ACETAMINOPHEN; BUTALBITAL - Generic Drug Details

What are the generic drug 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, Anda Repository, Halsey, Lgm Pharma, Ne Rx Pharma, Quagen, Senores Pharms, 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, Hikma Pharms, 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
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de 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
Strides Pharma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	203647-001	Sep 21, 2020		DISCN	No	No
Hikma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	215135-002	Mar 25, 2022		DISCN	No	No
Alvogen	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	205120-001	Oct 30, 2015		DISCN	No	No
Gilbert Labs	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	087629-001	Nov 13, 1984		DISCN	No	No
Genus	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	SOLUTION;ORAL	040387-001	Jan 31, 2003		RX	No	Yes
Graham Dm	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	088743-001	Jul 18, 1985		DISCN	No	No
Mallinckrodt	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	088758-001	Mar 27, 1985		DISCN	No	No