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Brexpiprazole Patent Expiration

Brexpiprazole is used for treating major depressive disorder (MDD) and schizophrenia in adults and pediatric patients ages 13 years and older. It was first introduced by Otsuka Pharmaceutical Co Ltd in its drug Rexulti on Jul 10, 2015. 13 different companies have introduced drugs containing Brexpiprazole.


Brexpiprazole Patents

Given below is the list of patents protecting Brexpiprazole, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Rexulti US10307419

(Pediatric)

 Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof Apr 12, 2033 Otsuka
Rexulti US10307419 Tablet comprising 7-[4-(4-benzo[b]thiopen-4-yl-piperazin-1-yl)butoxy]-1H-quinolin-2-one or a salt thereof Oct 12, 2032 Otsuka
Rexulti USRE48059

(Pediatric)

 Piperazine-substituted benzothiophenes for treatment of mental disorders Jun 23, 2029 Otsuka
Rexulti USRE48059 Piperazine-substituted benzothiophenes for treatment of mental disorders Dec 23, 2028 Otsuka
Rexulti US7888362

(Pediatric)

 Piperazine-substituted benzothiophenes for treatment of mental disorders Oct 12, 2026 Otsuka
Rexulti US8349840

(Pediatric)

 Piperazine-substituted benzothiophenes for treatment of mental disorders Oct 12, 2026 Otsuka
Rexulti US8618109

(Pediatric)

 Piperazine-substituted benzothiophenes for treatment of mental disorders Oct 12, 2026 Otsuka
Rexulti US9839637

(Pediatric)

 Piperazine-substituted benzothiophenes for treatment of mental disorders Oct 12, 2026 Otsuka
Rexulti US7888362 Piperazine-substituted benzothiophenes for treatment of mental disorders Apr 12, 2026 Otsuka
Rexulti US8349840 Piperazine-substituted benzothiophenes for treatment of mental disorders Apr 12, 2026 Otsuka
Rexulti US8618109 Piperazine-substituted benzothiophenes for treatment of mental disorders Apr 12, 2026 Otsuka
Rexulti US9839637 Piperazine-substituted benzothiophenes for treatment of mental disorders Apr 12, 2026 Otsuka



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Brexpiprazole's patents.

Given below is the list recent legal activities going on the following patents of Brexpiprazole.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 26 Jun, 2024 US8349840
Payment of Maintenance Fee, 4th Year, Large Entity 16 Nov, 2022 US10307419
Payment of Maintenance Fee, 8th Year, Large Entity 16 Jun, 2021 US8618109
Payment of Maintenance Fee, 4th Year, Large Entity 26 May, 2021 US9839637
Mail-Petition Decision - Granted 08 Oct, 2020 US7888362
Petition Decision - Granted
Critical
 06 Oct, 2020 US7888362
Petition Entered 06 Jul, 2020 US7888362
Payment of Maintenance Fee, 8th Year, Large Entity 25 Jun, 2020 US8349840
Mail Certificate of Correction Memo 27 Sep, 2019 US10307419
Post Issue Communication - Certificate of Correction 26 Sep, 2019 US10307419


Brexpiprazole's Family Patents

Family Patents

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Brexpiprazole Generic API Manufacturers

Several generic applications have been filed for Brexpiprazole. The first generic version for Brexpiprazole was by Teva Pharmaceuticals Usa Inc and was approved on Aug 11, 2022. And the latest generic version is by Apotex Inc and was approved on Feb 24, 2025.

Given below is the list of companies who have filed for Brexpiprazole generic, along with the locations of their manufacturing plants worldwide.


1. AJANTA PHARMA LTD

Ajanta Pharma Ltd has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Ajanta Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

tablet Discontinued ORAL N/A Feb 3, 2023
0.25MG

tablet Discontinued ORAL N/A Feb 3, 2023
4MG

tablet Discontinued ORAL N/A Feb 3, 2023
3MG

tablet Discontinued ORAL N/A Feb 3, 2023
2MG

tablet Discontinued ORAL N/A Feb 3, 2023
1MG

tablet Discontinued ORAL N/A Feb 3, 2023


Manufacturing Plant Locations
New

Ajanta Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Ajanta Pharma Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Ajanta Pharma Ltd.





2. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG

tablet Prescription ORAL AB Jan 13, 2025
0.5MG

tablet Prescription ORAL AB Jan 13, 2025
1MG

tablet Prescription ORAL AB Jan 13, 2025
2MG

tablet Prescription ORAL AB Jan 13, 2025
3MG

tablet Prescription ORAL AB Jan 13, 2025
4MG

tablet Prescription ORAL AB Jan 13, 2025


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)
Vadodara Alembic Pharmaceuticals, Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd





3. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

tablet Discontinued ORAL N/A Nov 28, 2023
0.25MG

tablet Discontinued ORAL N/A Nov 28, 2023
4MG

tablet Discontinued ORAL N/A Nov 28, 2023
3MG

tablet Discontinued ORAL N/A Nov 28, 2023
2MG

tablet Discontinued ORAL N/A Nov 28, 2023
1MG

tablet Discontinued ORAL N/A Nov 28, 2023





4. AMNEAL

Amneal Eu Ltd has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Amneal.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG

tablet Discontinued ORAL N/A Jan 31, 2023
4MG

tablet Discontinued ORAL N/A Jan 31, 2023
3MG

tablet Discontinued ORAL N/A Jan 31, 2023
2MG

tablet Discontinued ORAL N/A Jan 31, 2023
1MG

tablet Discontinued ORAL N/A Jan 31, 2023
0.5MG

tablet Discontinued ORAL N/A Jan 31, 2023


Manufacturing Plant Locations
New

Amneal's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Amneal as present at those locations.

Country City Firm Name
United States
Brookhaven Amneal Pharmaceuticals of New York, LLC
Bridgewater Amneal Complex Products Research LLC
Branchburg Amneal Pharmaceuticals, LLC
Glasgow Amneal Pharmaceuticals LLC
Hauppauge Amneal Pharmaceuticals of New York, LLC
Paterson Amneal Pharmaceuticals, Llc
Piscataway Amneal Pharmaceuticals, LLC
East Hanover Amneal Pharmaceuticals LLC
India
Tal Bavla, Ahmedabad Amneal Pharmaceuticals Pvt. Ltd.
Ahmedabad Amneal Pharmaceuticals Private Ltd.
Hyderabad Amneal Oncology Private Limited
Matoda Amneal Pharmaceuticals Private Ltd.





5. ANDA REPOSITORY

Anda Repository Llc has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Anda Repository.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1MG

tablet Discontinued ORAL N/A Oct 25, 2023
0.25MG

tablet Discontinued ORAL N/A Oct 25, 2023
0.5MG

tablet Discontinued ORAL N/A Oct 25, 2023
2MG

tablet Discontinued ORAL N/A Oct 25, 2023
3MG

tablet Discontinued ORAL N/A Oct 25, 2023
4MG

tablet Discontinued ORAL N/A Oct 25, 2023





6. APOTEX

Apotex Inc has filed for 5 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3MG

tablet Discontinued ORAL N/A Feb 24, 2025
2MG

tablet Discontinued ORAL N/A Feb 24, 2025
1MG

tablet Discontinued ORAL N/A Feb 24, 2025
0.5MG

tablet Discontinued ORAL N/A Feb 24, 2025
0.25MG

tablet Discontinued ORAL N/A Feb 24, 2025


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Richmond Hill Apotex Inc.
Brantford Apotex Pharmachem Inc.
Toronto Apotex Inc.
Etobicoke Apotex, Inc.
North York Apotex Inc.
Winnipeg Apotex Fermentation Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre





7. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG

tablet Discontinued ORAL N/A Nov 2, 2023
4MG

tablet Discontinued ORAL N/A Nov 2, 2023
3MG

tablet Discontinued ORAL N/A Nov 2, 2023
2MG

tablet Discontinued ORAL N/A Nov 2, 2023
1MG

tablet Discontinued ORAL N/A Nov 2, 2023
0.5MG

tablet Discontinued ORAL N/A Nov 2, 2023


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





8. HETERO LABS LTD V

Hetero Labs Ltd Unit V has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Hetero Labs Ltd V.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.25MG

tablet Discontinued ORAL N/A Nov 20, 2023
3MG

tablet Discontinued ORAL N/A Nov 20, 2023
2MG

tablet Discontinued ORAL N/A Nov 20, 2023
1MG

tablet Discontinued ORAL N/A Nov 20, 2023
0.5MG

tablet Discontinued ORAL N/A Nov 20, 2023
4MG

tablet Discontinued ORAL N/A Nov 20, 2023





9. LUPIN LTD

Lupin Ltd has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
3MG

tablet Discontinued ORAL N/A Mar 17, 2023
4MG

tablet Discontinued ORAL N/A Mar 17, 2023
2MG

tablet Discontinued ORAL N/A Mar 17, 2023
1MG

tablet Discontinued ORAL N/A Mar 17, 2023
0.5MG

tablet Discontinued ORAL N/A Mar 17, 2023
0.25MG

tablet Discontinued ORAL N/A Mar 17, 2023


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





10. SANDOZ

Sandoz Inc has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Sandoz.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

tablet Discontinued ORAL N/A Sep 26, 2022
4MG

tablet Discontinued ORAL N/A Sep 26, 2022
3MG

tablet Discontinued ORAL N/A Sep 26, 2022
2MG

tablet Discontinued ORAL N/A Sep 26, 2022
1MG

tablet Discontinued ORAL N/A Sep 26, 2022
0.25MG

tablet Discontinued ORAL N/A Sep 26, 2022


Manufacturing Plant Locations
New

Sandoz's manufacturing plants are situated in 4 countries - Austria, United States, Spain, India. Given below are the details of these plant locations as well as the firm names of Sandoz as present at those locations.

Country City Firm Name
Austria
Kundl Sandoz GmbH
Langkampfen Sandoz GmbH
United States
East Hanover Sandoz Incorporated
Princeton Sandoz Inc
Spain
Palafolls Sandoz Industrial Products, S.A.
Les Franqueses Del Valles Sandoz Industrial Products S.A.
India
Navi Mumbai Sandoz Private Limited





11. TEVA PHARMS USA INC

Teva Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

tablet Discontinued ORAL N/A Aug 11, 2022
1MG

tablet Discontinued ORAL N/A Aug 11, 2022
2MG

tablet Discontinued ORAL N/A Aug 11, 2022
3MG

tablet Discontinued ORAL N/A Aug 11, 2022
4MG

tablet Discontinued ORAL N/A Aug 11, 2022
0.25MG

tablet Discontinued ORAL N/A Aug 11, 2022





12. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 6 different strengths of generic version for Brexpiprazole. Given below are the details of the strengths of this generic introduced by Zydus Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
0.5MG

tablet Discontinued ORAL N/A Jan 10, 2023
0.25MG

tablet Discontinued ORAL N/A Jan 10, 2023
1MG

tablet Discontinued ORAL N/A Jan 10, 2023
2MG

tablet Discontinued ORAL N/A Jan 10, 2023
3MG

tablet Discontinued ORAL N/A Jan 10, 2023
4MG

tablet Discontinued ORAL N/A Jan 10, 2023