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Last Updated: March 26, 2023

Acetaminophen; butalbital; caffeine - Generic Drug Details

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

Acetaminophen; butalbital; caffeine is the generic ingredient in ten branded drugs marketed by Shire, Aurolife Pharma Llc, Gilbert Labs, Graham Dm, Granules, Hikma, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Mayne Pharma Inc, Novast Labs, Nuvo Pharms Inc, Senores Pharms, Taro Pharm Inds Ltd, 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-seven NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-four suppliers are listed for this compound.

Summary for acetaminophen; butalbital; caffeine

US Patents:	0
Tradenames:	10
Applicants:	33
NDAs:	57
Finished Product Suppliers / Packagers:	34
Clinical Trials:	1
DailyMed Link:	acetaminophen; butalbital; caffeine at DailyMed

Recent Clinical Trials for acetaminophen; butalbital; caffeine

Identify potential brand extensions & 505(b)(2) entrants

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

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

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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
Strides Pharma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	203647-001	Sep 21, 2020	AA	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Taro Pharm Inds Ltd	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	213046-001	Jul 1, 2020	AA	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Nostrum Labs Inc	BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE	acetaminophen; butalbital; caffeine; codeine phosphate	CAPSULE;ORAL	075929-001	Apr 22, 2002	AB	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Watson Labs	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	089536-001	Feb 16, 1988		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Novast Labs	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	215047-001	Nov 17, 2021	AA	RX	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
Mikart	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040496-001	Dec 23, 2003		DISCN	No	No	See Plans and Pricing	See Plans and Pricing				See Plans and Pricing
>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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