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Carbinoxamine maleate - Generic Drug Details

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

This ingredient has nineteen 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 Generic Name: carbinoxamine maleate

Tradenames:3
Patents:2
Applicants:9
NDAs:12
Drug Master File Entries: see list7
Suppliers / Packagers: see list8
Bulk Api Vendors: see list20
Clinical Trials: see list70
Patent Applications: see list624
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:carbinoxamine maleate at DailyMed

Pharmacology for Ingredient: carbinoxamine maleate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mikart Inc
CARBINOXAMINE MALEATE
carbinoxamine maleate
TABLET;ORAL207484-001May 31, 2016RXNoNo► subscribe► subscribe
Mission Pharmacal Co
CARBINOXAMINE MALEATE
carbinoxamine maleate
TABLET;ORAL090756-001May 27, 2011RXNoNo► subscribe► subscribe
Mikart
CARBINOXAMINE MALEATE
carbinoxamine maleate
TABLET;ORAL040442-001Mar 19, 2003RXNoYes► subscribe► subscribe
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Non-Orange Book Patents for Generic Ingredient: carbinoxamine maleate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
9,198,864Modified release formulations containing drug-ion exchange resin complexes► subscribe
8,883,217Modified release formulations containing drug-ion exchange resin complexes► subscribe
8,597,684Modified release formulations containing drug-ion exchange resin complexes► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: carbinoxamine maleate

Country Document Number Estimated Expiration
Japan5479086► subscribe
Israel194042► subscribe
Taiwan200812649► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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