ASPIRIN; BUTALBITAL - Generic Drug Details

What are the generic drug sources for aspirin; butalbital and what is the scope of freedom to operate?

Aspirin; butalbital is the generic ingredient in six branded drugs marketed by Savage Labs, Lgm Pharma, Mpp Pharma, Watson Labs, Allergan, Sandoz, Actavis Elizabeth, Fosun Pharma, Halsey, Hikma Intl Pharms, Ivax Pharms, Puracap Pharm, Quantum Pharmics, Strides Pharma, Lannett, Dr Reddys Labs Sa, Novitium Pharma, and Stevens J, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for ASPIRIN; BUTALBITAL

US Patents:	0
Tradenames:	6
Applicants:	18
NDAs:	22
Clinical Trials:	1
DailyMed Link:	ASPIRIN; BUTALBITAL at DailyMed

Recent Clinical Trials for ASPIRIN; 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

See all ASPIRIN; BUTALBITAL clinical trials

US Patents and Regulatory Information for ASPIRIN; BUTALBITAL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Watson Labs	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	086237-002	Mar 23, 1984		DISCN	No	No
Quantum Pharmics	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	088972-001	Jun 18, 1985		DISCN	No	No
Allergan	FIORINAL	aspirin; butalbital; caffeine	CAPSULE;ORAL	017534-005	Apr 16, 1986		DISCN	Yes	No
Watson Labs	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074359-001	Aug 31, 1995		DISCN	No	No
Allergan	FIORINAL W/CODEINE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	019429-003	Oct 26, 1990		DISCN	Yes	No
Lgm Pharma	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	075231-001	Nov 30, 2001	AB	RX	No	No
Watson Labs	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	086231-002	Feb 12, 1985		DISCN	No	No