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
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.
Latest 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 |
|---|---|---|
 | ||
| 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
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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 Alkem Laboratories Ltd and was approved on Nov 28, 2023.
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 |
| |||
2. 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 | Discontinued | ORAL | N/A | Nov 28, 2023 |
| 1MG | tablet | Discontinued | ORAL | N/A | Nov 28, 2023 |
| 2MG | tablet | Discontinued | ORAL | N/A | Nov 28, 2023 |
| 0.5MG | tablet | Discontinued | ORAL | N/A | Nov 28, 2023 |
| 3MG | tablet | Discontinued | ORAL | N/A | Nov 28, 2023 |
| 4MG | tablet | Discontinued | ORAL | N/A | Nov 28, 2023 |
3. 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 |
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| India |
| |||||||||||||||||
4. 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 |
|---|---|---|---|---|---|
| 2MG | 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 |
| 1MG | 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 |
5. 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 |
| |||
6. 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 | Discontinued | ORAL | N/A | Nov 20, 2023 |
| 4MG | 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 |
| 0.25MG | tablet | Discontinued | ORAL | N/A | Nov 20, 2023 |
7. 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 |
| |||
8. 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 |
| |||||
| United States |
| |||||
| Spain |
| |||||
| India |
| |||||
9. 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 |
10. 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 |