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Generic Diclegis Availability

Last updated on July 7, 2021.

Diclegis is a brand name of doxylamine/pyridoxine, approved by the FDA in the following formulation(s):

DICLEGIS (doxylamine succinate; pyridoxine hydrochloride - tablet, delayed release;oral)

  • Manufacturer: DUCHESNAY
    Approval date: April 8, 2013
    Strength(s): 10MG;10MG [RLD] [AB]

Has a generic version of Diclegis been approved?

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

DOXYLAMINE SUCCINATE AND PYRIDOXINE HYDROCHLORIDE (doxylamine succinate; pyridoxine hydrochloride tablet, delayed release;oral)

  • Manufacturer: ACTAVIS LABS FL INC
    Approval date: August 19, 2016
    Strength(s): 10MG;10MG [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: July 6, 2020
    Strength(s): 10MG;10MG [AB]
  • Manufacturer: PAR PHARM INC
    Approval date: December 6, 2017
    Strength(s): 10MG;10MG [AB]

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

  • Rapid onset formulation
    Patent 6,340,695
    Issued: January 22, 2002
    Inventor(s): Eric; Gervais
    Assignee(s): Duchesnay Inc.

    Provided herein is a novel enterically-coated pyridoxine HCl and doxylamine succinate rapid onset formulation comprising a disintegrating agent such that the following dissolution profiles are satisfied when measured in 1000 ml phosphate buffer at pH 6.8 and 37° C. in a type 2 dissolution apparatus at 100 rpm: (a) at least about 40% of the total pyridoxine HCl and doxylamine succinate is dissolved after 30 minutes of measurement; (b) at least about 70% of the total pyridoxine HCl and doxylamine succinate is dissolved after 60 minutes of measurement; (c) at least about 80% of the total pyridoxine HCl and doxylamine succinate is dissolved after 90 minutes of measurement; (d) at about 90% of the total pyridoxine HCl and doxylamine succinate is dissolved after 120 minutes of measurement. Preferably the formulation will contain a core coated with at least one enteric coating, the core comprising pyridoxine HCl, doxylamine succinate and the following non-active excipients: a filler or binder, a disintegrating agent, a lubricant, a silica flow conditioner and a stabilizing agent.

    Patent expiration dates:

    • June 21, 2021
      ✓ 
      Patent use: TREATMENT OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO CONSERVATIVE MANAGEMENT
      ✓ 
      Drug product

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.
AB Products meeting necessary bioequivalence requirements. Multisource drug products listed under the same heading (e.g. identical active ingredients, dosage form, and routes 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 (e.g. AB1, AB2, AB7). 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.

Further information

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