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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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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