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 Tris Pharma Inc 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. 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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Summary for TUZISTRA XR

International Patents:	21
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Patent Applications:	24
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TUZISTRA XR
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TUZISTRA XR
What excipients (inactive ingredients) are in TUZISTRA XR?	TUZISTRA XR excipients list
DailyMed Link:	TUZISTRA XR at DailyMed

Drug patent expirations by year for TUZISTRA XR

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for TUZISTRA XR

Generic Entry Date for TUZISTRA XR^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial NDA: 207768 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.

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 ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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Glossary

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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		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Tris Pharma Inc	TUZISTRA XR	chlorpheniramine polistirex; codeine polistirex	SUSPENSION, EXTENDED RELEASE;ORAL	207768-001	Apr 30, 2015		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>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: ⤷ Try a Trial

Austria

Patent: 6867
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 0709606
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 45855
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1400343
Estimated Expiration: ⤷ Try a Trial

Patent: 2488652
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 18160
Estimated Expiration: ⤷ Try a Trial

Patent: 28205
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 18160
Estimated Expiration: ⤷ Try a Trial

Patent: 28205
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 4042
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 79086
Estimated Expiration: ⤷ Try a Trial

Patent: 09530298
Estimated Expiration: ⤷ Try a Trial

Russian Federation

Patent: 35569
Estimated Expiration: ⤷ Try a Trial

Patent: 08140944
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1495146
Estimated Expiration: ⤷ Try a Trial

Patent: 080108520
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 78573
Estimated Expiration: ⤷ Try a Trial

Patent: 96039
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 0812649
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
China	102488652	Modified release formulations containing drug-ion exchange resin complexes	⤷ Try a Trial
Spain	2396039		⤷ Try a Trial
European Patent Office	2428205	Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration