Last Updated: November 8, 2026

ACETAMINOPHEN; BUTALBITAL; CAFFEINE - Generic Drug Details

Name: ACETAMINOPHEN; BUTALBITAL; CAFFEINE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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, Ingenus Pharms Llc, Key Therap, Lannett Co Inc, Lgm Pharma, Mallinckrodt, Nuvo Pharms Inc, Pharmazone, Quagen, Taro, Mikart, Us Chem, Genus, Abhai Llc, Able, Actavis Labs Ut Inc, Alvogen, Mirror Pharms Llc, Nesher Pharms, Pharmobedient, Specgx Llc, Strides Pharma, Strides Pharma Intl, Sun Pharm Industries, Vintage Pharms, Watson Labs, Forest Pharms, Hikma Intl Pharms, and Valeant, and is included in sixty NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-five suppliers are listed for this compound.

Summary for ACETAMINOPHEN; BUTALBITAL; CAFFEINE

US Patents:	0
Tradenames:	10
Applicants:	36
NDAs:	60
Finished Product Suppliers / Packagers:	37
Raw Ingredient (Bulk) Api Vendors:	6
Clinical Trials:	1
Patent Applications:	258
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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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
Mikart	ESGIC-PLUS	acetaminophen; butalbital; caffeine	TABLET;ORAL	089451-001	May 23, 1988		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Us Chem	MEDIGESIC PLUS	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089115-001	Jan 14, 1986		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Pharmazone	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	214087-001	Aug 13, 2021	AA	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Strides Pharma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	203647-001	Sep 21, 2020		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Graham Dm	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	088765-001	Mar 27, 1985		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Lgm Pharma	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	040885-001	Nov 16, 2009	AA	RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start 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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