HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE - Generic Drug Details

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

Homatropine methylbromide; hydrocodone bitartrate is the generic ingredient in five branded drugs marketed by Genus, Abhai Llc, Actavis Mid Atlantic, Apozeal Pharms, Ivax Sub Teva Pharms, Nostrum Labs Inc, Novel Labs Inc, Padagis Us, Wockhardt Bio Ag, Halsey, Actavis Elizabeth, Avanthi Inc, and King Pharms, and is included in fifteen NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

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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
Novel Labs Inc	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	091528-001	Apr 20, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
King Pharms	TUSSIGON	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	088508-001	Jul 30, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Padagis Us	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	205731-001	Feb 15, 2017	AA	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Halsey	HYDROPANE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	088066-001	Jun 28, 1985		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Avanthi Inc	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	207176-001	Aug 7, 2017	AA	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novel Labs Inc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	203535-001	Feb 13, 2017	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:	5
Applicants:	13
NDAs:	15
Finished Product Suppliers / Packagers:	6
DailyMed Link:	HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE at DailyMed

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists