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Generic Diclegis Availability

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]

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: 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.

  • 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
  • Pharmaceutical dosage form bearing pregnancy-friendly indicia
    Patent 7,560,122
    Issued: July 14, 2009
    Inventor(s): Gervais; Éric & Atanackovic; Gordana & Hébert; Raymond
    Assignee(s): Duchesnay Inc.
    A pharmaceutical dosage form comprising at least one active ingredient and destined for administration to pregnant women. The pharmaceutical dosage form bears pregnancy-friendly indicia apt to improve patient compliance with medically recommended dosage regimen resulting in improved product effectiveness. The pregnancy-friendly indicia is also apt to diminish the incidence of erroneous dispensing of or erroneous ingestion of pharmaceutical dosage forms not intended for pregnant women. Also disclosed is a method for achieving improved patient compliance resulting in improved product effectiveness. Also disclosed is a method for diminishing the incidence of erroneous dispensing of or erroneous ingestion of dosage forms not intended for pregnant women. Said methods comprising providing a pharmaceutical dosage form, intended for use by pregnant women, bearing pregnancy-friendly indicia apt to graphically distinguish dosage forms intended to be used during pregnancy from others.
    Patent expiration dates:
    • January 25, 2019
      ✓ 
      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:
    • April 8, 2016 - NEW PRODUCT

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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