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. 11 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 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 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
Rexulti USRE48059 Piperazine-substituted benzothiophenes for treatment of mental disorders Dec 23, 2028 Otsuka


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Brexpiprazole Generics

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 Alkem Laboratories Ltd and was approved on Nov 28, 2023.

Given below is the list of companies who have filed for Brexpiprazole generic.


1. 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


2. 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


3. 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


4. 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


5. 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


6. 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


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


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
0.5MG tablet Prescription ORAL AB Nov 20, 2023
4MG tablet Prescription ORAL AB Nov 20, 2023
3MG tablet Prescription ORAL AB Nov 20, 2023
2MG tablet Prescription ORAL AB Nov 20, 2023
1MG tablet Prescription ORAL AB Nov 20, 2023
0.25MG tablet Prescription ORAL AB Nov 20, 2023


9. 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
0.25MG tablet Prescription ORAL AB Nov 28, 2023
1MG tablet Prescription ORAL AB Nov 28, 2023
2MG tablet Prescription ORAL AB Nov 28, 2023
0.5MG tablet Prescription ORAL AB Nov 28, 2023
3MG tablet Prescription ORAL AB Nov 28, 2023
4MG tablet Prescription ORAL AB Nov 28, 2023


10. OPTIMUS

Optimus Pharma Private 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 Optimus.

Strength Dosage Form Availability Application Pathway TE code Launch Date
2MG tablet Prescription ORAL AB Oct 25, 2023
0.25MG tablet Prescription ORAL AB Oct 25, 2023
0.5MG tablet Prescription ORAL AB Oct 25, 2023
1MG tablet Prescription ORAL AB Oct 25, 2023
3MG tablet Prescription ORAL AB Oct 25, 2023
4MG tablet Prescription ORAL AB Oct 25, 2023