Generic Uloric Availability
Last updated on Oct 9, 2024.
Uloric is a brand name of febuxostat, approved by the FDA in the following formulation(s):
ULORIC (febuxostat - tablet;oral)
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Manufacturer: TAKEDA PHARMS USA
Approval date: February 13, 2009
Strength(s): 40MG [RLD] [AB], 80MG [RLD] [AB]
Has a generic version of Uloric been approved?
A generic version of Uloric has been approved by the FDA. However, this does not mean that the product will necessarily be commercially available - possibly because of drug patents and/or drug exclusivity. The following products are equivalent to Uloric and have been approved by the FDA:
febuxostat tablet;oral
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Manufacturer: ALEMBIC
Approval date: July 1, 2019
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: ALKEM LABS LTD
Approval date: December 7, 2021
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: AUROBINDO PHARMA LTD
Approval date: October 25, 2023
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: DR REDDYS
Approval date: October 22, 2020
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: HIKMA
Approval date: October 15, 2019
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: INDOCO
Approval date: December 30, 2019
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: MACLEODS PHARMS LTD
Approval date: September 28, 2023
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: PRINSTON INC
Approval date: March 28, 2022
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: SUN PHARM
Approval date: July 1, 2019
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: SUNSHINE
Approval date: June 2, 2020
Strength(s): 40MG [AB], 80MG [AB] -
Manufacturer: ZYDUS LIFESCIENCES
Approval date: January 9, 2023
Strength(s): 40MG [AB], 80MG [AB]
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Uloric. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: Generic Drug FAQ.
Related patents
Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.
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Patent 7,361,676
Patent expiration dates:
- March 8, 2024✓
- March 8, 2024
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Methods for concomitant treatment of theophylline and febuxostat
Patent 8,372,872
Issued: February 12, 2013
Inventor(s): Gunawardhana Lhanoo & Naik Himanshu & Tsai Max
Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.Co-administration of febuxostat and theophylline to a hyperuricemic patient suffering from gout is disclosed.
Patent expiration dates:
- September 8, 2031✓
- September 8, 2031
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Methods for concomitant treatment of theophylline and febuxostat
Patent 9,107,912
Issued: August 18, 2015
Inventor(s): Gunawardhana Lhanoo & Tsai Max & Naik Himanshu
Assignee(s): Takeda Pharmaceuticals U.S.A., Inc.The present disclosure relates to a method of treating hyperuricemia in a patient that also suffers from a second disease state requiring treatment with theophylline, wherein the patient receives concomitant treatment with a xanthine oxidoreductase inhibitor and theophylline without resulting in theophylline toxicity to the patient and without substantial adjustments to the manufacturer's recommended dosage of theophylline.
Patent expiration dates:
- September 8, 2031✓
- September 8, 2031
More about Uloric (febuxostat)
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Glossary
Term | Definition |
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Drug Patent | A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation. |
Drug Exclusivity | Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant. |
RLD | A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart. |
AB | Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes of administration) and having the same strength (see Therapeutic Equivalence-Related Terms, Pharmaceutical Equivalents) generally will be coded AB if a study is submitted demonstrating bioequivalence. In certain instances, a number is added to the end of the AB code to make a three character code (e.g. AB1, AB2, AB7). Three-character codes are assigned only in situations when more than one reference listed drug of the same strength has been designated under the same heading. Two or more reference listed drugs are generally selected only when there are at least two potential reference drug products which are not bioequivalent to each other. If a study is submitted that demonstrates bioequivalence to a specific listed drug product, the generic product will be given the same three-character code as the reference listed drug it was compared against. |
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.