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 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.

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

Activity Date Patent Number
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


Bosentan's Family Patents

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

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
62.5MG

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

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
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals, Ltd
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)





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
125MG

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

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
Dayton Hikma Injectables USA Inc
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





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
125MG

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

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
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





8. 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


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
Hyderabad NATCO PHARMA LTD
Rangareddy District Natco Pharma Ltd. - Chemical Division





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
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
India
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Bharuch Sun Pharmaceutical Industries Ltd
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Ahmednagar Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Dadra Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.





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