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
(6 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
(3 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
(6 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
(4 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
(3 years from now) | Active |
| US10183012 | Compounds and compositions and methods of use |
Nov, 2028
(3 years from now) | Active |
| US8283369 | Compounds and compositions and methods of use |
Nov, 2028
(3 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.
Latest 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 |
|---|---|---|
 | ||
| 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 Critical | 21 Apr, 2022 | US8003681 |
| Withdrawal of Application for PTE Critical | 21 Apr, 2022 | US8546437 |
| Withdrawal of Application for PTE Critical | 21 Apr, 2022 | US8283369 |
| Withdrawal of Application for PTE Critical | 21 Apr, 2022 | US8084483 |
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 |
|---|---|---|---|
 | |||
| 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
Explore Our Curated Drug Screens
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 |