sedation with CNS 7056 (Remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10472365 Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Jul 10, 2027 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10722522 Dosing regimen for sedation with CNS 7056 (remimazolam)
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 23, 2020
Nov 7, 2031 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Pat. No. 10961250 DP* Short-acting benzodiazepine salts and their polymorphic forms
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Jul 8, 2022
Jul 10, 2027 U-2968: Use of remimazolam for induction and maintenance of procedural sedation in adults undergoing procedures lasting 30 minutes or less
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Oct 6, 2025  

ACADIA PHARMS INC
DAYBUE (SOLUTION) (ORAL) TROFINETIDE
NDA Applicant: ACADIA PHARMS INC      NDA No.:
217026  Prod. No.: 001 RX (200MG/ML)
Patents Expiration Patented Use
Pat. No. 9212204 Treatment of rett syndrome using glycyl-L-2-methylprolyl-L-glutamic acid
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 7, 2023
Jan 27, 2032 U-3556: Treatment of Rett syndrome or a symptom thereof
Pat. No. 11370755 DS* DP* Compositions of trofinetide
Claim Types: Formulation; Product-by-process
Pat. Sub. Date(s): 001: Apr 7, 2023
Aug 3, 2040  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Mar 10, 2028  
Exclusivity Code: ODE - Orphan drug exclusivity Mar 10, 2030 ODE-425: Treatment of Rett syndrome in adults and pediatric patients 2 years of age and older

ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical
NDA Applicant: ACADIA PHARMS INC      NDA No.:
207318  Prod. No.: 001 DISC (EQ 17MG BASE)
Patents Expiration Patented Use
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation
Pat. Sub. Date(s): 001: May 25, 2016
Apr 29, 2030  
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: May 25, 2016
Aug 24, 2026 U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: May 25, 2016
Jun 3, 2028  
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: May 25, 2016
Sep 26, 2025  
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016
Jan 15, 2024 U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 25, 2016
Jan 15, 2024 U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 14, 2017
Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 6, 2018
Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

ACADIA PHARMS INC
NUPLAZID (TABLET) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical
NDA Applicant: ACADIA PHARMS INC      NDA No.:
207318  Prod. No.: 002 RX (EQ 10MG BASE)
Patents Expiration Patented Use
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation
Pat. Sub. Date(s): 002: Jul 25, 2018
Apr 29, 2030  
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration
Pat. Sub. Date(s): 002: Jul 25, 2018
Aug 24, 2026 U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 002: Jul 25, 2018
Jun 3, 2028  
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 002: Jul 25, 2018
Sep 26, 2025  
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024 U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024 U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jul 25, 2018
Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10517860 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of use
Pat. Sub. Date(s): 002: Jan 10, 2020
Mar 23, 2037 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10953000 Combination of pimavanserin and cytochrome P450 modulators
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 002: Mar 30, 2021
Mar 23, 2037 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis

ACADIA PHARMS INC
NUPLAZID (CAPSULE) (ORAL) PIMAVANSERIN TARTRATE
Drug Classes: Antipsychotics:2nd Generation/Atypical
NDA Applicant: ACADIA PHARMS INC      NDA No.:
210793  Prod. No.: 001 RX (EQ 34MG BASE)
Patents Expiration Patented Use
Pat. No. 7601740 DS* DP* [Extended 1315 days (3.6 years)]
Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Jul 25, 2018
Apr 29, 2030  
Pat. No. 7659285 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseasesClaim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jul 25, 2018
Aug 24, 2026 U-1844: Treatment of Parkinson's disease psychosis
Pat. No. 7732615 DS* DP* N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy)phe- nylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process
Pat. Sub. Date(s): 001: Jul 25, 2018
Jun 3, 2028  
Pat. No. 7923564 DS* DP* Synthesis of N-(4-fluorobenzyl)-N-(1-methylpiperidin-4-yl)-N'-(4-(2-methylpropyloxy) phenylmethyl)carbamide and its tartrate salt and crystalline forms
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Jul 25, 2018
Sep 26, 2025  
Pat. No. 8618130 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024 U-1845: Treatment of psychosis or a symptom thereof
Pat. No. 8921393 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024 U-1846: Treatment of a neurodegenerative disease or a symptom thereof
Pat. No. 9566271 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10028944 Selective serotonin 2A/2C receptor inverse agonists as therapeutics for neurodegenerative diseases
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2018
Jan 15, 2024 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 10449185 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 1, 2019
Aug 27, 2038  
Pat. No. 10646480 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: May 15, 2020
Aug 27, 2038  
Pat. No. 10849891 DP* Formulations of pimavanserin
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 11, 2020
Aug 27, 2038 U-1974: Treatment of hallucinations and delusions associated with Parkinson's disease psychosis
Pat. No. 11452721 DP* Formulations of pimavanserin
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 27, 2022
Aug 27, 2038  

ACCORD
CAMCEVI KIT (EMULSION) (SUBCUTANEOUS) LEUPROLIDE MESYLATE
Drug Classes: Hormonal Agents, Suppressant (Pituitary)
NDA Applicant: ACCORD      NDA No.:
211488  Prod. No.: 001 RX (EQ 42MG BASE)
Patents Expiration Patented Use
Pat. No. 9572857 DP* Pharmaceutical compositions with enhanced stability
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 15, 2021
Jan 16, 2027  
Pat. No. 9744207 DP* Pharmaceutical compositions with enhanced stability
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 15, 2021
Jan 16, 2027  
Pat. No. 10646572 DP* Pharmaceutical compositions with enhanced stability
Claim Types: Formulation; Kit; Process
Pat. Sub. Date(s): 001: Jul 15, 2021
Jan 16, 2027  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NP - New product May 25, 2024  

ACCORD HLTHCARE
BENDAMUSTINE HYDROCHLORIDE (POWDER) (IV (INFUSION)) BENDAMUSTINE HYDROCHLORIDE [GENERIC AP]
Drug Classes: Antineoplastics:Alkylating Agents
NDA Applicant: ACCORD HLTHCARE      NDA No.:
205574  Prod. No.: 001 RX (25MG/VIAL); 002 RX (100MG/VIAL)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: PC - Patent challenge Jun 5, 2023  

ACCORD HLTHCARE
FINGOLIMOD HYDROCHLORIDE (CAPSULE) (ORAL) FINGOLIMOD HYDROCHLORIDE [GENERIC AB]
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents
NDA Applicant: ACCORD HLTHCARE      NDA No.:
207991  Prod. No.: 001 RX (EQ 0.5MG BASE)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: PC - Patent challenge Mar 20, 2023  

ACCORD HLTHCARE
TERIFLUNOMIDE (TABLET) (ORAL) TERIFLUNOMIDE [GENERIC AB]
Drug Classes: Central Nervous System Agents:Multiple Sclerosis Agents
NDA Applicant: ACCORD HLTHCARE      NDA No.:
209690  Prod. No.: 001 RX (7MG); 002 RX (14MG)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: PC - Patent challenge Sep 8, 2023  

ACER
OLPRUVA (FOR SUSPENSION) (ORAL) SODIUM PHENYLBUTYRATE
NDA Applicant: ACER      NDA No.:
214860  Prod. No.: 001 RX (2GM/PACKET); 002 RX (3GM/PACKET); 003 RX (4GM/PACKET); 004 RX (5GM/PACKET); 005 RX (6GM/PACKET); 006 RX (6.67GM/PACKET)
Patents Expiration Patented Use
Pat. No. 11154521 DP* Palatable compositions including sodium phenylbutyrate and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 12, 2023
Oct 17, 2036  
Pat. No. 11202767 Methods of treating urea cycle disorders and maple syrup urine disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 12, 2023
Oct 17, 2036 U-3502: Treatment of a urea cycle disorder involving deficiencies of carbamylphosphate synthetase, ornithine transcarbamylase, or argininosuccinic acid synthetase
Pat. No. 11433041 DP* Palatable compositions including sodium phenylbutyrate and uses thereof
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Jan 12, 2023
Oct 17, 2036  

ACERUS
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)
Patents Expiration Patented 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, 2024 U-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, 2024 U-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, 2034 U-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

ACERUS PHARMS
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary)
NDA Applicant: ACERUS PHARMS      NDA No.:
201656  Prod. No.: 001 DISC (0.00083MG/SPRAY)
Patents Expiration Patented 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, 2030 U-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

ACERUS PHARMS
NOCTIVA (SPRAY, METERED) (NASAL) DESMOPRESSIN ACETATE
Drug Classes: Blood Products and Modifiers:Blood Component Deficiency/ Replacement == Hormonal Agents, Stimulant/Replacement/ Modifying (Pituitary)
NDA Applicant: ACERUS PHARMS      NDA No.:
201656  Prod. No.: 002 DISC (0.00166MG/SPRAY)
Patents Expiration Patented Use
Pat. No. 9539302 DP* Safe desmopressin administration
Claim Types: Device
Pat. Sub. Date(s): 002: Mar 31, 2017
Jun 15, 2030  
Pat. No. 11419914 Safe desmopressin administration
Claim Types: Method of use
Pat. Sub. Date(s): 002: Sep 20, 2022
Jun 15, 2030 U-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

ACLARIS
ESKATA (SOLUTION) (TOPICAL) HYDROGEN PEROXIDE
NDA Applicant: ACLARIS      NDA No.:
209305  Prod. No.: 001 DISC (40%)
Patents Expiration Patented Use
Pat. No. 9675639 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Formulation; Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 3, 2018
Jul 4, 2035 U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 9980983 Peroxide formulations and methods and applicators for using the same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 18, 2018
Apr 21, 2035 U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 10098910 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Device; Method of use
Pat. Sub. Date(s): 001: Oct 25, 2018
Apr 21, 2035 U-2205: Treatment of seborrheic keratoses that are raised
Pat. No. 10493103 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Device
Pat. Sub. Date(s): 001: Jan 21, 2020
Apr 21, 2035  
Pat. No. 10729720 DP* Peroxide formulations and methods and applicators for using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 11, 2020
Apr 21, 2035  

ACORDA
INBRIJA (POWDER) (INHALATION) LEVODOPA
Drug Classes: Antiparkinson Agents:Dopamine Precursors and/or L-Amino Acid Decarboxylase Inhibitors
NDA Applicant: ACORDA      NDA No.:
209184  Prod. No.: 001 RX (42MG)
Patents Expiration Patented Use
Pat. No. RE43711 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Feb 3, 2029 U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 7182961 DP* Particulate compositions for pulmonary delivery
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Feb 22, 2024  
Pat. No. 8404276 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Mar 19, 2023 U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 8545878 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032  
Pat. No. 8586093 Pulmonary delivery for levodopa
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 18, 2019
Mar 19, 2023 U-2484: Intermittent treatment of off episodes in patients with Parkinson's Disease treated with carbidopa/levodopa by inhalation of levodopa powder particles
Pat. No. 8685442 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032  
Pat. No. 8945612 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032  
Pat. No. 9155699 DP* Pulmonary delivery for levodopa
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Mar 19, 2023  
Pat. No. 9393210 DP* Capsules containing high doses of levodopa for pulmonary use
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jan 18, 2019
Nov 16, 2032  

ACROTECH BIOPHARMA
BELEODAQ (POWDER) (INTRAVENOUS) BELINOSTAT
Drug Classes: Antineoplastics:Molecular Target Inhibitors
NDA Applicant: ACROTECH BIOPHARMA      NDA No.:
206256  Prod. No.: 001 RX (500MG/VIAL)
Patents Expiration Patented Use
Pat. No. 6888027 DS* DP* [Extended 1778 days (4.9 years)]
Carbamic acid compounds comprising a sulfonamide linkage as HDAC inhibitors
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Aug 1, 2014
Aug 10, 2026 U-1544: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL).
Pat. No. 8835501 DP* Pharmaceutical formulations of HDAC inhibitors
Claim Types: Formulation; Drug in a container; Kit
Pat. Sub. Date(s): 001: Oct 9, 2014
Oct 27, 2027  

ACROTECH BIOPHARMA
EVOMELA (POWDER) (INTRAVENOUS) MELPHALAN HYDROCHLORIDE
Drug Classes: Antineoplastics:Alkylating Agents == alkylating drug
NDA Applicant: ACROTECH BIOPHARMA      NDA No.:
207155  Prod. No.: 001 RX (EQ 50MG BASE/VIAL)
Patents Expiration Patented Use
Pat. No. 8410077 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Compound; Product-by-process; Formulation
Pat. Sub. Date(s): 001: Apr 5, 2016
Mar 13, 2029  
Pat. No. 9200088 DP* Sulfoalkyl ether cyclodextrin compositions
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Apr 5, 2016
Mar 13, 2029  
Pat. No. 9493582 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Formulation; Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 14, 2017
Feb 27, 2033  
Pat. No. 10040872 DP* Alkylated cyclodextrin compositions and processes for preparing and using the same
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Sep 6, 2018
Jan 30, 2034  
Pat. No. 10864183 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 15, 2020
May 28, 2030  
Pat. No. 10940128 DP* Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Mar 19, 2021
Jun 14, 2030 U-3086: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma
Pat. No. 11020363 DP* Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 10, 2021
May 28, 2030  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Mar 10, 2023 ODE-110: For high-dose conditioning treatment prior to hematopoietic progenitor (stem) cell transplantation in patients with multiple myeloma

ACROTECH BIOPHARMA
FOLOTYN (SOLUTION) (INTRAVENOUS) PRALATREXATE
NDA Applicant: ACROTECH BIOPHARMA      NDA No.:
022468  Prod. No.: 001 RX (20MG/ML (20MG/ML)); 002 RX (40MG/2ML (20MG/ML))
Patents Expiration Patented Use
Pat. No. 7622470 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: None
May 31, 2025 U-1015: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma
Pat. No. 8299078 Treatment of T-cell lymphoma using 10-propargyl-10-deazaaminopterin
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 19, 2012; 002: None
May 31, 2025 U-1004: Treatment of patients with relapsed or refractory peripheral T-cell lymphoma

ACROTECH BIOPHARMA
KHAPZORY (POWDER) (INTRAVENOUS) LEVOLEUCOVORIN
Drug Classes: Antineoplastics:Treatment Adjuncts == Antineoplastics:Antineoplastics, Other
NDA Applicant: ACROTECH BIOPHARMA      NDA No.:
211226  Prod. No.: 001 RX (175MG/VIAL); 002 RX (300MG/VIAL )
Patents Expiration Patented Use
Pat. No. 11541012 DP* Compositions comprising disodium levofolinate
Claim Types: Product-by-process
Pat. Sub. Date(s): All strengths: Jan 9, 2023
Mar 25, 2039  

ACTELION
OPSUMIT (TABLET) (ORAL) MACITENTAN
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
NDA Applicant: ACTELION      NDA No.:
204410  Prod. No.: 001 RX (10MG)
Patents Expiration Patented Use
Pat. No. 7094781 DS* DP* [Extended 1150 days (3.2 years)]
Sulfamides and their use as endothelin receptor antagonists
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 6, 2013
Dec 5, 2025  
Pat. No. 8268847 Therapeutic compositions comprising a specific endothelin receptor antagonist and a PDE5 inhibitor
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 6, 2013
Apr 18, 2029 U-1446: Method of treating pulmonary hypertension comprising administering macitentan in combination with a compound having phosphodiesterase-5 inhibitory properties
Pat. No. 8367685 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 6, 2013
Oct 4, 2028 U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition
Pat. No. 9265762 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 16, 2016
May 29, 2027 U-1820: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherein the polysorbate represents 0.1 to 3% of the weight of said pharmaceutical composition
Pat. No. 10946015 DP* Stable pharmaceutical compositions comprising a pyrimidine-sulfamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 8, 2021
Sep 11, 2026 U-1445: Method of treating pulmonary arterial hypertension by administering a pharmaceutical composition comprising macitentan and a polysorbate, wherin [sic, wherein] the polysorbate represents 0.1 to 1% of the weight of said pharmaceutical composition

ACTELION
TRACLEER (TABLET) (ORAL) BOSENTAN [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
NDA Applicant: ACTELION      NDA No.:
021290  Prod. No.: 001 RX (62.5MG); 002 RX (125MG)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE* - FDA has not recognized orphan-drug exclusivity (ODE) for this drug, but it contains the same active moiety or moieties as another drug(s) that was eligible for ODE, and also shares ODE-protected use(s) or indication(s) with that drug(s). An application seeking approval for the same active moiety or moieties, including an ANDA that cites this NDA as its basis of submission, may not be approved for such ODE-protected use(s) and indication(s) Sep 5, 2024  

ACTELION
TRACLEER (TABLET, FOR SUSPENSION) (ORAL) BOSENTAN
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
NDA Applicant: ACTELION      NDA No.:
209279  Prod. No.: 001 RX (32MG)
Patents Expiration Patented Use
Pat. No. 7959945 DP* Dispersible bosentan tablet
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 3, 2017
Dec 28, 2027  
Pat. No. 8309126 DP* Dispersible bosentan tablet
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Oct 3, 2017
May 15, 2026  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Sep 5, 2024 ODE-161: Treatment of pulmonary arterial hypertension (PAH) (WHO group 1) in pediatric patients aged 3 yrs and older with idiopathic or congenital pah to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability

ACTELION
UPTRAVI (TABLET) (ORAL) SELEXIPAG [GENERIC AB]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
NDA Applicant: ACTELION      NDA No.:
207947  Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (0.8MG); 005 RX (1MG); 006 RX (1.2MG); 007 RX (1.4MG); 008 RX (1.6MG)
Patents Expiration Patented Use
Pat. No. 7205302 DS* DP* [Extended 1306 days (3.6 years)]
Heterocyclic compound derivatives and medicines
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2016
Oct 31, 2026 U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag
Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Jan 19, 2016
Aug 1, 2030  
Pat. No. 9173881 Therapeutic compositions containing macitentan
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 19, 2016
Aug 12, 2029 U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan
Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 12, 2016
Jun 25, 2030 U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag
Pat. No. 10821108 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2020
Dec 1, 2036 U-2992: Method of treating pulmonary arterial hypertension comprising administering a solid preparation containing selexipag
Pat. No. 10828298 DP* Pharmaceutical composition containing 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy]-N-(methylsu- lfonyl)acetamide
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 2, 2020
Dec 1, 2036 U-2991: Method of treating pulmonary arterial hypertension comprising administering a tablet containing selexipag
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Dec 21, 2022 ODE-106: For use of UPTRAVI (selexipag) tablets, 200, 400, 600, 800, 1000, 1200, 1400, and 1600 mcg for treatment of pulmonary arterial hypertension (PAH, WHO group I) to reduce the risks of disease progression and hospitalization for pah

ACTELION
UPTRAVI (POWDER) (INTRAVENOUS) SELEXIPAG
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
NDA Applicant: ACTELION      NDA No.:
214275  Prod. No.: 001 RX (1.8MG/VIAL)
Patents Expiration Patented Use
Pat. No. 7205302 DS* DP* [Extended 1306 days (3.6 years)]
Heterocyclic compound derivatives and medicines
Claim Types: Composition; Compound; Method of use
Pat. Sub. Date(s): 001: Aug 27, 2021
Oct 31, 2026 U-1797: Method of treating pulmonary arterial hypertension comprising administering a pharmaceutical composition comprising selexipag
Pat. No. 8791122 DS* DP* Form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide and method for producing the same
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 001: Aug 27, 2021
Aug 1, 2030  
Pat. No. 9173881 Therapeutic compositions containing macitentan
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 27, 2021
Aug 12, 2029 U-1798: Method of treating pulmonary arterial hypertension comprising administering selexipag in combination with the endothelin receptor antagonist macitentan
Pat. No. 9284280 Use of form-I crystal of 2-{4-[N-(5,6-diphenylpyrazin-2-yl)-N-isopropylamino]butyloxy}-N-(methylsu- lfonyl)acetamide
Claim Types: Method of use
Pat. Sub. Date(s): 001: Aug 27, 2021
Jun 25, 2030 U-1831: Method of treating pulmonary arterial hypertension comprising administering a crystalline form of selexipag

ACTELION
VELETRI (INJECTABLE) (INJECTION) EPOPROSTENOL SODIUM [GENERIC AP2]
Drug Classes: Respiratory Tract/ Pulmonary Agents:Pulmonary Antihypertensives
NDA Applicant: ACTELION      NDA No.:
022260  Prod. No.: 001 RX (EQ 1.5MG BASE/VIAL); 002 RX (EQ 0.5MG BASE/VIAL)
Patents Expiration Patented Use
Pat. No. 8318802 DP* Epoprostenol formulation and method of making thereof
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 26, 2012; 002: None
Mar 15, 2027  
Pat. No. 8598227 Epoprostenol formulation and method of making thereof
Claim Types: Method of use; Process
Pat. Sub. Date(s): All strengths: None
Feb 2, 2027  

ADALVO
ONSOLIS (FILM) (BUCCAL) FENTANYL CITRATE
Drug Classes: Analgesics:Opioid Analgesics, Long-acting == Analgesics:Opioid Analgesics, Short-acting
NDA Applicant: ADALVO      NDA No.:
022266  Prod. No.: 001 DISC (EQ 0.2MG BASE); 002 DISC (EQ 0.4MG BASE); 003 DISC (EQ 0.6MG BASE); 004 DISC (EQ 0.8MG BASE); 005 DISC (EQ 1.2MG BASE)
Patents Expiration Patented Use
Pat. No. 9597288 DP* Transmucosal delivery devices with enhanced uptake
Claim Types: Method of administration; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Apr 3, 2017
Jul 23, 2027 U-767: Management of breakthrough pain in patients with cancer

ADAMAS OPERATIONS
GOCOVRI (CAPSULE, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents
NDA Applicant: ADAMAS OPERATIONS      NDA No.:
208944  Prod. No.: 001 RX (EQ 68.5MG BASE); 002 RX (EQ 137MG BASE)
Patents Expiration Patented Use
Pat. No. 8389578 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Jan 22, 2028 U-2105: Treatment of dyskinesia in patients with Parkinson's disease receiving immediate release levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8741343 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8796337 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8889740 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025  
Pat. No. 8895614 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025  
Pat. No. 8895615 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895616 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895617 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 8895618 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Sep 21, 2017
Nov 23, 2025  
Pat. No. 9867791 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018
Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9867792 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018
Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9867793 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 16, 2018
Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 9877933 Method of administering amantadine prior to a sleep period
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Jan 30, 2018
Dec 2, 2030 U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 10154971 Methods of administering amantadine
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Dec 18, 2018
Dec 4, 2034 U-2459: Treatment of dyskinesia and decreasing off time in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 10646456 Methods of administering amantadine
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Jul 14, 2020
Jun 17, 2034 U-2808: Treatment of dyskinesia, decreasing off time, and increasing on time without troublesome dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 11065213 DP* Amantadine compositions and preparations thereof
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): All strengths: Jul 20, 2021
Aug 23, 2038  
Pat. No. 11077073 Methods of using amantadine compositions
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 4, 2021
Aug 23, 2038 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
U-2224: Treatment of dyskinesia and increasing on time without troublesome dyskinesia in patients with Parkinson's Disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
U-3180: Decreasing off time in patients with parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Pat. No. 11197835 Method of administering amantadine prior to a sleep period
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jan 12, 2022
Dec 2, 2030 U-2106: Treatment of dyskinesia in patients with Parkinson's disease receiving levodopa-based therapy, with or without concomitant dopaminergic medications
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Aug 24, 2024 ODE-153: Treatment of dyskinesia in patients with parkinson's disease receiving levodopa-based therapy with or without concomitant dopaminergic medications

ADAMAS OPERATIONS
OSMOLEX ER (TABLET, EXTENDED RELEASE) (ORAL) AMANTADINE HYDROCHLORIDE
Drug Classes: Antiparkinson Agents:Antiparkinson Agents, Other == Antivirals:Anti-influenza Agents
NDA Applicant: ADAMAS OPERATIONS      NDA No.:
209410  Prod. No.: 001 RX (EQ 129MG BASE); 002 RX (EQ 193MG BASE) NDA No.: 209410  Prod. No.: 003 DISC (EQ 258MG BASE); 004 DISC (EQ 161MG BASE)
Patents Expiration Patented Use
Pat. No. 8252331 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020
Mar 13, 2030  
Pat. No. 8389578 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Jan 22, 2028 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8574626 DP* Osmotic device containing amantadine and an osmotic salt
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 1, 2018; 002: Mar 1, 2018; 003: Mar 1, 2018; 004: Oct 29, 2020
Nov 28, 2025 U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 8796337 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8889740 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025  
Pat. No. 8895614 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025  
Pat. No. 8895615 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895616 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895617 Composition and method for treating neurological disease
Claim Types: Method of administration
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 8895618 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025  
Pat. No. 8987333 DP* Composition and method for treating neurological disease
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025  
Pat. No. 9072697 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2021
Nov 23, 2025 U-219: Treatment of Parkinson's disease
U-3054: Treatment of drug-induced extrapyramidal reactions in adult patients with Parkinson's Disease
Pat. No. 10213393 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020
Feb 15, 2038 U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10213394 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 13, 2019; 002: Mar 13, 2019; 003: Mar 13, 2019; 004: Oct 29, 2020
Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500170 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020
Feb 15, 2038 U-20: A process for treating a patient suffering from parkinson's syndrome and in need of treatment
Pat. No. 10500171 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020
Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10500172 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 17, 2019; 002: Dec 17, 2019; 003: Dec 17, 2019; 004: Oct 29, 2020
Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients
Pat. No. 10512617 Composition and method for treating neurological disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 2, 2020; 002: Jan 2, 2020; 003: Jan 2, 2020; 004: Oct 29, 2020
Feb 15, 2038 U-2497: Treatment of drug-induced extrapyramidal reaction in adult patients

ADAMIS PHARMS CORP
SYMJEPI (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes: Respiratory Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic
NDA Applicant: ADAMIS PHARMS CORP      NDA No.:
207534  Prod. No.: 001 RX (0.3MG/0.3ML (0.3MG/0.3ML)); 002 RX (0.15MG/0.3ML (0.15MG/0.3ML))
Patents Expiration Patented Use
Pat. No. 11141540 DP* Syringe devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): All strengths: Jun 16, 2022
Oct 20, 2036 U-3379: A method for administering a therapeutic dose of epinephrine

ADAMIS PHARMS CORP
ZIMHI (SOLUTION) (INTRAMUSCULAR, SUBCUTANEOUS) NALOXONE HYDROCHLORIDE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Reversal Agents
NDA Applicant: ADAMIS PHARMS CORP      NDA No.:
212854  Prod. No.: 001 RX (5MG/0.5ML (5MG/0.5ML))
Patents Expiration Patented Use
Pat. No. 11027072 DP* Emergency devices
Claim Types: Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Jun 6, 2022
May 24, 2039  
Pat. No. 11571518 DP* Emergency devices
Claim Types: Device; Method of administration
Pat. Sub. Date(s): 001: Feb 10, 2023
Jun 14, 2041 U-3515: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device
U-3516: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a needle guard
U-3517: A method for administering a therapeutic dose of an opioid antagonist comprising an emergency syringe device including a window configured to allow the user to view the opioid antagonist in the syringe

ADDMEDICA SAS
SIKLOS (TABLET) (ORAL) HYDROXYUREA
Drug Classes: Antineoplastics:Antimetabolites
NDA Applicant: ADDMEDICA SAS      NDA No.:
208843  Prod. No.: 001 RX (100MG); 002 RX (1GM)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Dec 21, 2024 ODE-177: To reduce the frequency of painful crises and to reduce the need for blood transfusions in pediatric patients, 2 years of age and older, with sickle cell anemia with recurrent moderate to severe painful crisis

ADHERA
PRESTALIA (TABLET) (ORAL) AMLODIPINE BESYLATE; PERINDOPRIL ARGININE
Drug Classes: Cardiovascular Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular Agents:Cardiovascular Combinations == Cardiovascular Agents:Angiotensin-converting Enzyme (ACE) Inhibitors
NDA Applicant: ADHERA      NDA No.:
205003  Prod. No.: 001 RX (EQ 2.5MG BASE;3.5MG ); 002 RX (EQ 5MG BASE;7MG); 003 RX (EQ 10MG BASE;14MG)
Patents Expiration Patented Use
Pat. No. 6696481 DS* DP* Salt of perindopril and pharmaceutical compositions containing it
Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Method of use
Pat. Sub. Date(s): All strengths: Dec 29, 2015
Apr 15, 2023 U-3: Treatment of hypertension
Pat. No. 7846961 DS* DP* .alpha. crystalline form of the arginine salt of perindopril, a process for its preparation and pharm
Claim Types: New polymorph, salt or hydrate; Process; Composition; Method of use
Pat. Sub. Date(s): All strengths: Dec 29, 2015
Oct 5, 2029 U-3: Treatment of hypertension

ADIENNE SA
TEPADINA (POWDER) (INTRACAVITARY, INTRAVENOUS, INTRAVESICAL) THIOTEPA [GENERIC AP]
NDA Applicant: ADIENNE SA      NDA No.:
208264  Prod. No.: 001 RX (15MG/VIAL); 002 RX (100MG/VIAL)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: ODE - Orphan drug exclusivity Jan 26, 2024 ODE-129: Indicated for reducing the risk of graft rejection when used in conjunction with high-dose busulfan & cyclophosphamide as a preparative regimen for allogenic hematopoietic progenitor cell transplantation for peds. patients with class 3 beta-thalassemia

AERIE PHARMS INC
RHOPRESSA (SOLUTION/DROPS) (OPHTHALMIC) NETARSUDIL MESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: AERIE PHARMS INC      NDA No.:
208254  Prod. No.: 001 RX (EQ 0.02% BASE)
Patents Expiration Patented Use
Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 21, 2017
Nov 10, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 21, 2017
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Dec 21, 2017
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 9415043 DS* Combination therapy
Claim Types: Compound
Pat. Sub. Date(s): 001: Dec 21, 2017
Mar 14, 2034  
Pat. No. 9931336 DS* DP* Combination therapy
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Apr 11, 2018
Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2020
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10588901 DS* DP* Combination therapy
Claim Types: Formulation; Compound; Method of use
Pat. Sub. Date(s): 001: Apr 15, 2020
Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Jun 10, 2020
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2021
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Dec 16, 2021
Mar 14, 2034  
Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 21, 2023
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Dec 18, 2022  

AERIE PHARMS INC
ROCKLATAN (SOLUTION/DROPS) (OPHTHALMIC) LATANOPROST; NETARSUDIL DIMESYLATE
Drug Classes: Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: AERIE PHARMS INC      NDA No.:
208259  Prod. No.: 001 RX (0.005%;EQ 0.02% BASE)
Patents Expiration Patented Use
Pat. No. 8394826 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019
Nov 10, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 8450344 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 9096569 DS* DP* Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 9415043 DS* Combination therapy
Claim Types: Compound
Pat. Sub. Date(s): 001: Mar 28, 2019
Mar 14, 2034  
Pat. No. 9931336 DS* DP* Combination therapy
Claim Types: Composition; Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019
Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure
Pat. No. 9993470 DS* DP* Combination therapy
Claim Types: Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019
Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10174017 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 28, 2019
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10532993 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2020
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10588901 DS* DP* Combination therapy
Claim Types: Formulation; Compound; Method of use
Pat. Sub. Date(s): 001: Apr 15, 2020
Mar 14, 2034 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10654844 DS* DP* Dual mechanism inhibitors for the treatment of disease
Claim Types: New polymorph, salt or hydrate; Method of use; Composition
Pat. Sub. Date(s): 001: Jun 10, 2020
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 10882840 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 22, 2021
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 11021456 Beta- and gamma-amino-isoquinoline amide compounds and substituted benzamide compounds
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021
Jul 11, 2026 U-1524: Reduction of elevated intraocular pressure
Pat. No. 11028081 Dual mechanism inhibitors for the treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 28, 2021
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Pat. No. 11185538 DP* Compositions for treating glaucoma or reducing intraocular pressure
Claim Types: Composition; Formulation
Pat. Sub. Date(s): 001: Dec 16, 2021
Mar 14, 2034  
Pat. No. 11197853 DP* Combination therapy
Claim Types: Formulation
Pat. Sub. Date(s): 001: Dec 16, 2021
Mar 14, 2034  
Pat. No. 11618748 Dual mechanism inhibitors for the treatment of disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 21, 2023
Jan 27, 2030 U-1524: Reduction of elevated intraocular pressure
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Dec 18, 2022  

AFT PHARMS LTD
COMBOGESIC (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN
Drug Classes: Analgesics:Nonsteroidal Anti-inflammatory Drugs
NDA Applicant: AFT PHARMS LTD      NDA No.:
209471  Prod. No.: 001 RX (325MG;97.5MG)
Patents Expiration Patented Use
Pat. No. 10532036 Combination composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 29, 2023
Sep 22, 2025 U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration
Pat. No. 11197830 DP* Pharmaceutical composition containing acetaminophen and ibuprofen
Claim Types: Product-by-process
Pat. Sub. Date(s): 001: Mar 29, 2023
Feb 27, 2039 U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration
Pat. No. 11534407 DP* Pharmaceutical compostion containing acetominophen and ibuprofen
Claim Types: Product-by-process; Formulation claimed by its inherent performace characteristics; Method of use
Pat. Sub. Date(s): 001: Mar 29, 2023
Feb 27, 2039 U-3553: A method of treating mild to moderate acute pain in adults by administering 975-1000 mg of acetaminophen and 292.5-300 mg of ibuprofen in a single administration

AGILE
TWIRLA (SYSTEM) (TRANSDERMAL) ETHINYL ESTRADIOL; LEVONORGESTREL
Drug Classes: Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens == Contraceptives:Oral Contraceptives Combinations == Contraceptives:Oral Progestins == Contraceptives:Contraceptives, Other == Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Progestins
NDA Applicant: AGILE      NDA No.:
204017  Prod. No.: 001 RX (0.03MG/24HR;0.12MG/24HR)
Patents Expiration Patented Use
Pat. No. 8246978 DP* Dermal delivery device with reduced loss of its volatile components
Claim Types: Formulation; Device
Pat. Sub. Date(s): 001: Mar 10, 2020
Aug 26, 2028  
Pat. No. 8747888 DP* Dermal delivery device with in situ seal
Claim Types: Device; Formulation
Pat. Sub. Date(s): 001: Mar 10, 2020
Jul 10, 2028  
Pat. No. 9050348 DP* Dermal delivery device
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 10, 2020
Jul 10, 2028  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NP - New product Feb 14, 2023  

AGIOS PHARMS INC
PYRUKYND (TABLET) (ORAL) MITAPIVAT SULFATE
NDA Applicant: AGIOS PHARMS INC      NDA No.:
216196  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 20MG BASE); 003 RX (EQ 50MG BASE)
Patents Expiration Patented Use
Pat. No. 8785450 DS* DP* Therapeutic compounds and compositions
Claim Types: Compound; Composition
Pat. Sub. Date(s): All strengths: Mar 8, 2022
Feb 24, 2031  
Pat. No. 9193701 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022
Oct 26, 2032 U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 9682080 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022
May 3, 2032 U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 9980961 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022
May 3, 2032 U-3319: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 10632114 Pyruvate kinase activators for use in therapy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022
May 3, 2032 U-3320: Method for increasing the lifetime of red blood cells (RBCS) for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency
Pat. No. 11234976 Methods of using pyruvate kinase activators
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 8, 2022
Oct 11, 2038 U-3321: Method of using a pyruvate kinase activator for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency by administering a daily dose of 10mg to 100mg
Pat. No. 11254652 DS* DP* Crystalline forms of N-(4-(4-(cyclopropymethyl)piperazine-1-carbonyl)phenyl)quinoline-8-sulfon- amide
Claim Types: New polymorph, salt or hydrate; Composition; Process
Pat. Sub. Date(s): All strengths: Mar 8, 2022
Nov 21, 2038  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Feb 17, 2027  
Exclusivity Code: ODE - Orphan drug exclusivity Feb 17, 2029 ODE-392: Treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency

AKARX INC
DOPTELET (TABLET) (ORAL) AVATROMBOPAG MALEATE
Drug Classes: Blood Products and Modifiers:Platelet Modifying Agents
NDA Applicant: AKARX INC      NDA No.:
210238  Prod. No.: 001 RX (EQ 20MG BASE)
Patents Expiration Patented Use
Pat. No. 7638536 DS* DP* 2-Acylaminothiazole derivative or salt thereof
Claim Types: Compound; Composition
Pat. Sub. Date(s): 001: Jun 15, 2018
May 5, 2025  
Pat. No. 8338429 2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 25, 2019
Jun 30, 2023 U-2577: Treatment of thrombocytopenia in an adult patient with chronic immune thrombocytopenia who has had an insufficient response to a previous treatment
Pat. No. 8765764 2-acylaminothiazole derivative or salt thereof
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 15, 2018
Jan 15, 2023 U-2314: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure using DOPTELET
U-2578: Treatment of thrombocytopenia in an adult patient with chronic liver disease who is scheduled to undergo a procedure
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity May 21, 2023  
Exclusivity Code: ODE - Orphan drug exclusivity Jun 26, 2026 ODE-246: Treatment of thrombocytopenia in adult patients with chronic immune thrombocytopenia who have had an insufficient response to a previous treatment

AKCEA THERAPS
TEGSEDI (SOLUTION) (SUBCUTANEOUS) INOTERSEN SODIUM
Drug Classes: Genetic, Enzyme, or Protein Disorder: Replacement, Modifiers, Treatment
NDA Applicant: AKCEA THERAPS      NDA No.:
211172  Prod. No.: 001 RX (EQ 284MG BASE/1.5ML (EQ 189.3MG BASE/ML))
Patents Expiration Patented Use
Pat. No. 7015315 DS* Gapped oligonucleotides
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018
Mar 21, 2023  
Pat. No. 7101993 DS* Oligonucleotides containing 2'-O-modified purines
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018
Sep 5, 2023  
Pat. No. 8101743 DS* DP* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 1, 2025  
Pat. No. 8697860 DP* Diagnosis and treatment of disease
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 29, 2031  
Pat. No. 9061044 DS* Modulation of transthyretin expression
Claim Types: Compound
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 29, 2031  
Pat. No. 9399774 Modulation of transthyretin expression
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 1, 2018
Apr 29, 2031 U-2430: Treatment of polyneuropathy of hereditary transthyretin amyloidosis
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Oct 5, 2023  
Exclusivity Code: ODE - Orphan drug exclusivity Oct 5, 2025 ODE-212: Indicated for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

AKORN
CETRORELIX ACETATE (POWDER) (SUBCUTANEOUS) CETRORELIX ACETATE [GENERIC AP]
Drug Classes: Hormonal Agents, Suppressant (Pituitary) == Infertility Agents
NDA Applicant: AKORN      NDA No.:
215737  Prod. No.: 001 RX (EQ 0.25MG BASE/VIAL)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: CGT - Competitive generic therapy Apr 22, 2023  

ALBIREO
BYLVAY (CAPSULE, PELLETS) (ORAL) ODEVIXIBAT
NDA Applicant: ALBIREO      NDA No.:
215498  Prod. No.: 001 RX (0.2MG); 002 RX (0.4MG); 003 RX (0.6MG); 004 RX (1.2MG)
Patents Expiration Patented Use
Pat. No. 9694018 IBAT inhibitors for the treatment of liver disease
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021
Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10011633 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021
Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10093697 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021
Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10487111 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021
Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 10975046 DS* Crystal modifications of odevixibat
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Aug 18, 2021
Jun 20, 2039  
Pat. No. 10981952 IBAT inhibitors for the treatment of liver diseases
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Aug 18, 2021
Nov 8, 2031 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 11365182 Crystal modifications of odevixibat
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 12, 2022
Jun 20, 2039 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
U-3187: Method of reducing serum bile acids in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Pat. No. 11583539 Treating progressive familial intrahepatic cholestasis (PFIC) with IBAT inhibitors
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Mar 20, 2023
Nov 12, 2041 U-3186: Method of treating pruritus in patients 3 months or older suffering from progressive familial intrahepatic cholestasis (PFIC)
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Jul 20, 2026  
Exclusivity Code: ODE - Orphan drug exclusivity Jul 20, 2028 ODE-363: Treatment of pruritus in patients 3 months of age and older with progressive familial intrahepatic cholestasis (PFIC)

ALCON LABS INC
EYSUVIS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-inflammatories == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: ALCON LABS INC      NDA No.:
210933  Prod. No.: 001 RX (0.25%)
Patents Expiration Patented Use
Pat. No. 9056057 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Formulation; Method of administration; Process
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033 U-2491: A method for delivering a composition to a mucus membrane
Pat. No. 9393213 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033  
Pat. No. 9532955 Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Method of administration; Process
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033 U-2491: A method for delivering a composition to a mucus membrane
Pat. No. 9737491 Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033 U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier
Pat. No. 9827191 DP* Compositions and methods for ophthalmic and/or other applications
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033 U-2985: A method for treating dry eye in a patient
Pat. No. 10058511 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033 U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier
Pat. No. 10646436 DP* Compositions and methods for ophthalmic and/or other applications
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033  
Pat. No. 10688045 DP* Compositions and methods for ophthalmic and/or other applications
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 20, 2020
May 3, 2033  
Pat. No. 10857096 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 28, 2020
May 3, 2033 U-2985: A method for treating dry eye in a patient
Pat. No. 10940108 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of use; Process
Pat. Sub. Date(s): 001: Mar 30, 2021
May 3, 2033 U-2985: A method for treating dry eye in a patient
Pat. No. 10945948 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 30, 2021
May 3, 2033 U-2985: A method for treating dry eye in a patient
Pat. No. 10993908 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of administration
Pat. Sub. Date(s): 001: May 26, 2021
May 3, 2033 U-3117: Administration to the eye of a patient for treatment of dry eye condition
Pat. No. 11219596 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 21, 2022
May 3, 2033 U-2985: A method for treating dry eye in a patient
Pat. No. 11596599 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 31, 2023
May 3, 2033 U-2985: A method for treating dry eye in a patient
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NP - New product Oct 26, 2023  

ALCON LABS INC
INVELTYS (SUSPENSION/DROPS) (OPHTHALMIC) LOTEPREDNOL ETABONATE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-inflammatories == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: ALCON LABS INC      NDA No.:
210565  Prod. No.: 001 RX (1%)
Patents Expiration Patented Use
Pat. No. 9056057 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Formulation; Method of administration; Process
Pat. Sub. Date(s): 001: Sep 10, 2018
May 3, 2033 U-2491: A method for delivering a composition to a mucus membrane
Pat. No. 9393213 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Formulation
Pat. Sub. Date(s): 001: Sep 10, 2018
May 3, 2033  
Pat. No. 9532955 Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Method of administration; Process
Pat. Sub. Date(s): 001: Sep 10, 2018
May 3, 2033 U-2491: A method for delivering a composition to a mucus membrane
Pat. No. 9737491 Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 10, 2018
May 3, 2033 U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier
Pat. No. 9827191 DP* Compositions and methods for ophthalmic and/or other applications
Claim Types: Formulation; Method of use; Process
Pat. Sub. Date(s): 001: Sep 10, 2018
May 3, 2033 U-2493: A method for treating inflammation and/or other disorders in an eye of a patient
Pat. No. 10058511 DP* Nanocrystals, compositions, and methods that aid particle transport in mucus
Claim Types: Formulation; Method of administration
Pat. Sub. Date(s): 001: Sep 10, 2018
May 3, 2033 U-2492: A method for delivering a pharmaceutical agent across a mucosal barrier
Pat. No. 10646437 DP* Compositions and methods for ophthalmic and/or other applications
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 11, 2020
May 3, 2033  
Pat. No. 10688045 DP* Compositions and methods for ophthalmic and/or other applications
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 16, 2020
May 3, 2033  
Pat. No. 10864219 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 28, 2020
May 3, 2033 U-3011: A method for treating ocular inflammation
Pat. No. 11219597 Compositions and methods for ophthalmic and/or other applications
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 21, 2022
May 3, 2033 U-3278: A method of reducing post-surgical pain following ocular surgery
U-3279: A method of treating postoperative inflammation following ocular surgery

ALCON LABS INC
PATADAY ONCE DAILY RELIEF (SOLUTION/DROPS) (OPHTHALMIC) OLOPATADINE HYDROCHLORIDE
Drug Classes: Ophthalmic Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/ Pulmonary Agents:Antihistamines
NDA Applicant: ALCON LABS INC      NDA No.:
206276  Prod. No.: 001 OTC (EQ 0.7% BASE)
Patents Expiration Patented Use
Pat. No. 8791154 DP* High concentration olopatadine ophthalmic composition
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Mar 31, 2015
May 19, 2032 U-1680: Treatment of ocular itching associated with allergic conjunctivitis
Pat. No. 9533053 DP* High concentration olopatadine ophthalmic composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Aug 31, 2020
May 19, 2032  

ALCON LABS INC
SIMBRINZA (SUSPENSION/DROPS) (OPHTHALMIC) BRIMONIDINE TARTRATE; BRINZOLAMIDE
Drug Classes: Dermatological Agents:Acne and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
NDA Applicant: ALCON LABS INC      NDA No.:
204251  Prod. No.: 001 RX (0.2%;1%)
Patents Expiration Patented Use
Pat. No. 9044484 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 9, 2015
Oct 30, 2030  
Pat. No. 9421265 DP* Aqueous pharmaceutical compositions containing borate-polyol complexes
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 24, 2016
Jun 17, 2030  

ALEXZA PHARMS
ADASUVE (POWDER) (INHALATION) LOXAPINE
Drug Classes: Antipsychotics:1st Generation/Typical
NDA Applicant: ALEXZA PHARMS      NDA No.:
022549  Prod. No.: 001 RX (10MG)
Patents Expiration Patented Use
Pat. No. 7458374 DP* Method and apparatus for vaporizing a compound
Claim Types: Device; Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Aug 18, 2024  
Pat. No. 7537009 DP* Method of forming an aerosol for inhalation delivery
Claim Types: Process
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 28, 2024  
Pat. No. 8387612 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Mar 29, 2013
Oct 23, 2026  
Pat. No. 8991387 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device; Drug in a container
Pat. Sub. Date(s): 001: Apr 29, 2015
May 21, 2024  
Pat. No. 9370629 DP* Self-contained heating unit and drug-supply unit employing same
Claim Types: Device
Pat. Sub. Date(s): 001: Jul 7, 2016
May 20, 2024  

ALIMERA SCIENCES INC
ILUVIEN (IMPLANT) (INTRAVITREAL) FLUOCINOLONE ACETONIDE
Drug Classes: Dermatological Agents:Dermatitis and Pruritus Agents == Dermatological Agents:Dermatological Agents, Other == Otic Agents:Otic Glucocorticoids
NDA Applicant: ALIMERA SCIENCES INC      NDA No.:
201923  Prod. No.: 001 RX (0.19MG)
Patents Expiration Patented Use
Pat. No. 8871241 DP* Injectable sustained release delivery devices
Claim Types: Device
Pat. Sub. Date(s): 001: Nov 12, 2014
Aug 12, 2027  

ALK ABELLO
OTIPRIO (INJECTABLE, SUSPENSION) (OTIC) CIPROFLOXACIN
Drug Classes: Antibacterials:Quinolones == Ophthalmic Agents:Ophthalmic Anti-Infectives == Otic Agents:Otic Anti-Infectives == Otic Agents:Otic Combinations
NDA Applicant: ALK ABELLO      NDA No.:
207986  Prod. No.: 001 DISC (6% (60MG/ML))
Patents Expiration Patented Use
Pat. No. 8318817 Controlled release antimicrobial compositions and methods for the treatment of otic disordersClaim Types: Method of use
Pat. Sub. Date(s): 001: Jan 11, 2016
Apr 27, 2030 U-1792: Treatment of otic infection or inflammation
Pat. No. 9205048 Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jan 11, 2016
Apr 21, 2029 U-1793: Treatment of pediatric patients with otitis media with effusion undergoing tympanostomy tube placement
Pat. No. 9220796 DP* Sterilization of ciprofloxacin composition
Claim Types: Product-by-process; Drug in a container; Process
Pat. Sub. Date(s): 001: Jan 11, 2016
Jul 1, 2035  
Pat. No. 9233068 DP* Controlled release antimicrobial compositions and methods for the treatment of OTIC disorders
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 5, 2016
Dec 11, 2029  
Pat. No. 9603796 DS* DP* Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 26, 2018
Apr 21, 2029 U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus
Pat. No. 11040004 Otic gel formulations for treating otitis externa
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 21, 2021
Nov 12, 2037 U-2252: The treatment of acute otitis externa in patients 6 months of age and older due to pseudomonas aeruginosa and staphylococcus aureus
Pat. No. 11246863 DP* Ciprofloxacin otic composition and kits and method for using same
Claim Types: Kit
Pat. Sub. Date(s): 001: Mar 11, 2022
Nov 27, 2038  
Pat. No. 11369566 DP* Controlled release antimicrobial compositions and methods for the treatment of otic disorders
Claim Types: Formulation; Formulation claimed by its inherent performace characteristics
Pat. Sub. Date(s): 001: Jul 14, 2022
Apr 21, 2029  

ALKERMES
VIVITROL (FOR SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) NALTREXONE
Drug Classes: Anti-Addiction/ Substance Abuse Treatment Agents:Alcohol Deterrents/Anti-craving == Anti-Addiction/ Substance Abuse Treatment Agents:Opioid Dependence == Anti-Obesity Agents
NDA Applicant: ALKERMES      NDA No.:
021897  Prod. No.: 001 RX (380MG/VIAL)
Patents Expiration Patented Use
Pat. No. 7919499 Naltrexone long acting formulations and methods of use
Claim Types: Method of use
Pat. Sub. Date(s): 001: May 16, 2011
Oct 15, 2029 U-1123: Treatment of alcohol dependence
U-1124: Prevention of relapse to opioid dependence, following opioid detoxification

ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
NDA Applicant: ALKERMES INC      NDA No.:
207533  Prod. No.: 001 RX (441MG/1.6ML (275.63MG/ML)); 004 RX (1064MG/3.9ML (272.82MG/ML))
Patents Expiration Patented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Oct 26, 2030  
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Oct 14, 2015; 004: Jun 27, 2017
Nov 7, 2032 U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Dec 9, 2015; 004: Jun 27, 2017
Oct 24, 2033 U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Oct 5, 2016; 004: Jun 27, 2017
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): All strengths: Nov 20, 2018
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2032 U-543: Treatment of schizophrenia
Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Apr 8, 2019
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Nov 10, 2020
Mar 19, 2035 U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Oct 21, 2021
Oct 24, 2033 U-764: Treatment of schizophrenia
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Apr 13, 2022
Apr 6, 2039 U-543: Treatment of schizophrenia
Pat. No. 11406632 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): All strengths: Aug 19, 2022
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
NDA Applicant: ALKERMES INC      NDA No.:
207533  Prod. No.: 002 RX (662MG/2.4ML (275.83MG/ML))
Patents Expiration Patented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 002: Oct 14, 2015
Oct 26, 2030  
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 14, 2015
Nov 7, 2032 U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Dec 9, 2015
Oct 24, 2033 U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 002: Oct 5, 2016
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 002: Jan 19, 2017
Mar 19, 2035  
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 002: Nov 20, 2018
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2032 U-543: Treatment of schizophrenia
Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Apr 8, 2019
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 002: Nov 10, 2020
Mar 19, 2035 U-2983: Treatment of schizophrenia by rapid and continuous injection
Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 002: Oct 21, 2021
Oct 24, 2033 U-764: Treatment of schizophrenia
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 002: Apr 13, 2022
Apr 6, 2039 U-543: Treatment of schizophrenia
Pat. No. 11406632 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 002: Aug 19, 2022
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

ALKERMES INC
ARISTADA (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
NDA Applicant: ALKERMES INC      NDA No.:
207533  Prod. No.: 003 RX (882MG/3.2ML (275.63MG/ML))
Patents Expiration Patented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 003: Oct 14, 2015
Oct 26, 2030  
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 9034867 DP* Pharmaceutical compositions comprising sorbitan esters
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 14, 2015
Nov 7, 2032 U-543: Treatment of schizophrenia
Pat. No. 9193685 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Dec 9, 2015
Oct 24, 2033 U-543: Treatment of schizophrenia
Pat. No. 9452131 Aripiprazole formulations having increased injection speeds
Claim Types: Method of administration
Pat. Sub. Date(s): 003: Oct 5, 2016
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 9526726 DP* Aripiprazole formulations having increased injection speeds
Claim Types: Kit
Pat. Sub. Date(s): 003: Jan 19, 2017
Mar 19, 2035  
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 003: Nov 20, 2018
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 10226458 Pharmaceutical compositions comprising sorbitan esters
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2032 U-543: Treatment of schizophrenia
Pat. No. 10238651 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Apr 8, 2019
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 10813928 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use
Pat. Sub. Date(s): 003: Nov 10, 2020
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection
Pat. No. 11097006 DP* Pharmaceutical compositions having improved storage stability
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 003: Oct 21, 2021
Oct 24, 2033 U-764: Treatment of schizophrenia
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 003: Apr 13, 2022
Apr 6, 2039 U-543: Treatment of schizophrenia
Pat. No. 11406632 Aripiprazole formulations having increased injection speeds
Claim Types: Method of use; Kit
Pat. Sub. Date(s): 003: Aug 19, 2022
Mar 19, 2035 U-2402: Treatment of schizophrenia by rapid and continuous intramuscular injection

ALKERMES INC
ARISTADA INITIO KIT (SUSPENSION, EXTENDED RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
NDA Applicant: ALKERMES INC      NDA No.:
209830  Prod. No.: 001 RX (675MG/2.4ML)
Patents Expiration Patented Use
Pat. No. 8431576 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound
Pat. Sub. Date(s): 001: Jul 18, 2018
Oct 26, 2030  
Pat. No. 8796276 Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 18, 2018
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 10016415 DP* Aripiprazole prodrug compositions
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 18, 2018
Sep 8, 2035  
Pat. No. 10112903 DS* Heterocyclic compounds for the treatment of neurological and psychological disorders
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Nov 20, 2018
Jun 24, 2030 U-543: Treatment of schizophrenia
Pat. No. 10688091 DP* Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jul 8, 2020
Aug 17, 2035  
Pat. No. 10849894 Aripiprazole prodrug composition
Claim Types: Method of use
Pat. Sub. Date(s): 001: Dec 9, 2020
Aug 17, 2035 U-543: Treatment of schizophrenia
Pat. No. 11154552 DP* Aripiprazole prodrug composition
Claim Types: Formulation
Pat. Sub. Date(s): 001: Nov 10, 2021
Aug 17, 2035  
Pat. No. 11273158 Aripiprazole dosing strategy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 13, 2022
Apr 6, 2039 U-543: Treatment of schizophrenia

ALKERMES INC
LYBALVI (TABLET) (ORAL) OLANZAPINE; SAMIDORPHAN L-MALATE
Drug Classes: Antidepressants:Antidepressants, Other == Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other == opioid antagonist
NDA Applicant: ALKERMES INC      NDA No.:
213378  Prod. No.: 001 RX (5MG;EQ 10MG BASE); 002 RX (10MG;EQ 10MG BASE); 003 RX (15MG;EQ 10MG BASE); 004 RX (20MG;EQ 10MG BASE)
Patents Expiration Patented Use
Pat. No. 7262298 DS* 4-hydroxybenzomorphans
Claim Types: Compound
Pat. Sub. Date(s): All strengths: Jun 25, 2021
Nov 23, 2025  
Pat. No. 8778960 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021
Feb 13, 2032 U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Pat. No. 9119848 DS* Morphinan derivatives for the treatment of drug overdose
Claim Types: Method of use; Compound
Pat. Sub. Date(s): All strengths: Jun 25, 2021
Aug 30, 2031  
Pat. No. 9126977 DP* Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use; Formulation
Pat. Sub. Date(s): All strengths: Jun 25, 2021
Aug 23, 2031 U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Pat. No. 9517235 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021
Aug 23, 2031 U-3138: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile
U-3139: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduction of the adverse metabolic profile
Pat. No. 10300054 DP* Methods for treating antipsychotic-induced weight gain
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021
Aug 23, 2031 U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan
U-3141: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan
Pat. No. 10716785 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jun 25, 2021
Aug 23, 2031 U-3136: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Pat. No. 11185541 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Dec 22, 2021
Aug 23, 2031 U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan
Pat. No. 11241425 Composition for treating mental illness
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): All strengths: Mar 3, 2022
Aug 23, 2031 U-3137: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan, with reduced antipsychotic induced weight gain
Pat. No. 11351166 Methods for treating antipsychotic-induced weight gain
Claim Types: Method of use
Pat. Sub. Date(s): All strengths: Jul 11, 2022
Aug 23, 2031 U-3140: Method of treating schizophrenia by administering the atypical antipsychotic olanzapine and samidorphan
U-3141: Method of treating bipolar disorder by administering the atypical antipsychotic olanzapine and samidorphan
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity May 28, 2026  

ALLERGAN
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: Antibacterials:Beta-lactam, Cephalosporins
NDA Applicant: ALLERGAN      NDA No.:
206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)
Patents Expiration Patented Use
Pat. No. 7112592 DS* DP* [Extended 1413 days (3.9 years)]
Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents
Claim Types: Compound; Composition; Method of use
Pat. Sub. Date(s): 001: Mar 17, 2015
Jan 7, 2026 U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pnenumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium
U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium
U-282: Method of treating bacterial infections
Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Nov 12, 2026  
Pat. No. 8471025 DS* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: New polymorph, salt or hydrate
Pat. Sub. Date(s): 001: Mar 17, 2015
Aug 12, 2031  
Pat. No. 8835455 DP* Crystalline forms of trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide sodium salt
Claim Types: Formulation
Pat. Sub. Date(s): 001: Mar 17, 2015
Oct 8, 2030  
Pat. No. 8969566 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Mar 17, 2015
Jun 15, 2032  
Pat. No. 9284314 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Product-by-process; Process
Pat. Sub. Date(s): 001: Feb 24, 2017
Jun 15, 2032  
Pat. No. 9695122 DS* Processes for preparing heterocyclic compounds including trans-7-oxo-6-(sulphooxy)-1,6-diazabicyclo[3,2,1]octane-2-carboxamide and salts thereof
Claim Types: Formulation; Compound; Composition
Pat. Sub. Date(s): 001: Aug 8, 2017
Jun 15, 2032  
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity Feb 25, 2025 GAIN  
Exclusivity Code: NPP - New patient population Dec 20, 2025  

ALLERGAN
DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: Antibacterials:Antibacterials, Other
NDA Applicant: ALLERGAN      NDA No.:
021883  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)
Patents Expiration Patented Use
Pat. No. 6900175 [Extended 1611 days (4.4 years)]
Methods of administering dalbavancin for treatment of bacterial infections
Claim Types: Method of use; Method of administration
Pat. Sub. Date(s): 001: Jun 13, 2014
May 23, 2028 U-3499: Treatment of acute bacterial skin and skin structure infections (ABSSSI) in adult and pediatric patients using a two-dose regimen of dalbavancin
Pat. No. 7115564 DP* Stable pharmaceutical compositions of dalbavancin and methods of administration
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 13, 2014
Nov 14, 2023  
Pat. No. 7119061 DP* Dalbavancin compositions for treatment of bacterial infections
Claim Types: Formulation
Pat. Sub. Date(s): 001: Jun 13, 2014
Nov 14, 2023  
Pat. No. 8143212 Dalbavancin compositions for treatment of bacterial infections
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Jun 13, 2014
Nov 14, 2023 U-1517: Treatment of bacterial infections using a two-dose regimen of dalbavancin.
Exclusivity Expiration Exclusivity Description
Exclusivity Code: NCE - New chemical entity May 23, 2024 GAIN  
Exclusivity Code: NPP - New patient population Jul 22, 2024  

ALLERGAN
LUMIGAN (SOLUTION/DROPS) (OPHTHALMIC) BIMATOPROST
Drug Classes: Dermatological Agents:Dermatological Agents, Other == Ophthalmic Agents:Intraocular Pressure Lowering Agents
NDA Applicant: ALLERGAN      NDA No.:
022184  Prod. No.: 001 RX (0.01%)
Patents Expiration Patented Use
Pat. No. 7851504 DS* DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jun 13, 2027  
Pat. No. 8278353 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Oct 2, 2012
Mar 16, 2025  
Pat. No. 8299118 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2012
Mar 16, 2025 U-1295: A method of treating a patient with glaucoma or ocular hypertension
Pat. No. 8309605 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 16, 2012
Mar 16, 2025 U-1293: A method of lowering intraocular pressure in a patient with open angle glaucoma or ocular hypertension
U-1294: Method of treating glaucoma in a patient
Pat. No. 8338479 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: ;Composition; Method of administration
Pat. Sub. Date(s): 001: Dec 26, 2012
Mar 16, 2025 U-1295: A method of treating a patient with glaucoma or ocular hypertension
Pat. No. 8524777 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 2, 2013
Mar 16, 2025 U-1235: Reduction of elevated intraocular pressure in patients with glaucoma or ocular hypertension
Pat. No. 8586630 Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Mar 16, 2025 U-1458: A method of reducing intraocular pressure in patients with open angle glaucoma or ocular hypertension
Pat. No. 8772338 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jul 21, 2014
Mar 16, 2025 U-1528: A method of lowering intraocular pressure
Pat. No. 8933120 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 10, 2015
Mar 16, 2025  
Pat. No. 8933127 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation
Pat. Sub. Date(s): 001: Feb 10, 2015
Mar 16, 2025  
Pat. No. 9155716 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 12, 2015
Mar 16, 2025 U-1528: A method of lowering intraocular pressure
Pat. No. 9241918 DP* Enhanced bimatoprost ophthalmic solution
Claim Types: Formulation; Method of use
Pat. Sub. Date(s): 001: Feb 24, 2016
Mar 16, 2025 U-1814: Method of treating glaucoma or elevated intraocular pressure

ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
NDA Applicant: ALLERGAN      NDA No.:
022117  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE)
Patents Expiration Patented Use
Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): All strengths: Feb 10, 2017
Oct 6, 2026 *PED U-1064: Treatment of bipolar disorder and schizophrenia
U-1960: Use of the atypical antipsychotic asenapine for treatment of schizophrenia in adults
U-1961: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes (ages 10 to adult)
U-1962: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: maintenance monotherapy in adults
U-1963: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: as adjunctive treatment to lithium or valproate in adults
Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): All strengths: Jul 29, 2014
Oct 6, 2026 *PED  

ALLERGAN
SAPHRIS (TABLET) (SUBLINGUAL) ASENAPINE MALEATE [GENERIC AB]
Drug Classes: Antipsychotics:2nd Generation/Atypical == Bipolar Agents:Bipolar Agents, Other
NDA Applicant: ALLERGAN      NDA No.:
022117  Prod. No.: 003 RX (EQ 2.5MG BASE)
Patents Expiration Patented Use
Pat. No. 7741358 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Composition; Method of use
Pat. Sub. Date(s): 003: Sep 12, 2016
Oct 6, 2026 *PED U-1893: Method of treating manic or mixed episodes associated with bipolar disorder in pediatric patients
U-1966: Use of the atypical antipsychotic asenapine for treatment of manic or mixed episodes of bipolar i disorder: acute monotherapy of manic or mixed episodes in pediatric patients age 10-17
Pat. No. 8022228 DS* DP* Crystal form of asenapine maleate
Claim Types: New polymorph, salt or hydrate; Process
Pat. Sub. Date(s): 003: Sep 12, 2016
Oct 6, 2026 *PED  

ALLERGAN
TEFLARO (POWDER) (INTRAVENOUS) CEFTAROLINE FOSAMIL
Drug Classes: Antibacterials:Beta-lactam, Cephalosporins
NDA Applicant: ALLERGAN      NDA No.:
200327  Prod. No.: 001 RX (400MG/VIAL); 002 RX (600MG/VIAL)
Patents Expiration Patented Use
Pat. No. 8247400 DP* Cephem compounds useful for the treatment of bacterial infections
Claim Types: Compound; Composition; Method of use; New polymorph, salt or hydrate
Pat. Sub. Date(s): All strengths: None
Feb 10, 2031 U-282: Method of treating bacterial infections
Pat. No. 9629861 DP* Compositions and methods for treating bacterial infections using ceftaroline
Claim Types: Formulation
Pat. Sub. Date(s): All strengths: May 17, 2017
Sep 21, 2030  
Exclusivity Expiration Exclusivity Des