Butabarbital sodium - Generic Drug Details
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What are the generic sources for butabarbital sodium and what is the scope of patent protection?
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, Norvium Bioscience, 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: | 449 |
| DailyMed Link: | butabarbital sodium at DailyMed |
Recent Clinical Trials for butabarbital sodium
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 |
Anatomical Therapeutic Chemical (ATC) Classes for butabarbital sodium
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bundy | BUTABARBITAL | butabarbital sodium | TABLET;ORAL | 085550-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Halsey | SARISOL | butabarbital sodium | ELIXIR;ORAL | 084723-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Wockhardt | BUTABARBITAL SODIUM | butabarbital sodium | ELIXIR;ORAL | 085383-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Meda Pharms | BUTISOL SODIUM | butabarbital sodium | ELIXIR;ORAL | 085380-001 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Medpointe Pharm Hlc | BUTICAPS | butabarbital sodium | CAPSULE;ORAL | 085381-002 | Approved Prior to Jan 1, 1982 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Teva | BUTABARBITAL SODIUM | butabarbital sodium | TABLET;ORAL | 088632-001 | May 18, 1985 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Watson Labs | BUTABARBITAL SODIUM | butabarbital sodium | TABLET;ORAL | 085772-001 | Approved Prior to Jan 1, 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 |
