CARBINOXAMINE MALEATE - Generic Drug Details

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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, 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. Seven suppliers are listed for this compound.

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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
Mission Pharmacal	CARBINOXAMINE MALEATE	carbinoxamine maleate	TABLET;ORAL	090756-001	May 27, 2011	AA	RX	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
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
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

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Country	Patent Number	Title	Estimated Expiration
China	102488652	Modified release formulations containing drug-ion exchange resin complexes	⤷ Try a Trial
Japan	5479086		⤷ Try a Trial
Japan	2009530298		⤷ Try a Trial
South Korea	101495146		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Country

Patent Number

Title

Estimated Expiration

China

102488652

Modified release formulations containing drug-ion exchange resin complexes

Japan

5479086

Japan

2009530298

South Korea

101495146

>Country

>Patent Number

>Title

>Estimated Expiration

International Patents:	21
US Patents:	2
Tradenames:	3
Applicants:	10
NDAs:	12
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	7
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

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