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Last Updated: January 26, 2020

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TUZISTRA XR Drug Profile

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Which patents cover Tuzistra Xr, and when can generic versions of Tuzistra Xr launch?

Tuzistra Xr 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 TUZISTRA XR is chlorpheniramine polistirex; codeine polistirex. There are twenty-nine drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the chlorpheniramine polistirex; codeine polistirex profile page.

US ANDA Litigation and Generic Entry Outlook for Tuzistra Xr

Tuzistra Xr was eligible for patent challenges on December 31, 1968.

There have been three patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TUZISTRA XR
Drug Prices for TUZISTRA XR

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Recent Litigation for TUZISTRA XR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Tris Pharma Inc. v. Par Pharmaceutical Inc.2015-01-21
Tris Pharma Inc. v. Actavis Laboratories FL Inc.2014-10-15

See all TUZISTRA XR litigation

Pharmacology for TUZISTRA XR
Synonyms for TUZISTRA XR
Chlorpheniramine / hydrocodone
Chlorpheniramine Mixture With Hydrocodone
Chlorpheniramine polistirex / Hydrocodone polistirex
Chlorpheniramine polistirex and Hydrocodone polistirex
Hydrocodone conbination product 15 mg/du
Hydrocodone polistirex and chlorpheniramine polistirex
S-T Forte 2
Tussicaps extended-release
Tussionex Pennkinetic

US Patents and Regulatory Information for TUZISTRA XR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Aytu TUZISTRA XR chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768-001 Apr 30, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Aytu TUZISTRA XR chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768-001 Apr 30, 2015 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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