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Last Updated: September 20, 2020

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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 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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be March 15, 2027. This may change due to patent challenges or generic licensing.

There have been four 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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Generic Entry Opportunity Date for TUZISTRA XR
Generic Entry Date for TUZISTRA XR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SUSPENSION, EXTENDED RELEASE;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for TUZISTRA XR

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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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Dow
Mallinckrodt
AstraZeneca
Express Scripts
Medtronic

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 verification 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.