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.
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
Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
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NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
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Recently Granted Patents in EP
Find the opportunity to file Oppositions
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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.
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
Eatontown
Hikma Pharmaceuticals USA, Inc.
Cherry Hill
Hikma Pharmaceuticals USA Inc.
Carlsbad
Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton
Hikma Injectables USA Inc
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
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
Rockford
Mylan Institutional, Inc.
Morgantown
Mylan Specialty, L.P.
Greensboro
Mylan Pharmaceuticals Inc
San Carlos
Mylan Pharmaceuticals Inc.
Saint Albans
Mylan Technologies, Inc.
Santa Barbara
Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
Morgantown
MYLAN CONSUMER HEALTHCARE Inc.
India
Anekal Taluk, Bangalore
Mylan Laboratories Limited
Bangalore
Mylan Laboratories Limited
Hosur
Mylan Laboratories Limited
Hyderabad
Mylan Laboratories Limited
Sarigam
Mylan Laboratories Limited
Sinnar
Mylan Laboratories Limited
Pithampur, District Dhar
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 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
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
Princeton
SUN PHARMACEUTICAL INDUSTRIES INC
Billerica
Sun Pharmaceutical Industries, Inc.
Lexington
Sun Pharmaceutical Industries Inc
India
Ahmednagar
Sun Pharmaceutical Industries Limited
Kanchipuram
Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara
Sun Pharmaceutical Industries Ltd.
New Delhi
Sun Pharmaceutical Industries Limited
Dadra
Sun Pharmaceutical Industries Limited
Vadodara
Sun Pharmaceutical Industries Ltd
Baruch
Sun Pharmaceutical Industries Ltd.
Punjab
Sun Pharmaceutical Industries, Inc.
Vadodara
Sun Pharmaceutical Industries Limited - Karkhadi
Gurugram
Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Halol
Sun Pharmaceutical Industries Ltd.
Bharuch
Sun Pharmaceutical Industries Ltd
Malanpur, Bhind (District)
Sun Pharmaceutical Industries Limited
Mohali
Sun Pharmaceutical Industries Limited
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.
