Hydrocodone bitartrate; pseudoephedrine hydrochloride - Generic Drug Details

What are the generic sources for hydrocodone bitartrate; pseudoephedrine hydrochloride and what is the scope of patent protection?

Hydrocodone bitartrate; pseudoephedrine hydrochloride is the generic ingredient in two branded drugs marketed by Mayne Pharma Inc, Padagis Us, Sciegen Pharms Inc, Tris Pharma Inc, and Persion, and is included in five NDAs. Additional information is available in the individual branded drug profile pages.

Summary for hydrocodone bitartrate; pseudoephedrine hydrochloride

US Patents:	0
Tradenames:	2
Applicants:	5
NDAs:	5
DailyMed Link:	hydrocodone bitartrate; pseudoephedrine hydrochloride at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for hydrocodone bitartrate; pseudoephedrine hydrochloride

C01CA	Adrenergic and dopaminergic agents
C01C	CARDIAC STIMULANTS EXCL. CARDIAC GLYCOSIDES
C01	CARDIAC THERAPY
C	Cardiovascular system

R01AA	Sympathomimetics, plain
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01AB	Sympathomimetics, combinations excl. corticosteroids
R01A	DECONGESTANTS AND OTHER NASAL PREPARATIONS FOR TOPICAL USE
R01	NASAL PREPARATIONS
R	Respiratory system

R01BA	Sympathomimetics
R01B	NASAL DECONGESTANTS FOR SYSTEMIC USE
R01	NASAL PREPARATIONS
R	Respiratory system

R03CA	Alpha- and beta-adrenoreceptor agonists
R03C	ADRENERGICS FOR SYSTEMIC USE
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

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

S01FB	Sympathomimetics excl. antiglaucoma preparations
S01F	MYDRIATICS AND CYCLOPLEGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for hydrocodone bitartrate; pseudoephedrine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Padagis Us	HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE	hydrocodone bitartrate; pseudoephedrine hydrochloride	SOLUTION;ORAL	204658-001	Apr 29, 2014		DISCN	No	No
Sciegen Pharms Inc	HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE	hydrocodone bitartrate; pseudoephedrine hydrochloride	SOLUTION;ORAL	206661-001	Jan 23, 2019		DISCN	No	No
Tris Pharma Inc	HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE	hydrocodone bitartrate; pseudoephedrine hydrochloride	SOLUTION;ORAL	203839-001	Oct 28, 2014		DISCN	No	No