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, 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.

Summary for ASPIRIN; BUTALBITAL

US Patents:	0
Tradenames:	6
Applicants:	17
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
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of 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
Savage Labs	AXOTAL	aspirin; butalbital	TABLET;ORAL	088305-001	Oct 13, 1983		DISCN	No	No
Puracap Pharm	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	087048-002	Dec 9, 1983		DISCN	No	No
Stevens J	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074951-001	Aug 31, 1998	AB	RX	No	Yes
Strides Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	204195-001	Sep 22, 2016		RX	No	Yes
Watson Labs	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	086237-002	Mar 23, 1984		DISCN	No	No
Dr Reddys Labs Sa	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	203335-001	Oct 30, 2015		DISCN	No	No