Uloric Patent Expiration

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).
US9107912 Methods for concomitant treatment of theophylline and febuxostat
Sep, 2031

(6 years from now)

Active
US8372872 Methods for concomitant treatment of theophylline and febuxostat
Sep, 2031

(6 years from now)

Active
US7361676 Solid preparation containing single crystal form
Mar, 2024

(7 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.

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

Activity Date Patent Number
Patent litigations
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) 30 Jan, 2019 US9107912
Email Notification 30 Jan, 2019 US9107912
Correspondence Address Change 29 Jan, 2019 US9107912
Change in Power of Attorney (May Include Associate POA) 10 Sep, 2018 US8372872
Email Notification 10 Sep, 2018 US8372872
Correspondence Address Change 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

Stay ahead of others in designing the generic launch strategy of these 5 blockbuster drugs expiring in next 5 years.

Get the exclusive patent insights now. Don't be the last to know.

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
Patent litigations
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

Uloric has patent protection in a total of 15 countries. It's US patent count contributes only to 20.0% 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 Uloric.

Family Patents

Explore Our Curated Drug Screens

Drugs Generating Over $1 Billion in Annual Revenue
Explore the top-performing drugs that dominate the pharmaceutical industry
View List
NCE-1 Patent Expiry in the Next 1 Year
Identify opportunities as new chemical entity (NCE-1) patents approach expiry
View List
Recently Granted Patents in EP
Find the opportunity to file Oppositions
View List


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 Generics:

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