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Last Updated: May 17, 2022

TUZISTRA XR Drug Patent 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.

DrugPatentWatch® 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

See drug prices for TUZISTRA XR

DrugPatentWatch® Estimated 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

TUZISTRA XR is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TUZISTRA XR is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TUZISTRA XR

Modified release formulations containing drug-ion exchange resin complexes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Modified release formulations containing drug-ion exchange resin complexes
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

International Patents for TUZISTRA XR

When does loss-of-exclusivity occur for TUZISTRA XR?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 07227569
Estimated Expiration: See Plans and Pricing

Austria

Patent: 6867
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0709606
Estimated Expiration: See Plans and Pricing

Canada

Patent: 45855
Estimated Expiration: See Plans and Pricing

China

Patent: 1400343
Estimated Expiration: See Plans and Pricing

Patent: 2488652
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 18160
Estimated Expiration: See Plans and Pricing

Patent: 28205
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 18160
Estimated Expiration: See Plans and Pricing

Patent: 28205
Estimated Expiration: See Plans and Pricing

Israel

Patent: 4042
Estimated Expiration: See Plans and Pricing

Japan

Patent: 79086
Estimated Expiration: See Plans and Pricing

Patent: 09530298
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 35569
Estimated Expiration: See Plans and Pricing

Patent: 08140944
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1495146
Estimated Expiration: See Plans and Pricing

Patent: 080108520
Estimated Expiration: See Plans and Pricing

Spain

Patent: 78573
Estimated Expiration: See Plans and Pricing

Patent: 96039
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 0812649
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TUZISTRA XR around the world.

Country Patent Number Title Estimated Expiration
Japan 5479086 See Plans and Pricing
Japan 2009530298 See Plans and Pricing
China 101400343 Modified release formulations containing drug-ion exchange resin complexes See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Boehringer Ingelheim
Medtronic
Johnson and Johnson
McKesson
AstraZeneca

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.