Phenylbutazone - Generic Drug Details
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What are the generic drug sources for phenylbutazone and what is the scope of freedom to operate?
Phenylbutazone
is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Novartis, Chartwell Rx, Ivax Pharms, Sun Pharm Industries, Watson Labs, and Fosun Pharma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for phenylbutazone.
Summary for phenylbutazone
| US Patents: | 0 |
| Tradenames: | 3 |
| Applicants: | 7 |
| NDAs: | 11 |
| Drug Master File Entries: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 118 |
| Clinical Trials: | 1 |
| Patent Applications: | 6,882 |
| DailyMed Link: | phenylbutazone at DailyMed |
Recent Clinical Trials for phenylbutazone
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Federal University of São Paulo | Phase 4 |
| Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Medical Subject Heading (MeSH) Categories for phenylbutazone
Anatomical Therapeutic Chemical (ATC) Classes for phenylbutazone
US Patents and Regulatory Information for phenylbutazone
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Watson Labs | PHENYLBUTAZONE | phenylbutazone | TABLET;ORAL | 086151-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Ivax Pharms | PHENYLBUTAZONE | phenylbutazone | CAPSULE;ORAL | 088218-001 | Jun 24, 1983 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Fosun Pharma | PHENYLBUTAZONE | phenylbutazone | TABLET;ORAL | 084339-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | PHENYLBUTAZONE | phenylbutazone | CAPSULE;ORAL | 087756-001 | Dec 17, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Novartis | BUTAZOLIDIN | phenylbutazone | CAPSULE;ORAL | 008319-009 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | PHENYLBUTAZONE | phenylbutazone | TABLET;ORAL | 087674-001 | Apr 21, 1982 | 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 |
