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Last Updated: April 27, 2024

CHLORPHENIRAMINE MALEATE - Generic Drug Details

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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 four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-one drug master file entries for chlorpheniramine maleate. Two suppliers are listed for this compound.

Summary for CHLORPHENIRAMINE MALEATE

US Patents:	4
Tradenames:	23
Applicants:	44
NDAs:	62
Drug Master File Entries:	21
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	9
Patent Applications:	6,212
Formulation / Manufacturing:	see details
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

Drug Sales Revenue Trends 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
Dr. Ferrer BioPharma	Phase 2/Phase 3
Hospital CEMESA Cortés, San Pedro Sula, Honduras	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

US Patents and Regulatory Information for CHLORPHENIRAMINE MALEATE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Schering	CHLOR-TRIMETON	chlorpheniramine maleate	SYRUP;ORAL	006921-006	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Purepac Pharm	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET;ORAL	086306-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Halsey	KLOROMIN	chlorpheniramine maleate	TABLET;ORAL	083629-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Novartis	TRIAMINIC-12	chlorpheniramine maleate; phenylpropanolamine hydrochloride	TABLET, EXTENDED RELEASE;ORAL	018115-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Graham Dm	COLD CAPSULE IV	chlorpheniramine maleate; phenylpropanolamine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	018793-001	Apr 25, 1985		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Bell Pharma	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET;ORAL	083062-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Elkins Sinn	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	INJECTABLE;INJECTION	080797-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for CHLORPHENIRAMINE MALEATE

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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	⤷ Try a Trial	⤷ Try a Trial
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	⤷ Try a Trial	⤷ Try a Trial
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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