ABIRATERONE ACETATE Drug Patent Profile
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Which patents cover Abiraterone Acetate, and what generic alternatives are available?
Abiraterone Acetate is a drug marketed by Amneal Pharms, Apotex, Dr Reddys, Florida, Glenmark Speclt, Hikma, MSN, Mylan, Novugen, Qilu, Rising, Teva Pharms Usa, and Wockhardt Bio Ag. and is included in fifteen NDAs.
The generic ingredient in ABIRATERONE ACETATE is abiraterone acetate. There are twenty-five drug master file entries for this compound. Twenty-four suppliers are listed for this compound. Additional details are available on the abiraterone acetate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Abiraterone Acetate
A generic version of ABIRATERONE ACETATE was approved as abiraterone acetate by APOTEX on October 31st, 2018.
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Summary for ABIRATERONE ACETATE
| US Patents: | 0 |
| Applicants: | 13 |
| NDAs: | 15 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABIRATERONE ACETATE |
Paragraph IV (Patent) Challenges for ABIRATERONE ACETATE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| YONSA | Tablets | abiraterone acetate | 125 mg | 210308 | 1 | 2018-07-23 |
| ZYTIGA | Tablets | abiraterone acetate | 500 mg | 202379 | 1 | 2017-08-23 |
| ZYTIGA | Tablets | abiraterone acetate | 250 mg | 202379 | 13 | 2015-04-28 |
US Patents and Regulatory Information for ABIRATERONE ACETATE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amneal Pharms | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208327-001 | Jan 7, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Rising | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208371-001 | Feb 25, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Glenmark Speclt | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 209227-001 | Oct 16, 2019 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Dr Reddys | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208416-001 | May 18, 2020 | AB | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
