Pharsight

1. List of Abilify drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8642760	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Sep, 2022 (4 months ago)
US9359302	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Sep, 2022 (4 months ago)
US8580796	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Sep, 2022 (4 months ago)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9089567	OTSUKA	Method of treating cognitive impairments and schizophrenias	Jan, 2022 (1 year, 10 days ago)
US8642600	OTSUKA	Method of treating autism	Jan, 2022 (1 year, 10 days ago)
US7053092	OTSUKA	5-HT1a receptor subtype agonist	Jan, 2022 (1 year, 10 days ago)
US6977257	OTSUKA	Aripiprazole oral solution	Apr, 2022 (9 months ago)
US8642600 (Pediatric)	OTSUKA	Method of treating autism	Jul, 2022 (6 months ago)
US6977257 (Pediatric)	OTSUKA	Aripiprazole oral solution	Oct, 2022 (3 months ago)
US8642760 (Pediatric)	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Mar, 2023 (a month from now)
US8580796 (Pediatric)	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Mar, 2023 (a month from now)
US9387182	OTSUKA	Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders	Dec, 2023 (10 months from now)
US8017615	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Jun, 2024 (1 year, 4 months from now)
US7115587	OTSUKA	Aripiprazole complex formulation and method	Jul, 2024 (1 year, 5 months from now)
US7550445	OTSUKA	Aripiprazole complex formulation and method	Jul, 2024 (1 year, 5 months from now)
US8017615 (Pediatric)	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Dec, 2024 (1 year, 10 months from now)
US7115587 (Pediatric)	OTSUKA	Aripiprazole complex formulation and method	Jan, 2025 (1 year, 11 months from now)
US7550445 (Pediatric)	OTSUKA	Aripiprazole complex formulation and method	Jan, 2025 (1 year, 11 months from now)
US9125939	OTSUKA	Carbostyril derivatives and mood stabilizers for treating mood disorders	Jul, 2026 (3 years from now)
US8759350	OTSUKA	Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders	Mar, 2027 (4 years from now)

Drugs and Companies using ARIPIPRAZOLE ingredient

Market Authorisation Date: 07 June, 2006

Treatment: Treatment of schizophrenia; Treatment of irritability associated with autistic disorder; Treatment of major depressive disorder (mdd); Adjunctive treatment of major depressive disorder (mdd); Acute treatment of manic and mixed episodes associated with bipolar i disorder; 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

Dosage: TABLET, ORALLY DISINTEGRATING;ORAL

Strength	Submission Date	ANDA(s) Filed	Last patent expiry	180 day status
1 mg/mL	20 Dec, 2007	1	24 Apr, 2022	Extinguished
2 mg, 5 mg, 10 mg, 15 mg, 20 mg and 30 mg	15 Nov, 2006	8	20 Oct, 2014	Extinguished
10 mg, 15 mg, 20 mg and 30 mg	15 Nov, 2006	1	20 Oct, 2014	Extinguished

Strength	Dosage	Availability
10MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
15MG	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
20MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued
30MG Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	TABLET, ORALLY DISINTEGRATING;ORAL	Discontinued

2. List of Abilify Mycite Kit drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8580796	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Sep, 2022 (4 months ago)
US8642760	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Sep, 2022 (4 months ago)
US9359302	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Sep, 2022 (4 months ago)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US7053092	OTSUKA	5-HT1a receptor subtype agonist	Jan, 2022 (1 year, 10 days ago)
US9089567	OTSUKA	Method of treating cognitive impairments and schizophrenias	Jan, 2022 (1 year, 10 days ago)
US9387182	OTSUKA	Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders	Dec, 2023 (10 months from now)
US8017615	OTSUKA	Low hygroscopic aripiprazole drug substance and processes for the preparation thereof	Jun, 2024 (1 year, 4 months from now)
US11476952	OTSUKA	Pharma-informatics system	Apr, 2026 (3 years from now)
US9125939	OTSUKA	Carbostyril derivatives and mood stabilizers for treating mood disorders	Jul, 2026 (3 years from now)
US7978064	OTSUKA	Communication system with partial power source	Sep, 2026 (3 years from now)
US8759350	OTSUKA	Carbostyril derivatives and serotonin reuptake inhibitors for treatment of mood disorders	Mar, 2027 (4 years from now)
US9444503	OTSUKA	Active signal processing personal health signal receivers	Nov, 2027 (4 years from now)
US9119554	OTSUKA	Pharma-informatics system	Dec, 2028 (5 years from now)
US9258035	OTSUKA	Multi-mode communication ingestible event markers and systems, and methods of using the same	Mar, 2029 (6 years from now)
US9060708	OTSUKA	Multi-mode communication ingestible event markers and systems, and methods of using the same	Mar, 2029 (6 years from now)
US8674825	OTSUKA	Pharma-informatics system	Apr, 2029 (6 years from now)
US8956288	OTSUKA	In-body power source having high surface area electrode	Jul, 2029 (6 years from now)
US10441194	OTSUKA	Ingestible event marker systems	Jul, 2029 (6 years from now)
US8945005	OTSUKA	Controlled activation ingestible identifier	Aug, 2029 (6 years from now)
US9433371	OTSUKA	In-body device with virtual dipole signal amplification	Sep, 2029 (6 years from now)
US8718193	OTSUKA	Active signal processing personal health signal receivers	Dec, 2029 (6 years from now)
US9149577	OTSUKA	Body-associated receiver and method	Dec, 2029 (6 years from now)
US8847766	OTSUKA	Pharma-informatics system	Mar, 2030 (7 years from now)
US8545402	OTSUKA	Highly reliable ingestible event markers and methods for using the same	Apr, 2030 (7 years from now)
US8114021	OTSUKA	Body-associated receiver and method	Jun, 2030 (7 years from now)
US11464423	OTSUKA	In-body power source having high surface area electrode	Sep, 2030 (7 years from now)
US9941931	OTSUKA	System for supply chain management	Nov, 2030 (7 years from now)
US8961412	OTSUKA	In-body device with virtual dipole signal amplification	Nov, 2030 (7 years from now)
US8258962	OTSUKA	Multi-mode communication ingestible event markers and systems, and methods of using the same	Nov, 2030 (7 years from now)
US8547248	OTSUKA	Implantable zero-wire communications system	Dec, 2030 (7 years from now)
US11229378	OTSUKA	Communication system with enhanced partial power source and method of manufacturing same	Jul, 2031 (8 years from now)
US9320455	OTSUKA	Highly reliable ingestible event markers and methods for using the same	Dec, 2031 (8 years from now)
US10517507	OTSUKA	Communication system with enhanced partial power source and method of manufacturing same	Jun, 2032 (9 years from now)
US9268909	OTSUKA	Apparatus, system, and method to adaptively optimize power dissipation and broadcast power in a power source for a communication device	Oct, 2033 (10 years from now)

Drugs and Companies using ARIPIPRAZOLE ingredient

Market Authorisation Date: 13 November, 2017

Treatment: Adjunctive treatment of major depressive disorder (mdd); Treatment of schizophrenia; Acute treatment of manic and mixed episodes associated with bipolar i disorder; 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; 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; Method of using a tablet embedded with a sensor that communicates information via a signal through the body of a patient to a receiver; 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

Dosage: TABLET;ORAL

Strength	Dosage	Availability
2MG	TABLET;ORAL	Prescription
5MG	TABLET;ORAL	Prescription
10MG	TABLET;ORAL	Prescription
15MG	TABLET;ORAL	Prescription
20MG	TABLET;ORAL	Prescription
30MG	TABLET;ORAL	Prescription

3. List of Inqovi drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US9567363	OTSUKA	Certain compounds, compositions and methods	Oct, 2028 (5 years from now)
US8268800	OTSUKA	Certain compounds, compositions and methods	Aug, 2030 (7 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8618075	OTSUKA	Certain compounds, compositions and methods	Oct, 2028 (5 years from now)

Exclusivity	Exclusivity Expiration
New Chemical Entity Exclusivity (NCE)	Jul 7, 2025
Orphan Drug Exclusivity (ODE)	Jul 7, 2027

Drugs and Companies using CEDAZURIDINE; DECITABINE ingredient

NCE-1 date: July, 2024

Market Authorisation Date: 07 July, 2020

Treatment: Method for inhibiting cytidine deaminase by administering cedazuridine; Method for inhibiting degradation of a cda substrate by administering cedazuridine; Treatment of chronic myelomonocytic leukemia; Treatment of myelodysplastic syndrome

Dosage: TABLET;ORAL

Strength	Dosage	Availability
100MG;35MG	TABLET;ORAL	Prescription

4. List of Jynarque drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8501730	OTSUKA	Process for preparing benzazepine compounds or salts thereof	Sep, 2026 (3 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10905694	OTSUKA	Pharmaceutical solid preparation comprising benzazepines and production method thereof	Apr, 2030 (7 years from now)

Exclusivity	Exclusivity Expiration
Orphan Drug Exclusivity (ODE)	Apr 23, 2025

Drugs and Companies using TOLVAPTAN ingredient

Market Authorisation Date: 23 April, 2018

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
15 mg, 30 mg, 45 mg, 60 mg, 90 mg	08 Apr, 2021	1		07 Apr, 2030

Strength	Dosage	Availability
15MG	TABLET;ORAL	Prescription
30MG	TABLET;ORAL	Prescription
45MG	TABLET;ORAL	Prescription
60MG	TABLET;ORAL	Prescription
90MG	TABLET;ORAL	Prescription

5. List of Rexulti drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US7888362	OTSUKA	Piperazine-substituted benzothiophenes for treatment of mental disorders	Apr, 2026 (3 years from now)
USRE48059	OTSUKA	Piperazine-substituted benzothiophenes for treatment of mental disorders	Dec, 2028 (5 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US8349840	OTSUKA	Piperazine-substituted benzothiophenes for treatment of mental disorders	Apr, 2026 (3 years from now)
US9839637	OTSUKA	Piperazine-substituted benzothiophenes for treatment of mental disorders	Apr, 2026 (3 years from now)
US8618109	OTSUKA	Piperazine-substituted benzothiophenes for treatment of mental disorders	Apr, 2026 (3 years from now)
US10307419	OTSUKA	Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof	Oct, 2032 (9 years from now)

Exclusivity	Exclusivity Expiration
New Patient Population (NPP)	Dec 27, 2024

Drugs and Companies using BREXPIPRAZOLE ingredient

Market Authorisation Date: 10 July, 2015

Treatment: Adjunctive treatment of major depressive disorder (mdd); Treatment of schizophrenia; Treatment of schizophrenia in adults and pediatric patients ages 13 years and older

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg	10 Jul, 2019	18	11 Aug, 2022	12 Oct, 2032	Deferred

Strength	Dosage	Availability
0.25MG	TABLET;ORAL	Prescription
0.5MG	TABLET;ORAL	Prescription
1MG	TABLET;ORAL	Prescription
2MG	TABLET;ORAL	Prescription
3MG	TABLET;ORAL	Prescription
4MG	TABLET;ORAL	Prescription

6. List of Samsca drug patents

Patent Number	Company	Patent Title	Patent Expiry
These patents protects the active chemical substance. Only patent owner can launch products that use this active substance.
US8501730	OTSUKA	Process for preparing benzazepine compounds or salts thereof	Sep, 2026 (3 years from now)
These patents focus on the other aspects of the active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US10905694	OTSUKA	Pharmaceutical solid preparation comprising benzazepines and production method thereof	Apr, 2030 (7 years from now)

Drugs and Companies using TOLVAPTAN ingredient

Market Authorisation Date: 19 May, 2009

Treatment: NA

Dosage: TABLET;ORAL

Strength	Submission Date	ANDA(s) Filed	First applicant approval	Last patent expiry	180 day status
30mg	23 Sep, 2013	1		19 May, 2020	Extinguished Non-Forfeiture
15 mg	10 Oct, 2013	1	15 Feb, 2022	01 Sep, 2026	Non-Forfeiture
60 mg	26 Mar, 2018	1	19 May, 2020	01 Sep, 2026	Eligible