Codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride - Generic Drug Details

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

Codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms, Halsey, Genus, Nostrum Labs Inc, Hikma, Amneal Pharms, Cenci, and Wockhardt, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride

US Patents:	0
Tradenames:	7
Applicants:	8
NDAs:	8
Finished Product Suppliers / Packagers:	2
DailyMed Link:	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride at DailyMed

Pharmacology for codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride

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

Anatomical Therapeutic Chemical (ATC) Classes for codeine phosphate; 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

R05DA	Opium alkaloids and derivatives
R05D	COUGH SUPPRESSANTS, EXCL. COMBINATIONS WITH EXPECTORANTS
R05	COUGH AND COLD 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 codeine phosphate; 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
Amneal Pharms	PROMETHAZINE HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	200963-001	Aug 26, 2015	AA	RX	No	No
Wockhardt	PROMETHAZINE VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088896-001	Jan 4, 1985		DISCN	No	No
Halsey	PHERAZINE VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088870-001	Mar 2, 1987		DISCN	No	No
Genus	PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	040660-001	Dec 7, 2006	AA	RX	No	Yes
Nostrum Labs Inc	PROMETH VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	088764-001	Oct 31, 1984		DISCN	No	No
Ani Pharms	PHENERGAN VC W/ CODEINE	codeine phosphate; phenylephrine hydrochloride; promethazine hydrochloride	SYRUP;ORAL	008306-005	Apr 2, 1984		DISCN	Yes	No