Acetaminophen; butalbital - Generic Drug Details

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
GlaxoSmithKline	Phase 3

Sponsor

Phase

Federal University of São Paulo

Phase 4

Fundação de Amparo à Pesquisa do Estado de São Paulo

Phase 4

GlaxoSmithKline

Phase 3

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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
Larken Labs Inc	BUTALBITAL AND ACETAMINOPHEN	acetaminophen; butalbital	TABLET;ORAL	203484-002	Dec 4, 2015	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Graham Dm	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	089067-001	Apr 19, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novast Labs	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	CAPSULE;ORAL	215047-001	Nov 17, 2021	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Granules	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	040864-001	Dec 1, 2008	AA	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Alvogen	BUTALBITAL, ACETAMINOPHEN AND CAFFEINE	acetaminophen; butalbital; caffeine	TABLET;ORAL	204984-001	Jan 10, 2017		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

US Patents:	0
Tradenames:	20
Applicants:	39
NDAs:	81
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	3
Patent Applications:	8
DailyMed Link:	acetaminophen; butalbital at DailyMed