Phenylbutazone - Generic Drug Details
✉ Email this page to a colleague
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 |
---|---|
Fundação de Amparo à Pesquisa do Estado de São Paulo | Phase 4 |
Federal University of 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm Industries | PHENYLBUTAZONE | phenylbutazone | TABLET;ORAL | 088863-001 | Dec 4, 1985 | 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 | ||||
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 | ||||
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 | ||||
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 | ||||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |