Febuxostat Patent Expiration

Febuxostat is Used for managing hyperuricemia in patients with gout. It was first introduced by Takeda Pharmaceuticals Usa Inc in its drug Uloric on Feb 13, 2009. 16 different companies have introduced drugs containing Febuxostat.


Febuxostat Patents

Given below is the list of patents protecting Febuxostat, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Uloric US5614520 2-arylthiazole derivatives and pharmaceutical composition thereof Mar 25, 2019

(Expired)

Takeda Pharms Usa
Uloric US6225474 Polymorphs of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid and method of producing the same Jun 18, 2019

(Expired)

Takeda Pharms Usa
Uloric US7361676 Solid preparation containing single crystal form Mar 08, 2024

(Expired)

Takeda Pharms Usa
Uloric US8372872 Methods for concomitant treatment of theophylline and febuxostat Sep 08, 2031 Takeda Pharms Usa
Uloric US9107912 Methods for concomitant treatment of theophylline and febuxostat Sep 08, 2031 Takeda Pharms Usa


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Febuxostat Generics

Several generic applications have been filed for Febuxostat. The first generic version for Febuxostat was by Sun Pharmaceutical Industries Ltd and was approved on Jul 1, 2019. And the latest generic version is by Lupin Ltd and was approved on Jan 17, 2024.

Given below is the list of companies who have filed for Febuxostat generic.


1. MACLEODS PHARMS LTD

Macleods Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Macleods Pharms Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Sep 28, 2023
80MG tablet Prescription ORAL AB Sep 28, 2023


2. ALEMBIC

Alembic Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Alembic.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Jul 1, 2019
80MG tablet Prescription ORAL AB Jul 1, 2019


3. LUPIN LTD

Lupin Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Lupin Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Discontinued ORAL N/A Jan 17, 2024
80MG tablet Discontinued ORAL N/A Jan 17, 2024


4. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Oct 15, 2019
80MG tablet Prescription ORAL AB Oct 15, 2019


5. ZYDUS LIFESCIENCES

Zydus Lifesciences Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG tablet Prescription ORAL AB Jan 9, 2023
40MG tablet Prescription ORAL AB Jan 9, 2023


6. MYLAN

Mylan Pharmaceuticals Inc has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Mylan.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Discontinued ORAL N/A Jul 1, 2019
80MG tablet Discontinued ORAL N/A Jul 1, 2019


7. INDOCO

Indoco Remedies Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Indoco.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Dec 30, 2019
80MG tablet Prescription ORAL AB Dec 30, 2019


8. ALKEM LABS LTD

Alkem Laboratories Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Alkem Labs Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Dec 7, 2021
80MG tablet Prescription ORAL AB Dec 7, 2021


9. PRINSTON INC

Prinston Pharmaceutical Inc has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Prinston Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Mar 28, 2022
80MG tablet Prescription ORAL AB Mar 28, 2022


10. AUROBINDO PHARMA LTD

Aurobindo Pharma Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Aurobindo Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Oct 25, 2023
80MG tablet Prescription ORAL AB Oct 25, 2023


11. DR REDDYS

Dr Reddys Laboratories Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG tablet Prescription ORAL AB Oct 22, 2020
40MG tablet Prescription ORAL AB Oct 22, 2020


12. TORRENT

Torrent Pharmaceuticals Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Torrent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG tablet Discontinued ORAL N/A Dec 19, 2023
40MG tablet Discontinued ORAL N/A Dec 19, 2023


13. SUN PHARM

Sun Pharmaceutical Industries Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Sun Pharm.

Strength Dosage Form Availability Application Pathway TE code Launch Date
40MG tablet Prescription ORAL AB Jul 1, 2019
80MG tablet Prescription ORAL AB Jul 1, 2019


14. SUNSHINE

Sunshine Lake Pharma Co Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Sunshine.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG tablet Prescription ORAL AB Jun 2, 2020
40MG tablet Prescription ORAL AB Jun 2, 2020


15. MSN

Msn Laboratories Private Ltd has filed for 2 different strengths of generic version for Febuxostat. Given below are the details of the strengths of this generic introduced by Msn.

Strength Dosage Form Availability Application Pathway TE code Launch Date
80MG tablet Prescription ORAL AB Dec 30, 2019
40MG tablet Prescription ORAL AB Dec 30, 2019