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Last Updated: July 4, 2020

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KARBINAL ER Drug Profile


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When do Karbinal Er patents expire, and what generic alternatives are available?

Karbinal Er is a drug marketed by Aytu and is included in one NDA. There are two patents protecting this drug.

This drug has twenty-one patent family members in fourteen countries.

The generic ingredient in KARBINAL ER is carbinoxamine maleate. There are seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the carbinoxamine maleate profile page.

US ANDA Litigation and Generic Entry Outlook for Karbinal Er

A generic version of KARBINAL ER was approved as carbinoxamine maleate by MIKART on March 19th, 2003.

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US Patents and Regulatory Information for KARBINAL ER

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   Start Trial   Start Trial Y   Start Trial
Aytu KARBINAL ER carbinoxamine maleate SUSPENSION, EXTENDED RELEASE;ORAL 022556-001 Mar 28, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start 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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Dow
McKesson
Express Scripts
Harvard Business School
Colorcon

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