ABIRATERONE ACETATE Drug Patent Profile
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When do Abiraterone Acetate patents expire, 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-six 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 |
| Finished Product Suppliers / Packagers: | 24 |
| Raw Ingredient (Bulk) Api Vendors: | 86 |
| Clinical Trials: | 254 |
| Patent Applications: | 1,604 |
| Drug Prices: | Drug price information for ABIRATERONE ACETATE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ABIRATERONE ACETATE |
| What excipients (inactive ingredients) are in ABIRATERONE ACETATE? | ABIRATERONE ACETATE excipients list |
| DailyMed Link: | ABIRATERONE ACETATE at DailyMed |
Recent Clinical Trials for ABIRATERONE ACETATE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Changhai Hospital | N/A |
| Merck Sharp & Dohme LLC | Phase 3 |
| Orion Corporation, Orion Pharma | Phase 3 |
Pharmacology for ABIRATERONE ACETATE
| Drug Class | Cytochrome P450 17A1 Inhibitor |
| Mechanism of Action | Cytochrome P450 17A1 Inhibitors Cytochrome P450 2C8 Inhibitors Cytochrome P450 2D6 Inhibitors |
Medical Subject Heading (MeSH) Categories for ABIRATERONE ACETATE
Anatomical Therapeutic Chemical (ATC) Classes 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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Rising | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208371-001 | Feb 25, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Glenmark Speclt | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 209227-001 | Oct 16, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Dr Reddys | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208416-001 | May 18, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mylan | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208446-001 | Oct 31, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Teva Pharms Usa | ABIRATERONE ACETATE | abiraterone acetate | TABLET;ORAL | 208432-001 | Oct 31, 2018 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for ABIRATERONE ACETATE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Mylan Ireland Limited | Abiraterone Mylan | abiraterone acetate | EMEA/H/C/005368 Abiraterone Mylan is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT).the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated.the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel based chemotherapy regimen. |
Authorised | yes | no | no | 2021-08-20 | |
| Krka, d.d., Novo mesto | Abiraterone Krka | abiraterone acetate | EMEA/H/C/005649 Abiraterone Krka is indicated with prednisone or prednisolone for:the treatment of newly diagnosed high risk metastatic hormone sensitive prostate cancer (mHSPC) in adult men in combination with androgen deprivation therapy (ADT) (see section 5.1)the treatment of metastatic castration resistant prostate cancer (mCRPC) in adult men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy in whom chemotherapy is not yet clinically indicated (see section 5.1)the treatment of mCRPC in adult men whose disease has progressed on or after a docetaxel-based chemotherapy regimen. |
Authorised | yes | no | no | 2021-06-24 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
