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Generic Ambien CR Availability

See also: Generic Ambien

Ambien CR is a brand name of zolpidem, approved by the FDA in the following formulation(s):

AMBIEN CR (zolpidem tartrate - tablet, extended release;oral)

Has a generic version of Ambien CR been approved?

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

zolpidem tartrate tablet, extended release;oral

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: October 13, 2010
    Strength(s): 6.25MG [AB]
  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: June 6, 2011
    Strength(s): 12.5MG [AB]
  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: March 25, 2013
    Strength(s): 6.25MG [AB], 12.5MG [AB]
  • Manufacturer: ANCHEN PHARMS
    Approval date: December 3, 2010
    Strength(s): 12.5MG [AB]
  • Manufacturer: ANCHEN PHARMS
    Approval date: April 14, 2011
    Strength(s): 6.25MG [AB]
  • Manufacturer: APOTEX INC
    Approval date: September 10, 2013
    Strength(s): 6.25MG [AB], 12.5MG [AB]
  • Manufacturer: LUPIN LTD
    Approval date: September 11, 2013
    Strength(s): 6.25MG [AB], 12.5MG [AB]
  • Manufacturer: SANDOZ
    Approval date: July 1, 2011
    Strength(s): 6.25MG [AB], 12.5MG [AB]
  • Manufacturer: SUN PHARM
    Approval date: January 24, 2017
    Strength(s): 6.25MG [AB], 12.5MG [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Ambien CR. 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: Generic Drug FAQs.

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.

  • Controlled-release dosage forms comprising zolpidem or a salt thereof
    Patent 6,514,531
    Issued: February 4, 2003
    Inventor(s): Gérard; Alaux & Gareth; Lewis & Frédéric; Andre
    Assignee(s): Sanofi-Synthelabo

    The present invention relates to controlled-release dosage forms of zolpidem or salts thereof adapted to release zolpidem over a predetermined time period, according to a biphasic profile of dissolution, where the first phase is an immediate release phase and the second phase is a prolonged release phase and particular embodiments thereof intended to avoid abuse.

    Patent expiration dates:

    • December 1, 2019
      Drug product
    • June 1, 2020
      Pediatric exclusivity

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.


Term Definition
Drug Patent A 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 Exclusivity Exclusivity 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.
RLD A 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.
AB Products 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.