Generic Intuniv Availability

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 [AB], EQ 2MG BASE [AB], EQ 3MG BASE [AB], EQ 4MG BASE [RLD] [AB]

Has a generic version of Intuniv been approved?

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

guanfacine hydrochloride tablet, extended release;oral

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: October 5, 2012
    Strength(s): EQ 1MG BASE [AB], EQ 2MG BASE [AB], EQ 3MG BASE [AB], EQ 4MG BASE [AB]

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
      ✓ 
      Sponsor has requested patent be delisted
  • 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:
    • February 25, 2014 - ADJUNCTIVE TREATMENT WITH LONG-ACTING ORAL PSYCHOSTIMULANTS FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)

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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