Wednesday, October 12, 2016

Avodart


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


AVODART (dutasteride - capsule; oral)



  • Manufacturer: GLAXOSMITHKLINE

    Approval date: November 20, 2001

    Strength(s): 0.5MG [RLD][AB]

Has a generic version of Avodart been approved?


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


dutasteride capsule; oral



  • Manufacturer: BARR

    Approval date: December 21, 2010

    Strength(s): 0.5MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Avodart. 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.




  • Androstenone derivative
    Patent 5,565,467
    Issued: October 15, 1996
    Inventor(s): Batchelor; Kenneth W. & Frye; Stephen V. & Dorsey, Jr.; George F. & Mook, Jr.; Robert A.
    Assignee(s): Glaxo Wellcome Inc.
    The present invention relates to the compound of formula (I), ##STR1## also known as 17.beta.-N-(2,5-bis(Trifluoromethyl))phenylcarbamoyl-4-aza-5.alpha.-andros t-1-en-3-one, solvates thereof, its preparation, intermediates used in its preparation, pharmaceutical formulations thereof and its use in the treatment of androgen responsive and mediated diseases.
    Patent expiration dates:

    • November 20, 2015
      ✓ 
      Drug substance
      ✓ 
      Drug product




  • Androstenone derivative
    Patent 5,846,976
    Issued: December 8, 1998
    Inventor(s): Batchelor; Kenneth William & Frye; Stephen Vernon & Dorsey, Jr.; George F. & Mook, Jr.; Robert A.
    Assignee(s): Glaxo Wellcome Inc.
    The present invention relates to the compound of formula (I), ##STR1## also known as 17.beta.-N-(2,5-bis(Trifluoromethyl))phenylcarbamoyl-4-aza-5.alpha.-andros t-1-en-3-one, solvates thereof, its preparation, intermediates used in its preparation, pharmaceutical formulations thereof and its use in the treatment of androgen responsive and mediated diseases.
    Patent expiration dates:

    • September 17, 2013
      ✓ 
      Patent use: METHOD OF TREATING ANDROGEN RESPONSIVE/MEDIATED CONDITION IN MAMMAL BY ADMIN A SAFE, EFFECTIVE AMOUNT OF DUTASTERIDE OR PHARMACEUTICALLY ACCEPTABLE DERIVATIVE THEREOF..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY




  • Androstenones
    Patent 5,998,427
    Issued: December 7, 1999
    Inventor(s): Batchelor; Kenneth William & Frye; Stephen Vernon
    Assignee(s): Glaxo Wellcome Inc.
    The present invention relates to compounds of formula (I), wherein carbons 1 and 2 are joined by either a single or a double bond; R.sup.1 is hydrogen or methyl; R.sup.2 is hydrogen or methyl; R.sup.3 is (B) wherein X, R.sup.6, R.sup.7 and R.sup.8 are various groups, and pharmaceutically acceptable solvates thereof and their use in the treatment of androgen responsive and mediated diseases. ##STR1##
    Patent expiration dates:

    • September 17, 2013
      ✓ 
      Patent use: METHOD OF INHIBITING 5 ALPHA TESTOSTERONE REDUCTASE ENZYME WITH DUTASTERIDE OR ITS DERIVATIVE AND TREATING ANDROGEN RESPONSIVE/MEDIATED DISEASE INCLUDING BENIGN PROSTATIC HYPERPLASIA
      ✓ 
      Drug substance
      ✓ 
      Drug product



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:
    • June 19, 2011 - USE OF DUTASTERIDE IN COMBINATION WITH TAMSULOSIN FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH)

See also...

  • Avodart Consumer Information (Drugs.com)
  • Avodart Consumer Information (Wolters Kluwer)
  • Avodart Consumer Information (Cerner Multum)
  • Avodart Advanced Consumer Information (Micromedex)
  • Avodart AHFS DI Monographs (ASHP)
  • Dutasteride Consumer Information (Wolters Kluwer)
  • Dutasteride Consumer Information (Cerner Multum)
  • Dutasteride Advanced Consumer Information (Micromedex)
  • Dutasteride AHFS DI Monographs (ASHP)

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