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

(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 US5614520 2-arylthiazole derivatives and pharmaceutical composition thereof Mar 25, 2019

(Expired)

Takeda Pharms Usa



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 Febuxostat's patents.

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

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


Febuxostat's Family Patents

Family Patents

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Febuxostat Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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


Manufacturing Plant Locations
New

Alembic's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Alembic as present at those locations.

Country City Firm Name
India
Vadodara Alembic Pharmaceuticals Ltd
Panchmahal Alembic Pharmaceuticals Limited (Units I and II)
Panchmahal Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals, Ltd
Panelav Alembic Pharmaceuticals Limited
Vadodara Alembic Pharmaceuticals Ltd (API Division, Karakhadi)





2. 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





3. 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


Manufacturing Plant Locations
New

Aurobindo Pharma Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Aurobindo Pharma Ltd as present at those locations.

Country City Firm Name
India
Medchal Aurobindo Pharma Ltd





4. 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





5. 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


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Dayton Hikma Injectables USA Inc
Cherry Hill Hikma Pharmaceuticals USA Inc.
Eatontown Hikma Pharmaceuticals USA, Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





6. 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


Manufacturing Plant Locations
New

Indoco's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Indoco as present at those locations.

Country City Firm Name
India
Taluka Khalapur, District Raigad Indoco Remedies Limited
Verna Indoco Remedies Limited
Verna Indoco Remedies Limited (Plant I)
Navi Mumbai Indoco Remedies Limited





7. 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


Manufacturing Plant Locations
New

Lupin Ltd's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Lupin Ltd as present at those locations.

Country City Firm Name
India
Aurangabad Lupin Ltd.





8. 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





9. 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 BX Dec 30, 2019
40MG

tablet Prescription ORAL BX Dec 30, 2019


Manufacturing Plant Locations
New

Msn's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Msn as present at those locations.

Country City Firm Name
India
Kamareddy MSN Life Sciences Private Limited
Sangareddy MSN Pharmachem Private Limited
Rangareddy District MSN Laboratories Private Limited
Sangareddy MSN Laboratories Private Limited, R&D Center
Medak MSN LIFE SCIENCES PRIVATE LIMITED
Yadadri Bhuvanagiri District MSN Organics Private Limited
Rangareddy District MSN Laboratories Private Limited (Formulations Division, Unit-II)
Sangareddy MSN Laboratories Private Ltd.
Isnapur MSN Laboratories Private Limited, Unit-II
Jinnaram, Sangareddy MSN Laboratories Private Limited - Formulations Division
United States
Piscataway MSN PHARMACEUTICALS INC





10. 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


Manufacturing Plant Locations
New

Mylan's manufacturing plants are situated in 4 countries - United States, India, Canada, Ireland. Given below are the details of these plant locations as well as the firm names of Mylan as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.
Santa Barbara Mylandon LLC dba Debbie s Delights Santa Barbara Baking Co.
San Carlos Mylan Pharmaceuticals Inc.
Morgantown MYLAN CONSUMER HEALTHCARE Inc.
Morgantown Mylan Specialty, L.P.
Saint Albans Mylan Technologies, Inc.
Greensboro Mylan Pharmaceuticals Inc
India
Hyderabad Mylan Laboratories Limited
Sarigam Mylan Laboratories Limited
Bangalore Mylan Laboratories Limited
Anekal Taluk, Bangalore Mylan Laboratories Limited
Pithampur, District Dhar Mylan Laboratories Limited
Sinnar Mylan Laboratories Limited
Hosur Mylan Laboratories Limited
Aurangabad Mylan Laboratories Limited (FDF-2)
Canada
Etobicoke Mylan Pharmaceuticals ULC
Ireland
Inverin Mylan Teoranta





11. 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





12. 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


Manufacturing Plant Locations
New

Sun Pharm's manufacturing plants are situated in 2 countries - United States, India. Given below are the details of these plant locations as well as the firm names of Sun Pharm as present at those locations.

Country City Firm Name
United States
Lexington Sun Pharmaceutical Industries Inc
Princeton SUN PHARMACEUTICAL INDUSTRIES INC
Billerica Sun Pharmaceutical Industries, Inc.
India
Vadodara Sun Pharmaceutical Industries Ltd.
Vadodara Sun Pharmaceutical Industries Ltd
Vadodara Sun Pharmaceutical Industries Limited - Karkhadi
Halol Sun Pharmaceutical Industries Ltd.
New Delhi Sun Pharmaceutical Industries Limited
Punjab Sun Pharmaceutical Industries, Inc.
Mohali Sun Pharmaceutical Industries Limited
Gurugram Sun Pharmaceutical Industries Limited (prev. Ranbaxy)
Bharuch Sun Pharmaceutical Industries Ltd
Malanpur, Bhind (District) Sun Pharmaceutical Industries Limited
Ahmednagar Sun Pharmaceutical Industries Limited
Kanchipuram Sun Pharmaceutical Industries Limited- Madhuranthagam
Dadra Sun Pharmaceutical Industries Limited
Baruch Sun Pharmaceutical Industries Ltd.





13. 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


Manufacturing Plant Locations
New

Sunshine's manufacturing plants are situated in 6 countries - United States, Peru, India, Thailand, China, Mozambique. Given below are the details of these plant locations as well as the firm names of Sunshine as present at those locations.

Country City Firm Name
United States
Evergreen Sunshine Honey Bees LLC
Alhambra Sunshine Bakery
Bridgeville Sunshine Burger & Specialty Food Company, LLC
North Las Vegas Sunshine Fresh Nevada LLC
Artesia Sunshine Evergreen Inc.
Tupelo Sunshine Mills, Inc.
Doral Sunshine Bottling Co, Inc.
Jacksonville Sunshine Peanut Company
Halifax Sunshine Mills, Inc.
Red Bay Sunshine Mills aka World Pet Care
Andrews Sunshine Dairy, LLC
Augusta Sunshine Honey Inc.
Rochester Sunshine Fund Raising Co.
Portland Sunshine Dairy Foods Management LLC
Indianapolis SUNSHINE INTERNATIONAL LLC
Glenwood Springs Sunshine & Moons, LLC
Dublin Sunshine Mills, Inc
Columbus Sunshine Apiaries
Maumee Sunshine Inc Of Nw Ohio
Methuen Sunshine International Foods, Inc.
Peru
Tambogrande Sunshine Export S.A.C
India
Surat Sunshine Global Hospital
Thailand
Tha Mai Sunshine International
China
Dongguan Sunshine Lake Pharma Co., Ltd
Mozambique
Boane Sunshine Nut Limitada





14. 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


Manufacturing Plant Locations
New

Torrent's manufacturing plants are situated in 2 countries - India, United States. Given below are the details of these plant locations as well as the firm names of Torrent as present at those locations.

Country City Firm Name
India
Pithampur Torrent Pharmaceuticals Limited
Gandhi Nagar Torrent Pharmaceuticals Limited
Bharuch Torrent Pharmaceuticals Limited
Indrad Torrent Pharmaceuticals Limited
Thanam Torrent Pharmaceuticals Limited
United States
Basking Ridge Torrent Pharma Inc.
Kalamazoo Torrent Pharma Inc.





15. 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


Manufacturing Plant Locations
New

Zydus Lifesciences's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Zydus Lifesciences as present at those locations.

Country City Firm Name
India
Jarod Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited
Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Thane Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Ankleshwar Zydus Lifesciences Limited