CARBINOXAMINE MALEATE - Generic Drug Details

What are the generic 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, Endo Operations, Genus, 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. Eight 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:	8
Raw Ingredient (Bulk) Api Vendors:	62
Patent Applications:	2,360
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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ortho Mcneil Pharm	CLISTIN	carbinoxamine maleate	TABLET;ORAL	008915-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Cypress Pharm	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	090417-001	Aug 23, 2010		DISCN	No	No
Mcneil	CLISTIN	carbinoxamine maleate	ELIXIR;ORAL	008955-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Mission Pharmacal	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	090756-001	May 27, 2011	AA	RX	No	No
Strides Pharma	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	040639-002	May 30, 2008		DISCN	No	No
Aytu	KARBINAL ER	carbinoxamine maleate	SUSPENSION, EXTENDED RELEASE;ORAL	022556-001	Mar 28, 2013		RX	Yes	Yes			Y

International Patents for CARBINOXAMINE MALEATE

Country	Patent Number	Title	Estimated Expiration
South Korea	101495146
Denmark	2018160
Denmark	2428205
Canada	2645855	FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
European Patent Office	2428205	Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)
Austria	E536867