Homatropine methylbromide; hydrocodone bitartrate - Generic Drug Details

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, Pai Holdings Pharm, 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.

Summary for homatropine methylbromide; hydrocodone bitartrate

US Patents:	0
Tradenames:	5
Applicants:	14
NDAs:	15
Finished Product Suppliers / Packagers:	6
DailyMed Link:	homatropine methylbromide; hydrocodone bitartrate at DailyMed

Pharmacology for homatropine methylbromide; hydrocodone bitartrate

Drug Class	Opioid Agonist
Mechanism of Action	Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for homatropine methylbromide; hydrocodone bitartrate

A03BA	Belladonna alkaloids, tertiary amines
A03B	BELLADONNA AND DERIVATIVES, PLAIN
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

A03BB	Belladonna alkaloids, semisynthetic, quaternary ammonium compounds
A03B	BELLADONNA AND DERIVATIVES, PLAIN
A03	DRUGS FOR FUNCTIONAL GASTROINTESTINAL DISORDERS
A	Alimentary tract and metabolism

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD PREPARATIONS
R	Respiratory system

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

S01FA	Anticholinergics
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for homatropine methylbromide; hydrocodone bitartrate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	005213-002	Jul 26, 1988	AA	RX	Yes	No
Actavis Elizabeth	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	040295-001	Dec 1, 2000		DISCN	No	No
Novel Labs Inc	HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	091528-001	Apr 20, 2011		DISCN	No	No
Genus	HYCODAN	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	005213-001	Jul 26, 1988	AA	RX	Yes	No
Nostrum Labs Inc	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	210663-001	Jun 11, 2019		DISCN	No	No
Ivax Sub Teva Pharms	HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE	homatropine methylbromide; hydrocodone bitartrate	SYRUP;ORAL	040285-001	Jul 19, 1999		DISCN	No	No
King Pharms	TUSSIGON	homatropine methylbromide; hydrocodone bitartrate	TABLET;ORAL	088508-001	Jul 30, 1985		DISCN	No	No