Phenylephrine hydrochloride; promethazine hydrochloride - Generic Drug Details

What are the generic sources for phenylephrine hydrochloride; promethazine hydrochloride and what is the scope of freedom to operate?

Phenylephrine hydrochloride; promethazine hydrochloride is the generic ingredient in six branded drugs marketed by Ani Pharms, Genus, Hikma, Halsey, G And W Labs Inc, Amneal Pharms, Cenci, and Xttrium Labs Inc, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for phenylephrine hydrochloride; promethazine hydrochloride

US Patents:	0
Tradenames:	6
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	3
DailyMed Link:	phenylephrine hydrochloride; promethazine hydrochloride at DailyMed

Pharmacology for phenylephrine hydrochloride; promethazine hydrochloride

Drug Class	Phenothiazine alpha-1 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha1-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for phenylephrine hydrochloride; promethazine hydrochloride

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

C05AX	Other agents for treatment of hemorrhoids and anal fissures for topical use
C05A	AGENTS FOR TREATMENT OF HEMORRHOIDS AND ANAL FISSURES FOR TOPICAL USE
C05	VASOPROTECTIVES
C	Cardiovascular system

D04AA	Antihistamines for topical use
D04A	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D04	ANTIPRURITICS, INCL. ANTIHISTAMINES, ANESTHETICS, ETC.
D	Dermatologicals

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

R06AD	Phenothiazine derivatives
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

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

S01GA	Sympathomimetics used as decongestants
S01G	DECONGESTANTS AND ANTIALLERGICS
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for phenylephrine hydrochloride; promethazine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Xttrium Labs Inc	PROMETHAZINE VC PLAIN	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088897-001	Jan 4, 1985		DISCN	No	No
Genus	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040654-001	Dec 7, 2006	AA	RX	No	Yes
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040902-001	Aug 25, 2009	AA	RX	No	No
Cenci	PROMETHAZINE VC PLAIN	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088815-001	Nov 22, 1985		DISCN	No	No
Hikma	PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE	phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040675-001	Dec 23, 2014		DISCN	No	No