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Generic Doral Availability

Last updated on Mar 9, 2023.

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

DORAL (quazepam - tablet;oral)

  • Manufacturer: GALT PHARMS
    Approval date: December 27, 1985
    Strength(s): 15MG [RLD]
  • Manufacturer: GALT PHARMS
    Approval date: February 26, 1987
    Strength(s): 7.5MG (discontinued)

Has a generic version of Doral been approved?

An Authorized Generic version of Doral has been approved. An Authorized Generic is a prescription drug that is produced by a brand company under a New Drug Application (NDA) and marketed as a generic under a private label. It is identical to the branded product in appearance and has exactly the same inactive ingredients.

List of authorized generic versions:

  • Quazepam ORAL TABLET 15 mg
    Atland Pharmaceuticals, LLC
    NDC Code: 719930265

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

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.

  • Methods for reducing the risk of an adverse drug interaction in a patient suffering from insomnia
    Patent 7,608,616
    Issued: October 27, 2009
    Inventor(s): Cartt; Steve
    Assignee(s): Questcor Pharmaceuticals, Inc.

    Disclosed herein is a method for treating a patient with Quazepam that reduces the risk of an adverse interaction between the Quazepam and drug that is a substrate of the cytochrome P450 enzyme isoform 2B6 (CYP2B6 substrate drug), e.g., Bupropion. The method includes determining if the patient to be treated with Quazepam is being treated with a CYP2B6 substrate drug, and prescribing or treating the patient with Quazepam based on the determination.

    Patent expiration dates:

    • June 3, 2028
      ✓ 
      Patent use: METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG INTERACTION

Glossary

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.

Further information

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

Medical Disclaimer