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Ambrisentan Patent Expiration

Ambrisentan is used for treating pulmonary arterial hypertension (PAH) in combination with tadalafil by inhibiting endothelin receptors. It was first introduced by Gilead Sciences Inc in its drug Letairis on Jun 15, 2007. 10 different companies have introduced drugs containing Ambrisentan.


Ambrisentan Patents

Given below is the list of patents protecting Ambrisentan, 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
Letairis US9549926 Compositions and methods of treating pulmonary hypertension Oct 14, 2031 Gilead
Letairis US8377933 Method for treating a pulmonary hypertension condition Dec 11, 2027 Gilead
Letairis US9474752 Method for treating a pulmonary hypertension condition Dec 11, 2027 Gilead
Letairis USRE42462 Carboxylic acid derivatives, their preparation and use Jul 29, 2018

(Expired)

 Gilead
Letairis US5840722 Use of carboxylic acid derivatives as drugs Nov 24, 2015

(Expired)

 Gilead
Letairis US7109205 Carboxylic acid derivatives, their preparation and use Oct 07, 2015

(Expired)

 Gilead
Letairis US7601730 Carboxylic acid derivatives, their preparation and use Oct 07, 2015

(Expired)

 Gilead
Letairis US8349843 Carboxylic acid derivatives, their preparation and use Oct 07, 2015

(Expired)

 Gilead
Letairis US5703017 3-(Het) arylcarboxylic acid derivatives, their preparation and intermediates for their preparation Dec 30, 2014

(Expired)

 Gilead



Ambrisentan's Family Patents

Family Patents

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Ambrisentan Generic API Manufacturers

Several generic applications have been filed for Ambrisentan. The first generic version for Ambrisentan was by Watson Laboratories Inc and was approved on Mar 28, 2019. And the latest generic version is by Aurobindo Pharma Ltd and was approved on Jul 21, 2022.

Given below is the list of companies who have filed for Ambrisentan generic, along with the locations of their manufacturing plants worldwide.


1. APOTEX

Apotex Inc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB May 19, 2022
10MG

tablet Prescription ORAL AB May 19, 2022


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Toronto Apotex Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
Etobicoke Apotex, Inc.
Brantford Apotex Pharmachem Inc.
Winnipeg Apotex Fermentation Inc.
India
Bengaluru Apotex Research Private Limited
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bangalore Apotex Pharmachem India Pvt Ltd.





2. AUROBINDO PHARMA

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Jul 21, 2022
10MG

tablet Prescription ORAL AB Jul 21, 2022


Manufacturing Plant Locations
New

Aurobindo Pharma's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma as present at those locations.

Country City Firm Name
India
Sangareddy Aurobindo Pharma Limited
Bachupally Aurobindo Pharma Limited
Medchal Aurobindo Pharma Ltd
Polepally, Mahaboob Nagar Aurobindo Pharma Limited
United States
East Windsor Aurobindo Pharma USA Inc





3. CIPLA

Cipla Ltd has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Cipla.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Apr 26, 2019
10MG

tablet Prescription ORAL AB Apr 26, 2019


Manufacturing Plant Locations
New

Cipla'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 Cipla as present at those locations.

Country City Firm Name
India
Pithampur, District Dhar Cipla Limited
Raigad Cipla Limited
Kurkumbh Village, Dist. Pune Cipla, Ltd.
Bengaluru Cipla Limited
Bangalore Cipla Ltd.
Mumbai Cipla Limited
Vasco Da Gama Cipla Limited





4. ENDO OPERATIONS

Endo Operations Ltd has filed for 2 different strengths of generic version for Ambrisentan. 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
10MG

tablet Discontinued ORAL N/A Apr 10, 2019
5MG

tablet Discontinued ORAL N/A Apr 10, 2019





5. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
5MG

tablet Prescription ORAL AB Mar 28, 2019
10MG

tablet Prescription ORAL AB Mar 28, 2019


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





6. SIGMAPHARM LABS LLC

Sigmapharm Laboratories Llc has filed for 2 different strengths of generic version for Ambrisentan. Given below are the details of the strengths of this generic introduced by Sigmapharm Labs Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
10MG

tablet Prescription ORAL AB Apr 10, 2019
5MG

tablet Prescription ORAL AB Apr 10, 2019





7. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Ambrisentan. 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
5MG

tablet Prescription ORAL AB Mar 28, 2019
10MG

tablet Prescription ORAL AB Mar 28, 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
Billerica Sun Pharmaceutical Industries, Inc.
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
India
Mohali Sun Pharmaceutical Industries Limited
Ahmednagar Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Ltd
Bharuch Sun Pharmaceutical Industries Ltd
Baruch Sun Pharmaceutical Industries Ltd.
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Vadodara Sun Pharmaceutical Industries Ltd.
Punjab Sun Pharmaceutical Industries, Inc.
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Dadra Sun Pharmaceutical Industries Limited
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited





8. WATSON LABS INC

Watson Laboratories Inc has filed for 2 different strengths of generic version for Ambrisentan. 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
10MG

tablet Prescription ORAL AB Mar 28, 2019
5MG

tablet Prescription ORAL AB Mar 28, 2019





9. ZYDUS PHARMS

Zydus Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Ambrisentan. 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
5MG

tablet Prescription ORAL AB Mar 28, 2019
10MG

tablet Prescription ORAL AB Mar 28, 2019