Butabarbital sodium - Generic Drug Details
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What are the generic drug sources for butabarbital sodium and what is the scope of freedom to operate?
Butabarbital sodium
is the generic ingredient in ten branded drugs marketed by Medpointe Pharm Hlc, Alpharma Us Pharms, Wockhardt, Lannett, Meda Pharms, Halsey, Bundy, Sandoz, Solvay, Teva, Watson Labs, Whiteworth Town Plsn, Mylan Speciality Lp, Hikma, Ivax Sub Teva Pharms, and Marshall Pharma, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.There are four drug master file entries for butabarbital sodium.
Summary for butabarbital sodium
US Patents: | 0 |
Tradenames: | 10 |
Applicants: | 16 |
NDAs: | 32 |
Drug Master File Entries: | 4 |
Raw Ingredient (Bulk) Api Vendors: | 38 |
Clinical Trials: | 1 |
Patent Applications: | 450 |
Formulation / Manufacturing: | see details |
DailyMed Link: | butabarbital sodium at DailyMed |
Recent Clinical Trials for butabarbital sodium
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 |
US Patents and Regulatory Information for butabarbital sodium
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Halsey | SARISOL NO. 2 | butabarbital sodium | TABLET;ORAL | 084719-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Speciality Lp | BUTISOL SODIUM | butabarbital sodium | TABLET;ORAL | 000793-004 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Mylan Speciality Lp | BUTISOL SODIUM | butabarbital sodium | TABLET;ORAL | 000793-005 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Teva | BUTABARBITAL SODIUM | butabarbital sodium | TABLET;ORAL | 088631-001 | May 1, 1985 | 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 |