ENZALUTAMIDE Drug Patent Profile
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Which patents cover Enzalutamide, and what generic alternatives are available?
Enzalutamide is a drug marketed by Actavis Labs Fl Inc, Apotex, and Zydus Pharms. and is included in three NDAs.
The generic ingredient in ENZALUTAMIDE is enzalutamide. There are nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the enzalutamide profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Enzalutamide
A generic version of ENZALUTAMIDE was approved as enzalutamide by ZYDUS PHARMS on September 26th, 2024.
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Summary for ENZALUTAMIDE
| US Patents: | 0 |
| Applicants: | 3 |
| NDAs: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 122 |
| Clinical Trials: | 342 |
| Patent Applications: | 1,748 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENZALUTAMIDE |
| DailyMed Link: | ENZALUTAMIDE at DailyMed |
Recent Clinical Trials for ENZALUTAMIDE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of Oklahoma | Phase 1 |
| Merck Sharp & Dohme LLC | Phase 3 |
| Orion Corporation, Orion Pharma | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for ENZALUTAMIDE
Paragraph IV (Patent) Challenges for ENZALUTAMIDE
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| XTANDI | Tablets | enzalutamide | 40 mg and 80 mg | 213674 | 1 | 2021-03-31 |
| XTANDI | Capsules | enzalutamide | 40 mg | 203415 | 3 | 2016-08-31 |
US Patents and Regulatory Information for ENZALUTAMIDE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Actavis Labs Fl Inc | ENZALUTAMIDE | enzalutamide | CAPSULE;ORAL | 209614-001 | May 14, 2021 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | ENZALUTAMIDE | enzalutamide | CAPSULE;ORAL | 209645-001 | Apr 22, 2022 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Zydus Pharms | ENZALUTAMIDE | enzalutamide | CAPSULE;ORAL | 209667-001 | Sep 26, 2024 | 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 ENZALUTAMIDE
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Astellas Pharma Europe B.V. | Xtandi | enzalutamide | EMEA/H/C/002639 Xtandi is indicated for:the treatment of adult men with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with androgen deprivation therapy (see section 5.1).the treatment of adult men with high-risk non-metastatic castration-resistant prostate cancer (CRPC) (see section 5.1).the treatment of adult men with metastatic CRPC 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 adult men with metastatic CRPC whose disease has progressed on or after docetaxel therapy. |
Authorised | no | no | no | 2013-06-21 | 2013-04-26 |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
