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
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for TUZISTRA XR?
- What are the global sales for TUZISTRA XR?
- What is Average Wholesale Price for TUZISTRA XR?
Summary for TUZISTRA XR
International Patents: | 21 |
US Patents: | 2 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 1 |
Patent Applications: | 21 |
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 |
![TUZISTRA XR drug patent expirations Drug patent expirations by year for TUZISTRA XR](/p/graph/s/t/TUZISTRA_XR-patent-expirations.png)
![Drug Prices for TUZISTRA XR](/p/graph/drug-price/TUZISTRA+XR.png)
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.
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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Modified release formulations containing drug-ion exchange resin complexes
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 | ⤷ 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 | DISCN | Yes | No | ⤷ 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 |
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
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
Austria
Patent: 36867
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0709606
Patent: formulações de liberação modificada contendo complexos fármaco-resina de troca iÈnica
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 45855
Patent: FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1400343
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
Patent: 2488652
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 18160
Estimated Expiration: ⤷ Sign Up
Patent: 28205
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 18160
Patent: FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES)
Estimated Expiration: ⤷ Sign Up
Patent: 28205
Patent: Formulations à libération modifiée contenant des complexes médicament - résine échangeuse d'ions (Modified release formulations containing drug-ion exchange resin complexes)
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4042
Patent: פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 79086
Estimated Expiration: ⤷ Sign Up
Patent: 09530298
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 35569
Patent: КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN)
Estimated Expiration: ⤷ Sign Up
Patent: 08140944
Patent: КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО-ИОНООБМЕННАЯ СМОЛА
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1495146
Estimated Expiration: ⤷ Sign Up
Patent: 080108520
Patent: MODIFIED RELEASE FORMULATIONS CONTAINING DRUG - ION EXCHANGE RESIN COMPLEXES
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 78573
Estimated Expiration: ⤷ Sign Up
Patent: 96039
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 0812649
Patent: Modified release formulations containing drug-ion exchange resin complexes
Estimated Expiration: ⤷ Sign Up
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 | 2009530298 | ⤷ Sign Up | |
Russian Federation | 2435569 | КОМПОЗИЦИИ С МОДИФИЦИРОВАННЫМ ВЫСВОБОЖДЕНИЕМ, СОДЕРЖАЩИЕ КОМПЛЕКСЫ ЛЕКАРСТВЕННОЕ ВЕЩЕСТВО - ИОНООБМЕННАЯ СМОЛА (COMPOSITIONS WITH MODIFIED RELEASE, CONTAINING COMPLEXES MEDICATION-ION-EXCHANGING RESIN) | ⤷ Sign Up |
European Patent Office | 2018160 | FORMULATIONS A LIBERATION MODIFIEE CONTENANT DES COMPLEXES MEDICAMENT - RESINE ECHANGEUSE D'IONS (MODIFIED RELEASE FORMULATIONS CONTAINING DRUG-ION EXCHANGE RESIN COMPLEXES) | ⤷ Sign Up |
Israel | 194042 | פורמולציות לשחרור שונה המכילות קומפלקסים של תרופה ורזין מחליף יונים (Modified release formulations containing drug-ion exchange resin complexes) | ⤷ Sign Up |
Australia | 2007227569 | Modified release formulations containing drug-ion exchange resin complexes | ⤷ Sign Up |
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) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |