ASPIRIN; BUTALBITAL; CAFFEINE - Generic Drug Details

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

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

Five suppliers are listed for this compound.

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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
Watson Labs	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074359-001	Aug 31, 1995		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Puracap Pharm	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	087048-002	Dec 9, 1983		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Quantum Pharmics	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	088972-001	Jun 18, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Ivax Pharms	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	085441-002	Oct 31, 1984		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hikma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	086162-002	Feb 16, 1984		DISCN	Yes	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lgm Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	205230-001	Oct 18, 2021		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>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:	5
Applicants:	17
NDAs:	21
Finished Product Suppliers / Packagers:	5
DailyMed Link:	ASPIRIN; BUTALBITAL; CAFFEINE at DailyMed

Drug Class	Barbiturate Central Nervous System Stimulant Methylxanthine Nonsteroidal Anti-inflammatory Drug Platelet Aggregation Inhibitor
Mechanism of Action	Cyclooxygenase Inhibitors
Physiological Effect	Central Nervous System Stimulation Decreased Platelet Aggregation Decreased Prostaglandin Production