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Last Updated: March 28, 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 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, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Rise Pharma, Taro, Xspire Pharma, 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 fifty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-three suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine
US Patents:0
Tradenames:10
Applicants:34
NDAs:59
Finished Product Suppliers / Packagers: 33
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
Able BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 040390-001 Jul 23, 2001 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Us Chem MEDIGESIC PLUS acetaminophen; butalbital; caffeine CAPSULE;ORAL 089115-001 Jan 14, 1986 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Forest Pharms ESGIC acetaminophen; butalbital; caffeine TABLET;ORAL 089660-001 Dec 23, 1988 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mikart BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine SOLUTION;ORAL 040387-001 Jan 31, 2003 RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rise Pharma BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 214087-001 Aug 13, 2021 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lgm Pharma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076560-001 Jun 10, 2004 AB 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

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