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, Fosun Pharma, Ivax Pharms, Sun Pharm Industries, and Watson Labs, 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: | 6 |
NDAs: | 11 |
Drug Master File Entries: | 9 |
Raw Ingredient (Bulk) Api Vendors: | 118 |
Clinical Trials: | 1 |
Patent Applications: | 6,805 |
Formulation / Manufacturing: | see details |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Novartis | BUTAZOLIDIN | phenylbutazone | TABLET;ORAL | 008319-008 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm Industries | PHENYLBUTAZONE | phenylbutazone | CAPSULE;ORAL | 088994-001 | Dec 4, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sanofi Aventis Us | AZOLID | phenylbutazone | CAPSULE;ORAL | 087260-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Watson Labs | PHENYLBUTAZONE | phenylbutazone | TABLET;ORAL | 086151-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Fosun Pharma | PHENYLBUTAZONE | phenylbutazone | CAPSULE;ORAL | 087774-001 | Jun 16, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sun Pharm Industries | PHENYLBUTAZONE | phenylbutazone | TABLET;ORAL | 088863-001 | Dec 4, 1985 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Sanofi Aventis Us | AZOLID | phenylbutazone | TABLET;ORAL | 087091-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |