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Last Updated: December 4, 2021

DrugPatentWatch Database Preview

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, Gilbert Labs, Graham Dm, Granules, Hikma, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Mayne Pharma Inc, Nuvo Pharms Inc, Senores Pharms, Taro Pharm Inds Ltd, 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-four NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; butalbital; caffeine. Thirty-three suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine
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
Nostrum Labs Inc BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 075929-001 Apr 22, 2002 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Abhai Llc BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 211106-001 Sep 26, 2018 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lannett Co Inc BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 200243-001 Sep 13, 2012 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Lgm Pharma BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 040885-001 Nov 16, 2009 AA RX No Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Mayne Pharma Inc BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 210817-001 Dec 17, 2019 AA RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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Serving leading biopharmaceutical companies globally:

Colorcon
AstraZeneca
Harvard Business School
Boehringer Ingelheim
Johnson and Johnson
Baxter

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