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Bosentan Patent Expiration

Bosentan was first introduced by Actelion Pharmaceuticals Us Inc in its drug Tracleer on Nov 20, 2001. 12 different companies have introduced drugs containing Bosentan.


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 US5292740 Sulfonamides Nov 20, 2015

(Expired)

 Actelion
Tracleer US7959945 Dispersible bosentan tablet Dec 28, 2027 Actelion
Tracleer US8309126 Dispersible bosentan tablet May 15, 2026 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.

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

Event Date Patent/Publication
Patent litigations
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 23 Sep, 2013 US7959945
Recordation of Patent Grant Mailed 13 Nov, 2012 US8309126
Patent Issue Date Used in PTA Calculation 13 Nov, 2012 US8309126
Issue Notification Mailed 24 Oct, 2012 US8309126
Dispatch to FDC 19 Oct, 2012 US8309126



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Bosentan Generics

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 Alembic Pharmaceuticals Ltd and was approved on Jan 23, 2020.

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


1. 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
125MG tablet Discontinued ORAL N/A Jan 15, 2020
62.5MG tablet Discontinued ORAL N/A Jan 15, 2020


2. 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


3. 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
125MG tablet Discontinued ORAL N/A Jan 3, 2020
62.5MG tablet Discontinued ORAL N/A Jan 3, 2020


4. 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


5. 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


6. 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


7. 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
62.5MG tablet Discontinued ORAL N/A Jan 23, 2020
125MG tablet Discontinued ORAL N/A Jan 23, 2020


8. 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


9. NATCO PHARMA LTD

Natco Pharma 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 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


10. 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


11. 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