CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for codeine phosphate; promethazine hydrochloride and what is the scope of patent protection?

Codeine phosphate; promethazine hydrochloride is the generic ingredient in five branded drugs marketed by Ani Pharms, Halsey, Actavis Mid Atlantic, Amneal Pharms, Hikma, Nostrum Labs Inc, Pharm Assoc, Quagen, Tris Pharma Inc, Wockhardt Bio Ag, and Cenci, and is included in twelve NDAs. Additional information is available in the individual branded drug profile pages.

Six suppliers are listed for this compound.

Summary for CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

US Patents:	0
Tradenames:	5
Applicants:	11
NDAs:	12
Finished Product Suppliers / Packagers:	6
DailyMed Link:	CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE at DailyMed

Pharmacology for CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Drug Class	Opioid Agonist Phenothiazine
Mechanism of Action	Full Opioid Agonists

Anatomical Therapeutic Chemical (ATC) Classes for CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

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

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

US Patents and Regulatory Information for CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Tris Pharma Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	200386-001	Jun 29, 2012	AA	RX	No	Yes
Cenci	PROMETHAZINE W/ CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088814-001	Nov 22, 1985		DISCN	No	No
Quagen	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	214238-001	Oct 8, 2020	AA	RX	No	No
Halsey	PHERAZINE W/ CODEINE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088739-001	Dec 23, 1988		DISCN	No	No
Nostrum Labs Inc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	090180-001	Mar 17, 2010	AA	RX	No	No
Pharm Assoc	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	089647-001	Dec 22, 1988		DISCN	No	No
Actavis Mid Atlantic	PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE	codeine phosphate; promethazine hydrochloride	SYRUP;ORAL	088763-001	Oct 31, 1984		DISCN	Yes	No