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Last Updated: March 29, 2024

Acetaminophen; butalbital - Generic Drug Details


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

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

Nine suppliers are listed for this compound.

Summary for acetaminophen; butalbital
Recent Clinical Trials for acetaminophen; butalbital

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

SponsorPhase
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4
Federal University of São PauloPhase 4
GlaxoSmithKlinePhase 3

See all acetaminophen; butalbital clinical trials

Pharmacology for acetaminophen; butalbital
Drug ClassBarbiturate

US Patents and Regulatory Information for acetaminophen; butalbital

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mikart BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 207386-001 Nov 15, 2016 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Graham Dm BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 089067-001 Apr 19, 1985 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Senores Pharms BUTALBITAL AND ACETAMINOPHEN acetaminophen; butalbital TABLET;ORAL 214088-002 Apr 7, 2022 AA RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Strides Pharma BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 204649-001 Jul 8, 2020 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Aurolife Pharma Llc BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 204733-001 Sep 26, 2018 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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