FLUTAMIDE - Generic Drug Details
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What are the generic sources for flutamide and what is the scope of patent protection?
Flutamide
is the generic ingredient in two branded drugs marketed by Schering, Actavis Labs Fl Inc, Chartwell Rx, Cipla, Mylan, and Waylis Therap, and is included in six NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for flutamide. Two suppliers are listed for this compound.
Summary for FLUTAMIDE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 6 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 130 |
Clinical Trials: | 72 |
Patent Applications: | 7,324 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for FLUTAMIDE |
What excipients (inactive ingredients) are in FLUTAMIDE? | FLUTAMIDE excipients list |
DailyMed Link: | FLUTAMIDE at DailyMed |
Recent Clinical Trials for FLUTAMIDE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
University of Colorado, Denver | Phase 4 |
Kafrelsheikh University | Phase 2 |
2-Montefiore Health System and Albert Einstein College of Medicine, Newyork, United States of America (U.S.A). | Phase 3 |
Pharmacology for FLUTAMIDE
Drug Class | Androgen Receptor Inhibitor |
Mechanism of Action | Androgen Receptor Antagonists |
Medical Subject Heading (MeSH) Categories for FLUTAMIDE
Anatomical Therapeutic Chemical (ATC) Classes for FLUTAMIDE
US Patents and Regulatory Information for FLUTAMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mylan | FLUTAMIDE | flutamide | CAPSULE;ORAL | 076224-001 | May 9, 2003 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Actavis Labs Fl Inc | FLUTAMIDE | flutamide | CAPSULE;ORAL | 075820-001 | Sep 18, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Chartwell Rx | FLUTAMIDE | flutamide | CAPSULE;ORAL | 075818-001 | Sep 18, 2001 | DISCN | 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 |
Expired US Patents for FLUTAMIDE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Schering | EULEXIN | flutamide | CAPSULE;ORAL | 018554-001 | Jan 27, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Schering | EULEXIN | flutamide | CAPSULE;ORAL | 018554-001 | Jan 27, 1989 | ⤷ Sign Up | ⤷ Sign Up |
Schering | EULEXIN | flutamide | CAPSULE;ORAL | 018554-001 | Jan 27, 1989 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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