Acetaminophen; butalbital; caffeine; codeine phosphate - Generic Drug Details

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What are the generic drug sources for acetaminophen; butalbital; caffeine; codeine phosphate and what is the scope of freedom to operate?

Acetaminophen; butalbital; caffeine; codeine phosphate is the generic ingredient in three branded drugs marketed by Able, Hikma, Hikma Intl Pharms, Lgm Pharma, Nostrum Labs Inc, Strides Pharma, Actavis Labs Ut Inc, and Valeant, and is included in eight 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
Hikma Intl Pharms	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	075618-001	Mar 23, 2001		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Labs Ut Inc	FIORICET W/ CODEINE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	020232-001	Jul 30, 1992	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560-001	Jun 10, 2004	AB	RX	No	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:	3
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	5
DailyMed Link:	acetaminophen; butalbital; caffeine; codeine phosphate at DailyMed

Drug Class	Barbiturate Central Nervous System Stimulant Methylxanthine Opioid Agonist
Mechanism of Action	Full Opioid Agonists
Physiological Effect	Central Nervous System Stimulation