Monday, 21 November 2011

Uroxatral


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


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



  • Manufacturer: SANOFI AVENTIS US

    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: 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]

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.




  • Alfuzosine compositions and use
    Patent 4,661,491
    Issued: April 28, 1987
    Inventor(s): Regnier; Francois
    Assignee(s): Synthelabo
    A method for treating humans or non-human animals for dysuria comprising administering an effective non-toxic amount of alfuzosine or a pharmaceutically acceptable salt thereof to a human or non-human animal suffering dysuria.
    Patent expiration dates:

    • July 18, 2011
      ✓ 
      Pediatric exclusivity




  • 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 - PEDIATRIC EXCLUSIVITY

See also...

  • Uroxatral Consumer Information (Drugs.com)
  • Uroxatral Consumer Information (Wolters Kluwer)
  • Uroxatral Consumer Information (Cerner Multum)
  • Uroxatral Advanced Consumer Information (Micromedex)
  • Uroxatral AHFS DI Monographs (ASHP)
  • Alfuzosin Consumer Information (Wolters Kluwer)
  • Alfuzosin Consumer Information (Cerner Multum)
  • Alfuzosin Advanced Consumer Information (Micromedex)
  • Alfuzosin Hydrochloride AHFS DI Monographs (ASHP)

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