Patents whose numbers
are in italics have been extended under 35 USC 156. All expiration
dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have
had a generic equivalent approved for at
least one strength of the product.
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7053092
5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
Pat.
No. 8017615
DP* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None |
Dec 16, 2024 *PED | |
Pat.
No. 8580796
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None |
Mar 25, 2023 *PED | |
Pat.
No. 8642600
Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 |
Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
Pat.
No. 8642760
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 |
Mar 25, 2023 *PED | |
Pat.
No. 8759350
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 |
Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Pat.
No. 9089567
Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 |
Jan 28, 2022 | U-543: Treatment of schizophrenia |
Pat.
No. 9125939
Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 |
Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
Pat.
No. 9359302
DS* DP* Low hygroscopic aripiprazole drug
substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 |
Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
Pat.
No. 9387182
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 |
Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY (SOLUTION) (ORAL)
ARIPIPRAZOLE [Has competitive generic]
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant:
OTSUKA NDA No.:
021713 Prod. No.:
001 DISC (1MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6977257
DP* Aripiprazole oral solution Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Oct 24, 2022 *PED | |
Pat.
No. 7053092
5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): 001: None |
Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
Pat.
No. 8642600
Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 5, 2014 |
Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
Pat.
No. 8759350
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2014 |
Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Pat.
No. 9387182
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Aug 2, 2016 |
Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY (TABLET, ORALLY
DISINTEGRATING) (ORAL) ARIPIPRAZOLE [Has
competitive generic]
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant:
OTSUKA NDA No.:
021729 Prod. No.:
002 DISC (10MG); 003 DISC (15MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7053092
5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
Pat.
No. 8017615
DP* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None |
Dec 16, 2024 *PED | |
Pat.
No. 8580796
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None |
Mar 25, 2023 *PED | |
Pat.
No. 8642600
Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 |
Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
Pat.
No. 8642760
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 |
Mar 25, 2023 *PED | |
Pat.
No. 8759350
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 |
Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Pat.
No. 9089567
Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 |
Jan 28, 2022 | U-543: Treatment of schizophrenia |
Pat.
No. 9125939
Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 7, 2015 |
Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
Pat.
No. 9359302
DS* DP* Low hygroscopic aripiprazole drug
substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 |
Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
Pat.
No. 9387182
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 |
Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY (TABLET, ORALLY
DISINTEGRATING) (ORAL) ARIPIPRAZOLE
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant:
OTSUKA NDA No.:
021729 Prod. No.:
004 DISC (20MG**); 005 DISC (30MG**)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7053092
5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Jan 28, 2022 | U-839: Treatment of major depressive disorder (MDD) |
Pat.
No. 8017615
DP* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: None |
Dec 16, 2024 *PED | |
Pat.
No. 8580796
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: None |
Mar 25, 2023 *PED | |
Pat.
No. 8642600
Method of treating autism Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 5, 2014 |
Jul 28, 2022 *PED | U-1492: Treatment of irritability associated with autistic disorder |
Pat.
No. 8642760
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Mar 5, 2014 |
Mar 25, 2023 *PED | |
Pat.
No. 9359302
DS* DP* Low hygroscopic aripiprazole drug
substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Jun 30, 2016 |
Sep 25, 2022 | U-1859: Treatment of schizophrenia, acute treatment of manic and mixed episodes associated with bipolar I disorder, adjunctive treatment of major depressive disorder, and treatment of irritability associated with autistic disorder |
Pat.
No. 9387182
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2016 |
Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY (INJECTABLE) (INTRAMUSCULAR)
ARIPIPRAZOLE
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant:
OTSUKA NDA No.:
021866 Prod. No.:
001 DISC (9.75MG/1.3ML (7.5MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7115587
DP* Aripiprazole complex formulation and method Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None |
Jan 21, 2025 *PED | U-764: Treatment of schizophrenia |
Pat.
No. 7550445
DP* Aripiprazole complex formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 21, 2025 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Dec 12, 2021 | ODE-80: Treatment of pediatric patients with Tourette's |
ABILIFY MAINTENA KIT (FOR SUSPENSION, EXTENDED
RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant:
OTSUKA PHARM CO
LTD NDA No.: 202971 Prod. No.:
001 RX (300MG/VIAL); 002 RX (400MG/VIAL); 003 RX
(300MG); 004 RX (400MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7807680
DP* Controlled release sterile injectable aripiprazole
formulation and method Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None; 002: None; 003: None; 004: Oct 29, 2014 |
Oct 19, 2024 | |
Pat.
No. 8030313
Controlled release sterile injectable aripiprazole formulation and
method Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Oct 19, 2024 | U-1632:
Treatment of schizophrenia, with efficacy in treating acute episodes of
schizophrenia U-543: Treatment of schizophrenia |
Pat.
No. 8338427
DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None |
Mar 15, 2025 | U-1633:
Use of aripiprazole in extended release injectable suspension in
treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
Pat.
No. 8338428
DP* Methods for administering aripiprazole Claim Types: Formulation; Method of administration Pat. Sub. Date(s): All strengths: None |
Aug 6, 2023 | U-1633:
Use of aripiprazole in extended release injectable suspension in
treating acute episodes of schizophrenia U-543: Treatment of schizophrenia |
Pat.
No. 8399469
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): 001: Apr 15, 2013; 002: None; 003: None; 004: Oct 29, 2014 |
Jun 29, 2025 | |
Pat.
No. 8722679
DP* Controlled release sterile injectable aripiprazole
formulation and method Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 9, 2014; 002: Jun 9, 2014; 003: None; 004: Oct 29, 2014 |
Oct 19, 2024 | |
Pat.
No. 8759351
DP* Methods for administering aripiprazole Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Jul 22, 2014 |
Aug 6, 2023 | U-1530:
Use of aripiprazole in extended release injectable suspension U-1633: Use of aripiprazole in extended release injectable suspension in treating acute episodes of schizophrenia |
Pat.
No. 8993761
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process Pat. Sub. Date(s): All strengths: Apr 28, 2015 |
Sep 25, 2022 | |
Pat.
No. 9089567
Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 26, 2015 |
Jan 28, 2022 | U-543: Treatment of schizophrenia |
Pat.
No. 10525057
Method of providing aripiprazole to patients having impaired CYP2D6 or
CYP3A4 enzyme function Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Jan 31, 2020 |
Mar 8, 2034 | U-1632:
Treatment of schizophrenia, with efficacy in treating acute episodes of
schizophrenia U-2723: Maintenance monotherapy treatment of Bipolar 1 disorder U-543: Treatment of schizophrenia |
Pat.
No. 10980803
Method of providing aripiprazole to patients having impaired CYP2D6 or
CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: May 19, 2021 |
Sep 24, 2033 | U-1632:
Treatment of schizophrenia, with efficacy in treating acute episodes of
schizophrenia U-543: Treatment of schizophrenia |
Pat.
No. 11154553
Method of providing aripiprazole to patients having impaired CYP2D6 or
CYP3A4 enzyme function Claim Types: Method of use Pat. Sub. Date(s): All strengths: Nov 17, 2021 |
Sep 24, 2033 | U-1632:
Treatment of schizophrenia, with efficacy in treating acute episodes of
schizophrenia U-3245: Maintenance monotherapy treatment of bipolar I disorder U-814: Treatment of schizophrenia |
ABILIFY MYCITE KIT (TABLET) (ORAL)
ARIPIPRAZOLE [Has competitive generic]
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
NDA Applicant:
OTSUKA NDA No.:
207202 Prod. No.:
001 RX (2MG); 002 RX (5MG); 003 RX (10MG); 004
RX (15MG); 005 RX (20MG); 006 RX (30MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7053092
5-HT1a receptor subtype agonist Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Jan 28, 2022 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Pat.
No. 7978064
DP* Communication system with partial power source Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Sep 14, 2026 | |
Pat.
No. 8017615
DP* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Composition; Product-by-process; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Jun 16, 2024 | |
Pat.
No. 8114021
DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Jun 21, 2030 | |
Pat.
No. 8258962
DP* Multi-mode communication ingestible event markers and
systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Nov 25, 2030 | |
Pat.
No. 8545402
DP* Highly reliable ingestible event markers and methods
for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Apr 27, 2030 | |
Pat.
No. 8547248
DP* Implantable zero-wire communications system Claim Types: Device; Method of use; Kit Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Dec 18, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
Pat.
No. 8580796
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Sep 25, 2022 | |
Pat.
No. 8642760
DS* Low hygroscopic aripiprazole drug substance and
processes for the preparation thereof Claim Types: Compound Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Sep 25, 2022 | |
Pat.
No. 8674825
DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Apr 9, 2029 | U-2170: Method of using a receiver to receive a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
Pat.
No. 8718193
DP* Active signal processing personal health signal
receivers Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Dec 5, 2029 | |
Pat.
No. 8759350
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Mar 2, 2027 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Pat.
No. 8847766
DP* Pharma-informatics system Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Mar 29, 2030 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
Pat.
No. 8945005
DP* Controlled activation ingestible identifier Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Aug 19, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
Pat.
No. 8956288
DP* In-body power source having high surface area electrode Claim Types: Device; Method-of-use; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Jul 6, 2029 | U-2167: Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver |
Pat.
No. 8961412
DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Nov 17, 2030 | |
Pat.
No. 9060708
DP* Multi-mode communication ingestible event markers and
systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Mar 5, 2029 | |
Pat.
No. 9089567
Method of treating cognitive impairments and schizophrenias Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Jan 28, 2022 | U-543: Treatment of schizophrenia |
Pat.
No. 9119554
DP* Pharma-informatics system Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Dec 16, 2028 | |
Pat.
No. 9125939
Carbostyril derivatives and mood stabilizers for treating mood disorders Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Jul 28, 2026 | U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder |
Pat.
No. 9149577
DP* Body-associated receiver and method Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Dec 15, 2029 | |
Pat.
No. 9258035
DP* Multi-mode communication ingestible event markers and
systems, and methods of using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Mar 5, 2029 | |
Pat.
No. 9268909
DP* Apparatus, system, and method to adaptively optimize
power dissipation and broadcast power in a power source for a
communication device Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Oct 15, 2033 | U-2168: Method of using a logic circuit to stabilize battery voltage supplied to a sensor embedded with a tablet and that communicates information via a signal through the body of a patient to a receiver |
Pat.
No. 9320455
DP* Highly reliable ingestible event markers and methods
for using the same Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Dec 15, 2031 | |
Pat.
No. 9359302
DS* DP* Low hygroscopic aripiprazole drug
substance and processes for the preparation thereof Claim Types: New polymorph, salt or hydrate; Process; Product-by-process; Composition; Method of use; Kit; Formulation Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Sep 25, 2022 | U-1529:
Adjunctive treatment of major depressive disorder (MDD) U-1749: Acute treatment of manic and mixed episodes associated with bipolar I disorder U-543: Treatment of schizophrenia |
Pat.
No. 9387182
Carbostyril derivatives and serotonin reuptake inhibitors for treatment
of mood disorders Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Dec 25, 2023 | U-1529: Adjunctive treatment of major depressive disorder (MDD) |
Pat.
No. 9433371
DP* In-body device with virtual dipole signal amplification Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Sep 15, 2029 | |
Pat.
No. 9444503
DP* Active signal processing personal health signal
receivers Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Dec 12, 2017 |
Nov 19, 2027 | U-2169: Method of using a receiver to identify a signal from a tablet embedded with a sensor that communicates information through the body of a patient |
Pat.
No. 9941931
DP* System for supply chain management Claim Types: Device Pat. Sub. Date(s): All strengths: May 7, 2018 |
Nov 4, 2030 | |
Pat.
No. 10441194
DP* Ingestible event marker systems Claim Types: Device Pat. Sub. Date(s): All strengths: Nov 1, 2019 |
Jul 26, 2029 | |
Pat.
No. 10517507
DP* Communication system with enhanced partial power
source and method of manufacturing same Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 23, 2020 |
Jun 13, 2032 | |
Pat.
No. 11229378
DP* Communication system with enhanced partial power
source and method of manufacturing same Claim Types: Device; Process Pat. Sub. Date(s): All strengths: Feb 18, 2022 |
Jul 11, 2031 |
ABLYSINOL
(SOLUTION)
(INTRA-ARTERIAL) ALCOHOL
Drug Classes:
Anti-Addiction/ Substance
Abuse Treatment Agents:Alcohol Deterrents/Anti-craving
NDA Applicant:
BELCHER NDA No.:
207987 Prod. No.:
001 RX (99% (1ML)); 002 RX (99% (5ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: ODE - Orphan drug exclusivity | Jun 21, 2025 | ODE-192: Indicated to induce controlled cardiac septal infraction [sic, "infarction"] to improve exercise capacity in adults with symptomatic hypertrophic obstructive cardiomyopathy who are not candidates for surgical myectomy |
ABRAXANE
(POWDER) (INTRAVENOUS)
PACLITAXEL
Drug Classes:
microtubule inhibitor
NDA Applicant:
ABRAXIS
BIOSCIENCE NDA No.: 021660 Prod. No.:
001 RX (100MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7758891
Combinations and modes of administration of therapeutic agents and
combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2013 |
Aug 21, 2026 *PED | U-1434: Treatment of pancreatic cancer |
Pat.
No. 7820788
DP* Compositions and methods of delivery of
pharmacological agents Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 12, 2010 |
Apr 27, 2025 *PED | U-1092:
Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
Pat.
No. 7923536
Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 15, 2011 |
Jun 9, 2024 *PED | U-1117:
Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
Pat.
No. 8034375
Combinations and modes of administration of therapeutic agents and
combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 |
Feb 13, 2027 *PED | U-1290: Treatment of lung cancer |
Pat.
No. 8138229
DP* Compositions and methods of delivery of
pharmacological agents Claim Types: Formulation; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Mar 27, 2012 |
Jun 9, 2024 *PED | U-1092:
Treatment of breast cancer U-1290: Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
Pat.
No. 8268348
Combinations and modes of administration of therapeutic agents and
combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2012 |
Aug 21, 2026 *PED | U-1290: Treatment of lung cancer |
Pat.
No. 8314156
Compositions and methods of delivery of pharmacological agents Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 28, 2012 |
Jun 9, 2024 *PED | U-1290:
Treatment of lung cancer U-1434: Treatment of pancreatic cancer |
Pat.
No. 9101543
Combinations and modes of administration of therapeutic agents and
combination therapy Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 18, 2015 |
Aug 21, 2026 *PED | U-1434: Treatment of pancreatic cancer |
Pat.
No. 9393318
Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2016 |
Sep 4, 2032 *PED | U-1290: Treatment of lung cancer |
Pat.
No. 9511046
Methods of treating pancreatic cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 29, 2016 |
Jul 12, 2034 *PED | U-1434: Treatment of pancreatic cancer |
Pat.
No. 9597409
Methods of treating cancer Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 17, 2017 |
Sep 4, 2032 *PED | U-1290: Treatment of lung cancer |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Jun 6, 2023 PED | M-14: Additional clinical trial information added to pediatric use subsection |
ABSORICA
LD (CAPSULE)
(ORAL) ISOTRETINOIN [Has competitive
generic]
Drug Classes:
Dermatological Agents:Acne
and Rosacea Agents == retinoid
NDA Applicant:
SUN
PHARM NDA No.: 211913 Prod. No.:
001 RX (8MG); 002 RX (16MG); 004 RX (24MG); 006
RX (32MG) NDA
No.: 211913 Prod. No.:
003 DISC (20MG); 005 DISC (28MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9700535
DP* Oral pharmaceutical composition of isotretinoin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2019 |
Aug 4, 2035 | |
Pat.
No. 9750711
DP* Low dose oral pharmaceutical composition of
isotretinoin Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 25, 2019 |
May 29, 2035 |
ACANYA
(GEL) (TOPICAL)
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
[GENERIC AB]
Drug Classes:
Dermatological
Agents:Topical Anti-infectives == Antibacterials:Antibacterials,
Other == Dermatological Agents:Acne and Rosacea Agents == lincosamide
antibacterial
NDA Applicant:
BAUSCH NDA No.:
050819 Prod. No.:
001 RX (2.5%;EQ 1.2% BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8288434
DP* Topical pharmaceutical formulations containing a low
concentration of benzoyl peroxide in suspension in water and a
water-miscible organic solvent Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 19, 2012 |
Aug 5, 2029 | U-124: Treatment of acne |
Pat.
No. 8663699
Topical pharmaceutical formulations containing a low concentration of
benzoyl peroxide in suspension in water and a water-miscible organic
solvent Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 6, 2014 |
Jun 3, 2029 | U-124: Treatment of acne |
Pat.
No. 8895070
Topical pharmaceutical formulations containing a low concentration of
benzoyl peroxide in suspension in water and a water-miscible organic
solvent Claim Types: Method of use Pat. Sub. Date(s): 001: May 19, 2015 |
Jun 3, 2029 | U-124: Treatment of acne |
Pat.
No. 9078870
DP* Topical pharmaceutical formulations containing a low
concentration of benzoyl peroxide in suspension in water and a
water-miscible organic solvent Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 13, 2015 |
Jun 3, 2029 | |
Pat.
No. 10220049
DP* Topical pharmaceutical formulations containing a low
concentration of benzoyl peroxide in suspension in water and a
water-miscible organic solvent Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Mar 8, 2019 |
Jun 3, 2029 | U-916: Topical treatment of acne vulgaris in patients 12 years or older |
Pat.
No. 10624918
Topical pharmaceutical formulations containing a low concentration of
benzoyl peroxide in suspension in water and a water-miscible organic
solvent Claim Types: Method of use Pat. Sub. Date(s): 001: May 11, 2020 |
Jun 3, 2029 | U-916: Topical treatment of acne vulgaris in patients 12 years or older |
ACCRUFER
(CAPSULE) (ORAL)
FERRIC MALTOL
Drug Classes:
Electrolytes/ Minerals/
Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/
Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation
agent == iron replacement product
NDA Applicant:
SHIELD
TX NDA No.: 212320 Prod. No.:
001 RX (30MG IRON)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9248148
Mono (iron hydroxypyrone) and combination (iron hydroxypyrone and GI
inflammation inhibiting agents) compositions for anaemia or H. pylori
infections Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2019 |
Mar 29, 2031 | U-2603: Method of treating iron deficiency |
Pat.
No. 9802973
DS* DP* Crystalline forms of ferric maltol Claim Types: New polymorph, salt or hydrate; Process; Composition; Product-by-process; Method of use Pat. Sub. Date(s): 001: Aug 22, 2019 |
Oct 23, 2035 | U-2603: Method of treating iron deficiency |
Pat.
No. 10179120
Dosage regimen of ferric trimaltol Claim Types: Method of use Pat. Sub. Date(s): 001: Aug 22, 2019 |
Jan 6, 2035 | U-2603: Method of treating iron deficiency |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Jul 25, 2024 |
ACETADOTE
(INJECTABLE)
(INTRAVENOUS) ACETYLCYSTEINE [GENERIC AP]
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Respiratory Tract Agents, Other == antidote
== antidote for acetaminophen overdose == mucolytic
NDA Applicant:
CUMBERLAND
PHARMS NDA No.: 021539 Prod. No.:
001 RX (6GM/30ML (200MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8148356
DP* Acetylcysteine composition and uses therefor Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Apr 4, 2012 |
May 21, 2026 | |
Pat.
No. 8399445
Acetylcysteine composition and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 28, 2013 |
Aug 24, 2025 | U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions |
Pat.
No. 8653061
Acetylcysteine composition and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Feb 24, 2014 |
Aug 24, 2025 | U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions |
Pat.
No. 8722738
Acetycysteine compositions and methods of use thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 27, 2014 |
Apr 6, 2032 | U-1373: Method of treating acetaminophen overdose with acetylcysteine solutions |
Pat.
No. 9327028
Acetylcysteine compositions and methods of use thereof Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 18, 2016 |
Jul 21, 2031 | U-1839: Composition and method for providing a reduction in side effects for human patients in need of acetylcysteine therapy |
ACETAMINOPHEN
(SOLUTION) (INTRAVENOUS)
ACETAMINOPHEN [Has competitive generic]
NDA Applicant:
FRESENIUS KABI
USA NDA No.: 204767 Prod. No.:
001 RX (1GM/100ML (10MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8741959
DP* Paracetamol for parenteral administration Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 24, 2019 |
Apr 19, 2030 |
ACTONEL
(TABLET) (ORAL)
RISEDRONATE SODIUM [GENERIC AB]
Drug Classes:
Metabolic Bone Disease
Agents
NDA Applicant:
APIL NDA No.:
020835 Prod. No.:
005 RX (150MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7192938
Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 005: None |
Nov 6, 2023 *PED | U-353: Prevention and treatment of osteoporosis |
Pat.
No. 7718634
Method of treatment using bisphosphonic acid Claim Types: Method of use Pat. Sub. Date(s): 005: None |
Nov 6, 2023 *PED | U-662: Treatment of osteoporosis in postmenopausal women |
ACTOPLUS
MET (TABLET)
(ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE [GENERIC AB]
Drug Classes:
Blood Glucose
Regulators:Antidiabetic Agents == biguanide == Blood
Glucose Regulators:Antidiabetic Combinations == peroxisome
proliferator-activated receptor (PPAR) alpha agonist == peroxisome
proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant:
TAKEDA PHARMS
USA NDA No.: 021842 Prod. No.:
001 RX (500MG;EQ 15MG BASE); 002 RX (850MG;EQ 15MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9101660
DP* Solid preparation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Sep 10, 2015 |
Jan 22, 2027 | |
Pat.
No. 9320714
DP* Tablet Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 20, 2016 |
Feb 3, 2029 |
ACTOPLUS MET XR (TABLET, EXTENDED RELEASE)
(ORAL) METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
Drug Classes:
Blood Glucose
Regulators:Antidiabetic Agents == biguanide == Blood
Glucose Regulators:Antidiabetic Combinations == peroxisome
proliferator-activated receptor (PPAR) alpha agonist == peroxisome
proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant:
TAKEDA PHARMS
USA NDA No.: 022024 Prod. No.:
001 DISC (1GM;EQ 15MG BASE); 002 DISC (1GM;EQ 30MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7785627
DP* Pharmaceutical formulation containing a biguanide and
a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Jul 31, 2026 | |
Pat.
No. 7959946
DP* Pharmaceutical formulation containing a biguanide and
a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jun 30, 2011; 002: None |
Jul 31, 2026 | |
Pat.
No. 8470368
DP* Pharmaceutical formulation containing a biguanide and
a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2013; 002: None |
Sep 19, 2023 | |
Pat.
No. 8668931
DP* Pharmaceutical formulation containing a biguanide and
a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Sep 19, 2023 | |
Pat.
No. 9060941
DP* Pharmaceutical formulation containing a biguanide and
a thiazolidinedione derivative Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 21, 2015 |
Sep 19, 2023 |
ACULAR
LS (SOLUTION/DROPS)
(OPHTHALMIC) KETOROLAC TROMETHAMINE
[GENERIC AT]
Drug Classes:
Analgesics:Nonsteroidal
Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic
Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant:
ALLERGAN NDA No.:
021528 Prod. No.:
001 RX (0.4%)
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 |
ACUVAIL
(SOLUTION/DROPS)
(OPHTHALMIC) KETOROLAC TROMETHAMINE
Drug Classes:
Analgesics:Nonsteroidal
Anti-inflammatory Drugs == Ophthalmic Agents:Ophthalmic
Anti-inflammatories == cyclooxygenase inhibitor
NDA Applicant:
ALLERGAN NDA No.:
022427 Prod. No.:
001 RX (0.45%)
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 |
ACUVUE THERAVISION WITH
KETOTIFEN (DRUG-ELUTING
CONTACT LENS ) (OPHTHALMIC) KETOTIFEN FUMARATE
Drug Classes:
histamine-1 (H1) receptor
inhibitor
NDA Applicant:
JOHNSON JOHNSON
VISN NDA No.: 022388 Prod. No.:
001 RX (EQ 19MCG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9474746
DP* Methods for stabilizing oxidatively unstable
compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 23, 2022 |
Mar 27, 2028 | |
Pat.
No. 9962376
DP* Methods and ophthalmic devices used in the treatment
of ocular allergies Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 23, 2022 |
Jun 27, 2030 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Feb 25, 2025 |
ACZONE
(GEL) (TOPICAL)
DAPSONE [GENERIC AB]
Drug Classes:
Antimycobacterials:Antimycobacterials,
Other == Dermatological Agents:Topical Anti-infectives == sulfone
NDA Applicant:
ALMIRALL NDA No.:
207154 Prod. No.:
001 RX (7.5%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9161926
DP* Topical dapsone and dapsone/adaplene compositions and
methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 1, 2016 |
Nov 18, 2033 | |
Pat.
No. 9517219
Topical dapsone and dapsone/adapalene compositions and methods for use
thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 16, 2016 |
Nov 18, 2033 | U-1033: Topical treatment of acne vulgaris |
Pat.
No. 11273132
DP* Topical dapsone and dapsone/adapalene compositions and
methods for use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 28, 2022 |
Nov 18, 2033 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Sep 10, 2022 |
ADAPALENE AND BENZOYL
PEROXIDE (GEL)
(TOPICAL) ADAPALENE; BENZOYL PEROXIDE
[GENERIC AB]
Drug Classes:
Dermatological Agents:Acne
and Rosacea Agents == retinoid == Dermatological
Agents:Topical Anti-infectives
NDA Applicant:
TARO NDA No.:
209148 Prod. No.:
001 RX (0.3%;2.5%)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: PC - Patent challenge | May 30, 2022 |
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. 6716416
DP* Delivery of antipsychotics through an inhalation route Claim Types: Formulation; Product-by-process Pat. Sub. Date(s): 001: Mar 29, 2013 |
May 20, 2022 | |
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. 8074644
DP* Method of forming an aerosol for inhalation delivery Claim Types: Process Pat. Sub. Date(s): 001: Mar 29, 2013 |
Jul 25, 2022 | |
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 |
ADDYI
(TABLET) (ORAL)
FLIBANSERIN
Drug Classes:
Sexual Disorder
Agents:Sexual Disorder Agents (Female)
NDA Applicant:
SPROUT
PHARMS NDA No.: 022526 Prod. No.:
001 RX (100MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7151103
Method of treating female hypoactive sexual desire disorder with
flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 |
May 9, 2023 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
Pat.
No. 7420057
DS* DP* Stable polymorph of flibanserin Claim Types: New polymorph, salt or hydrate; Composition; Product-by-process Pat. Sub. Date(s): 001: Sep 14, 2015 |
Aug 1, 2022 | |
Pat.
No. 8227471
Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2015 |
May 9, 2023 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
Pat.
No. 9468639
Treating sexual desire disorders with flibanserin Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 8, 2016 |
Oct 16, 2022 | U-1734: Use of flibanserin or a pharmaceutically acceptable acid addition salt thereof to treat hypoactive sexual desire disorder (HSDD) |
ADEMPAS
(TABLET) (ORAL)
RIOCIGUAT
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Pulmonary Antihypertensives == soluble
guanylate cyclase (sGC) stimulator
NDA Applicant:
BAYER
HLTHCARE NDA No.: 204819 Prod. No.:
001 RX (0.5MG); 002 RX (1MG); 003 RX (1.5MG); 004
RX (2MG); 005 RX (2.5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7173037
DS* DP* [Extended 1319 days (3.6 years)] Carbamate-substituted pyrazolopyridines Claim Types: Compound; Process; Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Nov 6, 2013 |
Dec 4, 2026 | |
Pat.
No. 10662188
DS* DP* Forms of methyl {4,6-diamino-2-[1
(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimidino-5-yl}
methyl carbamate Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Jun 23, 2020 |
Feb 18, 2034 | U-2834:
Treatment of adults with persistent/recurrent chronic thromboembolic
pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment,
or inoperable CTEPH, to improve exercise capacity and WHO functional
class U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening |
Pat.
No. 11203593
DS* DP* Forms of methyl
{4,6-diamino-2-[1(2-fluorobenzyl)-1H-pyrazolo[3-4-b]pyridino-3-yl]pyrimid-
ino-5-yl}methyl carbamate Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Jan 14, 2022 |
Feb 18, 2034 | U-2834:
Treatment of adults with persistent/recurrent chronic thromboembolic
pulmonary hypertension (CTEPH), (WHO Group 4) after surgical treatment,
or inoperable CTEPH, to improve exercise capacity and WHO functional
class U-2835: Treatment of adults with pulmonary hypertension (PAH), (WHO Group 1), to improve exercise capacity, WHO functional class and to delay clinical worsening |
ADHANSIA
XR (CAPSULE,
EXTENDED RELEASE) (ORAL) METHYLPHENIDATE HYDROCHLORIDE [Has competitive generic]
Drug Classes:
Central Nervous System
Agents:Attention Deficit Hyperactivity Disorder Agents, Non-amphetamines
== central nervous system stimulant
NDA Applicant:
PURDUE PHARMA
LP NDA No.: 212038 Prod. No.:
001 RX (25MG); 002 RX (35MG); 003 RX (45MG); 004
RX (55MG); 005 RX (70MG); 006 RX (85MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9974752
DP* Methods and compositions particularly for treatment of
attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 8, 2019 |
Oct 30, 2035 | |
Pat.
No. 10111839
Methods and compositions particularly for treatment of attention
deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 8, 2019 |
Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
Pat.
No. 10292938
DP* Methods and compositions particularly for treatment of
attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: May 22, 2019 |
Oct 30, 2035 | |
Pat.
No. 10292939
DP* Methods and compositions particularly for treatment of
attention deficit disorder Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: May 22, 2019 |
Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
Pat.
No. 10449159
Methods and compositions particularly for treatment of attention
deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 22, 2019 |
Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
Pat.
No. 10500162
Methods and compositions particularly for treatment of attention
deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 11, 2019 |
Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
Pat.
No. 10507186
DP* Methods and compositions particularly for treatment of
attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Dec 18, 2019 |
Oct 30, 2035 | |
Pat.
No. 10512612
DP* Methods and compositions particularly for treatment of
attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 2, 2020 |
Oct 30, 2035 | |
Pat.
No. 10512613
Methods and compositions particularly for treatment of attention
deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jan 2, 2020 |
Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
Pat.
No. 10568841
DP* Methods and compositions particularly for treatment of
attention deficit disorder Claim Types: Method of use; Formulation Pat. Sub. Date(s): All strengths: Feb 26, 2020 |
Oct 30, 2035 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
Pat.
No. 10688060
DP* Methods and compositions particularly for treatment of
attention deficit disorder Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 23, 2020 |
Oct 30, 2035 | |
Pat.
No. 10722473
Methods and compositions particularly for treatment of attention
deficit disorder Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2020 |
Nov 19, 2038 | U-2357: Method of treating attention deficit hyperactivity disorder (ADHD) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Jun 28, 2024 | M-82: Labeling revisions related to clinical studies |
Exclusivity Code: NP - New product | Feb 27, 2022 |
ADLARITY
(SYSTEM) (TRANSDERMAL)
DONEPEZIL HYDROCHLORIDE
Drug Classes:
Antidementia
Agents:Cholinesterase Inhibitors == acetylcholinesterase
inhibitor
NDA Applicant:
CORIUM NDA No.:
212304 Prod. No.:
001 RX (5MG/DAY); 002 RX (10MG/DAY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9993466
DP* Donepezil transdermal delivery system Claim Types: Device Pat. Sub. Date(s): All strengths: Apr 6, 2022 |
Jul 26, 2037 | |
Pat.
No. 10016372
Transdermal delivery systems with pharmacokinetics bioequivalent to
oral delivery Claim Types: Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 |
Jul 26, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
Pat.
No. 10300025
DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022 |
Jul 26, 2037 | |
Pat.
No. 10307379
DP* Donepezil transdermal delivery system Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 6, 2022 |
Jul 26, 2037 | |
Pat.
No. 10835499
DP* Systems and methods for long term transdermal
administration Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 |
May 20, 2038 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
Pat.
No. 10966936
DP* Systems comprising a composite backing and methods for
long term transdermal administration Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 6, 2022 |
Aug 11, 2038 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
Pat.
No. 11103463
Methods for treating Alzheimer's disease with donepezil transdermal
system Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 6, 2022 |
Jul 26, 2037 | U-3334: A method of transdermal delivery of donepezil for treating mild, moderate and severe dementia of the Alzheimer's type |
ADRENACLICK
(INJECTABLE)
(INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha
adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant:
IMPAX NDA No.:
020800 Prod. No.:
003 RX (EQ 0.15MG/DELIVERY); 004 RX (EQ 0.3MG/DELIVERY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7905352
DP* Kits containing medicine injection devices and
containers Claim Types: Kit; Device Pat. Sub. Date(s): All strengths: Jun 2, 2017 |
Apr 12, 2027 | |
Pat.
No. 10166334
DP* Medicine injection apparatuses Claim Types: Device Pat. Sub. Date(s): All strengths: Feb 11, 2020 |
Jan 21, 2025 |
ADRENALIN
(SOLUTION)
(INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha
adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant:
PAR STERILE
PRODUCTS NDA No.: 204200 Prod. No.:
001 RX (EQ 1MG BASE/ML (EQ 1MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9119876
DP* Epinephrine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 14, 2016 |
Mar 13, 2035 | |
Pat.
No. 9295657
Epinephrine formulations Claim Types: Method Pat. Sub. Date(s): 001: Apr 12, 2016 |
Mar 13, 2035 | U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis |
ADRENALIN
(SOLUTION)
(INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS) EPINEPHRINE [GENERIC AP]
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha
adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant:
PAR STERILE
PRODUCTS NDA No.: 204640 Prod. No.:
001 RX (EQ 30MG BASE/30ML (EQ 1MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9119876
DP* Epinephrine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 1, 2015 |
Mar 13, 2035 | |
Pat.
No. 9295657
Epinephrine formulations Claim Types: Method Pat. Sub. Date(s): 001: Apr 12, 2016 |
Mar 13, 2035 | U-1829: Emergency treatment of allergic reactions (Type I), including anaphylaxis |
Pat.
No. 10130592
DP* Epinephrine formulations Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 26, 2018 |
Mar 13, 2035 |
ADVAIR
HFA (AEROSOL,
METERED) (INHALATION) FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory
Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2
adrenergic agonist
NDA Applicant:
GLAXO GRP
LTD NDA No.: 021254 Prod. No.:
001 RX (0.045MG/INH;EQ 0.021MG BASE/INH); 002 RX
(0.115MG/INH;EQ 0.021MG BASE/INH); 003 RX (0.23MG/INH;EQ
0.021MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7500444
DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): All strengths: None |
Aug 26, 2026 *PED | |
Pat.
No. 7832351
DP* Actuation indicator for a dispensing device Claim Types: Device Pat. Sub. Date(s): 001: Sep 6, 2012; 002: None; 003: None |
Dec 19, 2023 *PED |
ADVIL ALLERGY SINUS (TABLET) (ORAL)
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
Drug Classes:
histamine-1 (H1) receptor
antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
== alpha adrenergic agonist
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
021441 Prod. No.:
001 OTC (2MG;200MG;30MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7863287
DP* Compositions of non-steroidal anti-inflammatory drugs,
decongestants and anti-histamines Claim Types: Formulation Pat. Sub. Date(s): 001: May 6, 2011 |
Feb 28, 2027 |
ADVIL ALLERGY SINUS,
CHILDREN'S (SUSPENSION)
(ORAL) CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE
HYDROCHLORIDE
Drug Classes:
histamine-1 (H1) receptor
antagonist == Analgesics:Nonsteroidal Anti-inflammatory Drugs
== alpha adrenergic agonist
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
021587 Prod. No.:
001 OTC (1MG/5ML;100MG/5ML;15MG/5ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 10238640
DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 001: Apr 24, 2019 |
May 25, 2024 |
ADVIL DUAL ACTION WITH
ACETAMINOPHEN (TABLET) (ORAL) ACETAMINOPHEN; IBUPROFEN
Drug Classes:
Analgesics:Nonsteroidal
Anti-inflammatory Drugs
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
211733 Prod. No.:
001 OTC (250MG;125MG)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: NP - New product | Feb 28, 2023 |
ADVIL
PM (CAPSULE)
(ORAL) DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
[GENERIC OTC]
Drug Classes:
Antiemetics:Antiemetics,
Other == Antiparkinson Agents:Anticholinergics == Respiratory
Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1)
receptor antagonist == Analgesics:Nonsteroidal
Anti-inflammatory Drugs
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
021393 Prod. No.:
001 OTC (25MG;EQ 200MG FREE ACID AND POTASSIUM SALT)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8883849
Treatment of sleep disturbances Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2014 |
Jan 17, 2022 | U-1618: A method of treating a patient suffering from a pain associated sleep disturbance comprising administering a liquid composition formulated inside a soft gel capsule, as claimed, to the patient |
Pat.
No. 9155718
DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 10, 2015 |
Jan 17, 2022 |
ADVIL PM (TABLET) (ORAL)
DIPHENHYDRAMINE CITRATE; IBUPROFEN [GENERIC
OTC]
Drug Classes:
Antiemetics:Antiemetics,
Other == Antiparkinson Agents:Anticholinergics == Respiratory
Tract/ Pulmonary Agents:Antihistamines == histamine-1 (H1)
receptor antagonist == Analgesics:Nonsteroidal
Anti-inflammatory Drugs
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
021394 Prod. No.:
001 OTC (38MG;200MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8263647
DP* Treatment of sleep disturbances Claim Types: Formulation Pat. Sub. Date(s): 001: None |
May 30, 2022 |
ADVIL, CHILDREN'S FLAVORED
(SUSPENSION) (ORAL)
IBUPROFEN [GENERIC OTC]
Drug Classes:
Analgesics:Nonsteroidal
Anti-inflammatory Drugs
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
020589 Prod. No.:
002 OTC (100MG/5ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 10238640
DP* Pharmaceutical suspension composition Claim Types: Formulation Pat. Sub. Date(s): 002: Apr 24, 2019 |
May 25, 2024 |
ADZENYS
ER (SUSPENSION,
EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes:
Central Nervous System
Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines
== central nervous system stimulant
NDA Applicant:
NEOS THERAPS
INC NDA No.: 204325 Prod. No.:
001 DISC (EQ 1.25MG BASE/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8709491
DP* Composition comprising a mixture of dextro- and
levo-amphetamines complexed with ion-exchange resin particles to form
drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 |
Jun 28, 2032 | |
Pat.
No. 9017731
DP* Composition comprising a mixture of dextro- and
levo-amphetamines complexed with ion-exchange resin particles to form
drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 |
Jun 28, 2032 | |
Pat.
No. 9265737
DP* Pharmaceutical composition comprising amphetamines
complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 |
Jun 28, 2032 |
ADZENYS
XR-ODT (TABLET,
ORALLY DISINTEGRATING, EXTENDED RELEASE) (ORAL) AMPHETAMINE
Drug Classes:
Central Nervous System
Agents:Attention Deficit Hyperactivity Disorder Agents, Amphetamines
== central nervous system stimulant
NDA Applicant:
NEOS
THERAPS NDA No.: 204326 Prod. No.:
001 RX (EQ 3.1MG BASE); 002 RX (EQ 6.3MG BASE); 003
RX (EQ 9.4MG BASE); 004 RX (EQ 12.5MG BASE); 005 RX
(EQ 15.7MG BASE); 006 RX (EQ 18.8MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8709491
DP* Composition comprising a mixture of dextro- and
levo-amphetamines complexed with ion-exchange resin particles to form
drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None |
Jun 28, 2032 | |
Pat.
No. 8840924
DP* Compositions and methods of making rapidly dissolving
ionically masked formulations Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 26, 2016 |
Apr 9, 2026 | |
Pat.
No. 9017731
DP* Composition comprising a mixture of dextro- and
levo-amphetamines complexed with ion-exchange resin particles to form
drug resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None |
Jun 28, 2032 | |
Pat.
No. 9265737
DP* Pharmaceutical composition comprising amphetamines
complexed with ion-exchange resin particles Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 26, 2016; 002: None; 003: None; 004: None; 005: None; 006: None |
Jun 28, 2032 |
AEMCOLO
(TABLET, DELAYED
RELEASE) (ORAL) RIFAMYCIN SODIUM
Drug Classes:
Gastrointestinal
Agents:Anti-Diarrheal Agents == rifamycin antibacterial
NDA Applicant:
REDHILL NDA No.:
210910 Prod. No.:
001 RX (EQ 194MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8263120
DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2018 |
May 3, 2025 | |
Pat.
No. 8486446
DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2018 |
May 3, 2025 | |
Pat.
No. 8529945
DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 6, 2018 |
May 3, 2025 | |
Pat.
No. 8741948
DP* Oral antimicrobial pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Dec 6, 2018 |
May 3, 2025 | U-2448: Treatment of travelers' diarrhea caused by non-invasive strains of escherichia coli in adults |
AFINITOR
(TABLET) (ORAL)
EVEROLIMUS [GENERIC AB]
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == Immunological Agents:Immunosuppressants
== kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant:
NOVARTIS NDA No.:
022334 Prod. No.:
001 RX (5MG); 002 RX (10MG); 003 RX (2.5MG); 004
RX (7.5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8410131
Cancer treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 2, 2013 |
May 1, 2026 *PED | U-1368: Treatment of solid excretory system tumors; advanced renal cell carcinoma (RCC), after failure of treatment with sunitinib or sorafenib |
Pat.
No. 8436010
Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use; Method of administration Pat. Sub. Date(s): All strengths: Jun 3, 2013 |
Aug 22, 2022 *PED | U-1396: Treatment of advanced hormone receptor positive, her2-negative breast cancer in combination with exemestane after failure of treatment with letrozole or anastrozole |
Pat.
No. 8778962
Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014 |
Aug 18, 2022 *PED | U-1541: Treatment of patients with tuberous sclerosis complex (TSC) who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. |
Pat.
No. 9006224
Neuroendocrine tumor treatment Claim Types: Method of use Pat. Sub. Date(s): All strengths: Apr 20, 2015 |
Jul 1, 2028 | U-1681: Treatment of patients with progessive neuroendocrine tumors of pancreatic origin (PNET) that are unresectable, locally advanced or metastatic |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 26, 2023 | ODE-108: Treatment of adult patients with progressive, well-differentiated, non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin, (excluding pancreatic) with unresectable, locally advanced or metastatic disease |
AFINITOR DISPERZ (TABLET, FOR SUSPENSION)
(ORAL) EVEROLIMUS [GENERIC AB]
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == Immunological Agents:Immunosuppressants
== kinase inhibitor == mTor inhibitor immunosuppressant
NDA Applicant:
NOVARTIS
PHARM NDA No.: 203985 Prod. No.:
001 RX (2MG); 002 RX (3MG); 003 RX (5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8617598
DP* Pharmaceutical compositions comprising colloidal
silicon dioxide Claim Types: Formulation; Method of use; Process Pat. Sub. Date(s): All strengths: Mar 27, 2014 |
Mar 27, 2023 *PED | |
Pat.
No. 8778962
Treatment of solid tumors with rapamycin derivatives Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 28, 2014 |
Aug 18, 2022 *PED | U-1541:
Treatment of patients with tuberous sclerosis complex (TSC) who have
subependymal giant cell astrocytoma (SEGA) that requires therapeutic
intervention but cannot be curatively resected. U-2280: Adjunctive treatment of patients with TSC-associated partial-onset seizures |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 10, 2025 | ODE-169: For the adjunctive treatment of adult and pediatric patients aged 2 years and older with tuberous sclerosis complex (TSC)-associated partial-onset seizures |
AGGRASTAT
(INJECTABLE; SOLUTION)
(INJECTION) TIROFIBAN HYDROCHLORIDE
Drug Classes:
anti-platelet agent
NDA Applicant:
MEDICURE NDA No.:
020912 Prod. No.:
002 RX (EQ 3.75MG BASE/15ML (EQ 0.25MG BASE/ML)) NDA No.: 020912 Prod. No.:
001 DISC (EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6770660
Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Nov 7, 2013; 002: Sep 29, 2016 |
May 1, 2023 | U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS |
AGGRASTAT
(SOLUTION) (INTRAVENOUS)
TIROFIBAN HYDROCHLORIDE [GENERIC AP]
Drug Classes:
anti-platelet agent
NDA Applicant:
MEDICURE NDA No.:
020913 Prod. No.:
002 RX (EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)); 003 RX
(EQ 12.5MG BASE/250ML (EQ 0.05MG BASE/ML)) NDA No.: 020913 Prod. No.:
001 DISC (EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6770660
Method for inhibiting platelet aggregation Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: None; 002: None; 003: Nov 7, 2013 |
May 1, 2023 | U-1444: A dosing regimen of AGGRASTAT (tirofiban hydrochloride)(25mcg/kg followed by 0.15mcg/kg/min infusion) to reduce the rate of thrombotic coronary events associated with acute coronary syndrome (ACS) in patients with non-ST elevation ACS |
AIRDUO DIGIHALER (POWDER) (INHALATION)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory
Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2
adrenergic agonist
NDA Applicant:
TEVA
PHARM NDA No.: 208799 Prod. No.:
004 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Jul 13, 2032 *PED | |
Pat.
No. 9066957
DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 |
Apr 6, 2035 *PED | U-645: Treatment of asthma |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Dec 28, 2031 *PED | |
Pat.
No. 9415008
DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 004: Aug 2, 2019 |
Apr 6, 2035 *PED | U-645: Treatment of asthma |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Nov 18, 2031 *PED | |
Pat.
No. 9782550
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Aug 2, 2019 |
Feb 28, 2036 *PED | |
Pat.
No. 9782551
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Feb 28, 2036 *PED | |
Pat.
No. 9987229
DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 004: Aug 2, 2019 |
Mar 1, 2025 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Aug 2, 2019 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10569034
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 12, 2020 |
Feb 16, 2037 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020 |
Nov 19, 2025 *PED | |
Pat.
No. 10918816
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 18, 2021 |
Jun 14, 2036 *PED | |
Pat.
No. 11000653
DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 004: Jun 10, 2021 |
Jun 18, 2039 *PED | |
Pat.
No. 11173259
DP* Drug delivery device with electronics and power
management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021 |
Jan 6, 2041 *PED | |
Pat.
No. 11266796
DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022 |
Aug 22, 2041 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Jan 9, 2025 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AIRDUO DIGIHALER
(POWDER) (INHALATION)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory
Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2
adrenergic agonist
NDA Applicant:
TEVA
PHARM NDA No.: 208799 Prod. No.:
005 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 006 RX
(0.232MG/INH;EQ 0.014MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Jul 13, 2032 *PED | |
Pat.
No. 9066957
DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Apr 6, 2035 *PED | U-645: Treatment of asthma |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Nov 18, 2031 *PED | |
Pat.
No. 9782550
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Feb 28, 2036 *PED | |
Pat.
No. 9782551
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Feb 28, 2036 *PED | |
Pat.
No. 9987229
DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Mar 1, 2025 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Aug 2, 2019 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10569034
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 12, 2020 |
Feb 16, 2037 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 |
Nov 19, 2025 *PED | |
Pat.
No. 10918816
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 18, 2021 |
Jun 14, 2036 *PED | |
Pat.
No. 11000653
DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): All strengths: Jun 10, 2021 |
Jun 18, 2039 *PED | |
Pat.
No. 11173259
DP* Drug delivery device with electronics and power
management Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2021 |
Jan 6, 2041 *PED | |
Pat.
No. 11266796
DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 7, 2022 |
Aug 22, 2041 *PED |
AIRDUO RESPICLICK (POWDER) (INHALATION)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory
Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2
adrenergic agonist
NDA Applicant:
TEVA
PHARM NDA No.: 208799 Prod. No.:
001 RX (0.055MG/INH;EQ 0.014MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Jul 13, 2032 *PED | |
Pat.
No. 9066957
DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 |
Apr 6, 2035 *PED | U-645: Treatment of asthma |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Dec 28, 2031 *PED | |
Pat.
No. 9415008
DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 30, 2017 |
Apr 6, 2035 *PED | U-645: Treatment of asthma |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 001: May 10, 2017 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 |
Nov 18, 2031 *PED | |
Pat.
No. 9987229
DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Jul 3, 2018 |
Mar 1, 2025 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 13, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Mar 5, 2019 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 |
Nov 19, 2025 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Jan 9, 2025 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AIRDUO RESPICLICK
(POWDER) (INHALATION)
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations == Respiratory
Tract/ Pulmonary Agents:Bronchodilators, Sympathomimetic == beta-2
adrenergic agonist
NDA Applicant:
TEVA
PHARM NDA No.: 208799 Prod. No.:
002 RX (0.113MG/INH;EQ 0.014MG BASE/INH); 003 RX
(0.232MG/INH;EQ 0.014MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Jul 13, 2032 *PED | |
Pat.
No. 9066957
DP* Dry powder inhaler Claim Types: Device; Method of use Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Apr 6, 2035 *PED | U-645: Treatment of asthma |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 |
Nov 18, 2031 *PED | |
Pat.
No. 9987229
DP* Process for preparing a medicament Claim Types: Product-by-process; Process Pat. Sub. Date(s): All strengths: Jul 3, 2018 |
Mar 1, 2025 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Dec 12, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 5, 2019 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 |
Nov 19, 2025 *PED |
AKLIEF
(CREAM) (TOPICAL)
TRIFAROTENE
Drug Classes:
Dermatological Agents:Acne
and Rosacea Agents
NDA Applicant:
GALDERMA LABS
LP NDA No.: 211527 Prod. No.:
001 RX (0.005%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7807708
DS* DP* Ligands that modulate RAR receptors and
pharmaceutical/cosmetic compositions comprised thereof Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Oct 31, 2019 |
Oct 1, 2026 | |
Pat.
No. 8227507
Ligands that modulate RAR receptors Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 31, 2019 |
Dec 21, 2025 | U-818: Topical treatment of acne vulgaris |
Pat.
No. 8470871
Ligands that modulate RAR receptors Claim Types: Method of use defined by mechanism of action Pat. Sub. Date(s): 001: Oct 31, 2019 |
Dec 21, 2025 | U-2639: Method of activating rargamma receptor |
Pat.
No. 9084778
DP* Topical compositions containing a retinoid of the
oil-in-water emulsion type Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 31, 2019 |
May 30, 2033 | U-134: Treatment of acne vulgaris |
Pat.
No. 9498465
DP* Topical compositions in the form of a gel containing a
particular solubilized retinoid Claim Types: Formulation; Formulation claimed by its inherent performace characteristics; Method of use Pat. Sub. Date(s): 001: Jun 17, 2021 |
May 30, 2033 | U-1033: Topical treatment of acne vulgaris |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Oct 4, 2024 |
AKTEN
(GEL) (OPHTHALMIC)
LIDOCAINE HYDROCHLORIDE
Drug Classes:
Anesthetics:Local
Anesthetics == amide local anesthetic == antiarrhythmic
NDA Applicant:
THEA
PHARMA NDA No.: 022221 Prod. No.:
001 RX (3.5%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8759401
DP* Aqueous gel formulation and method for inducing
topical anesthesia Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jun 30, 2014 |
Jul 24, 2026 | U-1523: Method of inducing topical anesthesia in the eye |
AKYNZEO
(CAPSULE) (ORAL)
NETUPITANT; PALONOSETRON HYDROCHLORIDE
Drug Classes:
Antiemetics:Emetogenic
Therapy Adjuncts == substance P/neurokinin-1 (NK-1) receptor
antagonist == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant:
HELSINN
HLTHCARE NDA No.: 205718 Prod. No.:
001 RX (300MG;EQ 0.5MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6297375
DS* 4-phenyl-pyridine derivatives Claim Types: Compound Pat. Sub. Date(s): 001: Nov 6, 2014 |
Mar 17, 2023 | |
Pat.
No. 8623826
Compositions and methods for treating centrally mediated nausea and
vomiting Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 6, 2014 |
Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
Pat.
No. 8951969
DP* Compositions and methods for treating centrally
mediated nausea and vomiting Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 6, 2015 |
Nov 18, 2030 | |
Pat.
No. 9186357
Compositions and methods for treating centrally mediated nausea and
vomiting Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Dec 2, 2015 |
Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
Pat.
No. 9271975
Compositions and methods for treating centrally mediated nausea and
vomiting Claim Types: Method of administration; Method of use Pat. Sub. Date(s): 001: Jul 14, 2016 |
Sep 9, 2031 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
Pat.
No. 9943515
Compositions and methods for treating centrally mediated nausea and
vomiting Claim Types: Method of use Pat. Sub. Date(s): 001: May 16, 2018 |
Nov 18, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
Pat.
No. 9951016
DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: Formulation; New polymorph, salt or hydrate Pat. Sub. Date(s): 001: May 16, 2018 |
Sep 25, 2035 | |
Pat.
No. 10233154
DS* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Mar 28, 2019 |
Sep 25, 2035 | |
Pat.
No. 10676440
DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate; Composition Pat. Sub. Date(s): 001: Jul 8, 2020 |
Sep 25, 2035 | |
Pat.
No. 10828297
Compositions and methods for treating centrally mediated nausea and
vomiting Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 4, 2020 |
Dec 17, 2030 | U-2293: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of cancer chemotherapy, including, but not limited to, highly emetogenic chemotherapy |
Pat.
No. 10961195
DS* DP* Crystalline forms of an NK-1 antagonist Claim Types: New polymorph, salt or hydrate Pat. Sub. Date(s): 001: Apr 15, 2021 |
Sep 25, 2035 |
AKYNZEO (POWDER; SOLUTION)
(INTRAVENOUS) FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON
HYDROCHLORIDE
Drug Classes:
Antiemetics:Emetogenic
Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant:
HELSINN
HLTHCARE NDA No.: 210493 Prod. No.:
001 RX (EQ 235MG BASE/VIAL;EQ 0.25MG BASE/VIAL); 002 RX
(EQ 235MG BASE/20ML (EQ 11.75MG BASE/ML);EQ 0.25MG BASE/20ML (EQ
0.0125MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8426450
DS* DP* Substituted 4-phenyl pyridines having
anti-emetic effect Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020 |
May 23, 2032 | |
Pat.
No. 8895586
Methods of treating emesis Claim Types: Method of use Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020 |
May 23, 2032 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
Pat.
No. 9186357
Compositions and methods for treating centrally mediated nausea and
vomiting Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020 |
Nov 18, 2030 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
Pat.
No. 9403772
DS*
4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-tol-
yl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-ium as a
neurokinin receptor modulator Claim Types: New polymorph, salt or hydrate; Method of use; Process; Compound Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020 |
May 23, 2032 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
Pat.
No. 9908907
DS* DP* Substituted piperaziniums for the
treatment of emesis Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 17, 2018; 002: Jun 24, 2020 |
May 23, 2032 | |
Pat.
No. 10208073
Solution comprising the chloride hydrochloride salt of
4-(5-(2-(3,5-bis(trifluoromethyl)phenyl)-N,2-dimethylpropanamido)-4-(o-to-
lyl)pyridin-2-yl)-1-methyl-1-((phosphonooxy)methyl)piperazin-1-IUM-(fosnet-
upitant) and palonosetron hydrochloride in combination with
dexamethasone as a neurokinin receptor modulator Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 8, 2019; 002: Jun 24, 2020 |
May 23, 2032 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
Pat.
No. 10624911
DP* Physiologically balanced injectable formulations of
fosnetupitant Claim Types: Formulation; Process; Product-by-process Pat. Sub. Date(s): 001: May 26, 2020; 002: Jun 24, 2020 |
Jun 2, 2037 | |
Pat.
No. 10717721
DS* Substituted piperaziniums for the treatment of emesis Claim Types: Compound Pat. Sub. Date(s): All strengths: Aug 19, 2020 |
May 23, 2032 | |
Pat.
No. 10828297
Compositions and methods for treating centrally mediated nausea and
vomiting Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 9, 2020 |
Dec 17, 2030 | U-2301: Use in combination with dexamethasone in adults for the prevention of acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Apr 19, 2023 |
ALDARA
(CREAM) (TOPICAL)
IMIQUIMOD [GENERIC AB]
Drug Classes:
Dermatological
Agents:Dermatological Agents, Other
NDA Applicant:
BAUSCH NDA No.:
020723 Prod. No.:
001 RX (5%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7696159
DS* Treatment for basal cell carcinoma Claim Types: Method of use Pat. Sub. Date(s): 001: May 12, 2010 |
Oct 1, 2024 *PED | U-1047:
Treatment of biopsy-confirmed, primary superficial basal cell carcinoma
(SBCC) U-1048: Works through the induction of interferon and other cytokines |
ALECENSA
(CAPSULE) (ORAL)
ALECTINIB HYDROCHLORIDE
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == kinase inhibitor
NDA Applicant:
HOFFMANN-LA
ROCHE NDA No.: 208434 Prod. No.:
001 RX (EQ 150MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9126931
DS* Tetracyclic compound Claim Types: Compound Pat. Sub. Date(s): 001: Dec 22, 2015 |
May 29, 2031 | |
Pat.
No. 9365514
DP* Composition comprising tetracyclic compound Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 11, 2016 |
Mar 4, 2032 | |
Pat.
No. 9440922
DP* Tetracyclic compound Claim Types: Composition Pat. Sub. Date(s): 001: Oct 12, 2016 |
Jun 9, 2030 | |
Pat.
No. 10350214
DP* Preparation containing tetracyclic compound at high
dose Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Mar 9, 2020 |
Apr 24, 2035 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Dec 11, 2022 | ODE-105: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC), who have progressed on or are intolerant to crizotinib |
Exclusivity Code: ODE - Orphan drug exclusivity | Nov 6, 2024 | ODE-159: For treatment of patients with anaplastic lymphoma kinase (ALK) positive, metastatic non-small-cell lung cancer (NSCLC) as detected by an FDA approved test, excluding patients who have progressed on or are intolerant to crizotinib |
ALIMTA
(POWDER) (INTRAVENOUS)
PEMETREXED DISODIUM
Drug Classes:
Antineoplastics:Antineoplastics,
Other == folate analog metabolic inhibitor
NDA Applicant:
LILLY NDA No.:
021462 Prod. No.:
001 RX (EQ 500MG BASE/VIAL); 002 RX (EQ 100MG BASE/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7772209
Antifolate combination therapies Claim Types: Method of administration Pat. Sub. Date(s): All strengths: None |
May 24, 2022 *PED | U-1296: Use of Pemetrexed with prior and/or repeated vitamin B12 and folic acid administration |
ALIQOPA
(POWDER) (INTRAVENOUS)
COPANLISIB DIHYDROCHLORIDE
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == kinase inhibitor
NDA Applicant:
BAYER
HEALTHCARE NDA No.: 209936 Prod. No.:
001 RX (60MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. RE46856
DS* DP* Substituted
2,3-dihydroimidazo[1,2-c]quinazoline derivatives useful for treating
hyper-proliferative disorders and diseases associated with angiogenesis Claim Types: Compound; Composition; Kit; Method of use Pat. Sub. Date(s): 001: Jun 15, 2018 |
Oct 22, 2029 | U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
Pat.
No. 7511041
DS* DP* Fused azole-pyrimidine derivatives Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Oct 10, 2017 |
May 13, 2024 | |
Pat.
No. 9636344
Substituted 2,3-dihydroimidazo[1,2-C]quinazoline salts Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 10, 2017 |
Mar 29, 2032 | U-2124: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
Pat.
No. 10383876
DS* DP* Substituted
2,3-dihydroimidazo[1,2-c]quinazoline salts Claim Types: Compound; New polymorph, salt or hydrate; Process; Method of use; Composition Pat. Sub. Date(s): 001: Sep 18, 2019 |
Mar 29, 2032 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Sep 14, 2022 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Sep 14, 2024 | ODE-155: Treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies |
ALKINDI SPRINKLE (GRANULE) (ORAL)
HYDROCORTISONE
NDA Applicant:
ETON NDA No.:
213876 Prod. No.:
001 RX (0.5MG); 002 RX (1MG); 003 RX (2MG); 004
RX (5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9649280
DP* Composition comprising hydrocortisone Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2021 |
May 12, 2034 | U-3075: Treatment of adrenal insufficiency |
Pat.
No. 9675559
Treatment of adrenal insufficiency Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2021 |
Jan 10, 2033 | U-3075: Treatment of adrenal insufficiency |
Pat.
No. 9717740
Treatment of adrenal insufficiency Claim Types: Method of use Pat. Sub. Date(s): All strengths: Mar 3, 2021 |
Nov 19, 2032 | U-3075: Treatment of adrenal insufficiency |
ALLEGRA, CHILDREN'S ALLERGY;
ALLEGRA, CHILDREN'S HIVES (SUSPENSION) (ORAL) FEXOFENADINE HYDROCHLORIDE [GENERIC OTC]
Drug Classes:
histamine-1 (H1) receptor
antagonist
NDA Applicant:
CHATTEM
SANOFI NDA No.: 201373 Prod. No.:
001 OTC (30MG/5ML) NDA No.: 201373 Prod. No.:
002 DISC (30MG/5ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8933097
DP* Fexofenadine suspension formulation Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 19, 2015 |
Aug 2, 2030 |
ALOXI
(INJECTABLE)
(INTRAVENOUS) PALONOSETRON HYDROCHLORIDE
[Has competitive generic]
Drug Classes:
Antiemetics:Emetogenic
Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant:
HELSINN
HLTHCARE NDA No.: 021372 Prod. No.:
001 DISC (EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7947724
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: May 27, 2011 |
Jul 30, 2024 *PED | |
Pat.
No. 7947725
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jul 30, 2024 *PED | |
Pat.
No. 7960424
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jul 30, 2024 *PED | |
Pat.
No. 8518981
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Sep 3, 2013 |
Jul 30, 2024 *PED | |
Pat.
No. 8598218
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: None |
Jul 30, 2024 *PED | |
Pat.
No. 8598219
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jul 30, 2024 *PED | |
Pat.
No. 8729094
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: May 21, 2014 |
Jul 30, 2024 *PED | U-528: Prevention of chemotherapy-induced nausea and vomiting |
Pat.
No. 9066980
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Jul 22, 2015 |
Jul 30, 2024 *PED | U-528: Prevention of chemotherapy-induced nausea and vomiting |
Pat.
No. 9125905
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation; Process; Drug in a container Pat. Sub. Date(s): 001: Sep 9, 2015 |
Jul 30, 2024 *PED | |
Pat.
No. 9173942
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 5, 2015 |
Jul 30, 2024 *PED | |
Pat.
No. 9439854
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Sep 27, 2016 |
Jul 30, 2024 *PED | |
Pat.
No. 9457020
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 001: Oct 25, 2016 |
Jul 30, 2024 *PED | |
Pat.
No. 9457021
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 25, 2016 |
Jul 30, 2024 *PED |
ALOXI (INJECTABLE) (INTRAVENOUS)
PALONOSETRON HYDROCHLORIDE
Drug Classes:
Antiemetics:Emetogenic
Therapy Adjuncts == serotonin-3 (5-HT3) receptor antagonist
NDA Applicant:
HELSINN
HLTHCARE NDA No.: 021372 Prod. No.:
002 DISC (EQ 0.075MG BASE/1.5ML (EQ 0.05MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7947724
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None |
Jul 30, 2024 *PED | |
Pat.
No. 7947725
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None |
Jul 30, 2024 *PED | |
Pat.
No. 7960424
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: None |
Jul 30, 2024 *PED | |
Pat.
No. 8518981
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Sep 3, 2013 |
Jul 30, 2024 *PED | |
Pat.
No. 8598218
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: None |
Jul 30, 2024 *PED | |
Pat.
No. 9173942
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Formulation Pat. Sub. Date(s): 002: Nov 5, 2015 |
Jul 30, 2024 *PED | |
Pat.
No. 9439854
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Composition; Formulation Pat. Sub. Date(s): 002: Sep 27, 2016 |
Jul 30, 2024 *PED | |
Pat.
No. 9457020
DP* Liquid pharmaceutical formulations of palonosetron Claim Types: Product-by-process; Process Pat. Sub. Date(s): 002: Oct 25, 2016 |
Jul 30, 2024 *PED |
ALPHAGAN
P (SOLUTION/DROPS)
(OPHTHALMIC) BRIMONIDINE TARTRATE [GENERIC
AT]
Drug Classes:
Dermatological Agents:Acne
and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure
Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
== alpha adrenergic agonist
NDA Applicant:
ALLERGAN NDA No.:
021262 Prod. No.:
001 RX (0.15%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6562873
Compositions containing therapeutically active components having
enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 10, 2022 *PED | |
Pat.
No. 6627210
DP* Compositions containing .alpha.-2-adrenergic agonist
components Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 18, 2022 *PED | |
Pat.
No. 6641834
DP* Compositions containing alpha-2-adrenergic agonist
components Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 28, 2022 *PED | |
Pat.
No. 6673337
DP* Compositions containing alpha-2-adrenergic agonist
components Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 26, 2022 *PED | |
Pat.
No. 9295641
Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 |
Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
ALPHAGAN P
(SOLUTION/DROPS)
(OPHTHALMIC) BRIMONIDINE TARTRATE
Drug Classes:
Dermatological Agents:Acne
and Rosacea Agents == Ophthalmic Agents:Intraocular Pressure
Lowering Agents == Ophthalmic Agents:Ophthalmic Combinations
== alpha adrenergic agonist
NDA Applicant:
ALLERGAN NDA No.:
021770 Prod. No.:
001 RX (0.1%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6562873
DP* Compositions containing therapeutically active
components having enhanced solubility Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 10, 2022 *PED | |
Pat.
No. 6627210
DP* Compositions containing .alpha.-2-adrenergic agonist
components Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 18, 2022 *PED | |
Pat.
No. 6641834
DP* Compositions containing alpha-2-adrenergic agonist
components Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 28, 2022 *PED | |
Pat.
No. 6673337
DP* Compositions containing alpha-2-adrenergic agonist
components Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 26, 2022 *PED | |
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 | |
Pat.
No. 9295641
Compositions containing alpha-2-adrenergic agonist components Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 28, 2016 |
Jan 10, 2022 *PED | U-1833: Reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension |
Pat.
No. 9687443
DP* Compositions containing alpha-2-adrenergic agonist
components Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 10, 2017 |
Jan 10, 2022 *PED |
ALSUMA
(INJECTABLE)
(SUBCUTANEOUS) SUMATRIPTAN SUCCINATE [Has
competitive generic]
Drug Classes:
Antimigraine
Agents:Serotonin (5-HT) Receptor Agonists == serotonin
5-HT1B/1D receptor agonist (triptan)
NDA Applicant:
MERIDIAN
MEDCL NDA No.: 022377 Prod. No.:
001 DISC (EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7811254
DP* Autoinjector with needle depth adapter Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Oct 13, 2010 |
Aug 26, 2027 | U-1083: Acute treatment of migraine attacks, with or without aura, and the treatment of cluster headache episodes |
ALTABAX
(OINTMENT) (TOPICAL)
RETAPAMULIN
Drug Classes:
Dermatological
Agents:Topical Anti-infectives == pleuromutilin antibacterial
NDA Applicant:
ALMIRALL NDA No.:
022055 Prod. No.:
001 RX (1%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7875630
DS* Process salts compositions and use Claim Types: New polymorph, salt or hydrate; Composition; Formulation; Process Pat. Sub. Date(s): 001: Feb 10, 2011 |
Feb 14, 2027 | |
Pat.
No. 8207191
Process, salts, composition and use Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 13, 2016 |
Aug 30, 2024 | U-805: Treatment of impetigo due to staphylococcus aureus or streptococcus pyogenes |
ALTRENO
(LOTION) (TOPICAL)
TRETINOIN
Drug Classes:
Antineoplastics:Retinoids
== Dermatological Agents:Acne and Rosacea Agents
NDA Applicant:
DOW
PHARM NDA No.: 209353 Prod. No.:
001 RX (0.05%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 10653656
DP* Topical pharmaceutical compositions for treating skin
conditions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: May 28, 2020 |
Aug 22, 2038 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NDF - New dosage form | Aug 23, 2021 |
ALUNBRIG
(TABLET) (ORAL)
BRIGATINIB
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == kinase inhibitor
NDA Applicant:
TAKEDA PHARMS
USA NDA No.: 208772 Prod. No.:
001 RX (30MG); 002 RX (90MG); 003 RX (180MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9012462
DS* Phosphorous derivatives as kinase inhibitors Claim Types: Compound; Composition Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017 |
Jul 31, 2030 | |
Pat.
No. 9273077
Phosphorus derivatives as kinase inhibitors Claim Types: Method of use Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017 |
May 21, 2029 | U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) |
Pat.
No. 9611283
Methods for inhibiting cell proliferation in ALK-driven cancers Claim Types: Method of use Pat. Sub. Date(s): 001: May 26, 2017; 002: May 26, 2017; 003: Oct 23, 2017 |
Apr 10, 2034 | U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) |
Pat.
No. 10385078
DS* DP* Crystalline forms of
5-chloro-N4-[-2-(dimethylphosphoryl)phenyl]-N2-{2-methoxy-4-[4-(4-methylp-
iperazin-1-YL) piperidin-1-YL]phenyl}pyrimidine-2,4-diamine Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Sep 10, 2019 |
Nov 10, 2035 | U-2837: Treatment of anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | May 22, 2023 | I-847: Expanded indication of the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test |
Exclusivity Code: NCE - New chemical entity | Apr 28, 2022 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Apr 28, 2024 | ODE-142: Treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib |
Exclusivity Code: ODE - Orphan drug exclusivity | May 22, 2027 | ODE-300: For the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test, not including patients who have progressed on or are intolerant to crizotinib |
ALVESCO
(AEROSOL, METERED)
(INHALATION) CICLESONIDE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids
NDA Applicant:
COVIS NDA No.:
021658 Prod. No.:
002 RX (0.08MG/INH); 003 RX (0.16MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8371292
Use of ciclesonide for the treatment of respiratory diseases Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Feb 1, 2028 | U-1355: Maintenance treatment of asthma as prophylactic therapy in adult and adolescent patients 12 years of age and older. patent claims method for treating a respiratory disease in a child |
AMELUZ
(GEL) (TOPICAL)
AMINOLEVULINIC ACID HYDROCHLORIDE
Drug Classes:
porphyrin precursor
NDA Applicant:
BIOFRONTERA NDA No.:
208081 Prod. No.:
001 RX (10%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 11235169
Illumination device for photodynamic therapy, method for treating a
skin disease and method for operating an illumination device Claim Types: Device; Method of use; Method of administration Pat. Sub. Date(s): 001: Feb 23, 2022 |
Oct 15, 2040 | U-3303: Topical lesion-directed and field-directed treatment of actinic keratosis of the face and scalp with photodynamic therapy by positioning an illumination device in an appropriate distance and illuminating the treatment area with narrowband red light |
AMITIZA
(CAPSULE) (ORAL)
LUBIPROSTONE [GENERIC AB]
Drug Classes:
Gastrointestinal
Agents:Anti-Constipation Agents == chloride channel activator
NDA Applicant:
SUCAMPO PHARMA
LLC NDA No.: 021908 Prod. No.:
001 RX (24MCG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6982283
Method for treating drug-induced constipation Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2013 |
Dec 4, 2022 | U-1391: Method for treating opioid-induced constipation |
Pat.
No. 7064148
Chloride channel opener Claim Types: Method of use Pat. Sub. Date(s): 001: None |
Aug 30, 2022 | U-1404:
Method for treating constipation in a patient with opioid-induced
constipation by opening CIC channels U-739: Method for treating constipation by opening CIC channels in a mammalian subject |
Pat.
No. 8026393
DP* Soft-gelatin capsule formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 26, 2011 |
Oct 25, 2027 | |
Pat.
No. 8097653
Dosage unit comprising a prostaglandin analog for treating constipation Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 18, 2012 |
Nov 14, 2022 | U-1214:
Method for relieving constipation in a human patient that comprises
administering to the patient a dosage unit comprising (i) 24mcg+/- 10%
of a drug substance and (ii) a pharmaceutically suitable excipient U-1394: Method for relieving constipation in a patient with opioid-induced constipation that comprises administering to the patient a dosage unit comprising(i)24microg+/- 10% of a drug substance and (ii) a pharmaceutically suitable excipient |
Pat.
No. 8338639
DP* Soft-gelatin capsule formulation Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 20, 2012 |
Jan 23, 2027 | |
Pat.
No. 8389542
DP* Dosage unit comprising a prostaglandin analog for
treating constipation Claim Types: Formulation Pat. Sub. Date(s): 001: Feb 22, 2013 |
Nov 14, 2022 | U-1345:
Use in relieving or preventing constipation in a human patient with a
dosage unit comprising 24microg+/- 10% of a drug substance and a
pharmaceutically suitable excipient U-1395: Use in relieving or preventing constipation in a patient with opioid-induced constipation with a dosage unit comprising 24microg +/- 10% of a drug substance and a pharmaceutically suitable excipient |
Pat.
No. 8748481
Method for treating gastrointestinal disorder Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 20, 2014 |
Sep 1, 2025 | U-1520: Method for the long term treatment of chronic constipation in a human subject |
Pat.
No. 8779187
DP* Soft-gelatin capsule formulation Claim Types: Formulation; Process Pat. Sub. Date(s): 001: Aug 7, 2014 |
Jan 23, 2027 |
AMITIZA (CAPSULE) (ORAL)
LUBIPROSTONE [GENERIC AB]
Drug Classes:
Gastrointestinal
Agents:Anti-Constipation Agents == chloride channel activator
NDA Applicant:
SUCAMPO PHARMA
LLC NDA No.: 021908 Prod. No.:
002 RX (8MCG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7064148
Chloride channel opener Claim Types: Method of use Pat. Sub. Date(s): 002: None |
Aug 30, 2022 | U-739:
Method for treating constipation by opening CIC channels in a mammalian
subject U-873: Method of treating constipation in a patient with irritable bowel syndrome by opening chloride channels (CIC) |
Pat.
No. 7795312
Method for treating abdominal discomfort Claim Types: Method of use Pat. Sub. Date(s): 002: None |
Sep 17, 2024 | U-1085: Method for treating irritable bowel syndrome and method for treating abdominal discomfort associated with irritable bowel syndrome |
Pat.
No. 8026393
DP* Soft-gelatin capsule formulation Claim Types: Formulation; Method of use Pat. Sub. Date(s): 002: None |
Oct 25, 2027 | |
Pat.
No. 8338639
DP* Soft-gelatin capsule formulation Claim Types: Formulation Pat. Sub. Date(s): 002: None |
Jan 23, 2027 | |
Pat.
No. 8748481
Method for treating gastrointestinal disorder Claim Types: Method of use Pat. Sub. Date(s): 002: Jun 20, 2014 |
Sep 1, 2025 | U-1519: Method for the long term treatment of chronic constipation in a human subject with irritable bowel syndrome |
Pat.
No. 8779187
DP* Soft-gelatin capsule formulation Claim Types: Formulation; Process Pat. Sub. Date(s): 002: Aug 7, 2014 |
Jan 23, 2027 |
AMLODIPINE BESYLATE (TABLET, ORALLY
DISINTEGRATING) (ORAL) AMLODIPINE BESYLATE
Drug Classes:
Cardiovascular
Agents:Calcium Channel Blocking Agents, Dihydropyridines == Cardiovascular
Agents:Cardiovascular Combinations == dihydropyridine calcium
channel blocker
NDA Applicant:
SYNTHON
PHARMS NDA No.: 022026 Prod. No.:
001 DISC (EQ 2.5MG BASE); 002 DISC (EQ 5MG BASE); 003
DISC (EQ 10MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6828339
DS* Amlodipine salt forms and processes for preparing them Claim Types: New polymorph, salt or hydrate; Formulation Pat. Sub. Date(s): All strengths: None |
Nov 20, 2022 |
AMONDYS
45 (SOLUTION)
(INTRAVENOUS) CASIMERSEN
Drug Classes:
antisense oligonucleotide
NDA Applicant:
SAREPTA THERAPS
INC NDA No.: 213026 Prod. No.:
001 RX (100MG/2ML (50MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. RE48960
DS* DP* Antisense oligonucleotides for inducing
exon skipping and methods of use thereof Claim Types: Compound; Method of use; Formulation Pat. Sub. Date(s): 001: Mar 31, 2022 |
Jun 28, 2025 | U-3087:
Treatment of Duchenne muscular dystrophy (DMD) in patients who have a
mutation of the DMD gene that is amenable to exon 45 skipping by
inducing exon-skipping of exon 45 U-3088: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping |
Pat.
No. 9228187
DS* DP* Antisense molecules and methods for
treating pathologies Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 23, 2021 |
Nov 12, 2030 | |
Pat.
No. 9447415
DS* DP* Antisense oligonucleotides for inducing
exon skipping and methods of use thereof Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 23, 2021 |
Jun 28, 2025 | |
Pat.
No. 9758783
Antisense molecules and methods for treating pathologies Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 23, 2021 |
Nov 12, 2030 | U-3088:
Treatment of Duchenne muscular dystrophy (DMD) in patients who have a
mutation of the DMD gene that is amenable to exon 45 skipping U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production |
Pat.
No. 10287586
DS* DP* Antisense molecules and methods for
treating pathologies Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Mar 23, 2021 |
Nov 12, 2030 | |
Pat.
No. 10781450
Antisense molecules and methods for treating pathologies Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 23, 2021 |
Nov 12, 2030 | U-3089: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a mutation of the DMD gene that is amenable to exon 45 skipping by restoring an MRNA reading frame to induce dystrophin protein production |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Feb 25, 2026 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Feb 25, 2028 | ODE-347: Treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping |
AMPHOTERICIN
B (INJECTABLE,
LIPOSOMAL) (INJECTION) AMPHOTERICIN B
[GENERIC AB]
Drug Classes:
Antifungals == lipid-based
polyene antifungal
NDA Applicant:
SPIL NDA No.:
212514 Prod. No.:
001 RX (50MG/VIAL)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Aug 14, 2022 |
AMRIX
(CAPSULE, EXTENDED
RELEASE) (ORAL) CYCLOBENZAPRINE HYDROCHLORIDE
[GENERIC AB]
Drug Classes:
Skeletal Muscle Relaxants
NDA Applicant:
TEVA PHARMS
INTL NDA No.: 021777 Prod. No.:
001 RX (15MG); 002 RX (30MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7387793
DP* Modified release dosage forms of skeletal muscle
relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Feb 26, 2025 | |
Pat.
No. 7544372
Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Nov 14, 2023 | U-979: Relief of muscle spasm |
Pat.
No. 7790199
DP* Modified release dosage forms of skeletal muscle
relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Nov 14, 2023 | |
Pat.
No. 7820203
DP* Modified release dosage forms of skeletal muscle
relaxants Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Nov 14, 2023 | |
Pat.
No. 7829121
Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Nov 14, 2023 | U-1088: Relief of muscle spasm |
Pat.
No. 8877245
Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 1, 2018 |
Nov 14, 2023 | U-979: Relief of muscle spasm |
Pat.
No. 9375410
Modified release dosage forms of skeletal muscle relaxants Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 12, 2016 |
Nov 14, 2023 | U-1088: Relief of muscle spasm |
Pat.
No. 9399025
DP* Modified release dosage forms of skeletal muscle
relaxants Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Aug 4, 2016 |
Nov 14, 2023 | U-979: Relief of muscle spasm |
AMTURNIDE
(TABLET) (ORAL)
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
Drug Classes:
Cardiovascular
Agents:Cardiovascular Agents, Other == Cardiovascular
Agents:Cardiovascular Combinations == renin inhibitor == Cardiovascular
Agents:Calcium Channel Blocking Agents, Dihydropyridines == dihydropyridine
calcium channel blocker == Cardiovascular Agents:Diuretics,
Thiazide == thiazide diuretic
NDA Applicant:
NOVARTIS NDA No.:
200045 Prod. No.:
001 DISC (EQ 150MG BASE;EQ 5MG BASE;12.5MG); 002 DISC
(EQ 300MG BASE;EQ 5MG BASE;12.5MG); 003 DISC (EQ 300MG BASE;EQ
5MG BASE;25MG); 004 DISC (EQ 300MG BASE;EQ 10MG BASE;12.5MG); 005
DISC (EQ 300MG BASE;EQ 10MG BASE;25MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8183295
DP* Pharmaceutical composition comprising a renin
inhibitor, a calcium channel blocker and a diuretic Claim Types: Formulation Pat. Sub. Date(s): 001: Jan 3, 2013; 002: None; 003: None; 004: None; 005: None |
May 16, 2023 |
AMYVID
(SOLUTION) (INTRAVENOUS)
FLORBETAPIR F-18
Drug Classes:
radioactive diagnostic
agent
NDA Applicant:
AVID RADIOPHARMS
INC NDA No.: 202008 Prod. No.:
002 RX (10-30ML (13.5-51mCi/ML)); 003 RX (10-50ML
(13.5-51mCi/ML))
NDA No.: 202008 Prod. No.:
001 DISC (10ML (13.5-51mCi/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7687052
DS* DP* Styrylpyridine derivatives and their use
for binding and imaging amyloid plaques Claim Types: Compound; Formulation; Diagnostic or surgical method Pat. Sub. Date(s): 001: May 4, 2012; 002: None; 003: None |
Apr 30, 2027 | |
Pat.
No. 8506929
DS* DP* Styrylpyridine derivatives and their use
for binding and imaging amyloid plaques Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Sep 6, 2013; 002: None; 003: None |
Apr 30, 2027 | U-1423: Amyvid is a radioactive diagnostic agent for positron emission tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment |
AMZEEQ
(AEROSOL, FOAM)
(TOPICAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes:
Antibacterials:Tetracyclines
== Dental and Oral Agents == tetracycline-class drug
NDA Applicant:
JOURNEY NDA No.:
212379 Prod. No.:
001 RX (EQ 4% BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8865139
DP* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 8945516
DP* Surfactant-free water-free foamable compositions,
breakable foams and gels and their uses Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | |
Pat.
No. 8992896
DP* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 9675700
DP* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 10086080
Topical tetracycline compositions Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 10137200
Surfactant-free water-free foamable compositions, breakable foams and
gels and their uses Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 10213512
DP* Topical tetracycline compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 10265404
DP* Compositions, gels and foams with rheology modulators
and uses thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Nov 15, 2019 |
Oct 1, 2030 | |
Pat.
No. 10398641
Compositions and methods for treating rosacea and acne Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 15, 2019 |
Sep 8, 2037 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 10517882
Method for healing of an infected acne lesion without scarring Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 10, 2020 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 10821187
Compositions, gels and foams with rheology modulators and uses thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 16, 2020 |
Oct 1, 2030 | U-2647: Treatment of non-nodular acne vulgaris |
Pat.
No. 10849847
Compositions and methods for treating rosacea and acne Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 9, 2020 |
Sep 8, 2037 | U-2647: Treatment of non-nodular acne vulgaris |
ANDROGEL
(GEL, METERED)
(TRANSDERMAL) TESTOSTERONE [GENERIC AB]
Drug Classes:
Hormonal Agents,
Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant:
ABBVIE NDA No.:
022309 Prod. No.:
001 RX (1.62% (20.25MG/1.25GM ACTUATION)) NDA No.: 022309 Prod. No.:
002 DISC (1.62% (20.25MG/1.25GM PACKET)); 003 DISC
(1.62% (40.5MG/2.5GM PACKET))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8466136
DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jun 24, 2013 |
Oct 12, 2026 | |
Pat.
No. 8466137
Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 |
Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
Pat.
No. 8466138
Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 24, 2013 |
Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
Pat.
No. 8486925
DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 19, 2013 |
Oct 12, 2026 | |
Pat.
No. 8729057
DP* Testosterone gel and method of use Claim Types: Composition Pat. Sub. Date(s): 001: None; 002: Jun 13, 2014; 003: Jun 13, 2014 |
Oct 12, 2026 | |
Pat.
No. 8741881
Testosterone gel and method of use Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 25, 2014 |
Oct 12, 2026 | U-1103: Testosterone replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone |
Pat.
No. 8754070
DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 16, 2014 |
Oct 12, 2026 | |
Pat.
No. 8759329
DP* Testosterone gel and method of use Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 9, 2014 |
Oct 12, 2026 |
ANGELIQ
(TABLET) (ORAL)
DROSPIRENONE; ESTRADIOL
Drug Classes:
Contraceptives:Oral
Contraceptives Combinations == Contraceptives:Oral Progestins
== Hormonal Agents, Stimulant/ Replacement/ Modifying (Sex
Hormones/ Modifiers):Estrogens == Hormonal Agents, Stimulant/
Replacement/ Modifying (Sex Hormones/ Modifiers):Hormonal Agents,
Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers), Other
NDA Applicant:
BAYER
HLTHCARE NDA No.: 021355 Prod. No.:
001 RX (0.25MG;0.5MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8906890
DP* Very low-dosed solid oral dosage forms for HRT Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: Jan 8, 2015 |
Oct 22, 2031 |
ANGIOMAX
(INJECTABLE)
(INTRAVENOUS) BIVALIRUDIN [GENERIC AP]
Drug Classes:
anticoagulant == direct
thrombin inhibitor
NDA Applicant:
SANDOZ
INC NDA No.: 020873 Prod. No.:
001 RX (250MG/VIAL)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7582727
DP* Pharmaceutical formulations of bivalirudin and
processes of making the same Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jan 27, 2029 *PED | |
Pat.
No. 7598343
DP* Pharmaceutical formulations of bivalirudin and
processes of making the same Claim Types: Product-by-process Pat. Sub. Date(s): 001: None |
Jan 27, 2029 *PED |
ANJESO
(SOLUTION) (INTRAVENOUS)
MELOXICAM
Drug Classes:
Analgesics:Nonsteroidal
Anti-inflammatory Drugs
NDA Applicant:
BAUDAX NDA No.:
210583 Prod. No.:
001 RX (30MG/ML (30MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8512727
DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Process; Method of use Pat. Sub. Date(s): 001: Mar 6, 2020 |
Dec 25, 2022 | U-2750: Management of moderate-to-severe pain by intravenous injection |
Pat.
No. 9974746
DP* Reduction of flake-like aggregation in nanoparticulate
active agent compositions Claim Types: Product-by-process Pat. Sub. Date(s): 001: Mar 6, 2020 |
May 26, 2030 | |
Pat.
No. 10463673
DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Mar 6, 2020 |
Feb 24, 2024 | U-2750: Management of moderate-to-severe pain by intravenous injection |
Pat.
No. 10471067
DP* Nanoparticulate meloxicam formulations Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Mar 6, 2020 |
Feb 24, 2024 | U-2750: Management of moderate-to-severe pain by intravenous injection |
Pat.
No. 10709713
Nanoparticulate meloxicam formulations Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 24, 2020 |
May 26, 2030 | U-2750: Management of moderate-to-severe pain by intravenous injection |
Pat.
No. 10881663
Method of treating pain in elderly patients with mild renal impairment Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 19, 2021 |
Mar 8, 2039 | U-3038: Management of moderate-to-severe pain by intravenous injection in patients with mild renal impairment |
Pat.
No. 11253478
DP* Reduction of flake-like aggregation in nanoparticulate
active agent compositions Claim Types: Formulation claimed by its inherent performace characteristics Pat. Sub. Date(s): 001: Mar 4, 2022 |
May 26, 2030 | U-3318: Management of moderate-to-severe pain by injection |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Feb 20, 2023 |
ANNOVERA
(RING) (VAGINAL)
ETHINYL ESTRADIOL; SEGESTERONE ACETATE
Drug Classes:
Hormonal Agents,
Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Estrogens
== Contraceptives:Contraceptives, Other == progestin/estrogen
CHC
NDA Applicant:
THERAPEUTICSMD
INC NDA No.: 209627 Prod. No.:
001 RX (0.013MG/24HR;0.15MG/24HR)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 10632066
Method of providing birth control Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 29, 2020 |
Feb 1, 2039 | U-2786:
Method of preventing pregnancy by inserting a vaginal system containing
103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a
vagina for up to thirteen 21/7-day (in/out) cycles U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception |
Pat.
No. 10765628
Method of providing birth control Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2020 |
Feb 1, 2039 | U-2786:
Method of preventing pregnancy by inserting a vaginal system containing
103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a
vagina for up to thirteen 21/7-day (in/out) cycles U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception |
Pat.
No. 10780047
Method of providing birth control Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2020 |
Feb 1, 2039 | U-2786:
Method of preventing pregnancy by inserting a vaginal system containing
103 mg of segesterone acetate and 17.4 mg ethinyl estradiol into a
vagina for up to thirteen 21/7-day (in/out) cycles U-2787: Method of contraception by inserting a vaginal system for up to 13 21/7-day (in/out) cycles, wherein efficacy requires the system cannot be out of the vagina for more than 2 cumulative hours in any such cycle without using alternative contraception |
Pat.
No. 10918649
DP* System for providing birth control Claim Types: Device Pat. Sub. Date(s): 001: Feb 17, 2021 |
Jun 21, 2039 | |
Pat.
No. 10925882
DP* System for providing birth control Claim Types: Device Pat. Sub. Date(s): 001: Feb 24, 2021 |
Jun 21, 2039 | |
Pat.
No. 10940157
DP* System for providing birth control Claim Types: Device Pat. Sub. Date(s): 001: Mar 11, 2021 |
Jun 21, 2039 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Aug 10, 2023 |
ANORO
ELLIPTA (POWDER)
(INHALATION) UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations == beta-2
adrenergic agonist
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
203975 Prod. No.:
001 RX (EQ 0.0625MG BASE/INH;EQ 0.025MG BASE/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. RE44874
DS* DP* Phenethanolamine derivatives for treatment
of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use; Process; Drug in a container Pat. Sub. Date(s): 001: May 14, 2014 |
Mar 23, 2023 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
Pat.
No. 7439393
DS* DP* [Extended 983 days (2.7 years)] Phenethanolamine derivatives for treatment of respiratory diseases Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 |
May 21, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
Pat.
No. 7488827
DS* DP* [Extended 965 days (2.6 years)] Muscarinic acetylcholine receptor antagonists Claim Types: Compound; Composition; Formulation Pat. Sub. Date(s): 001: Jan 9, 2014 |
Dec 18, 2027 | |
Pat.
No. 7498440
DS* DP* Muscarinic acetylcholine receptor
antagonists Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 9, 2014 |
Apr 27, 2025 | |
Pat.
No. 7776895
DP* Inhalation devices for delivering phenethanolamine
derivatives for the treatment of respiratory diseases Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 |
Sep 11, 2022 | |
Pat.
No. 8113199
DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 |
Oct 23, 2027 | |
Pat.
No. 8161968
DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 |
Feb 5, 2028 | |
Pat.
No. 8183257
Muscarinic acetylcholine receptor antagonists Claim Types: Method of use Pat. Sub. Date(s): 001: None |
Jul 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
Pat.
No. 8309572
Muscarinic acetylcholine receptor antagonists Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: Jan 9, 2014 |
Apr 27, 2025 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
Pat.
No. 8511304
DP* Medicament dispenser Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Jan 9, 2014 |
Jun 14, 2027 | U-1476: Indicated for the long-term, once-daily, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. |
Pat.
No. 8534281
DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jan 9, 2014 |
Mar 8, 2030 | |
Pat.
No. 8746242
DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Jun 26, 2014 |
Oct 11, 2030 | |
Pat.
No. 9333310
DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 20, 2016 |
Oct 2, 2027 | |
Pat.
No. 9750726
DP* Combinations of a muscarinic receptor antagonist and a
beta-2 adrenoreceptor agonist Claim Types: Formulation Pat. Sub. Date(s): 001: Sep 21, 2017 |
Nov 29, 2030 | |
Pat.
No. 11090294
Combinations of a muscarinic receptor antagonist and a beta-2
adrenoreceptor agonist Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 14, 2021 |
Nov 29, 2030 | U-3203: Maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Jun 9, 2022 | M-245: Additional information added to the labeling based on safety and efficacy data from the IMPACT trial |
ANTARA (MICRONIZED) (CAPSULE) (ORAL)
FENOFIBRATE
Drug Classes:
Cardiovascular
Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome
proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant:
LUPIN NDA No.:
021695 Prod. No.:
004 RX (30MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8026281
Treating metabolic syndrome with fenofibrate Claim Types: Method of use Pat. Sub. Date(s): 004: None |
Apr 22, 2025 | U-1447:
Treating primary hypercholesterolemia and mixed dyslipidemia U-1448: Treating severe hypertriglyceridemia |
ANTARA (MICRONIZED)
(CAPSULE) (ORAL)
FENOFIBRATE
Drug Classes:
Cardiovascular
Agents:Dyslipidemics, Fibric Acid Derivatives == peroxisome
proliferator-activated receptor (PPAR) alpha agonist
NDA Applicant:
LUPIN NDA No.:
021695 Prod. No.:
005 RX (90MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8026281
Treating metabolic syndrome with fenofibrate Claim Types: Method of use Pat. Sub. Date(s): 005: None |
Apr 22, 2025 | U-1447:
Treating primary hypercholesterolemia and mixed dyslipidemia U-1448: Treating severe hypertriglyceridemia |
Pat.
No. 9314447
DP* Reduced dose pharmaceutical compositions of fenofibrate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 005: May 2, 2016 |
May 31, 2033 | U-1447:
Treating primary hypercholesterolemia and mixed dyslipidemia U-1448: Treating severe hypertriglyceridemia |
ANTIZOL
(INJECTABLE) (INJECTION)
FOMEPIZOLE [Has competitive generic]
Drug Classes:
antidote
NDA Applicant:
PAR PHARM
INC NDA No.: 020696 Prod. No.:
001 DISC (1.5GM/1.5ML (1GM/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7553863
DS* DP* Ultrapure 4-methylpyrazole Claim Types: Formulation; Process Pat. Sub. Date(s): 001: None |
Jun 30, 2027 |
APADAZ
(TABLET) (ORAL)
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
NDA Applicant:
KVK TECH
INC NDA No.: 208653 Prod. No.:
001 RX (325MG;EQ 6.12MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8461137
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and use thereof Claim Types: Composition Pat. Sub. Date(s): 001: Mar 22, 2018 |
Feb 22, 2031 | |
Pat.
No. 8748413
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Mar 22, 2018 |
Jul 1, 2030 | |
Pat.
No. 8828978
DP* Benzoic acid, benzoic acid derivatives and heteroaryl
carboxylic acid conjugates of hydrocodone, prodrugs, methods of making
and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Mar 22, 2018 |
Jul 1, 2030 | |
Pat.
No. 9132125
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and use thereof Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Mar 22, 2018 |
Jul 1, 2030 | U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
Pat.
No. 9549923
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and uses thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Mar 22, 2018 |
Jul 1, 2030 |
APADAZ (TABLET) (ORAL)
ACETAMINOPHEN; BENZHYDROCODONE HYDROCHLORIDE
NDA Applicant:
KVK TECH
INC NDA No.: 208653 Prod. No.:
002 RX (325MG;EQ 4.08MG BASE); 003 RX (325MG;EQ 8.16MG
BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8461137
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and use thereof Claim Types: Composition Pat. Sub. Date(s): All strengths: Jan 25, 2019 |
Feb 22, 2031 | |
Pat.
No. 8748413
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jan 25, 2019 |
Jul 10, 2030 | |
Pat.
No. 8828978
DP* Benzoic acid, benzoic acid derivatives and heteroaryl
carboxylic acid conjugates of hydrocodone, prodrugs, methods of making
and use thereof Claim Types: Composition; Formulation Pat. Sub. Date(s): All strengths: Jan 25, 2019 |
Jul 1, 2030 | |
Pat.
No. 9132125
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and use thereof Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): All strengths: Jan 25, 2019 |
Jul 1, 2030 | U-2249: Management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate |
Pat.
No. 9549923
DS* DP* Benzoic acid, benzoic acid derivatives and
heteroaryl carboxylic acid conjugates of hydrocodone, prodrugs, methods
of making and uses thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jan 25, 2019 |
Jul 1, 2030 |
APLENZIN
(TABLET, EXTENDED
RELEASE) (ORAL) BUPROPION HYDROBROMIDE
Drug Classes:
Anti-Addiction/ Substance
Abuse Treatment Agents:Smoking Cessation Agents == Antidepressants:Antidepressants,
Other == aminoketone
NDA Applicant:
BAUSCH NDA No.:
022108 Prod. No.:
001 RX (174MG); 002 RX (348MG); 003 RX (522MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7241805
DP* Modified release formulations of a bupropion salt Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 | |
Pat.
No. 7569610
Modified release formulations of a bupropion salt Claim Types: Method of use Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 | U-997: Treatment of major depressive disorder by dosing at intervals of 24 hours |
Pat.
No. 7572935
DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 | |
Pat.
No. 7585897
DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 | |
Pat.
No. 7645802
DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 | |
Pat.
No. 7649019
DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 | |
Pat.
No. 7662407
DP* Modified release formulations of a bupropion salt Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 | |
Pat.
No. 7671094
DP* Bupropion hydrobromide and therapeutic applications Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: None |
Jun 27, 2026 |
APOMORPHINE HYDROCHLORIDE
(INJECTABLE)
(SUBCUTANEOUS) APOMORPHINE HYDROCHLORIDE
[GENERIC AP]
Drug Classes:
Antiparkinson
Agents:Dopamine Agonists == dopaminergic agonist
NDA Applicant:
SAGE
CHEMS NDA No.: 212025 Prod. No.:
001 RX (30MG/3ML (10MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Aug 24, 2022 |
APRETUDE
(SUSPENSION, EXTENDED
RELEASE) (INTRAMUSCULAR) CABOTEGRAVIR
Drug Classes:
human immunodeficiency
virus type 1 (HIV-1) integrase strand transfer inhibitor (INSTI)
NDA Applicant:
VIIV
HLTHCARE NDA No.: 215499 Prod. No.:
001 RX (600MG/3ML (200MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8410103
DS* DP*
(3S,11aR)-N-[2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5-
,7,11,11a-hexahydro[1,3]oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide
useful as anti-HIV agent Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 001: Jan 14, 2022 |
Apr 28, 2026 | |
Pat.
No. 10927129
DS* DP*
N-[(2,4-difluorophenyl)methyl]-6-hydroxy-3-methyl-5,7-dioxo-2,3,5,7,11,11a-
-hexahydro[1,3] oxazolo[3,2-a]pyrido[1,2-d]pyrazine-8-carboxamide
having HIV integrase inhibitory activity Claim Types: Compound; Composition Pat. Sub. Date(s): 001: Jan 14, 2022 |
Apr 28, 2026 | |
Pat.
No. 11224597
DP* Pharmaceutical compositions Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Feb 10, 2022 |
Sep 15, 2031 | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Jan 21, 2026 |
APRISO
(CAPSULE, EXTENDED
RELEASE) (ORAL) MESALAMINE [GENERIC AB]
Drug Classes:
Inflammatory Bowel Disease
Agents:Aminosalicylates and/ or Prodrugs
NDA Applicant:
VALEANT PHARMS
INTL NDA No.: 022301 Prod. No.:
001 RX (375MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8865688
Compositions and methods for treatment of bowel diseases with
granulated mesalamine Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 22, 2014 |
May 1, 2030 | U-1310: For the maintenance of remission of ulcerative colitis |
APTIOM
(TABLET) (ORAL)
ESLICARBAZEPINE ACETATE [GENERIC AB]
Drug Classes:
Anticonvulsants:Sodium
Channel Agents
NDA Applicant:
SUNOVION PHARMS
INC NDA No.: 022416 Prod. No.:
001 RX (200MG); 002 RX (400MG); 003 RX (600MG); 004
RX (800MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8372431
DP* Pharmaceutical composition comprising licarbazepine
acetate Claim Types: Formulation Pat. Sub. Date(s): All strengths: None |
Apr 17, 2030 | |
Pat.
No. 9206135
DS* Asymmetric catalytic reduction of oxcarbazepine Claim Types: Compound; Product-by-process; Method of use Pat. Sub. Date(s): All strengths: May 20, 2016 |
Apr 21, 2026 | |
Pat.
No. 9566244
DP* Pharmaceutical composition comprising licarbazepine
acetate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Mar 8, 2017 |
Oct 23, 2028 | |
Pat.
No. 9643929
DP* Asymmetric catalytic reduction of oxcarbazepine Claim Types: Composition Pat. Sub. Date(s): All strengths: Jun 8, 2017 |
Apr 21, 2026 | |
Pat.
No. 9750747
Treatments involving eslicarbazepine acetate or eslicarbazepine Claim Types: Method of use; Method of use Pat. Sub. Date(s): All strengths: Sep 28, 2017 |
Aug 24, 2032 | U-2041:
Treatment of partial-onset seizures U-2121: Treatment of partial-onset seizures in a patient suffering from or susceptible to absence seizures |
Pat.
No. 9763954
Therapeutical uses of eslicarbazepine Claim Types: Method of use Pat. Sub. Date(s): All strengths: Oct 10, 2017 |
Sep 13, 2028 | U-2123: Treatment of partial-onset seizures in patients with epilepsy who have been previously treated with oxcarbazepine |
Pat.
No. 10675287
Methods of treatment of partial onset seizures using eslicarbazepine
acetate Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 10, 2020 |
May 6, 2025 | U-2041:
Treatment of partial-onset seizures U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures |
Pat.
No. 10695354
Methods of treatment of partial onset seizures using eslicarbazepine
acetate Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jun 30, 2020 |
May 6, 2025 | U-2501:
Treatment of partial-onset seizures U-2831: Treatment of partial-onset seizures in a patient with refractory partial-onset seizures |
Pat.
No. 10702536
Methods of treatment of partial onset seizures using eslicarbazepine
acetate Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 7, 2020 |
May 6, 2025 | U-2501: Treatment of partial-onset seizures |
Pat.
No. 10912781
DP* Pharmaceutical composition comprising licarbazepine
acetate Claim Types: Formulation Pat. Sub. Date(s): All strengths: Feb 10, 2021 |
Oct 23, 2028 |
ARAKODA
(TABLET) (ORAL)
TAFENOQUINE SUCCINATE
Drug Classes:
Antiparasitics:Antiprotozoals
NDA Applicant:
60 DEGREES
PHARMS NDA No.: 210607 Prod. No.:
001 RX (EQ 100MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 10342791
Regimens of tafenoquine for prevention of malaria in malaria-naive
subjects Claim Types: Method of use (dosaage regimen); Kit Pat. Sub. Date(s): 001: Jul 31, 2019 |
Dec 2, 2035 | U-2582: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose |
Pat.
No. 10888558
Regimens of tafenoquine for prevention of malaria in malaria-naive
subjects Claim Types: Method of use; Kit Pat. Sub. Date(s): 001: Feb 10, 2021 |
Dec 2, 2035 | U-2582: For the oral prevention/prophylaxis of malaria in adults, comprising a three-phase dosing regimen consisting of a loading/initial dose, a maintenance/exposure dose, and a terminal/post-exposure dose |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Jul 20, 2023 | |
Exclusivity Code: NP - New product | Aug 8, 2021 |
ARAZLO
(LOTION) (TOPICAL)
TAZAROTENE
Drug Classes:
Dermatological Agents:Acne
and Rosacea Agents == retinoid
NDA Applicant:
BAUSCH NDA No.:
211882 Prod. No.:
001 RX (0.045%)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 11311482
Topical compositions and methods for treating skin diseases Claim Types: Method of use Pat. Sub. Date(s): 001: May 5, 2022 |
May 11, 2038 | U-2368: Topical treatment of acne vulgaris in patients 9 years of age and older |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NP - New product | Dec 18, 2022 |
ARCAPTA NEOHALER (POWDER) (INHALATION)
INDACATEROL MALEATE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Sympathomimetic == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations == beta-2
adrenergic agonist
NDA Applicant:
NOVARTIS NDA No.:
022383 Prod. No.:
001 DISC (EQ 75MCG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6878721
DS* DP* [Extended 1599 days (4.4 years)] Beta2-adrenoceptor agonists Claim Types: Compound; Composition; Method of use; Process Pat. Sub. Date(s): 001: None |
Feb 25, 2025 | U-1168: The long term, once-daily maintenance bronchodilator treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema |
Pat.
No. 8479730
DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: Aug 6, 2013 |
Oct 11, 2028 |
ARESTIN
(POWDER, EXTENDED
RELEASE) (DENTAL) MINOCYCLINE HYDROCHLORIDE
Drug Classes:
Antibacterials:Tetracyclines
== Dental and Oral Agents == tetracycline-class drug
NDA Applicant:
ORAPHARMA NDA No.:
050781 Prod. No.:
001 RX (EQ 1MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6682348
DP* Dispensing apparatus and cartridge Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 24, 2012 |
Mar 29, 2022 | |
Pat.
No. 7699609
DP* Dispensing apparatus and cartridge with deformable tip Claim Types: Device Pat. Sub. Date(s): 001: Mar 26, 2015 |
Mar 29, 2022 |
ARGATROBAN IN SODIUM CHLORIDE
(INJECTABLE)
(INTRAVENOUS) ARGATROBAN
Drug Classes:
anticoagulant == direct
thrombin inhibitor
NDA Applicant:
CIPLA NDA No.:
022434 Prod. No.:
001 DISC (50MG/50ML (1MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7589106
DP* Alcohol free formulation of argatroban Claim Types: Formulation; Drug in a container; Method of use Pat. Sub. Date(s): 001: Jul 20, 2011 |
Sep 26, 2027 | U-1163: Method of treating thrombosis |
Pat.
No. 7687516
DP* Alcohol free formulation of argatroban Claim Types: Formulation; Drug in a container; Method of administration; Method of use Pat. Sub. Date(s): 001: Jul 20, 2011 |
Sep 26, 2027 | U-1164: Method of treating an argatroban treatable condition |
ARICEPT
(TABLET) (ORAL)
DONEPEZIL HYDROCHLORIDE [GENERIC AB]
Drug Classes:
Antidementia
Agents:Cholinesterase Inhibitors == acetylcholinesterase
inhibitor
NDA Applicant:
EISAI
INC NDA No.: 022568 Prod. No.:
001 RX (23MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8481565
DP* Method for stabilizing anti-dementia drug Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 9, 2013 |
Oct 4, 2026 |
ARIKAYCE
KIT (SUSPENSION,
LIPOSOMAL) (INHALATION) AMIKACIN SULFATE
Drug Classes:
Antibacterials:Aminoglycosides
== aminoglycoside antibacterial
NDA Applicant:
INSMED
INC NDA No.: 207356 Prod. No.:
001 RX (EQ 590MG BASE/8.4ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7718189
DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
Jun 6, 2025 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
Pat.
No. 8226975
DP* Lipid-based compositions of antiinfectives for
treating pulmonary infections and methods of use thereof Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
Aug 15, 2028 | |
Pat.
No. 8632804
Lipid-based compositions of antiinfectives for treating pulmonary
infections and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
Dec 5, 2026 | U-2416: Treating mycobacterium avium complex (MAC) lung disease in adults with cystic fibrosis as part of a combination drug regimen |
Pat.
No. 8642075
DP* Lipid-based compositions of antiinfectives for
treating pulmonary infections and methods of use thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 24, 2018 |
Dec 5, 2026 | |
Pat.
No. 8679532
Lipid-based compositions of antiinfectives for treating pulmonary
infections and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
Dec 5, 2026 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
Pat.
No. 8802137
DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
Apr 8, 2024 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
Pat.
No. 9566234
DP* Systems for treating pulmonary infections Claim Types: Kit; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
Jan 18, 2034 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
Pat.
No. 9827317
DP* Sustained release of antiinfectives Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
Apr 8, 2024 | U-2415: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination antibacterial drug regimen |
Pat.
No. 9895385
Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 24, 2018 |
May 15, 2035 | U-2417: Treating mycobacterium avium complex (MAC) lung disease in non-cystic fibrosis adults as part of a combination antibacterial drug regimen |
Pat.
No. 10251900
Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: May 2, 2019 |
May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
Pat.
No. 10751355
Methods for treating pulmonary non-tuberculous mycobacterial infections Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 24, 2020 |
May 15, 2035 | U-2414: Treating mycobacterium avium complex (MAC) lung disease in adults as part of a combination drug regimen |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: ODE - Orphan drug exclusivity | Sep 28, 2030 GAIN | ODE-214: Tx of MAC lung disease in adults with limited or no alternative tx options as part of a combo antibacterial drug regimen who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy |
ARISTADA
(SUSPENSION, EXTENDED
RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
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 |
ARISTADA (SUSPENSION, EXTENDED
RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
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 |
ARISTADA (SUSPENSION, EXTENDED
RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
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 |
ARISTADA INITIO KIT (SUSPENSION, EXTENDED
RELEASE) (INTRAMUSCULAR) ARIPIPRAZOLE LAUROXIL
Drug Classes:
Antidepressants:Antidepressants,
Other == Antipsychotics:2nd Generation/Atypical == Bipolar
Agents:Bipolar Agents, Other == atypical antipsychotic
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 |
ARMONAIR DIGIHALER (POWDER) (INHALATION)
FLUTICASONE PROPIONATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
TEVA
PHARM NDA No.: 208798 Prod. No.:
004 RX (0.055MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Jul 13, 2032 *PED | |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Nov 18, 2031 *PED | |
Pat.
No. 9782550
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 20, 2020 |
Feb 28, 2036 *PED | |
Pat.
No. 9782551
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Feb 28, 2036 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 004: Mar 20, 2020 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 004: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10569034
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 12, 2020 |
Feb 16, 2037 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 004: Oct 6, 2020 |
Nov 19, 2025 *PED | |
Pat.
No. 10918816
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Mar 18, 2021 |
Jun 14, 2036 *PED | |
Pat.
No. 11000653
DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 004: Jun 10, 2021 |
Jun 18, 2039 *PED | |
Pat.
No. 11173259
DP* Drug delivery device with electronics and power
management Claim Types: Device Pat. Sub. Date(s): 004: Dec 8, 2021 |
Jan 6, 2041 *PED | |
Pat.
No. 11266796
DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 004: Apr 7, 2022 |
Aug 22, 2041 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Jan 9, 2025 PED |
ARMONAIR DIGIHALER
(POWDER) (INHALATION)
FLUTICASONE PROPIONATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
TEVA
PHARM NDA No.: 208798 Prod. No.:
005 RX (0.113MG/INH); 006 RX (0.232MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Jul 13, 2032 *PED | |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Nov 18, 2031 *PED | |
Pat.
No. 9782550
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Feb 28, 2036 *PED | |
Pat.
No. 9782551
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Feb 28, 2036 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 20, 2020 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10569034
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 12, 2020 |
Feb 16, 2037 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 |
Nov 19, 2025 *PED | |
Pat.
No. 10918816
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Mar 18, 2021 |
Jun 14, 2036 *PED | |
Pat.
No. 11000653
DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): All strengths: Jun 10, 2021 |
Jun 18, 2039 *PED | |
Pat.
No. 11173259
DP* Drug delivery device with electronics and power
management Claim Types: Device Pat. Sub. Date(s): All strengths: Dec 8, 2021 |
Jan 6, 2041 *PED | |
Pat.
No. 11266796
DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): All strengths: Apr 7, 2022 |
Aug 22, 2041 *PED |
ARMONAIR DIGIHALER
(POWDER) (INHALATION)
FLUTICASONE PROPIONATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
TEVA
PHARM NDA No.: 208798 Prod. No.:
008 DISC (0.03MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
May 8, 2031 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Jul 13, 2032 *PED | |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 008: May 5, 2022 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Nov 18, 2031 *PED | |
Pat.
No. 9782550
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 |
Feb 28, 2036 *PED | |
Pat.
No. 9782551
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Feb 28, 2036 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 008: May 5, 2022 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 008: May 5, 2022 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 008: May 5, 2022 |
Jul 1, 2032 *PED | |
Pat.
No. 10569034
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 |
Feb 16, 2037 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Nov 19, 2025 *PED | |
Pat.
No. 10918816
DP* Compliance monitoring module for a breath-actuated
inhaler Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 |
Jun 14, 2036 *PED | |
Pat.
No. 11000653
DP* Inhaler Claim Types: Part of a dosage form; Device; Method of use Pat. Sub. Date(s): 008: May 5, 2022 |
Jun 18, 2039 *PED | |
Pat.
No. 11173259
DP* Drug delivery device with electronics and power
management Claim Types: Device Pat. Sub. Date(s): 008: May 5, 2022 |
Jan 6, 2041 *PED | |
Pat.
No. 11266796
DP* Inhalation device with integrated electronics Claim Types: Device; Method of administration Pat. Sub. Date(s): 008: May 5, 2022 |
Aug 22, 2041 *PED |
ARMONAIR RESPICLICK (POWDER) (INHALATION)
FLUTICASONE PROPIONATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
TEVA
PHARM NDA No.: 208798 Prod. No.:
001 DISC (0.055MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Jul 13, 2032 *PED | |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Jan 30, 2017 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 001: May 10, 2017 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): 001: Aug 31, 2017 |
Nov 18, 2031 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 001: Aug 13, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Dec 12, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 001: Mar 5, 2019 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 001: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 001: Oct 6, 2020 |
Nov 19, 2025 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NPP - New patient population | Jan 9, 2025 PED |
ARMONAIR RESPICLICK
(POWDER) (INHALATION)
FLUTICASONE PROPIONATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
TEVA
PHARM NDA No.: 208798 Prod. No.:
002 DISC (0.113MG/INH); 003 DISC (0.232MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Jul 13, 2032 *PED | |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Jan 30, 2017 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): All strengths: May 10, 2017 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 31, 2017 |
Nov 18, 2031 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): All strengths: Aug 13, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Dec 12, 2018 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): All strengths: Mar 5, 2019 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): All strengths: Mar 19, 2020 |
Jul 1, 2032 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): All strengths: Oct 6, 2020 |
Nov 19, 2025 *PED |
ARMONAIR RESPICLICK
(POWDER) (INHALATION)
FLUTICASONE PROPIONATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
TEVA
PHARM NDA No.: 208798 Prod. No.:
007 DISC (0.03MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7540282
DP* Reservoir pressure system for medicament inhaler Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Nov 6, 2023 *PED | |
Pat.
No. 8651103
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Sep 26, 2028 *PED | |
Pat.
No. 8714149
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Aug 25, 2032 *PED | |
Pat.
No. 8978966
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Jul 13, 2032 *PED | |
Pat.
No. 9216260
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Dec 28, 2031 *PED | |
Pat.
No. 9463288
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Nov 19, 2025 *PED | |
Pat.
No. 9616024
DP* Process for preparing a medicament Claim Types: Product-by-process; Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Mar 1, 2025 *PED | |
Pat.
No. 9731087
DP* Dose counter for inhaler having a bore and shaft
arrangement Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Nov 18, 2031 *PED | |
Pat.
No. 10022510
DP* Dose counters for inhalers, inhalers and methods of
assembly thereof Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Nov 18, 2031 *PED | |
Pat.
No. 10124131
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Nov 18, 2031 *PED | |
Pat.
No. 10195375
DP* Airflow adaptor for a breath-actuated dry powder
inhaler Claim Types: Part of a dosage form; Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Aug 14, 2031 *PED | |
Pat.
No. 10561808
DP* Dose counter for inhaler having an anti-reverse
rotation actuator Claim Types: Part of a dosage form Pat. Sub. Date(s): 007: Aug 5, 2021 |
Jul 1, 2032 *PED | |
Pat.
No. 10765820
DP* Dry powder inhalation apparatus Claim Types: Device Pat. Sub. Date(s): 007: Aug 5, 2021 |
Nov 19, 2025 *PED | |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NS - New strength | Jan 9, 2025 PED |
ARNUITY ELLIPTA (POWDER) (INHALATION)
FLUTICASONE FUROATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
GLAXOSMITHKLINE NDA No.:
205625 Prod. No.:
001 RX (0.1MG/INH); 002 RX (0.2MG/INH); 003 RX
(0.05MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8113199
DP* Counter for use with a medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018 |
Oct 23, 2027 | |
Pat.
No. 8161968
DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018 |
Feb 5, 2028 | |
Pat.
No. 8201556
DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018 |
Feb 5, 2029 | |
Pat.
No. 8534281
DP* Manifold for use in medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018 |
Mar 8, 2030 | |
Pat.
No. 8746242
DP* Medicament dispenser Claim Types: Device Pat. Sub. Date(s): 001: Aug 28, 2014; 002: Aug 28, 2014; 003: Jun 13, 2018 |
Oct 11, 2030 | |
Pat.
No. 9333310
DP* Medicament dispenser Claim Types: Device; Drug in a container Pat. Sub. Date(s): 001: May 18, 2016; 002: May 18, 2016; 003: Jun 13, 2018 |
Oct 2, 2027 |
ARTESUNATE
(POWDER) (INTRAVENOUS)
ARTESUNATE
NDA Applicant:
AMIVAS NDA No.:
213036 Prod. No.:
001 RX (110MG/VIAL)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: NCE - New chemical entity | May 26, 2025 | |
Exclusivity Code: ODE - Orphan drug exclusivity | May 26, 2027 | ODE-290: Indicated for the initial treatment of severe malaria in adult and pediatric patients to always be followed by a complete treatment course of an appropriate oral antimalarial regimen |
ARYMO
ER (TABLET,
EXTENDED RELEASE) (ORAL) MORPHINE SULFATE
[Has competitive generic]
Drug Classes:
Analgesics:Opioid
Analgesics, Long-acting == Analgesics:Opioid Analgesics,
Short-acting == opioid agonist
NDA Applicant:
ZYLA NDA No.:
208603 Prod. No.:
001 DISC (15MG); 002 DISC (30MG); 003 DISC (60MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9044402
DP* Abuse-deterrent pharmaceutical compositions for
controlled release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 8, 2017 |
Jul 1, 2033 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
Pat.
No. 9549899
DP* Abuse deterrent pharmaceutical compositions for
controlled release Claim Types: Formulation; Method of use Pat. Sub. Date(s): All strengths: Feb 21, 2017 |
Jul 1, 2033 | U-1556: Management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. |
ASCOR
(SOLUTION) (INTRAVENOUS)
ASCORBIC ACID
Drug Classes:
vitamin C
NDA Applicant:
MCGUFF NDA No.:
209112 Prod. No.:
001 RX (25,000MG/50ML (500MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: ODE - Orphan drug exclusivity | Oct 2, 2024 | ODE-160: For treatment of scurvy in adult and pediatric patients age 5 months and older for whom oral administration is not possible, insufficient or contraindicated |
ASMANEX
HFA (AEROSOL,
METERED) (INHALATION) MOMETASONE FUROATE
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Respiratory Tract/
Pulmonary Agents:Anti-inflammatories, Inhaled Corticosteroids == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
ORGANON NDA No.:
205641 Prod. No.:
003 RX (0.05MG/INH)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: NS - New strength | Feb 12, 2023 PED |
ASPRUZYO SPRINKLE (GRANULES, EXTENDED RELEASE)
(ORAL) RANOLAZINE
Drug Classes:
Cardiovascular
Agents:Cardiovascular Agents, Other == antianginal
NDA Applicant:
SPIL NDA No.:
216018 Prod. No.:
002 RX (1GM)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 10898444
DP* Extended release multiparticulates of ranolazine Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 3, 2022 |
Jan 24, 2038 |
ASTAGRAF
XL (CAPSULE,
EXTENDED RELEASE) (ORAL) TACROLIMUS
Drug Classes:
Dermatological
Agents:Dermatitis and Pruritus Agents == Immunological
Agents:Immunosuppressants == calcineurin inhibitor
immunosuppressant
NDA Applicant:
ASTELLAS NDA No.:
204096 Prod. No.:
001 RX (EQ 0.5MG BASE); 002 RX (EQ 1MG BASE); 003 RX
(EQ 5MG BASE)
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) | May 24, 2025 |
ASTEPRO
(SPRAY, METERED) (NASAL)
AZELASTINE HYDROCHLORIDE [Has competitive
generic]
Drug Classes:
Ophthalmic
Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/
Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor
antagonist
NDA Applicant:
MYLAN SPECIALITY
LP NDA No.: 022203 Prod. No.:
001 DISC (0.137MG/SPRAY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8071073
DP* Compositions comprising azelastine and methods of use
thereof Claim Types: Formulation Pat. Sub. Date(s): 001: Dec 15, 2011 |
Jun 4, 2028 | |
Pat.
No. 8518919
Compositions comprising azelastine and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 001: Sep 18, 2013 |
Nov 22, 2025 | U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis |
ASTEPRO (SPRAY, METERED) (NASAL)
AZELASTINE HYDROCHLORIDE [Has competitive
generic]
Drug Classes:
Ophthalmic
Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/
Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor
antagonist
NDA Applicant:
MYLAN SPECIALITY
LP NDA No.: 022203 Prod. No.:
002 DISC (0.2055MG/SPRAY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8071073
DP* Compositions comprising azelastine and methods of use
thereof Claim Types: Formulation Pat. Sub. Date(s): 002: Dec 15, 2011 |
Jun 4, 2028 | |
Pat.
No. 8518919
Compositions comprising azelastine and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): 002: Sep 18, 2013 |
Nov 22, 2025 | U-1430: Treatment of allergic rhinitis, including seasonal and perennial allergic rhinitis |
Pat.
No. 9919050
DP* Compositions comprising azelastine Claim Types: Formulation Pat. Sub. Date(s): 002: Mar 29, 2018 |
Nov 22, 2025 |
ASTEPRO
ALLERGY; ASTEPRO ALLERGY, CHILDREN'S (SPRAY, METERED) (NASAL)
AZELASTINE HYDROCHLORIDE [Has competitive
generic]
Drug Classes:
Ophthalmic
Agents:Ophthalmic Anti-allergy Agents == Respiratory Tract/
Pulmonary Agents:Antihistamines == histamine-1 (H1) receptor
antagonist
NDA Applicant:
BAYER
HLTHCARE NDA No.: 213872 Prod. No.:
001 OTC (0.2055MG/SPRAY); 002 OTC (0.2055MG/SPRAY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8071073
DP* Compositions comprising azelastine and methods of use
thereof Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 8, 2021 |
Jun 4, 2028 | |
Pat.
No. 8518919
Compositions comprising azelastine and methods of use thereof Claim Types: Method of use Pat. Sub. Date(s): All strengths: Jul 8, 2021 |
Nov 22, 2025 | U-3166: OTC use: allergy symptom reliever; temporary relief of these symptoms due to hay fever or other upper respiratory allergies: nasal congestion, runny nose, sneezing and itchy nose |
Pat.
No. 9919050
DP* Compositions comprising azelastine Claim Types: Formulation Pat. Sub. Date(s): All strengths: Jul 8, 2021 |
Nov 22, 2025 |
ATELVIA
(TABLET, DELAYED
RELEASE) (ORAL) RISEDRONATE SODIUM
[GENERIC AB]
Drug Classes:
Metabolic Bone Disease
Agents
NDA Applicant:
APIL NDA No.:
022560 Prod. No.:
001 RX (35MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7645459
DP* Dosage forms of bisphosphonates Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 |
Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
Pat.
No. 7645460
DP* Dosage forms of risedronate Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 1, 2010 |
Jan 9, 2028 | U-662: Treatment of osteoporosis in postmenopausal women |
Pat.
No. 8246989
DP* Dosage forms of bisphosphonates Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 28, 2012 |
Jan 16, 2026 |
ATRIPLA
(TABLET) (ORAL)
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE [GENERIC AB]
Drug Classes:
Antivirals:Anti-HIV
Agents, Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) == Antivirals:Anti-HIV
Combinations == HIV-1 non-nucleoside reverse transcriptase
inhibitor (NNRTI) == Antivirals:Anti-HIV Agents, Nucleoside and
Nucleotide Reverse Transcriptase Inhibitors (NRTI) == HIV
nucleoside analog reverse transcriptase inhibitor (HIV NRTI) == Antivirals:Anti-hepatitis
B (HBV) Agents == HBV nucleoside analog reverse transcriptase
inhibitor (HBV-NRTI)
NDA Applicant:
GILEAD
SCIENCES NDA No.: 021937 Prod. No.:
001 RX (600MG;200MG;300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8592397
DP* Compositions and methods for combination antiviral
therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: None |
Jan 13, 2024 | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of HIV-1 infection in adults |
Pat.
No. 8598185
DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Drug in a container Pat. Sub. Date(s): 001: None |
Apr 28, 2029 | |
Pat.
No. 8716264
DP* Compositions and methods for combination antiviral
therapy Claim Types: Method of use Pat. Sub. Date(s): 001: May 30, 2014 |
Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat.
No. 9018192
Unitary pharmaceutical dosage form Claim Types: Method of use Pat. Sub. Date(s): 001: May 28, 2015 |
Jun 13, 2026 | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of HIV-1 infection in adults |
Pat.
No. 9457036
DP* Compositions and methods for combination antiviral
therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Nov 10, 2016 |
Jan 13, 2024 | U-257: Treatment of HIV infection |
Pat.
No. 9545414
DP* Unitary pharmaceutical dosage form Claim Types: Formulation; Method of use; Drug in a container; Method of administration Pat. Sub. Date(s): 001: Feb 13, 2017 |
Jun 13, 2026 | U-1170:
Treatment of HIV-1 infection in pediatric patients 12 years of age and
older U-750: Treatment of HIV-1 infection in adults |
Pat.
No. 9744181
DP* Compositions and methods for combination antiviral
therapy Claim Types: Formulation; Method of use Pat. Sub. Date(s): 001: Sep 19, 2017 |
Jan 13, 2024 | U-257: Treatment of HIV infection |
ATROPINE SULFATE (SOLUTION) (INTRAVENOUS)
ATROPINE SULFATE [GENERIC AP]
Drug Classes:
anticholinergic == muscarinic
antagonist
NDA Applicant:
ACCORD
HLTHCARE NDA No.: 212868 Prod. No.:
001 RX (0.25MG/5ML (0.05MG/ML)); 002 RX (0.5MG/5ML
(0.1MG/ML)); 003 RX (1MG/10ML (0.1MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Jan 26, 2022 |
ATROPINE SULFATE
(SOLUTION)
(INTRAVENOUS, INTRAMUSCULAR, SUBCUTANEOUS, INTRAOSSEOUS, ENDOTRACHEAL)
ATROPINE SULFATE [GENERIC AP]
Drug Classes:
anticholinergic == muscarinic
antagonist
NDA Applicant:
ACCORD
HLTHCARE NDA No.: 213424 Prod. No.:
001 RX (8MG/20ML (0.4MG/ML))
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | Sep 21, 2021 |
ATROPINE SULFATE
(SOLUTION/DROPS)
(OPHTHALMIC) ATROPINE SULFATE [GENERIC AT]
Drug Classes:
anticholinergic == muscarinic
antagonist
NDA Applicant:
APOTEX
INC NDA No.: 215624 Prod. No.:
001 RX (1%)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: CGT - Competitive generic therapy | May 25, 2022 |
ATROVENT
HFA (AEROSOL,
METERED) (INHALATION) IPRATROPIUM BROMIDE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Anticholinergic == Respiratory
Tract/ Pulmonary Agents:Bronchodilator Combinations
NDA Applicant:
BOEHRINGER
INGELHEIM NDA No.: 021527 Prod. No.:
001 RX (0.021MG/INH)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8474447
DP* Inhaler device Claim Types: Device Pat. Sub. Date(s): 001: May 28, 2015 |
Jan 17, 2030 |
AUBAGIO
(TABLET) (ORAL)
TERIFLUNOMIDE [GENERIC AB]
Drug Classes:
Central Nervous System
Agents:Multiple Sclerosis Agents == pyrimidine synthesis
inhibitor
NDA Applicant:
SANOFI AVENTIS
US NDA No.: 202992 Prod. No.:
001 RX (7MG); 002 RX (14MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6794410
[Extended 1625 days (4.5 years)] Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluoromethylphenyl)-amide for treating multiple sclerosis Claim Types: Method of use Pat. Sub. Date(s): All strengths: Aug 20, 2013 |
Mar 12, 2027 *PED | U-1285: Treatment of patients with relapsing forms of multiple sclerosis |
Pat.
No. 8802735
DP* (Z)-2-cyano-3-hydroxy-but-2-enoic
acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved
stability Claim Types: Formulation; Composition Pat. Sub. Date(s): All strengths: Sep 11, 2014 |
Mar 14, 2031 *PED | |
Pat.
No. 9186346
Methods for reducing the risk of an adverse teriflunomide and
rosuvastatin interaction in multiple sclerosis patients Claim Types: Method of use Pat. Sub. Date(s): All strengths: Dec 15, 2015 |
Aug 4, 2034 *PED | U-1786: Treatment of patients with relapsing forms of multiple sclerosis while managing the risk of teriflunomide and rosuvastatin interaction by limiting the rosuvastatin dose to no more than 10mg and/or administering about half the normal dose |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Oct 30, 2024 PED | M-61: Revisions to labeling based on data submitted in response to pediatric written request |
AURYXIA
(TABLET) (ORAL)
FERRIC CITRATE
Drug Classes:
Electrolytes/ Minerals/
Metals/ Vitamins:Electrolyte/Mineral Replacement == Electrolytes/
Minerals/ Metals/ Vitamins:Phosphate Binders == decorporation
agent == iron replacement product
NDA Applicant:
KERYX
BIOPHARMS NDA No.: 205874 Prod. No.:
001 RX (EQ 210MG IRON)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 5753706
DP* Methods for treating renal failure Claim Types: Method of use; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 |
Feb 3, 2022 | U-1577: Control of serum phosphorous levels |
Pat.
No. 7767851
DS* DP* Ferric organic compounds, uses thereof and
methods of making same Claim Types: Product-by-process; Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 |
Feb 18, 2024 | |
Pat.
No. 8093423
Pharmaceutical-grade ferric organic compounds, uses thereof and method
of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 |
Apr 21, 2026 | U-1577: Control of serum phosphorous levels |
Pat.
No. 8299298
DP* Pharmaceutical-grade ferric organic compounds, uses
thereof and method of making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 |
Feb 18, 2024 | |
Pat.
No. 8338642
DS* DP* Ferric organic compounds, uses thereof and
methods of making same Claim Types: Compound; Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Oct 2, 2014 |
Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
Pat.
No. 8609896
DP* Ferric organic compounds, uses thereof and methods of
making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 |
Feb 18, 2024 | |
Pat.
No. 8754257
DP* Pharmaceutical-grade ferric organic compounds, uses
thereof and methods of making same Claim Types: Composition; Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 |
Feb 18, 2024 | |
Pat.
No. 8754258
DP* Ferric organic compounds, uses thereof and methods of
making same Claim Types: Formulation Pat. Sub. Date(s): 001: Oct 2, 2014 |
Feb 18, 2024 | |
Pat.
No. 8846976
Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Nov 3, 2014 |
Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
Pat.
No. 8901349
Ferric organic compounds, uses thereof and methods of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Mar 16, 2015 |
Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
Pat.
No. 9050316
Pharmaceutical-grade ferric organic compounds, uses thereof and methods
of making same Claim Types: Method of use Pat. Sub. Date(s): 001: Jul 9, 2015 |
Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
Pat.
No. 9328133
DS* DP* Ferric organic compounds, uses thereof and
methods of making same Claim Types: Composition; Formulation; Method of use Pat. Sub. Date(s): 001: Dec 30, 2016 |
Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
Pat.
No. 9387191
DP* Ferric citrate dosage forms Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 9, 2016 |
Jul 21, 2030 | |
Pat.
No. 9757416
DS* DP* Pharmaceutical-grade ferric organic
compounds, uses thereof and methods of making same Claim Types: Method of administration Pat. Sub. Date(s): 001: Oct 5, 2017 |
Feb 18, 2024 | U-1577: Control of serum phosphorous levels |
Pat.
No. 10300039
Ferric citrate dosage forms Claim Types: Method of use Pat. Sub. Date(s): 001: Jun 24, 2019 |
Jul 21, 2030 | U-2549: Control of serum phosphorus levels |
AUSTEDO
(TABLET) (ORAL)
DEUTETRABENAZINE
Drug Classes:
Central Nervous System
Agents:Central Nervous System, Other
NDA Applicant:
TEVA BRANDED
PHARM NDA No.: 208082 Prod. No.:
001 RX (6MG); 002 RX (9MG); 003 RX (12MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8524733
DS* DP* Benzoquinoline inhibitors of vesicular
monoamine transporter 2 Claim Types: Compound; Composition Pat. Sub. Date(s): All strengths: Apr 4, 2017 |
Oct 3, 2031 *PED | |
Pat.
No. 9233959
DP* Formulations and pharmacokinetics of deuterated
benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2017 |
Mar 18, 2034 *PED | |
Pat.
No. 9296739
DP* Formulations and pharmacokinetics of deuterated
benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Apr 4, 2017 |
Mar 18, 2034 *PED | |
Pat.
No. 9550780
DS* DP* Formulations pharmacokinetics of
deuterated benzoquinoline inhibitors of vesicular monoamine transporter
2 Claim Types: New polymorph, salt or hydrate; Composition; Method of use Pat. Sub. Date(s): All strengths: Apr 4, 2017 |
Mar 18, 2034 *PED | U-1995:
Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
Pat.
No. 9814708
DP* Formulations and pharmacokinetics of deuterated
benzoquinoline inhibitors of vesicular monoamine transporter 2 Claim Types: Formulation Pat. Sub. Date(s): All strengths: Nov 16, 2017 |
Mar 18, 2034 *PED | |
Pat.
No. 10959996
Methods for the treatment of abnormal involuntary movement disorders Claim Types: Method of improving a treatment Pat. Sub. Date(s): All strengths: Mar 31, 2021 |
Sep 7, 2036 *PED | U-3055: A method of treating Huntington's chorea |
Pat.
No. 11179386
DP* Analogs of deutetrabenazine, their preparation and use Claim Types: Composition; Method of use Pat. Sub. Date(s): All strengths: Dec 2, 2021 |
Sep 15, 2038 *PED | U-1995:
Treatment of tardive dyskinesia U-3055: A method of treating Huntington's chorea |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: M - Miscellaneous | Dec 24, 2024 PED | M-54: Information from pediatric studies added to label |
Exclusivity Code: NCE - New chemical entity | Oct 3, 2022 PED | |
Exclusivity Code: ODE - Orphan drug exclusivity | Oct 3, 2024 PED | ODE-134: Treatment of chorea associated with Huntington's disease |
AUVI-Q
(SOLUTION)
(INTRAMUSCULAR, SUBCUTANEOUS) EPINEPHRINE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha
adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant:
KALEO
INC NDA No.: 201739 Prod. No.:
001 RX (EQ 0.3MG/DELIVERY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7731686
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 |
Jun 1, 2026 | |
Pat.
No. 7731690
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 |
Jan 15, 2025 | |
Pat.
No. 7749194
DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 |
Oct 30, 2028 | |
Pat.
No. 7918823
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 |
Nov 23, 2024 | |
Pat.
No. 7947017
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 |
Mar 12, 2028 | |
Pat.
No. 8016788
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 |
Mar 21, 2025 | |
Pat.
No. 8021344
DP* Medicament delivery device configured to produce an
audible output Claim Types: Device Pat. Sub. Date(s): 001: Jul 26, 2013 |
Nov 2, 2029 | |
Pat.
No. 8206360
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Mar 21, 2013 |
Feb 27, 2027 | |
Pat.
No. 8226610
DP* Medical injector with compliance tracking and
monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 001: Aug 21, 2012 |
Apr 10, 2029 | |
Pat.
No. 8231573
DP* Medicament delivery device having an electronic
circuit system Claim Types: Device Pat. Sub. Date(s): 001: Aug 21, 2012 |
Nov 25, 2028 | |
Pat.
No. 8313466
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Dec 20, 2012 |
Nov 23, 2024 | |
Pat.
No. 8361029
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 22, 2013 |
Nov 23, 2024 | |
Pat.
No. 8425462
DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 001: May 23, 2013 |
Nov 23, 2024 | |
Pat.
No. 8608698
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 15, 2014 |
Nov 23, 2024 | |
Pat.
No. 8920377
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jan 29, 2015 |
Nov 23, 2024 | |
Pat.
No. 8926594
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Feb 5, 2015 |
Mar 31, 2026 | |
Pat.
No. 9056170
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 16, 2015 |
Nov 23, 2024 | |
Pat.
No. 9149579
Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: Nov 6, 2015 |
Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
Pat.
No. 9238108
DP* Medicament delivery device having an electronic
circuit system Claim Types: Device Pat. Sub. Date(s): 001: Feb 18, 2016 |
Feb 20, 2027 | |
Pat.
No. 9259539
DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 23, 2016 |
Feb 1, 2026 | |
Pat.
No. 9278182
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Apr 11, 2016 |
Feb 1, 2026 | |
Pat.
No. 9724471
DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 001: Aug 23, 2017 |
May 23, 2027 | U-2092: Method for confirming dose delivery |
Pat.
No. 9737669
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Aug 30, 2017 |
Nov 23, 2024 | |
Pat.
No. 10314977
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jun 11, 2019 |
Nov 23, 2024 | |
Pat.
No. 10335549
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Jul 2, 2019 |
Apr 30, 2025 | |
Pat.
No. 10737028
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Aug 25, 2020 |
Nov 23, 2024 | |
Pat.
No. 10960155
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 001: Apr 22, 2021 |
Jun 25, 2026 |
AUVI-Q (SOLUTION) (INTRAMUSCULAR,
SUBCUTANEOUS) EPINEPHRINE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha
adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant:
KALEO
INC NDA No.: 201739 Prod. No.:
002 RX (EQ 0.15MG/DELIVERY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7731686
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Jun 1, 2026 | |
Pat.
No. 7731690
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Jan 15, 2025 | |
Pat.
No. 7749194
DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Oct 30, 2028 | |
Pat.
No. 7918823
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Nov 23, 2024 | |
Pat.
No. 7947017
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Mar 12, 2028 | |
Pat.
No. 8016788
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Mar 21, 2025 | |
Pat.
No. 8021344
DP* Medicament delivery device configured to produce an
audible output Claim Types: Device Pat. Sub. Date(s): 002: Jul 26, 2013 |
Nov 2, 2029 | |
Pat.
No. 8206360
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Feb 27, 2027 | |
Pat.
No. 8226610
DP* Medical injector with compliance tracking and
monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 002: None |
Apr 10, 2029 | |
Pat.
No. 8231573
DP* Medicament delivery device having an electronic
circuit system Claim Types: Device Pat. Sub. Date(s): 002: None |
Nov 25, 2028 | |
Pat.
No. 8313466
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Nov 23, 2024 | |
Pat.
No. 8361029
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: None |
Nov 23, 2024 | |
Pat.
No. 8425462
DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 002: None |
Nov 23, 2024 | |
Pat.
No. 8608698
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 15, 2014 |
Nov 23, 2024 | |
Pat.
No. 8920377
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jan 29, 2015 |
Nov 23, 2024 | |
Pat.
No. 8926594
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Feb 5, 2015 |
Mar 31, 2026 | |
Pat.
No. 9056170
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jul 16, 2015 |
Nov 23, 2024 | |
Pat.
No. 9149579
Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 002: Nov 6, 2015 |
Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
Pat.
No. 9238108
DP* Medicament delivery device having an electronic
circuit system Claim Types: Device Pat. Sub. Date(s): 002: Feb 18, 2016 |
Feb 20, 2027 | |
Pat.
No. 9259539
DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 002: Mar 23, 2016 |
Feb 1, 2026 | |
Pat.
No. 9278182
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Apr 11, 2016 |
Feb 1, 2026 | |
Pat.
No. 9724471
DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 002: Aug 23, 2017 |
May 23, 2027 | U-2092: Method for confirming dose delivery |
Pat.
No. 9737669
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Aug 30, 2017 |
Nov 23, 2024 | |
Pat.
No. 10314977
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jun 11, 2019 |
Nov 23, 2024 | |
Pat.
No. 10335549
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Jul 2, 2019 |
Apr 30, 2025 | |
Pat.
No. 10688244
DP* Medicament delivery device and methods for delivering
drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 002: Nov 4, 2020 |
Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
Pat.
No. 10737028
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Aug 25, 2020 |
Nov 23, 2024 | |
Pat.
No. 10842938
DP* Medicament delivery device and methods for delivering
drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 002: Dec 10, 2020 |
Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
Pat.
No. 10960155
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 002: Apr 22, 2021 |
Jun 25, 2026 |
AUVI-Q (SOLUTION) (INTRAMUSCULAR,
SUBCUTANEOUS) EPINEPHRINE
Drug Classes:
Respiratory Tract/
Pulmonary Agents:Bronchodilators, Sympathomimetic == alpha
adrenergic agonist == beta adrenergic agonist == catecholamine
NDA Applicant:
KALEO
INC NDA No.: 201739 Prod. No.:
003 RX (EQ 0.1MG/DELIVERY)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7731686
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Jun 1, 2026 | |
Pat.
No. 7731690
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Jan 15, 2025 | |
Pat.
No. 7749194
DP* Devices, systems, and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Oct 30, 2028 | |
Pat.
No. 7918823
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 7947017
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Mar 12, 2028 | |
Pat.
No. 8016788
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Mar 21, 2025 | |
Pat.
No. 8021344
DP* Medicament delivery device configured to produce an
audible output Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 2, 2029 | |
Pat.
No. 8206360
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Feb 27, 2027 | |
Pat.
No. 8226610
DP* Medical injector with compliance tracking and
monitoring Claim Types: Device; Method of use Pat. Sub. Date(s): 003: Dec 15, 2017 |
Apr 10, 2029 | |
Pat.
No. 8231573
DP* Medicament delivery device having an electronic
circuit system Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 25, 2028 | |
Pat.
No. 8313466
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 8361029
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 8425462
DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of use Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 8608698
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 8920377
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 8926594
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Mar 31, 2026 | |
Pat.
No. 9056170
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 9149579
Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 |
Jul 19, 2025 | U-1758: Method of treating allergic reaction via injection |
Pat.
No. 9238108
DP* Medicament delivery device having an electronic
circuit system Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Feb 20, 2027 | |
Pat.
No. 9259539
DP* Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 |
Feb 1, 2026 | |
Pat.
No. 9278182
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Feb 1, 2026 | |
Pat.
No. 9724471
DP* Devices, systems, and methods for medicament delivery Claim Types: Device; Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 |
May 23, 2027 | U-2092: Method for confirming dose delivery |
Pat.
No. 9737669
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | |
Pat.
No. 9833573
Devices, systems and methods for medicament delivery Claim Types: Method of administration Pat. Sub. Date(s): 003: Dec 15, 2017 |
Nov 23, 2024 | U-2172: Method to treat severe allergic emergencies in patients weighing 7.5 to 15 kg (16.5 to 33 lbs) |
Pat.
No. 10314977
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Jun 11, 2019 |
Nov 23, 2024 | |
Pat.
No. 10335549
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Jul 2, 2019 |
Apr 30, 2025 | |
Pat.
No. 10688244
DP* Medicament delivery device and methods for delivering
drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 003: Nov 4, 2020 |
Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
Pat.
No. 10737028
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Aug 25, 2020 |
Nov 23, 2024 | |
Pat.
No. 10842938
DP* Medicament delivery device and methods for delivering
drugs to infants and children Claim Types: Method of administration; Device Pat. Sub. Date(s): 003: Dec 10, 2020 |
Dec 21, 2037 | U-2980: Method of treating an allergic reaction using an auto-injector |
Pat.
No. 10960155
DP* Devices, systems and methods for medicament delivery Claim Types: Device Pat. Sub. Date(s): 003: Apr 22, 2021 |
Jun 25, 2026 |
AVACLYR
(OINTMENT) (OPHTHALMIC)
ACYCLOVIR
Drug Classes:
Antivirals:Antiherpetic
Agents == Dermatological Agents:Topical Anti-infectives == Dermatological
Agents:Dermatological Agents, Other == nucleoside analog HSV
DNA polymerase inhibitor / VZV DNA polymerase inhibitor
NDA Applicant:
FERA PHARMS
LLC NDA No.: 202408 Prod. No.:
001 DISC (3%)
Exclusivity | Expiration | Exclusivity Description |
---|---|---|
Exclusivity Code: ODE - Orphan drug exclusivity | Mar 29, 2026 | ODE-235: Indicated for the treatment of acute herpetic keratitis (dendritic ulcers) in patients with herpes simplex (HSV-1 and HSV-2) virus |
AVANDAMET
(TABLET) (ORAL)
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
Drug Classes:
Blood Glucose
Regulators:Antidiabetic Agents == biguanide == peroxisome
proliferator-activated receptor (PPAR) gamma agonist == thiazolidinedione
NDA Applicant:
SB
PHARMCO NDA No.: 021410 Prod. No.:
001 DISC (500MG;EQ 1MG BASE); 002 DISC (500MG;EQ 2MG
BASE); 003 DISC (500MG;EQ 4MG BASE); 004 DISC (1GM;EQ
2MG BASE); 005 DISC (1GM;EQ 4MG BASE)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8236345
DP* Composition and use Claim Types: Formulation Pat. Sub. Date(s): 001: Aug 20, 2012; 002: None; 003: None; 004: None; 005: None |
Oct 7, 2022 |
AVEED
(INJECTABLE)
(INTRAMUSCULAR) TESTOSTERONE UNDECANOATE
Drug Classes:
Hormonal Agents,
Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant:
ENDO PHARMS
INC NDA No.: 022219 Prod. No.:
001 RX (750MG/3ML (250MG/ML))
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 7718640
DP* Methods and pharmaceutical compositions for reliable
achievement of acceptable serum testosterone levels Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Mar 14, 2027 | |
Pat.
No. 8338395
Methods and pharmaceutical compositions for reliable achievement of
acceptable serum testosterone levels Claim Types: Method of use; Method of administration Pat. Sub. Date(s): 001: None |
May 8, 2027 | U-1500: Testosterone replacement therapy in adult males for conditions associated with a deficiency or absence of endogenous testosterone; primary hypogonadism (congenital or acquired); hypogonadotropic hypogonadism (congenital or acquired). |
AVYCAZ
(POWDER) (INTRAVENOUS)
AVIBACTAM SODIUM; CEFTAZIDIME
Drug Classes:
beta lactamase inhibitor
== Antibacterials:Beta-lactam, Cephalosporins == cephalosporin
antibacterial
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* 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 |
AXID
(SOLUTION) (ORAL)
NIZATIDINE [Has competitive generic]
Drug Classes:
Gastrointestinal
Agents:Histamine2 (H2) Receptor Antagonists == histamine-2 (H2)
receptor antagonist
NDA Applicant:
BRAINTREE NDA No.:
021494 Prod. No.:
001 DISC (15MG/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 6930119
DP* Liquid pharmaceutical composition Claim Types: Formulation Pat. Sub. Date(s): 001: None |
Jul 17, 2022 |
AXIRON
(SOLUTION, METERED)
(TRANSDERMAL) TESTOSTERONE [Has
competitive generic]
Drug Classes:
Hormonal Agents,
Stimulant/ Replacement/ Modifying (Sex Hormones/ Modifiers):Androgens
NDA Applicant:
ELI LILLY AND
CO NDA No.: 022504 Prod. No.:
001 DISC (30MG/1.5ML ACTUATION)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 8419307
Spreading implement Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 30, 2013 |
Feb 26, 2027 | U-1386: A method of increasing the testosterone blood level of a person in need thereof |
Pat.
No. 8435944
Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: None |
Sep 27, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
Pat.
No. 8784878
DP* Transdermal delivery rate control using amorphous
pharmaceutical compositions Claim Types: Formulation; Method of administration Pat. Sub. Date(s): 001: Aug 7, 2014 |
Jul 13, 2023 | U-1545: A method of transdermally delivering testosterone |
Pat.
No. 8807861
DP* Spreading implement Claim Types: Device; Drug in a container; Method of use Pat. Sub. Date(s): 001: Sep 10, 2014 |
Feb 26, 2027 | U-1563: A method of transdermal administration of a physiologically active agent to a subject. |
Pat.
No. 8993520
Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Apr 9, 2015 |
Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
Pat.
No. 9180194
Method and composition for transdermal drug delivery Claim Types: Method of use Pat. Sub. Date(s): 001: Dec 3, 2015 |
Jun 2, 2026 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
Pat.
No. 9289586
Spreading implement Claim Types: Method of administration Pat. Sub. Date(s): 001: Apr 19, 2016 |
Feb 26, 2027 | U-1390: A method of increasing the testosterone blood level of an adult male subject in need thereof |
AXUMIN
(SOLUTION) (INTRAVENOUS)
FLUCICLOVINE F-18
Drug Classes:
radioactive diagnostic
agent
NDA Applicant:
BLUE
EARTH NDA No.: 208054 Prod. No.:
001 RX (9-221mCi/ML)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9387266
Precursor compound of radioactive halogen-labeled organic compound Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Jul 28, 2016 |
Nov 28, 2026 | U-1879: Method of diagnosing tumors using positron emission tomography |
Pat.
No. 10010632
DP* Precursor compound of radioactive halogen-labeled
organic compound Claim Types: Formulation Pat. Sub. Date(s): 001: Jul 27, 2018 |
Nov 28, 2026 | |
Pat.
No. 10124079
Imaging of metastatic or recurrent cancer Claim Types: Method of administration; Diagnostic or surgical method Pat. Sub. Date(s): 001: Dec 12, 2018 |
Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
Pat.
No. 10716868
Imaging of metastatic or recurrent cancer Claim Types: Method of administration Pat. Sub. Date(s): 001: Jul 22, 2020 |
Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
Pat.
No. 10933147
Imaging of metastatic or recurrent cancer Claim Types: Method of administration Pat. Sub. Date(s): 001: Mar 9, 2021 |
Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
Pat.
No. 10953112
Precursor compound of radioactive halogen-labeled organic compound Claim Types: Product-by-process Pat. Sub. Date(s): 001: Apr 20, 2021 |
Nov 28, 2026 | U-1879: Method of diagnosing tumors using positron emission tomography |
Pat.
No. 10967077
Imaging of metastatic or recurrent cancer Claim Types: Diagnostic or surgical method Pat. Sub. Date(s): 001: Apr 20, 2021 |
Dec 30, 2035 | U-2450: Positron emission tomography diagnostic agent in adults with suspected prostate cancer recurrence based on elevated blood prostate specific antigen levels following prior treatment |
AYVAKIT
(TABLET) (ORAL)
AVAPRITINIB
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == kinase inhibitor
NDA Applicant:
BLUEPRINT
MEDICINES NDA No.: 212608 Prod. No.:
001 RX (100MG); 002 RX (200MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9200002
DS* DP* Compositions useful for treating disorders
related to KIT Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 5, 2020 |
Oct 15, 2034 | U-2726:
Treatment of unresectable or metastatic gastrointestinal stromal tumor
(gist) harboring a platelet-derived growth factor receptor alpha
(PDGFRA) exon 18 mutation U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Pat.
No. 9944651
DS* DP* Compositions useful for treating disorders
related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 5, 2020 |
Oct 15, 2034 | U-2726:
Treatment of unresectable or metastatic gastrointestinal stromal tumor
(gist) harboring a platelet-derived growth factor receptor alpha
(PDGFRA) exon 18 mutation U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Pat.
No. 9994575
DS* DP* Compositions useful for treating disorders
related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Feb 5, 2020 |
Oct 15, 2034 | U-2726:
Treatment of unresectable or metastatic gastrointestinal stromal tumor
(gist) harboring a platelet-derived growth factor receptor alpha
(PDGFRA) exon 18 mutation U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Jun 16, 2024 | I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN) |
Exclusivity Code: I - New Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2027 | ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
AYVAKIT (TABLET) (ORAL)
AVAPRITINIB
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == kinase inhibitor
NDA Applicant:
BLUEPRINT
MEDICINES NDA No.: 212608 Prod. No.:
003 RX (300MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9200002
DS* DP* Compositions useful for treating disorders
related to KIT Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Feb 5, 2020 |
Oct 15, 2034 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
Pat.
No. 9944651
DS* DP* Compositions useful for treating disorders
related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Feb 5, 2020 |
Oct 15, 2034 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
Pat.
No. 9994575
DS* DP* Compositions useful for treating disorders
related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): 003: Feb 5, 2020 |
Oct 15, 2034 | U-2726: Treatment of unresectable or metastatic gastrointestinal stromal tumor (gist) harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: NCE - New chemical entity | Jan 9, 2025 | |
Exclusivity Code: ODE - Orphan drug exclusivity | Jun 16, 2028 | ODE-356: For the treatment of adult patients with advanced systemic mastocytosis (ADVSM). ADVSM includes patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Exclusivity Code: ODE - Orphan drug exclusivity | Jan 9, 2027 | ODE-366: Indicated for the treatment of adults with unresectable or metastatic GIST harboring a platelet-derived growth factor receptor alpha (PDGFRA) exon 18 mutation, including PDGFRA D842V mutations |
AYVAKIT (TABLET) (ORAL)
AVAPRITINIB
Drug Classes:
Antineoplastics:Molecular
Target Inhibitors == kinase inhibitor
NDA Applicant:
BLUEPRINT
MEDICINES NDA No.: 212608 Prod. No.:
004 RX (25MG); 005 RX (50MG)
Patents | Expiration | Patented Use |
---|---|---|
Pat.
No. 9200002
DS* DP* Compositions useful for treating disorders
related to KIT Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jul 13, 2021 |
Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Pat.
No. 9944651
DS* DP* Compositions useful for treating disorders
related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jul 13, 2021 |
Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Pat.
No. 9994575
DS* DP* Compositions useful for treating disorders
related to kit Claim Types: Compound; Composition; Method of use Pat. Sub. Date(s): All strengths: Jul 13, 2021 |
Oct 15, 2034 | U-3168: Treatment of advanced systemic mastocytosis, including patients with aggressive systemic mastocytosis (ASM), systemic mastocytosis with an associated hematological neoplasm (SM-AHN), and mast cell leukemia (MCL) |
Exclusivity | Expiration | Exclusivity Description |
Exclusivity Code: I - New Indication | Jun 16, 2024 | I-863: Treatment of adult patients with advanced systemic mastocytosis (ADVSM), including patients with aggressive systemic mastocytosis (ASM) and systemic mastocytosis with an associated hematological neoplasm (SM-AHN) |
Exclusivity Code: I - New Indication | Jun 16, 2024 | I-864: Treatment of adult patients with mast cell leukemia (MCL) |
Exclu |