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Last Updated: November 30, 2023

Carbinoxamine maleate - Generic Drug Details

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

Carbinoxamine maleate is the generic ingredient in three branded drugs marketed by Mcneil, Cypress Pharm, Genus, Vintage Pharms, Aytu, Invagen Pharms, Mikart, Mission Pharmacal, Strides Pharma, and Ortho Mcneil Pharm, and is included in twelve NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Carbinoxamine maleate has twenty-one patent family members in fourteen countries.

There are seven drug master file entries for carbinoxamine maleate. Six suppliers are listed for this compound.

Summary for carbinoxamine maleate

International Patents:	21
US Patents:	2
Tradenames:	3
Applicants:	10
NDAs:	12
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	2,522
Drug Prices:	Drug price trends for carbinoxamine maleate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for carbinoxamine maleate
What excipients (inactive ingredients) are in carbinoxamine maleate?	carbinoxamine maleate excipients list
DailyMed Link:	carbinoxamine maleate at DailyMed

See drug prices for carbinoxamine maleate

Pharmacology for carbinoxamine maleate

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

Anatomical Therapeutic Chemical (ATC) Classes for carbinoxamine maleate

R06AA	Aminoalkyl ethers
R06A	ANTIHISTAMINES FOR SYSTEMIC USE
R06	ANTIHISTAMINES FOR SYSTEMIC USE
R	Respiratory system

US Patents and Regulatory Information for carbinoxamine 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
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Cypress Pharm	CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	090418-001	May 4, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Genus	CARBINOXAMINE MALEATE	carbinoxamine maleate	SOLUTION;ORAL	040458-001	Apr 25, 2003		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Strides Pharma	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	040639-002	May 30, 2008		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mikart	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	207484-001	May 31, 2016		RX	No	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Mcneil	CLISTIN	carbinoxamine maleate	ELIXIR;ORAL	008955-001	Approved Prior to Jan 1, 1982		DISCN	Yes	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

International Patents for carbinoxamine maleate

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Country	Patent Number	Title	Estimated Expiration
Denmark	2428205		⤷ Try a Trial
Russian Federation	2008140944	КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2007109104		⤷ Try a Trial
Australia	2007227569	Modified release formulations containing drug-ion exchange resin complexes	⤷ Try a Trial
Israel	194042	פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)	⤷ Try a Trial
European Patent Office	2018160	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)	⤷ Try a Trial
Japan	5479086		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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