Bosentan Patent Expiration
Bosentan was first introduced by Actelion Pharmaceuticals Us Inc
Bosentan Patents
Given below is the list of patents protecting Bosentan, 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 |
|---|---|---|---|---|
| Tracleer | US7959945 | Dispersible bosentan tablet | Dec 28, 2027 | Actelion |
| Tracleer | US8309126 | Dispersible bosentan tablet | May 15, 2026 | Actelion |
| Tracleer | US5292740 | Sulfonamides |
Nov 20, 2015
(Expired) | Actelion |
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 Bosentan's patents.
Latest Legal Activities on Bosentan's Patents
Given below is the list recent legal activities going on the following patents of Bosentan.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 May, 2024 | US8309126 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 30 Nov, 2022 | US7959945 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 30 Apr, 2020 | US8309126 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 04 Dec, 2018 | US7959945 |
| Filing Receipt - Corrected | 23 Sep, 2013 | US7959945 |
| Email Notification Critical | 23 Sep, 2013 | US7959945 |
| Recordation of Patent Grant Mailed Critical | 13 Nov, 2012 | US8309126 |
| Patent Issue Date Used in PTA Calculation Critical | 13 Nov, 2012 | US8309126 |
| Issue Notification Mailed Critical | 24 Oct, 2012 | US8309126 |
| Dispatch to FDC | 19 Oct, 2012 | US8309126 |
Bosentan's Family Patents
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Bosentan Generic API Manufacturers
Several generic applications have been filed for Bosentan. The first generic version for Bosentan was by Alvogen Pine Brook Inc and was approved on Apr 26, 2019. And the latest generic version is by Natco Pharma Ltd and was approved on Feb 5, 2025.
Given below is the list of companies who have filed for Bosentan generic, along with the locations of their manufacturing plants worldwide.
1. ALEMBIC
Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Alembic.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 125MG | tablet | Discontinued | ORAL | N/A | Jan 23, 2020 |
| 62.5MG | tablet | Discontinued | ORAL | N/A | Jan 23, 2020 |
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 |
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2. ALVOGEN PINE BROOK
Alvogen Pine Brook Inc has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Alvogen Pine Brook.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
| 125MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
3. AMNEAL PHARMS CO
Amneal Pharmaceuticals Co Gmbh has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Amneal Pharms Co.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
| 125MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
4. CHARTWELL MOLECULAR
Chartwell Molecular Holdings Llc has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Chartwell Molecular.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Discontinued | ORAL | N/A | Jan 3, 2020 |
| 125MG | tablet | Discontinued | ORAL | N/A | Jan 3, 2020 |
5. ENDO OPERATIONS
Endo Operations Ltd has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Endo Operations.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
| 125MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
6. HIKMA
Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Hikma.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
| 125MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
Manufacturing Plant Locations New
Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.
| Country | City | Firm Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| Portugal |
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| Jordan |
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7. MYLAN
Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Mylan.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Discontinued | ORAL | N/A | Jan 15, 2020 |
| 125MG | tablet | Discontinued | ORAL | N/A | Jan 15, 2020 |
Manufacturing Plant Locations New
Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.
| Country | City | Firm Name | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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| Canada |
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| Ireland |
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8. NATCO PHARMA LTD
Natco Pharma Ltd has filed for 3 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Natco Pharma Ltd.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
| 125MG | tablet | Discontinued | ORAL | N/A | Apr 26, 2019 |
| 32MG | tablet, for suspension | Prescription | ORAL | AB | Feb 5, 2025 |
Manufacturing Plant Locations New
Natco 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 Natco Pharma Ltd as present at those locations.
| Country | City | Firm Name | ||||
|---|---|---|---|---|---|---|
| India |
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9. SUN PHARM
Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Sun Pharm.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Prescription | ORAL | AB | Apr 26, 2019 |
| 125MG | tablet | Prescription | ORAL | AB | Apr 26, 2019 |
Manufacturing Plant Locations New
Sun Pharm'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 Sun Pharm as present at those locations.
| Country | City | Firm Name | ||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| United States |
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| India |
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10. WATSON LABS INC
Watson Laboratories Inc has filed for 2 different strengths of generic version for Bosentan. Given below are the details of the strengths of this generic introduced by Watson Labs Inc.
| Strength | Dosage Form | Availability | Application Pathway | TE code | Launch Date |
|---|---|---|---|---|---|
| 62.5MG | tablet | Prescription | ORAL | AB | Apr 26, 2019 |
| 125MG | tablet | Prescription | ORAL | AB | Apr 26, 2019 |
11. ZYDUS PHARMS
Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Bosentan. 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 |
|---|---|---|---|---|---|
| 62.5MG | tablet | Prescription | ORAL | AB | Apr 26, 2019 |
| 125MG | tablet | Prescription | ORAL | AB | Apr 26, 2019 |