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, Key Therap, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Novast Labs, Nuvo Pharms Inc, Quagen, Senores Pharms, Taro, 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 sixty NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-seven suppliers are listed for this compound.

Summary for ACETAMINOPHEN; BUTALBITAL; CAFFEINE

US Patents:	0
Tradenames:	10
Applicants:	34
NDAs:	60
Finished Product Suppliers / Packagers:	37
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

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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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Specgx Llc	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	087804-001	Jan 24, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma Pharms	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	089718-001	Jun 12, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040511-001	Aug 27, 2003	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mikart	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	SOLUTION;ORAL	040387-001	Jan 31, 2003		RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mallinckrodt	TRIAD	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089023-001	Jun 19, 1985		DISCN	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

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