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 Granules, Mayne Pharma Inc, Aace Pharms, Alvogen, Halsey, Larken Labs Inc, Lgm Pharma, Mikart, Rise Pharma, and Watson Labs. and is included in eleven NDAs.
The generic ingredient in BUTALBITAL AND ACETAMINOPHEN is acetaminophen; butalbital. There are sixty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital profile page.
Summary for BUTALBITAL AND ACETAMINOPHEN
| US Patents: | 0 |
| Applicants: | 10 |
| NDAs: | 11 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 3 |
| Patent Applications: | 3 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Granules | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | CAPSULE;ORAL | 213115-001 | Nov 22, 2019 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Larken Labs Inc | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 203484-002 | Dec 4, 2015 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alvogen | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 207635-001 | Jun 5, 2017 | AA | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Rise Pharma | BUTALBITAL AND ACETAMINOPHEN | acetaminophen; butalbital | TABLET;ORAL | 214088-003 | Apr 7, 2022 | AA | RX | 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 |
