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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Mallinckrodt
Boehringer Ingelheim
Chinese Patent Office
Julphar
Queensland Health
Cantor Fitzgerald
Argus Health
McKinsey

Generated: September 19, 2018

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TUZISTRA XR Drug Profile

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When do Tuzistra Xr patents expire, and when can generic versions of Tuzistra Xr launch?

Tuzistra Xr is a drug marketed by Tris Pharma Inc and is included in one NDA. There are two patents protecting this drug.

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.

Drug patent expirations by year for TUZISTRA XR
Pharmacology for TUZISTRA XR
Synonyms for TUZISTRA XR
131219-97-1
Chlorpheniramine / hydrocodone
Chlorpheniramine Mixture With Hydrocodone
Chlorpheniramine polistirex / Hydrocodone polistirex
Chlorpheniramine polistirex and Hydrocodone polistirex
DTXSID50156960
Hydrocodone conbination product 15 mg/du
Hydrocodone polistirex and chlorpheniramine polistirex
S-T Forte 2
SCHEMBL2522788
Tussicaps
Tussicaps extended-release
Tussionex
Tussionex Pennkinetic
Vituz

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
Tris Pharma Inc TUZISTRA XR chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768-001 Apr 30, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Tris Pharma Inc TUZISTRA XR chlorpheniramine polistirex; codeine polistirex SUSPENSION, EXTENDED RELEASE;ORAL 207768-001 Apr 30, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
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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Non-Orange Book US Patents for TUZISTRA XR

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
9,675,704 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,202,537 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,747,902 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
8,597,684 Modified release formulations containing drug-ion exchange resin complexes ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Mallinckrodt
Boehringer Ingelheim
Chinese Patent Office
Julphar
Queensland Health
Cantor Fitzgerald
Argus Health
McKinsey

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