Acetaminophen; hydrocodone bitartrate - Generic Drug Details

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

Sponsor	Phase
Sun Pharma Advanced Research Company Limited	Phase 1
Grünenthal GmbH	Phase 1
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3

Sponsor

Phase

Sun Pharma Advanced Research Company Limited

Phase 1

Grünenthal GmbH

Phase 1

Teva Branded Pharmaceutical Products R&D, Inc.

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
Mallinckrodt	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040084-002	Jun 1, 1995		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Prinston Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	214928-003	Dec 30, 2021		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apil	NORCO	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040099-001	Jun 25, 1997		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Strides Pharma	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040355-001	May 31, 2000	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs Florida	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	040494-001	May 28, 2003		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Wes Pharma Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	207509-002	Oct 29, 2018	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Tris Pharma Inc	HYDROCODONE BITARTRATE AND ACETAMINOPHEN	acetaminophen; hydrocodone bitartrate	TABLET;ORAL	202214-002	Mar 27, 2013	AA	RX	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

US Patents:	0
Tradenames:	21
Applicants:	54
NDAs:	150
Finished Product Suppliers / Packagers:	41
Clinical Trials:	8
DailyMed Link:	acetaminophen; hydrocodone bitartrate at DailyMed

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists