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Last Updated: September 27, 2020

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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, Granules Pharms, Mayne Pharma Inc, Valeant, Dunhall, Larken Labs Inc, Cnty Line Pharms, Halsey, Mikart, Nexgen Pharma, Watson Labs, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Lannett Co Inc, Nuvo Pharms Inc, Taro Pharm Inds Ltd, Wraser Pharms Llc, Us Chem, Abhai Llc, Able, Actavis Labs Ut Inc, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Nexgen Pharma Inc, Novast Labs, Specgx Llc, Sun Pharm Industries, Vintage Pharms, Hikma Intl Pharms, and Strides Pharma, and is included in seventy NDAs. Additional information is available in the individual branded drug profile pages.

There are sixty-six drug master file entries for acetaminophen; butalbital. Fourteen 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
Lannett Co Inc BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 212082-001 Dec 17, 2019 AA RX No No   Start Trial   Start Trial   Start Trial
Nexgen Pharma BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine CAPSULE;ORAL 040885-001 Nov 16, 2009 AA RX No Yes   Start Trial   Start Trial   Start Trial
Valeant PHRENILIN WITH CAFFEINE AND CODEINE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 074911-001 Aug 22, 2001 DISCN No No   Start Trial   Start Trial   Start Trial
Hikma Pharms BUTALBITAL, ACETAMINOPHEN AND CAFFEINE acetaminophen; butalbital; caffeine TABLET;ORAL 089718-001 Jun 12, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Mikart ESGIC-PLUS acetaminophen; butalbital; caffeine TABLET;ORAL 089451-001 May 23, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Able BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE acetaminophen; butalbital; caffeine; codeine phosphate CAPSULE;ORAL 076528-001 Aug 21, 2003 DISCN No No   Start Trial   Start Trial   Start 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:

Harvard Business School
Colorcon
Express Scripts
McKesson
McKinsey
Dow

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