Aspirin; butalbital; caffeine - Generic Drug Details

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What are the generic drug sources for aspirin; butalbital; caffeine and what is the scope of patent protection?

Aspirin; butalbital; caffeine is the generic ingredient in five branded drugs marketed by 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-one NDAs. Additional information is available in the individual branded drug profile pages.

Four 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
Halsey	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	089448-001	Dec 1, 1986		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lgm Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	205230-001	Oct 18, 2021		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Watson Labs	BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE	aspirin; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	074359-001	Aug 31, 1995		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	FIORINAL	aspirin; butalbital; caffeine	TABLET;ORAL	017534-003	Apr 16, 1986		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Fosun Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	086398-002	Apr 6, 1984		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Intl Pharms	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	086162-002	Feb 16, 1984		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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:	16
NDAs:	21
Finished Product Suppliers / Packagers:	4
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