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, Pharmobedient, Alvogen, Halsey, Lgm Pharma, Ne Rx Pharma, Pharmazone, Quagen, Watson Labs, Mikart, Mayrand, Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Hikma, Ingenus Pharms Llc, Key Therap, Lannett Co Inc, Nuvo Pharms Inc, Taro, Us Chem, Genus, Abhai Llc, Able, Actavis Labs Ut Inc, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Strides Pharma Intl, Sun Pharm Industries, Vintage Pharms, and Hikma Intl Pharms, and is included in eighty-two NDAs. Additional information is available in the individual branded drug profile pages.

Ten suppliers are listed for this compound.

Summary for acetaminophen; butalbital

US Patents:	0
Tradenames:	20
Applicants:	41
NDAs:	82
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
DailyMed Link:	acetaminophen; butalbital at DailyMed

Recent Clinical Trials for acetaminophen; butalbital

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

Sponsor	Phase
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4
GlaxoSmithKline	Phase 3

See all acetaminophen; butalbital clinical trials

Pharmacology for acetaminophen; butalbital

Drug Class

Barbiturate

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
Genus	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	SOLUTION;ORAL	040387-001	Jan 31, 2003		RX	No	Yes
Aurolife Pharma Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	204733-001	Sep 26, 2018	AA	RX	No	No
Quagen	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	214291-001	Jan 18, 2024	AA	RX	No	No
Quagen	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	214288-001	Feb 8, 2024	AA	RX	No	No
Watson Labs	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040267-001	Jul 30, 1998		DISCN	No	No