Chlorpheniramine maleate - Generic Drug Details

What are the generic drug sources for chlorpheniramine maleate and what is the scope of patent protection?

Chlorpheniramine maleate is the generic ingredient in twenty-three branded drugs marketed by Aurolife Pharma Llc, Glaxosmithkline, Schering Plough, Bel Mar, Elkins Sinn, Watson Labs, Schering, Pharm Assoc, Bayer Healthcare Llc, Avanthi Inc, Alza, Bayer Pharms, Anabolic, Bell Pharma, Impax Labs, Ivax Sub Teva Pharms, Kv Pharm, Lederle, Newtron Pharms, Panray, Pharmavite, Pharmeral, Pioneer Pharms, Purepac Pharm, Pvt Form, Roxane, Sun Pharm Industries, Vitarine, West Ward, Halsey, Lannett, Mainpointe, Acella, Tris Pharma Inc, Persion, Apozeal Pharms, Mayne Pharma Inc, Padagis Us, Haleon Us Holdings, Graham Dm, Novartis, Schwarz Pharma, Fisons, and Cent Pharms, and is included in sixty-two NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for chlorpheniramine maleate

US Patents:	3
Tradenames:	23
Applicants:	44
NDAs:	62
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	9
Patent Applications:	7,596
Drug Prices:	Drug price trends for chlorpheniramine maleate
What excipients (inactive ingredients) are in chlorpheniramine maleate?	chlorpheniramine maleate excipients list
DailyMed Link:	chlorpheniramine maleate at DailyMed

See drug prices for chlorpheniramine maleate

See drug sales revenues for chlorpheniramine maleate

Recent Clinical Trials for chlorpheniramine maleate

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Hospital CEMESA Cortés, San Pedro Sula, Honduras	Phase 2/Phase 3
Dr. Ferrer BioPharma	Phase 2/Phase 3
Marcos Sanchez-Gonzalez, MD, PhD	Phase 2/Phase 3

See all chlorpheniramine maleate clinical trials

Pharmacology for chlorpheniramine maleate

Drug Class	Histamine-1 Receptor Antagonist
Mechanism of Action	Histamine H1 Receptor Antagonists

Medical Subject Heading (MeSH) Categories for chlorpheniramine maleate

Anti-Allergic Agents

Antipruritics

Histamine H1 Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for chlorpheniramine maleate

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

R06AB	Substituted alkylamines
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for chlorpheniramine maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sun Pharm Industries	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET;ORAL	080700-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Watson Labs	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	INJECTABLE;INJECTION	086095-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Novartis	TRIAMINIC-12	chlorpheniramine maleate; phenylpropanolamine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	018115-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Haleon Us Holdings	ADVIL ALLERGY AND CONGESTION RELIEF	chlorpheniramine maleate; ibuprofen; phenylephrine hydrochloride	TABLET;ORAL	022113-001	Dec 21, 2011		OTC	Yes	Yes
Pharmeral	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET;ORAL	083753-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lannett	PHENETRON	chlorpheniramine maleate	TABLET;ORAL	080846-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for chlorpheniramine maleate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	4,576,604
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	4,857,330
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	4,673,405