Aspirin; butalbital; caffeine - Generic Drug Details

What are the generic drug 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 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-one NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for aspirin; butalbital; caffeine

US Patents:	0
Tradenames:	5
Applicants:	17
NDAs:	21
Finished Product Suppliers / Packagers:	5
DailyMed Link:	aspirin; butalbital; caffeine at DailyMed

Pharmacology for aspirin; butalbital; caffeine

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

Anatomical Therapeutic Chemical (ATC) Classes for aspirin; butalbital; caffeine

D11AX	Other dermatologicals
D11A	OTHER DERMATOLOGICAL PREPARATIONS
D11	OTHER DERMATOLOGICAL PREPARATIONS
D	Dermatologicals

N06BC	Xanthine derivatives
N06B	PSYCHOSTIMULANTS, AGENTS USED FOR ADHD AND NOOTROPICS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for aspirin; butalbital; caffeine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	204195-001	Sep 22, 2016		DISCN	No	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
Fosun Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	086398-002	Apr 6, 1984		DISCN	No	No
Ivax Pharms	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	085441-002	Oct 31, 1984		DISCN	No	No
Mpp Pharma	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	CAPSULE;ORAL	078149-001	Jun 13, 2007	AA	RX	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
Watson Labs	BUTALBITAL, ASPIRIN AND CAFFEINE	aspirin; butalbital; caffeine	TABLET;ORAL	086237-002	Mar 23, 1984		DISCN	No	No