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 two branded drugs marketed by Actavis Labs Fl Inc and Astellas, and is included in three 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 thirty-three 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: | 133 |
US Patents: | 3 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 3 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 112 |
Clinical Trials: | 310 |
Patent Applications: | 5,423 |
Formulation / Manufacturing: | see details |
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 |
---|---|
Nuvation Bio Inc. | Phase 1/Phase 2 |
Fudan University | Phase 2 |
Curium US LLC | Phase 3 |
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 | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Astellas | XTANDI | enzalutamide | CAPSULE;ORAL | 203415-001 | Aug 31, 2012 | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
Astellas | XTANDI | enzalutamide | TABLET;ORAL | 213674-001 | Aug 4, 2020 | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | Y | See Plans and Pricing | ||
Actavis Labs Fl Inc | ENZALUTAMIDE | enzalutamide | CAPSULE;ORAL | 209614-001 | May 14, 2021 | DISCN | No | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | ||||
>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 | Title | Estimated Expiration |
---|---|---|---|
Luxembourg | 92338 | See Plans and Pricing | |
Serbia | 52274 | JEDINJENJE DIARILHIDANTOINA (DIARZLHZDANTOIN COMPOUND) | See Plans and Pricing |
Japan | 2017031224 | ジアリールチオヒダントイン化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS) | See Plans and Pricing |
Hong Kong | 1177691 | 二芳基硫代乙內酰脲化合物 (DIARYLTHIOHYDANTOIN COMPOUNDS) | See Plans and Pricing |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for enzalutamide
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1893196 | PA2013029,C1893196 | Lithuania | See Plans and Pricing | PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130625 |
1893196 | 92338 | Luxembourg | See Plans and Pricing | PRODUCT NAME: ENZALUTAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (XTANDI); FIRST REGISTRATION DATE: 20130625 |
1893196 | PA2013029 | Lithuania | See Plans and Pricing | PRODUCT NAME: ENZALUTAMIDUM; REGISTRATION NO/DATE: EU/1/13/846 20130621 |
1893196 | 70/2013 | Austria | See Plans and Pricing | 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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