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.
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 |