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.
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.
Latest 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
Payment of Maintenance Fee, 8th Year, Large Entity
Drugs Generating Over $1 Billion in Annual Revenue
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NCE-1 Patent Expiry in the Next 1 Year
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Recently Granted Patents in EP
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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.
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.
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.
