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

AADI
FYARRO (POWDER) (INTRAVENOUS) SIROLIMUS
Drug Classes: kinase inhibitor == mTor inhibitor immunosuppressant
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
Pat. No. 12061183 DP* Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug Claim Types: Method of improving a treatment Pat. Sub. Date(s): 001: Aug 13, 2024	Mar 5, 2036
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: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
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: cyclooxygenase inhibitor == nonsteroidal anti-inflammatory drug
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: alpha-adrenergic receptor agonist
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
AVYCAZ (POWDER) (INTRAVENOUS) AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes: beta lactamase inhibitor == cephalosporin antibacterial
NDA Applicant: ABBVIE      NDA No.: 206494  Prod. No.: 001 RX (EQ 0.5GM BASE;2GM/VIAL)

Patents	Expiration	Patented Use
Pat. No. 7112592 DS* DP* Azabicyclic compounds, preparation thereof and use as medicines, in particular as antibacterial agents Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Mar 17, 2015	Jan 7, 2026	U-2244: A method of treating bacterial infections in hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia (HABP/VABP) patients comprising administering a bactericidally effective amount of avibactam sodium U-2508: A method of treating bacterial infections in complicated intra-abdominal infection and complicated urinary tract infection, including pyelonephritis, patients comprising administering a bactericidally effective amount of avibactam sodium U-282: Method of treating bacterial infections U-3818: Treatment of complicated intra-abdominal infections, complicated urinary tract infections, and hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia in adult and pediatric patients (at least 31 weeks gestational age)
Pat. No. 7612087 DP* Heterocyclic compounds as inhibitors of beta-lactamases Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 17, 2015	Nov 12, 2026
Pat. No. 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
Exclusivity Code: NPP - New patient population	Jan 26, 2027

ABBVIE
BYVALSON (TABLET) (ORAL) NEBIVOLOL HYDROCHLORIDE; VALSARTAN [Has competitive generic]
Drug Classes: beta-adrenergic receptor inhibitor == angiotensin II receptor blocker
NDA Applicant: ABBVIE      NDA No.: 206302  Prod. No.: 001 DISC (EQ 5MG BASE;80MG)

Patents	Expiration	Patented Use
Pat. No. 7803838 DP* Compositions comprising nebivolol Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 5, 2016	Aug 29, 2026
Pat. No. 7838552 Compositions comprising nebivolol Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 5, 2016	Oct 4, 2027	U-185: Method of treating hypertension

ABBVIE
CANASA (SUPPOSITORY) (RECTAL) MESALAMINE [GENERIC AB]
Drug Classes: aminosalicylate
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
DALVANCE (POWDER) (INTRAVENOUS) DALBAVANCIN HYDROCHLORIDE
Drug Classes: lipoglycopeptide antibacterial
NDA Applicant: ABBVIE      NDA No.: 021883  Prod. No.: 001 RX (EQ 500MG BASE/VIAL)

Patents	Expiration	Patented Use
Pat. No. 6900175 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
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	May 23, 2024 GAIN
Exclusivity Code: NPP - New patient population	Jul 22, 2024

ABBVIE
DURYSTA (IMPLANT) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
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

ABBVIE
FETZIMA (CAPSULE, EXTENDED RELEASE) (ORAL) LEVOMILNACIPRAN HYDROCHLORIDE [Has competitive generic]
Drug Classes: serotonin and norepinephrine reuptake inhibitor (SNRI)
NDA Applicant: ABBVIE      NDA No.: 204168  Prod. No.: 001 RX (EQ 20MG BASE); 002 RX (EQ 40MG BASE); 003 RX (EQ 80MG BASE); 004 RX (EQ 120MG BASE)

Patents	Expiration	Patented Use
Pat. No. RE43879 Use of the dextrogyral enantiomer of milnacipran for the preparation of a drug Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 15, 2013	Jan 11, 2026	U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8481598 Stable dosage forms of levomilnacipran Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Aug 15, 2013	Mar 2, 2031	U-839: Treatment of major depressive disorder (MDD)
Pat. No. 8865937 DS* DP* Crystalline forms of (1S,2R)-2-(amino methyl)-N,N-diethyl-1-phenyl cyclopropane carboxamide Claim Types: New polymorph, salt or hydrate; Process; Composition Pat. Sub. Date(s): All strengths: Nov 20, 2014	May 23, 2032
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: M - Miscellaneous	Mar 24, 2026	M-304: Information added to section 8.4 of the labeling to describe the results from study LVM-MD-11 and LVM-MD-14

ABBVIE
GELNIQUE (GEL) (TRANSDERMAL) OXYBUTYNIN CHLORIDE
Drug Classes: muscarinic antagonist
NDA Applicant: ABBVIE      NDA No.: 022204  Prod. No.: 001 DISC (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
KYBELLA (SOLUTION) (SUBCUTANEOUS) DEOXYCHOLIC ACID [GENERIC AP]
NDA Applicant: ABBVIE      NDA No.: 206333  Prod. No.: 001 RX (20MG/2ML (10MG/ML))

Patents	Expiration	Patented Use
Pat. No. 7622130 Methods and compositions for the non-surgical removal of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Dec 10, 2027	U-1690: Method for reduction of submental fat
Pat. No. 7754230 Methods and related compositions for reduction of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Dec 10, 2027	U-1690: Method for reduction of submental fat
Pat. No. 8101593 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Mar 2, 2030
Pat. No. 8242294 DS* Synthetic bile acid compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	May 16, 2028
Pat. No. 8298556 Methods and related compositions for the non-surgical removal of fat Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Aug 3, 2025	U-1690: Method for reduction of submental fat
Pat. No. 8367649 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Mar 2, 2030
Pat. No. 8461140 DP* Synthetic bile acid compositions and methods Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Feb 21, 2028
Pat. No. 8546367 DP* Synthetic bile acid compositions and methods Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: May 27, 2015	Feb 21, 2028	U-1690: Method for reduction of submental fat
Pat. No. 8653058 DP* Compositions comprising deoxycholic acid and salts thereof suitable for use in treating fat deposits Claim Types: Formulation Pat. Sub. Date(s): 001: May 7, 2015	Mar 2, 2030
Pat. No. 8846066 Methods and related compositions for reduction of fat and skin tightening Claim Types: Method of use Pat. Sub. Date(s): 001: May 7, 2015	Feb 8, 2025	U-1690: Method for reduction of submental fat
Pat. No. 8883770 DP* Synthetic bile acid compositions and methods Claim Types: Composition Pat. Sub. Date(s): 001: May 27, 2015	Feb 21, 2028
Pat. No. 9522155 DP* Synthetic bile acid compositions and methods Claim Types: Composition; Method of use; Drug in a container Pat. Sub. Date(s): 001: Jan 19, 2017	Feb 21, 2028	U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 9636349 Synthetic bile acid compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 29, 2017	Feb 21, 2028	U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 9949986 Synthetic bile acid compositions and methods Claim Types: Method of use Pat. Sub. Date(s): 001: May 24, 2018	Feb 21, 2028	U-1940: Improvement in the appearance of moderate to severe convexity or fullness associated with submental fat in adults by means of reducing submental fat volume as described in the approved labeling
Pat. No. 10500214 DP* Formulations of deoxycholic acid and salts thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2020	Mar 2, 2030

ABBVIE
LASTACAFT (SOLUTION/DROPS) (OPHTHALMIC) ALCAFTADINE [GENERIC OTC]
Drug Classes: histamine-1 (H1) receptor antagonist
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: prostaglandin analog
NDA Applicant: ABBVIE      NDA No.: 022369  Prod. No.: 001 RX (0.03%)

Patents	Expiration	Patented Use
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

ABBVIE
LEXAPRO (TABLET) (ORAL) ESCITALOPRAM OXALATE [GENERIC AB]
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ABBVIE      NDA No.: 021323  Prod. No.: 001 RX (EQ 5MG BASE); 002 RX (EQ 10MG BASE); 003 RX (EQ 20MG BASE)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	May 12, 2026

ABBVIE
LEXAPRO (SOLUTION) (ORAL) ESCITALOPRAM OXALATE
Drug Classes: selective serotonin reuptake inhibitor (SSRI)
NDA Applicant: ABBVIE      NDA No.: 021365  Prod. No.: 001 DISC (EQ 5MG BASE/5ML**)

Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NPP - New patient population	May 12, 2026

ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE      NDA No.: 202811  Prod. No.: 001 RX (145MCG)

Patents	Expiration	Patented Use
Pat. No. 7304036 DS* DP* 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.
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jun 12, 2026	I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age

ABBVIE
LINZESS (CAPSULE) (ORAL) LINACLOTIDE
Drug Classes: guanylate cyclase-C agonist
NDA Applicant: ABBVIE      NDA No.: 202811  Prod. No.: 002 RX (290MCG)

Patents	Expiration	Patented Use
Pat. No. 7304036 DS* DP* 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: guanylate cyclase-C agonist
NDA Applicant: ABBVIE      NDA No.: 202811  Prod. No.: 003 RX (72MCG)

Patents	Expiration	Patented Use
Pat. No. 7304036 DS* DP* Methods and compositions for the treatment of gastrointestinal disorders Claim Types: Compound; Method of use; Composition Pat. Sub. Date(s): 003: Feb 24, 2017	Aug 30, 2026	U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 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. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 8933030 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Feb 24, 2017	Feb 17, 2031	U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 9708371 DP* Treatments for gastrointestinal disorders Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 003: Aug 10, 2017	Aug 16, 2033	U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Pat. No. 10675325 DP* Stable formulations of linaclotide Claim Types: Composition Pat. Sub. Date(s): 003: Jun 22, 2020	Aug 11, 2031
Pat. No. 10702576 Stable formulations of linaclotide Claim Types: Method of use Pat. Sub. Date(s): 003: Aug 4, 2020	Aug 11, 2031	U-1516: Method of treating chronic idiopathic constipation in adult patients. U-3644: Treatment of functional constipation in pediatric patients 6 to 17 years of age
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Jun 12, 2026	I-921: Treatment of functional constipation in pediatric patients 6 to 17 years of age

ABBVIE
LUMIGAN (SOLUTION/DROPS) (OPHTHALMIC) BIMATOPROST
Drug Classes: prostaglandin analog
NDA Applicant: ABBVIE      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

ABBVIE
MAVYRET (TABLET) (ORAL) GLECAPREVIR; PIBRENTASVIR
Drug Classes: hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
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 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: 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: hepatitis C virus (HCV) NS3/4A protease inhibitor == hepatitis C virus (HCV) NS5A inhibitor
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 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: 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 [Has competitive generic]
Drug Classes: N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 022525  Prod. No.: 001 DISC (7MG**); 002 DISC (14MG); 003 DISC (21MG); 004 DISC (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: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 206439  Prod. No.: 001 RX (10MG;14MG)

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	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	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* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 22, 2015	May 22, 2026 *PED
Pat. No. 8173708 DLR* 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	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 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 22, 2015	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	Nov 22, 2025
Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 001: 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	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. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 001: 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

ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 206439  Prod. No.: 002 RX (10MG;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): 002: Jan 22, 2015	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): 002: Jan 22, 2015	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* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015	May 22, 2026 *PED
Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 002: Jan 22, 2015	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 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015	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): 002: Jan 22, 2015	Nov 22, 2025
Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015	May 22, 2026 *PED
Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015	Nov 22, 2025
Pat. No. 8338486 Methods for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015	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 DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 002: Jan 22, 2015	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): 002: Jan 22, 2015	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* DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 002: Jan 22, 2015	May 22, 2026 *PED

ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 206439  Prod. No.: 003 RX (10MG;7MG)

Patents	Expiration	Patented Use
Pat. No. 8039009 Modified release formulations of memantine oral dosage forms Claim Types: Method of use Pat. Sub. Date(s): 003: 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): 003: 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. 8293794 DP* Methods and compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 003: Aug 16, 2016	Nov 22, 2025
Pat. No. 8338485 DP* Compositions for the treatment of CNS-related conditions Claim Types: Formulation Pat. Sub. Date(s): 003: 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): 003: 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. 8580858 Compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 003: 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

ABBVIE
NAMZARIC (CAPSULE, EXTENDED RELEASE) (ORAL) DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE [GENERIC AB]
Drug Classes: acetylcholinesterase inhibitor == N-methyl-D-aspartate (NMDA) receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 206439  Prod. No.: 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): 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): 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* DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016	May 22, 2026 *PED
Pat. No. 8173708 DLR* Method and composition for administering an NMDA receptor antagonist to a subject Claim Types: Method of administration Pat. Sub. Date(s): 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 DLR* Methods and compositions for the treatment of CNS-related conditions Claim Types: Method of use Pat. Sub. Date(s): 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): 004: Aug 16, 2016	Nov 22, 2025
Pat. No. 8329752 DP* DLR* Composition for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 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): 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): 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 DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Method of use Pat. Sub. Date(s): 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): 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* DLR* Method for administering an NMDA receptor antagonist to a subject Claim Types: Formulation Pat. Sub. Date(s): 004: Aug 16, 2016	May 22, 2026 *PED

ABBVIE
ORIAHNN (COPACKAGED) (CAPSULE) (ORAL) ELAGOLIX SODIUM,ESTRADIOL,NORETHINDRONE ACETATE; ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
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, 2029
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
Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023	Aug 27, 2040	U-3655: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) using 300 mg elagolix while co-administering omeprazole
Pat. No. 12083227 DP* Solid pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 8, 2024	Aug 20, 2038	U-2842: Management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids)
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 23, 2023

ABBVIE
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
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, 2029	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
Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023	Aug 27, 2040	U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole
Pat. No. 11690854 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 2, 2023	Apr 19, 2038	U-3653: Management of moderate to severe pain associated with endometriosis in a patient with moderate hepatic impairment
Pat. No. 11707464 Methods of treating heavy menstrual bleeding Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 23, 2023	Mar 14, 2034	U-3672: Management of moderate to severe pain associated with endometriosis using 150 mg elagolix for up to 24 months
Pat. No. 12102637 DP* Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 29, 2024	Aug 20, 2038
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 23, 2023

ABBVIE
ORILISSA (TABLET) (ORAL) ELAGOLIX SODIUM
Drug Classes: gonadotropin-releasing hormone (GnRH) receptor antagonist
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, 2029	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
Pat. No. 11690845 Methods of administering elagolix Claim Types: Method of use Pat. Sub. Date(s): 002: Aug 2, 2023	Aug 27, 2040	U-3654: Management of moderate to severe pain associated with endometriosis using 150 mg or 200 mg elagolix while co-administering omeprazole
Pat. No. 12102637 DP* Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis Claim Types: Formulation Pat. Sub. Date(s): 002: Oct 29, 2024	Aug 20, 2038
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: NCE - New chemical entity	Jul 23, 2023

ABBVIE
QULIPTA (TABLET) (ORAL) ATOGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 215206  Prod. No.: 001 RX (10MG); 002 RX (30MG)

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-3534: Preventive treatment of 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-3534: Preventive treatment of 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: I - New Indication	Apr 17, 2026	I-909: Preventive treatment of migraine in adults
Exclusivity Code: NCE - New chemical entity	Sep 28, 2026

ABBVIE
QULIPTA (TABLET) (ORAL) ATOGEPANT
Drug Classes: calcitonin gene-related peptide receptor antagonist
NDA Applicant: ABBVIE      NDA No.: 215206  Prod. No.: 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): 003: Oct 26, 2021	Jul 19, 2032	U-3534: Preventive treatment of 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): 003: Oct 26, 2021	Nov 10, 2031	U-3534: Preventive treatment of migraine in adults
Pat. No. 9850246 DS* Process for making CGRP receptor antagonists Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 003: Oct 26, 2021	Mar 13, 2033
Pat. No. 10117836 DP* Tablet formulation for CGRP active compounds Claim Types: Formulation Pat. Sub. Date(s): 003: Oct 26, 2021	Jan 30, 2035
Pat. No. 12090148 Treatment of migraine Claim Types: Method of use Pat. Sub. Date(s): 003: Oct 16, 2024	Jul 29, 2041	U-3534: Preventive treatment of migraine in adults
Exclusivity	Expiration	Exclusivity Description
Exclusivity Code: I - New Indication	Apr 17, 2026	I-909: Preventive treatment of migraine in adults
Exclusivity Code: NCE - New chemical entity	Sep 28, 2026

ABBVIE
RESTASIS MULTIDOSE (EMULSION) (OPHTHALMIC) CYCLOSPORINE [Has competitive generic]
Drug Classes: calcineurin inhibitor immunosuppressant
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* DLR* 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 DLR* 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* DLR* 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 DLR* 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* DLR* 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 DLR* 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: Janus kinase (JAK) inhibitor
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	Aug 16, 2033
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 U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers U-3945: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more TNF blockers U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF 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 U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF 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 U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF 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. 11564922 Methods of treating Crohn's disease and ulcerative colitis Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 15, 2023	Mar 9, 2038	U-3624: Treatment of adults with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers
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
Pat. No. 11661425 DS* 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: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jun 29, 2023	Oct 17, 2036
Pat. No. 11680069 DS* 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: New polymorph, salt or hydrate; Composition; Process; Product-by-process Pat. Sub. Date(s): 001: Jul 20, 2023	Oct 17, 2036
Pat. No. 11718627 DS* 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: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Aug 11, 2023	Oct 17, 2036
Pat. No. 11767326 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: Oct 23, 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. 11773105 DS* 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: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Nov 2, 2023	Oct 17, 2036
Pat. No. 11773106 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: Nov 2, 2023	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 U-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 11780847 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 Pat. Sub. Date(s): 001: Nov 8, 2023	Oct 17, 2036
Pat. No. 11780848 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 claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 8, 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. 11787815 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: Nov 8, 2023	Oct 17, 2036
Pat. No. 11795175 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 claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Nov 22, 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. 11976077 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 therof Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 5, 2024	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. 11993605 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: Jun 26, 2024	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-3946: Treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers
Pat. No. 11993606 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: Jun 26, 2024	Oct 17, 2036	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. 12077545 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: Sep 27, 2024	Oct 17, 2036
Pat. No. 12103933 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 Pat. Sub. Date(s): 001: Oct 31, 2024	Oct 17, 2036
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: I - New Indication	May 18, 2026	I-919: Treatment of adult patients with moderately to severely active Crohn's disease who have had an inadequate response or intolerance to one or more TNF blockers
Exclusivity Code: I - New Indication	Apr 26, 2027	I-946: Treatment of patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) who have had an inadequate response or intolerance to one of more tumor necrosis factor (TNF) blockers
Exclusivity Code: NCE - New chemical entity	Aug 16, 2024
Exclusivity Code: NPP - New patient population	Apr 26, 2027
Exclusivity Code: ODE - Orphan drug exclusivity	Apr 26, 2031	ODE-481: Treatment of pediatric patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis who have had an inadequate response or intolerance to one or more tumor necrosis factor (TNF) blockers, and for the treatment of pediatric patients 2 years of age and older with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers