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Last Updated: December 13, 2024

Acetaminophen; butalbital; caffeine - Generic Drug Details


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What are the generic drug sources for acetaminophen; butalbital; caffeine and what is the scope of patent protection?

Acetaminophen; butalbital; caffeine is the generic ingredient in ten branded drugs marketed by Shire, Aurolife Pharma Llc, Dr Reddys Labs Sa, Gilbert Labs, Graham Dm, Granules, Hikma, Key Therap, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Senores Pharms, Taro, Mikart, Us Chem, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Watson Labs, Forest Pharms, Hikma Intl Pharms, Nostrum Labs Inc, and Valeant, and is included in sixty NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-seven suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine
US Patents:0
Tradenames:10
Applicants:34
NDAs:60
Finished Product Suppliers / Packagers: 37
Clinical Trials: 1
DailyMed Link:acetaminophen; butalbital; caffeine at DailyMed
Recent Clinical Trials for acetaminophen; butalbital; caffeine

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
GlaxoSmithKlinePhase 3

See all acetaminophen; butalbital; caffeine clinical trials

Pharmacology for acetaminophen; butalbital; caffeine

US Patents and Regulatory Information for acetaminophen; butalbital; caffeine

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 040261-001 Oct 28, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mallinckrodt BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 088758-001 Mar 27, 1985 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Novast Labs BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 215047-001 Nov 17, 2021 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Gilbert Labs BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 087629-001 Nov 13, 1984 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Watson Labs BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 040267-001 Jul 30, 1998 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Key Therap BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 206615-001 Aug 4, 2017 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

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