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Last Updated: April 19, 2024

Acetaminophen; butalbital; caffeine - Generic Drug Details

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

Acetaminophen; butalbital; caffeine is the generic ingredient in ten branded drugs marketed by Shire, Aurolife Pharma Llc, Dr Reddys Labs Sa, Gilbert Labs, Graham Dm, Granules, Hikma, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Senores Pharms, Taro, Xspire Pharma, Mikart, Us Chem, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Hikma Pharms, Mirror Pharms Llc, Nesher Pharms, Specgx Llc, Strides Pharma, Sun Pharm Industries, Vintage Pharms, Watson Labs, Forest Pharms, Hikma Intl Pharms, Nostrum Labs Inc, and Valeant, and is included in fifty-nine NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-two suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine

US Patents:	0
Tradenames:	10
Applicants:	34
NDAs:	59
Finished Product Suppliers / Packagers:	32
Clinical Trials:	1
DailyMed Link:	acetaminophen; butalbital; caffeine at DailyMed

Recent Clinical Trials for acetaminophen; butalbital; caffeine

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Sponsor	Phase
GlaxoSmithKline	Phase 3

See all acetaminophen; butalbital; caffeine clinical trials

Pharmacology for acetaminophen; butalbital; caffeine

Drug Class	Barbiturate Central Nervous System Stimulant Methylxanthine
Physiological Effect	Central Nervous System Stimulation

US Patents and Regulatory Information for acetaminophen; butalbital; caffeine

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Glossary

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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	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	215135-002	Mar 25, 2022		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	076560-002	Jul 19, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Lannett Co Inc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	200243-001	Sep 13, 2012	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Actavis Labs Ut Inc	FIORICET W/ CODEINE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	020232-001	Jul 30, 1992	AB	RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Able	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040390-001	Jul 23, 2001		DISCN	No	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

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