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Last Updated: March 18, 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, 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
Hikma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 215138-001 Jan 26, 2022 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Novast Labs BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 215047-001 Nov 17, 2021 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Able BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076528-001 Aug 21, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Taro BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 213046-001 Jul 1, 2020 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hikma BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 215135-002 Mar 25, 2022 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alvogen BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 204984-001 Jan 10, 2017 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lannett Co Inc BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 212082-001 Dec 17, 2019 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

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