Zurampic is a drug owned by Ironwood Pharmaceuticals Inc. It is protected by 9 US drug patents filed from 2016 to 2019 out of which none have expired yet. Zurampic's patents have been open to challenges since 23 December, 2019. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 29, 2032. Details of Zurampic'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
(9 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 |
| US8283369 | Compounds and compositions and methods of use |
Nov, 2028
(4 years from now) | Active |
| US10183012 | Compounds and compositions and methods of use |
Nov, 2028
(4 years from now) | Active |
FDA has granted several exclusivities to Zurampic. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Zurampic, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Zurampic.
Exclusivity Information
Zurampic holds 1 exclusivities. All of its exclusivities have expired in 2020. Details of Zurampic's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Dec 22, 2020 |
Several oppositions have been filed on Zurampic'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 Zurampic's generic, the next section provides detailed information on ongoing and past EP oppositions related to Zurampic patents.
Zurampic's Oppositions Filed in EPO
Zurampic 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 Zurampic 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 Zurampic's family patents as well as insights into ongoing legal events on those patents.
Zurampic's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Zurampic's generic launch date based on the last expiry date of its patents and exclusivities combined 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)
Zurampic Generics:
There are no approved generic versions for Zurampic as of now.
Alternative Brands for Zurampic
Zurampic which is used for reducing serum uric acid levels, treating gout, and managing hyperuricemia in patients unresponsive to xanthine oxidase inhibitors alone., has several other brand drugs using the same active ingredient (Lesinurad). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Ironwood Pharms Inc |
|
About Zurampic
Zurampic is a drug owned by Ironwood Pharmaceuticals Inc. It is used for reducing serum uric acid levels, treating gout, and managing hyperuricemia in patients unresponsive to xanthine oxidase inhibitors alone. Zurampic uses Lesinurad as an active ingredient. Zurampic was launched by Ironwood Pharms Inc in 2015.
Can you believe Zurampic 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:
Zurampic was approved by FDA for market use on 22 December, 2015.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Zurampic is 22 December, 2015, its NCE-1 date is estimated to be 23 December, 2019.
Active Ingredient:
Zurampic uses Lesinurad as the active ingredient. Check out other Drugs and Companies using Lesinurad ingredient
Treatment:
Zurampic is used for reducing serum uric acid levels, treating gout, and managing hyperuricemia in patients unresponsive to xanthine oxidase inhibitors alone.
Dosage:
Zurampic is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 200MG | TABLET | Discontinued | ORAL |