Duzallo Patent Expiration

Duzallo is a drug owned by Ironwood Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2017 to 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 29, 2032. Details of Duzallo's patents and their expiration are given in the table below.

Drug Patent Number Drug Patent Title Drug Patent Expiry Status
These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire.
US8546436 Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid and uses thereof
Feb, 2032

(7 years from now)

Active
US8003681 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid and methyl ester
Aug, 2025

(10 months from now)

Active
These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US9956205 Polymorphic forms of 2-(5-bromo-4-(4-cyclopropylnaphthalen-1-yl)-4H-1,2,4-triazol-3-ylthio)acetic acid and uses thereof
Dec, 2031

(7 years from now)

Active
US9216179 Treatment of gout and hyperuricemia
Aug, 2031

(6 years from now)

Active
US8357713 Compounds and compositions and methods of use
Dec, 2029

(5 years from now)

Active
US8084483 Compounds and compositions and methods of use
Aug, 2029

(4 years from now)

Active
US8546437 Compounds and compositions and methods of use
Apr, 2029

(4 years from now)

Active
US10183012 Compounds and compositions and methods of use
Nov, 2028

(4 years from now)

Active
US8283369 Compounds and compositions and methods of use
Nov, 2028

(4 years from now)

Active


A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Duzallo's patents.

Given below is the list of recent legal activities going on the following patents of Duzallo.

Activity Date Patent Number
Patent litigations
Payment of Maintenance Fee, 12th Year, Large Entity 10 Jul, 2024 US8357713
Payment of Maintenance Fee, 12th Year, Large Entity 27 Mar, 2024 US8283369
Payment of Maintenance Fee, 12th Year, Large Entity 14 Jun, 2023 US8084483
Payment of Maintenance Fee, 8th Year, Large Entity 07 Jun, 2023 US9216179
Payment of Maintenance Fee, 12th Year, Large Entity 08 Feb, 2023 US8003681
Payment of Maintenance Fee, 4th Year, Large Entity 06 Jul, 2022 US10183012
Withdrawal of Application for PTE 21 Apr, 2022 US8003681
Withdrawal of Application for PTE 21 Apr, 2022 US8546437
Withdrawal of Application for PTE 21 Apr, 2022 US8283369
Withdrawal of Application for PTE 21 Apr, 2022 US8084483

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Several oppositions have been filed on Duzallo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Duzallo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Duzallo patents.

Duzallo's Oppositions Filed in EPO

Duzallo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 14, 2017, by Stada Arzneimittel Ag. This opposition was filed on patent number EP11853861A. Click below to reveal the latest opposition data.


Application Filing Date Opposition Party Legal Status
Patent litigations
EP11796324A Dec, 2018 Hexal AG Revoked
EP11796324A Dec, 2018 Bülle Dr., Jan Revoked
EP11796324A Dec, 2018 Alfred E. Tiefenbacher (GmbH & Co. KG) Revoked
EP11853861A Sep, 2017 Alfred E. Tiefenbacher (GmbH & Co. KG) Opposition rejected
EP11853861A Sep, 2017 STADA Arzneimittel AG Opposition rejected


US patents provide insights into the exclusivity only within the United States, but Duzallo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Duzallo's family patents as well as insights into ongoing legal events on those patents.

Duzallo's Family Patents

Duzallo has patent protection in a total of 41 countries. It's US patent count contributes only to 26.6% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Duzallo.

Family Patents

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Generic Launch

Generic Release Date:

Duzallo's generic launch date based on the expiry of its last outstanding patent is estimated to be Feb 29, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)

Duzallo Generics:

There are no approved generic versions for Duzallo as of now.





About Duzallo

Duzallo is a drug owned by Ironwood Pharmaceuticals Inc. It is used for treating hyperuricemia associated with gout in patients who have not responded to a sufficient dose of allopurinol alone. Duzallo uses Allopurinol; Lesinurad as an active ingredient. Duzallo was launched by Ironwood Pharms Inc in 2017.

Can you believe Duzallo received compensation for the extended wait time during the regulatory approval process?

A supplementary protection certificate (SPC) is a type of intellectual property right granted in the European Union. It provides an extension of the term of protection for a medicinal product that has been authorized for sale in the EU, beyond the 20-year term provided by the basic patent. The aim of SPCs is to compensate for the time taken to get regulatory approval for a new drug, and to provide an incentive for companies to invest in research and development in the field of medicinal products.

Approval Date:

Duzallo was approved by FDA for market use on 18 August, 2017.

Active Ingredient:

Duzallo uses Allopurinol; Lesinurad as the active ingredient. Check out other Drugs and Companies using Allopurinol; Lesinurad ingredient

Treatment:

Duzallo is used for treating hyperuricemia associated with gout in patients who have not responded to a sufficient dose of allopurinol alone.

Dosage:

Duzallo is available in tablet form for oral use. Given below is detailed information on Dosage -

Strength Dosage Form Availability Application Pathway
200MG;200MG TABLET Discontinued ORAL
300MG;200MG TABLET Discontinued ORAL