Uloric is a drug owned by Takeda Pharmaceuticals Usa Inc. It is protected by 5 US drug patents filed from 2013 to 2015. Out of these, 2 drug patents are active and 3 have expired. Uloric's patents have been open to challenges since 13 February, 2013. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 08, 2031. Details of Uloric's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8372872 | Methods for concomitant treatment of theophylline and febuxostat |
Sep, 2031
(6 years from now) | Active |
| US9107912 | Methods for concomitant treatment of theophylline and febuxostat |
Sep, 2031
(6 years from now) | Active |
| US7361676 | Solid preparation containing single crystal form |
Mar, 2024
(8 months ago) |
Expired
|
| US6225474 | Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and method of producing the same |
Jun, 2019
(5 years ago) |
Expired
|
| US5614520 | 2-arylthiazole derivatives and pharmaceutical composition thereof |
Mar, 2019
(5 years ago) |
Expired
|
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 Uloric's patents.
Latest Legal Activities on Uloric's Patents
Given below is the list of recent legal activities going on the following patents of Uloric.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 20 Feb, 2023 | US9107912 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 12 Aug, 2020 | US8372872 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 01 Oct, 2019 | US7361676 (Litigated) |
| Payment of Maintenance Fee, 4th Year, Large Entity | 18 Feb, 2019 | US9107912 |
| Change in Power of Attorney (May Include Associate POA) Critical | 30 Jan, 2019 | US9107912 |
| Email Notification Critical | 30 Jan, 2019 | US9107912 |
| Correspondence Address Change Critical | 29 Jan, 2019 | US9107912 |
| Change in Power of Attorney (May Include Associate POA) Critical | 10 Sep, 2018 | US8372872 |
| Email Notification Critical | 10 Sep, 2018 | US8372872 |
| Correspondence Address Change Critical | 07 Sep, 2018 | US8372872 |
FDA has granted several exclusivities to Uloric. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Uloric, 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 Uloric.
Exclusivity Information
Uloric holds 2 exclusivities. All of its exclusivities have expired in 2020. Details of Uloric's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Feb 13, 2014 |
| M(M-205) | Aug 15, 2020 |
Several oppositions have been filed on Uloric'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 Uloric's generic, the next section provides detailed information on ongoing and past EP oppositions related to Uloric patents.
Uloric's Oppositions Filed in EPO
Uloric has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Aug 04, 2015, by Alfred E. Tiefenbacher (Gmbh & Co. Kg). This opposition was filed on patent number EP11758053A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP11758053A | Aug, 2015 | FRKelly | Revoked |
| EP11758053A | Aug, 2015 | Dr. Reddy's Laboratories (UK) Limited/ betapharm Arzneimittel GmbH | Revoked |
| EP11758053A | Aug, 2015 | STADA Arzneimittel AG | Revoked |
| EP11758053A | Aug, 2015 | Actavis PTC ehf | Revoked |
| EP11758053A | Aug, 2015 | Strawman Limited | Revoked |
| EP11758053A | Aug, 2015 | Alfred E. Tiefenbacher (GmbH & Co. KG) | Revoked |
US patents provide insights into the exclusivity only within the United States, but Uloric 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 Uloric's family patents as well as insights into ongoing legal events on those patents.
Uloric's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Uloric's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 08, 2031 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Uloric Generic API suppliers:
Febuxostat is the generic name for the brand Uloric. 15 different companies have already filed for the generic of Uloric, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Uloric's generic
How can I launch a generic of Uloric before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Uloric's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Uloric's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Uloric -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg and 80 mg | 13 Feb, 2013 | 10 | 01 Jul, 2019 | 08 Mar, 2024 | Eligible |
About Uloric
Uloric is a drug owned by Takeda Pharmaceuticals Usa Inc. It is used for managing hyperuricemia in patients with gout. Uloric uses Febuxostat as an active ingredient. Uloric was launched by Takeda Pharms Usa in 2009.
Approval Date:
Uloric was approved by FDA for market use on 13 February, 2009.
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 Uloric is 13 February, 2009, its NCE-1 date is estimated to be 13 February, 2013.
Active Ingredient:
Uloric uses Febuxostat as the active ingredient. Check out other Drugs and Companies using Febuxostat ingredient
Treatment:
Uloric is used for managing hyperuricemia in patients with gout.
Dosage:
Uloric is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 40MG | TABLET | Prescription | ORAL |
| 80MG | TABLET | Prescription | ORAL |