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Enzalutamide - Generic Drug Details
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What are the generic drug sources for enzalutamide and what is the scope of patent protection?
Enzalutamide
is the generic ingredient in one branded drug marketed by Astellas and is included in two NDAs. There are three 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 twenty-eight patent family members in twenty-eight countries.
There are nine drug master file entries for enzalutamide. One supplier is listed for this compound.
Summary for enzalutamide
International Patents: | 128 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 9 |
Suppliers / Packagers: | 1 |
Bulk Api Vendors: | 103 |
Clinical Trials: | 280 |
Patent Applications: | 1,921 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Novartis Pharmaceuticals | Phase 3 |
POINT Biopharma | Phase 3 |
Amgen | Phase 1 |
Pharmacology for enzalutamide
Drug Class | Androgen Receptor Inhibitor |
Mechanism of Action | Androgen Receptor Antagonists Cytochrome P450 3A4 Inducers Cytochrome P450 2C9 Inducers Cytochrome P450 2C19 Inducers |
Paragraph IV (Patent) Challenges for ENZALUTAMIDE
Tradename | Dosage | Ingredient | NDA | Submissiondate |
---|---|---|---|---|
XTANDI | CAPSULE;ORAL | enzalutamide | 203415 | 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 | TABLET;ORAL | 213674-001 | Aug 4, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
Astellas | XTANDI | enzalutamide | TABLET;ORAL | 213674-002 | Aug 4, 2020 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
Astellas | XTANDI | enzalutamide | TABLET;ORAL | 213674-001 | Aug 4, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
Astellas | XTANDI | enzalutamide | TABLET;ORAL | 213674-001 | Aug 4, 2020 | RX | Yes | 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 |
International Patents for enzalutamide
Country | Patent Number | Estimated Expiration |
---|---|---|
Singapore | 10201408699T | Start Trial |
Russian Federation | 2638833 | Start Trial |
Japan | 4644737 | Start Trial |
South Korea | 20080014039 | Start Trial |
Japan | 6013535 | Start Trial |
>Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for enzalutamide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1893196 | C20130036 00106 | Estonia | Start Trial | PRODUCT NAME: ENSALUTAMIID;REG NO/DATE: K(2013)4019 (LOPLIK) 25.06.2013 |
1893196 | CR 2013 00065 | Denmark | Start Trial | PRODUCT NAME: ENZALUTAMID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/13/846 20130625 |
1893196 | C300632 | Netherlands | Start Trial | PRODUCT NAME: ENZALUTAMIDE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/846 20130621 |
1893196 | 13C0071 | France | Start Trial | PRODUCT NAME: ENZALUTAMIDE OU SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/13/846 20130625 |
1893196 | 70/2013 | Austria | Start Trial | PRODUCT NAME: ENZALUTAMID; REGISTRATION NO/DATE: EU/1/13/836 20130621 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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