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Last Updated: November 4, 2024

ACETAMINOPHEN; BUTALBITAL; CAFFEINE - Generic Drug Details


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What are the generic sources for acetaminophen; butalbital; caffeine and what is the scope of freedom to operate?

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 TABLET;ORAL 040336-001 Aug 18, 1999 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Hikma Intl Pharms BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075618-001 Mar 23, 2001 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Strides Pharma BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 203647-001 Sep 21, 2020 AA RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Taro BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 213046-001 Jul 1, 2020 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

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