ASPIRIN; BUTALBITAL - Generic Drug Details

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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, Nostrum Labs Inc, 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, and Stevens J, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

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

Sponsor

Phase

Federal University of São Paulo

Phase 4

Fundação de Amparo à Pesquisa do Estado de São Paulo

Phase 4

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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
Halsey	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	089448-001	Dec 1, 1986		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Stevens J	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074951-001	Aug 31, 1998	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Allergan	FIORINAL	aspirin; butalbital; caffeine	CAPSULE;ORAL	017534-005	Apr 16, 1986		DISCN	Yes	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

US Patents:	0
Tradenames:	6
Applicants:	17
NDAs:	22
Clinical Trials:	1
DailyMed Link:	ASPIRIN; BUTALBITAL at DailyMed