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Generic Uloric Availability

Uloric is a brand name of febuxostat, approved by the FDA in the following formulation(s):

ULORIC (febuxostat - tablet;oral)

  • 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

  • Manufacturer: ALEMBIC PHARMS LTD
    Approval date: July 1, 2019
    Strength(s): 40MG [AB], 80MG [AB]
  • Manufacturer: HIKMA
    Approval date: October 15, 2019
    Strength(s): 40MG [AB], 80MG [AB]
  • Manufacturer: INDOCO REMEDIES
    Approval date: December 30, 2019
    Strength(s): 40MG [AB], 80MG [AB]
  • Manufacturer: MSN
    Approval date: December 30, 2019
    Strength(s): 40MG [AB], 80MG [AB]
  • Manufacturer: MYLAN
    Approval date: July 1, 2019
    Strength(s): 40MG [AB], 80MG [AB]
  • Manufacturer: SUN PHARM
    Approval date: July 1, 2019
    Strength(s): 40MG [AB], 80MG [AB]
  • Manufacturer: SUNSHINE LAKE
    Approval date: June 2, 2020
    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 FAQs.

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.

  • Solid preparation containing single crystal form
    Patent 7,361,676
    Issued: April 22, 2008
    Inventor(s): Iwai; Michio & Nakamura; Kazuhiro & Dohi; Masahiko & Mochizuki; Hiroko & Mochizuki; Seiji
    Assignee(s): Teijin Limited

    There are provided a solid preparation containing a single crystal of 2-(3-cyano-4-isobutyloxyphenyl)-4-methyl-5-thiazolecarboxylic acid, an excipient and a disintegrating agent, and a method for producing the same.

    Patent expiration dates:

    • March 8, 2024
      ✓ 
      Drug product
  • Methods for concomitant treatment of theophylline and febuxostat
    Patent 8,372,872
    Issued: February 12, 2013
    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
      ✓ 
      Patent use: USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE
  • Methods for concomitant treatment of theophylline and febuxostat
    Patent 9,107,912
    Issued: August 18, 2015
    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
      ✓ 
      Patent use: USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF THEOPHYLLINE

Related Exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • August 15, 2020 - INFORMATION ADDED TO THE LABELING REGARDING RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDIES ON PATIENTS WITH SEVERE RENAL IMPAIRMENT

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Glossary

Term Definition
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 (i.e., identical active ingredients(s), dosage form, and route(s) 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 (i.e., AB1, AB2, AB3, etc.). 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.