BUTALBITAL AND ACETAMINOPHEN Drug Patent Profile
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Which patents cover Butalbital And Acetaminophen, and what generic alternatives are available?
Butalbital And Acetaminophen is a drug marketed by Dr Reddys Labs Sa, Granules, Alvogen, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, Ne Rx Pharma, Quagen, Senores Pharms, and Watson Labs. and is included in thirteen NDAs.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
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Summary for BUTALBITAL AND ACETAMINOPHEN
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 13 |
| Finished Product Suppliers / Packagers: | 9 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 3 |
| Patent Applications: | 2 |
| DailyMed Link: | BUTALBITAL AND ACETAMINOPHEN at DailyMed |
Recent Clinical Trials for BUTALBITAL AND ACETAMINOPHEN
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 |
| GlaxoSmithKline | Phase 3 |
Pharmacology for BUTALBITAL AND ACETAMINOPHEN
| Drug Class | Barbiturate |
US Patents and Regulatory Information for BUTALBITAL AND ACETAMINOPHEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dr Reddys Labs Sa | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | CAPSULE;ORAL | 207313-001 | Dec 27, 2017 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Lgm Pharma | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 090956-001 | Aug 23, 2011 | AA | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Alvogen | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 205120-001 | Oct 30, 2015 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Senores Pharms | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 214088-001 | Apr 7, 2022 | AA | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Mikart | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 207386-001 | Nov 15, 2016 | AA | RX | 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 |
