BUTALBITAL, ACETAMINOPHEN AND CAFFEINE Drug Patent Profile

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Butalbital, Acetaminophen And Caffeine is a drug marketed by Aurolife Pharma Llc, Dr Reddys Labs Sa, Gilbert Labs, Graham Dm, Granules, Hikma, Key Therap, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Senores Pharms, Taro, Mikart, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, and Watson Labs. and is included in forty-five NDAs.

The generic ingredient in BUTALBITAL, ACETAMINOPHEN AND CAFFEINE is acetaminophen; butalbital; caffeine. There are sixty-six drug master file entries for this compound. Thirty-seven suppliers are listed for this compound. Additional details are available on the acetaminophen; butalbital; caffeine profile page.

US Patents:	0
Applicants:	28
NDAs:	45
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	8
Clinical Trials:	1
Patent Applications:	35
DailyMed Link:	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE at DailyMed

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

Sponsor	Phase
GlaxoSmithKline	Phase 3

Drug Class	Barbiturate Central Nervous System Stimulant Methylxanthine
Physiological Effect	Central Nervous System Stimulation

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Specgx Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	087804-001	Jan 24, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040336-001	Aug 18, 1999		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Vintage Pharms	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040513-001	Aug 25, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Ut Inc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	088616-001	Nov 9, 1984	AA	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharms	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	089718-001	Jun 12, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration