Flutamide - Generic Drug Details
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What are the generic drug sources for flutamide and what is the scope of freedom to operate?
Flutamide
is the generic ingredient in two branded drugs marketed by Schering, Actavis Labs Fl Inc, Chartwell Rx, Cipla, Norvium Bioscience, 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: | 7,340 |
| 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 |
| Kafrelsheikh University | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Cipla | FLUTAMIDE | flutamide | CAPSULE;ORAL | 075780-001 | Sep 19, 2001 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Waylis Therap | FLUTAMIDE | flutamide | CAPSULE;ORAL | 075298-001 | Sep 18, 2001 | RX | No | Yes | ⤷ 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 | ||||
| Schering | EULEXIN | flutamide | CAPSULE;ORAL | 018554-001 | Jan 27, 1989 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Norvium Bioscience | FLUTAMIDE | flutamide | CAPSULE;ORAL | 076224-001 | May 9, 2003 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
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.
ISSN: 2162-2639
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