Generic Uroxatral Availability

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

UROXATRAL (alfuzosin hydrochloride - tablet, extended release;oral)

  • Manufacturer: COVIS PHARMA SARL
    Approval date: June 12, 2003
    Strength(s): 10MG [RLD] [AB]

Has a generic version of Uroxatral been approved?

A generic version of Uroxatral 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 Uroxatral and have been approved by the FDA:

alfuzosin hydrochloride tablet, extended release;oral

  • Manufacturer: APOTEX INC
    Approval date: July 18, 2011
    Strength(s): 10MG [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: August 30, 2012
    Strength(s): 10MG [AB]
  • Manufacturer: INVAGEN PHARMS
    Approval date: January 17, 2012
    Strength(s): 10MG [AB]
  • Manufacturer: MYLAN
    Approval date: July 18, 2011
    Strength(s): 10MG [AB]
  • Manufacturer: SUN PHARMA GLOBAL
    Approval date: July 18, 2011
    Strength(s): 10MG [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: July 18, 2011
    Strength(s): 10MG [AB]
  • Manufacturer: TORRENT PHARMS
    Approval date: July 18, 2011
    Strength(s): 10MG [AB]
  • Manufacturer: WOCKHARDT LTD
    Approval date: August 10, 2012
    Strength(s): 10MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Uroxatral. 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: About generic drugs.

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.

  • Tablet with controlled release of alfuzosine chlorhydrate
    Patent 6,149,940
    Issued: November 21, 2000
    Inventor(s): Maggi; Lauretta & Conte; Ubaldo & Grenier; Pascal & Vergnault; Guy & Dufour; Alain & Jarreau; Fran.cedilla.ois Xavier & Rauch-Desanti; Clemence
    Assignee(s): Synthelabo Jagotec AB
    Pharmaceutical tablet which consists of: a) a first layer having the property of swelling considerably and quickly on contact with aqueous biological fluids, the first layer being produced by compression of a mixture or of a granulate comprising hydrophilic polymers, and b) a second layer adjacent to the first layer being formulated with hydrophilic polymers and with other auxiliary substances in order to give the preparation suitable properties of compressibility and in order to allow the release of alfuzosin hydrochloride within a predetermined time period.
    Patent expiration dates:
    • August 22, 2017
    • February 22, 2018
      ✓ 
      Pediatric exclusivity

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:
    • December 15, 2013 - LABELING CHANGES IN RESPONSE TO PEDIATRIC STUDIES - NOT INDICATED FOR USE IN PEDIATRIC POPULATION
    • June 15, 2014 -

Glossary

TermDefinition
Drug PatentA 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 ExclusivityExclusivity 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.
RLDA 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.
ABProducts 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.
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