Abiraterone Acetate Patent Expiration

Abiraterone Acetate is Used for the treatment of advanced prostate cancer in combination with prednisone, including metastatic castration-resistant and high-risk castration-sensitive types. It was first introduced by Janssen Biotech Inc in its drug Zytiga on Apr 28, 2011. Another drug containing Abiraterone Acetate is Yonsa. 15 different companies have introduced drugs containing Abiraterone Acetate.


Abiraterone Acetate Patents

Given below is the list of patents protecting Abiraterone Acetate, 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
Yonsa US10292990 Abiraterone steroid formulation May 20, 2034 Sun Pharm
Yonsa US9889144 Abiraterone acetate formulation and methods of use Mar 17, 2034 Sun Pharm
Zytiga US8822438 Methods and compositions for treating cancer Aug 24, 2027 Janssen Biotech
Zytiga US5604213 17-substituted steroids useful in cancer treatment Feb 18, 2014

(Expired)

Janssen Biotech



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 Abiraterone Acetate's patents.

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

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 4th Year, Large Entity 21 Nov, 2022 US10292990
Payment of Maintenance Fee, 8th Year, Large Entity 16 Feb, 2022 US8822438
Payment of Maintenance Fee, 4th Year, Large Entity 13 Aug, 2021 US9889144
Review Certificate Mailed 21 Oct, 2019 US8822438
Review Certificate 11 Sep, 2019 US8822438
Recordation of Patent Grant Mailed 21 May, 2019 US10292990
Patent Issue Date Used in PTA Calculation 21 May, 2019 US10292990
Email Notification 02 May, 2019 US10292990
Issue Notification Mailed 01 May, 2019 US10292990
Dispatch to FDC 02 Apr, 2019 US10292990


Abiraterone Acetate's Family Patents

Family Patents

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Abiraterone Acetate Generic API Manufacturers

Several generic applications have been filed for Abiraterone Acetate. The first generic version for Abiraterone Acetate was by Apotex Inc and was approved on Oct 31, 2018. And the latest generic version is by Msn Laboratories Private Ltd and was approved on Apr 24, 2024.

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


1. AMNEAL PHARMS

Amneal Pharmaceuticals Of New York Llc has filed for 2 different strengths of generic version for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Amneal Pharms.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Jan 7, 2019
500MG

tablet Prescription ORAL AB Dec 23, 2020





2. APOTEX

Apotex Inc has filed for 1 generic for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Oct 31, 2018


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.
Brantford Apotex Pharmachem Inc.
Etobicoke Apotex, Inc.
Winnipeg Apotex Fermentation Inc.
North York Apotex Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bangalore Apotex Research Private Limited - Bioequivalence Centre
Bengaluru Apotex Research Private Limited





3. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB May 18, 2020
500MG

tablet Prescription ORAL AB Sep 1, 2023





4. FLORIDA

Florida Pharmaceutical Products Llc has filed for 1 generic for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Florida.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

tablet Prescription ORAL AB Mar 23, 2023





5. GLENMARK SPECLT

Glenmark Specialty Sa has filed for 2 different strengths of generic version for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Glenmark Speclt.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Oct 16, 2019
500MG

tablet Prescription ORAL AB May 19, 2022





6. HIKMA

Hikma Pharmaceuticals Llc has filed for 1 generic for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Oct 31, 2018


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. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Jul 10, 2019
500MG

tablet Prescription ORAL AB Apr 24, 2024


Manufacturing Plant Locations
New

Msn'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 Msn as present at those locations.

Country City Firm Name
India
Kamareddy MSN Life Sciences Private Limited
Sangareddy MSN Pharmachem Private Limited
Rangareddy District MSN Laboratories Private Limited
Sangareddy MSN Laboratories Private Limited, R&D Center
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Yadadri Bhuvanagiri District MSN Organics Private Limited
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Ltd.
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
United States
Piscataway MSN PHARMACEUTICALS INC





8. MYLAN

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

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Oct 31, 2018
500MG

tablet Prescription ORAL AB Dec 14, 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





9. NOVUGEN

Novugen Oncology Sdn Bhd has filed for 2 different strengths of generic version for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Novugen.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Jan 5, 2022
500MG

tablet Prescription ORAL AB Jan 5, 2022





10. QILU

Qilu Pharmaceutical Co Ltd has filed for 2 different strengths of generic version for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Qilu.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Sep 27, 2019
500MG

tablet Prescription ORAL AB Jun 25, 2021


Manufacturing Plant Locations
New

Qilu's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Qilu as present at those locations.

Country City Firm Name
China
Jinan Qilu Antibiotics Pharmaceutical Co. , Ltd.
Hohhot Qilu Pharmaceutical (Inner Mongolia) Co., Ltd.
Dezhou Qilu SYNVA Pharmaceutical Co. Ltd
Haikou Qilu Pharmaceutical (Hainan) Co. Ltd.
Jinan Qilu Pharmaceutical Co., Ltd.
Jinan Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
Hulunbeier Qilu Pharmaceutical Hulun Buir Branch





11. RISING

Rising Pharma Holdings Inc has filed for 1 generic for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Rising.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Feb 25, 2019


Manufacturing Plant Locations
New

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

Country City Firm Name
United States
Phoenix Rising Sun Farms Inc
Fort Bragg Rising Tide Sea Vegetables
Saddle Brook Rising Pharmaceuticals, Inc.
Decatur Rising Pharma Holdings, Inc
Livingston Risingsun Iodine Products Corp.
East Brunswick Rising Pharma Holding, Inc.
Mount Morris Rising Creek Bakery LLC
Rising Sun Rising Sun Veterinary Clinic
Flagstaff Rising High Enterprises, LLC (DBA RisingHy)
Mexico
Pueblo San Clemente RISING FARMS SAPI DE CV
India
Ahmedabad Rising Retina Clinic





12. TEVA PHARMS USA

Teva Pharmaceuticals Usa Inc has filed for 3 different strengths of generic version for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Oct 31, 2018
125MG

tablet Discontinued ORAL N/A Jun 24, 2022
500MG

tablet Prescription ORAL AB Jan 26, 2023





13. WOCKHARDT BIO AG

Wockhardt Bio Ag has filed for 1 generic for Abiraterone Acetate. Given below are the details of the strengths of this generic introduced by Wockhardt Bio Ag.

Strength Dosage Form Availability Application Pathway TE code Launch Date
250MG

tablet Prescription ORAL AB Feb 27, 2019