Tuesday, September 13, 2016

Intuniv


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


INTUNIV (guanfacine hydrochloride - tablet, extended release; oral)



  • Manufacturer: SHIRE

    Approval date: September 2, 2009

    Strength(s): EQ 1MG BASE, EQ 2MG BASE, EQ 3MG BASE, EQ 4MG BASE [RLD]

Has a generic version of Intuniv been approved?


No. There is currently no therapeutically equivalent version of Intuniv available.


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




  • Use of guanfacine in the treatment of behavioral disorders
    Patent 5,854,290
    Issued: December 29, 1998
    Inventor(s): Arnsten; Amy F. T. & Goldman-Rakic; Patricia S. & Hunt; Robert H.
    Assignee(s): Arnsten; Amy F. T.
    Goldman-Rakic; Patricia
    Hunt; Robert H.
    Disclosed is a method of treating disorders which have prominent symptoms of behavioral disinhibition (e.g., Attention-Deficit Hyperactivity Disorder, Conduct Disorder, Oppositional Defiant Disorder, Tourette's Syndrome, Lesch-Nyhan Syndrome, or the disinhibitory symptoms accompanying Post-traumatic Stress Disorder or dementia) in a primate with minimal sedative side effects by administering thereto a therapeutically effective amount of guanfacine.
    Patent expiration dates:

    • September 21, 2015
      ✓ 
      Patent use: TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER




  • Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
    Patent 6,287,599
    Issued: September 11, 2001
    Inventor(s): Burnside; Beth A. & Chang; Rong-Kun & Guo; Xiaodi
    Assignee(s): Shire Laboratories, Inc.
    A pharmaceutical composition comprising at least one pharmaceutically active agent that is pH dependent, at least one non-pH dependent sustained release agent, and at least one pH dependent agent that increases the dissolution rate of the at least one pharmaceutically active agent at a pH in excess of 5.5. Such compositions have minimized pH-dependent dissolution profiles or pH-independent dissolution profiles.
    Patent expiration dates:

    • December 20, 2020
      ✓ 
      Drug product




  • Sustained release pharmaceutical dosage forms with minimized pH dependent dissolution profiles
    Patent 6,811,794
    Issued: November 2, 2004
    Inventor(s): Beth A.; Burnside & Rong-Kun; Chang & Xiaodi; Guo
    Assignee(s): Shire Laboratories, Inc.
    A pharmaceutical composition comprising at least one pharmaceutically active agent that is pH dependent, at least one non-pH dependent sustained release agent, and at least one pH dependent agent that increases the dissolution rate of the at least one pharmaceutically active agent at a pH in excess of 5.5. Such compositions have minimized pH-dependent dissolution profiles or pH-independent dissolution profiles.
    Patent expiration dates:

    • July 4, 2022
      ✓ 
      Patent use: TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER
      ✓ 
      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:
    • September 2, 2012 - NEW PRODUCT

    • February 25, 2014 - ADJUNCTIVE TREATMENT WITH LONG-ACTING ORAL PSYCHOSTIMULANTS FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

See also...

  • Intuniv Consumer Information (Drugs.com)
  • Intuniv Extended-Release Tablets Consumer Information (Wolters Kluwer)
  • Intuniv Consumer Information (Cerner Multum)
  • Intuniv Advanced Consumer Information (Micromedex)
  • Guanfacine Consumer Information (Wolters Kluwer)
  • Guanfacine Extended-Release Tablets Consumer Information (Wolters Kluwer)
  • Guanfacine Consumer Information (Cerner Multum)
  • Guanfacine Advanced Consumer Information (Micromedex)
  • Guanfacine AHFS DI Monographs (ASHP)

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