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, Mayne Pharma Inc, Padagis Us, Sciegen Pharms Inc, 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:	6,711
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

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Drug Sales Revenue Trends for CHLORPHENIRAMINE MALEATE

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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

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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
Bel Mar	PYRIDAMAL 100	chlorpheniramine maleate	INJECTABLE;INJECTION	083733-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Acella	HYDROCODONE BITARTRATE AND CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate; hydrocodone bitartrate	SOLUTION;ORAL	206891-001	Jun 9, 2017		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Watson Labs	CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET;ORAL	080696-001	Approved Prior to Jan 1, 1982		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	⤷ Sign Up	⤷ Sign Up
Alza	EFIDAC 24 CHLORPHENIRAMINE MALEATE	chlorpheniramine maleate	TABLET, EXTENDED RELEASE;ORAL	019746-002	Nov 18, 1994	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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