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, 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, 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

US Patents:	0
Tradenames:	20
Applicants:	39
NDAs:	81
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	8
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
Mikart	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	089175-001	Jan 21, 1987	AA	RX	No	No
Mikart	ESGIC-PLUS	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	040085-001	Mar 28, 1996		DISCN	No	No
Strides Pharma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040511-001	Aug 27, 2003	AA	RX	No	Yes
Dr Reddys Labs Sa	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	210817-001	Dec 17, 2019	AA	RX	No	No
Mikart	ESGIC-PLUS	acetaminophen; butalbital; caffeine	TABLET;ORAL	089451-001	May 23, 1988		DISCN	No	No
Mallinckrodt	FEMCET	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089102-001	Jun 19, 1985		DISCN	No	No