ENZALUTAMIDE - Generic Drug Details
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What are the generic drug sources for enzalutamide and what is the scope of freedom to operate?
Enzalutamide
is the generic ingredient in two branded drugs marketed by Actavis Labs Fl Inc, Apotex, and Astellas, and is included in four NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.Enzalutamide has one hundred and eighty-four patent family members in thirty-four countries.
There are nine drug master file entries for enzalutamide. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for ENZALUTAMIDE
International Patents: | 184 |
US Patents: | 4 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 4 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 122 |
Clinical Trials: | 342 |
Patent Applications: | 3,887 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ENZALUTAMIDE |
What excipients (inactive ingredients) are in ENZALUTAMIDE? | ENZALUTAMIDE excipients list |
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 |
Generic filers with tentative approvals for ENZALUTAMIDE
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 80MG | TABLET;ORAL |
⤷ Sign Up | ⤷ Sign Up | 40MG | TABLET;ORAL |
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for ENZALUTAMIDE
Drug Class | Androgen Receptor Inhibitor |
Mechanism of Action | Androgen Receptor Antagonists Cytochrome P450 2C19 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 3A4 Inducers |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | ⤷ 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 | ||||
Astellas | XTANDI | enzalutamide | TABLET;ORAL | 213674-002 | Aug 4, 2020 | RX | Yes | Yes | ⤷ 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 |
International Patents for ENZALUTAMIDE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Australia | 2018200316 | Formulations of enzalutamide | ⤷ Sign Up |
Singapore | 170809 | DIARYLTHIOHYDANTOIN COMPOUNDS | ⤷ Sign Up |
Poland | 3725778 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ENZALUTAMIDE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1893196 | PA2013029 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621 |
1893196 | CA 2013 00065 | Denmark | ⤷ Sign Up | PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625 |
1893196 | PA2013029,C1893196 | Lithuania | ⤷ Sign Up | PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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