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Generic Edluar Availability

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

EDLUAR (zolpidem tartrate - tablet;sublingual)

  • Manufacturer: MEDA PHARMS
    Approval date: March 13, 2009
    Strength(s): 10MG [RLD] [AB], 5MG [AB]

Has a generic version of Edluar been approved?

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

zolpidem tartrate tablet;sublingual

  • Manufacturer: MYLAN PHARMS INC
    Approval date: August 8, 2016
    Strength(s): 5MG [AB], 10MG [AB]
  • Manufacturer: PAR FORM
    Approval date: August 1, 2016
    Strength(s): 5MG [AB], 10MG [AB]

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

  • Pharmaceutical composition for the treatment of acute disorders
    Patent 6,761,910
    Issued: July 13, 2004
    Inventor(s): Anders; Pettersson & Christer; Nystrom
    Assignee(s): Diabact AB
    A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.
    Patent expiration dates:
    • September 24, 2019
      ✓ 
      Patent use: METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
      ✓ 
      Drug product
  • Pharmaceutical composition for the treatment of acute disorders
    Patent 8,512,747
    Issued: August 20, 2013
    Assignee(s): Orexo AB
    A pharmaceutical composition for the treatment of acute disorders is described. The composition comprises an essentially water-free, ordered mixture of at least one pharmaceutically active agent in the form of microparticles which are adhered to the surfaces of carrier particles which are substantially larger than the particles of the active agent or agents, and are essentially water-soluble, in combination with the bioadhesion and/or mucoadhesion promoting agent. The invention also relates to a method for preparing the composition and to the use of the composition for the treatment of acute disorders.
    Patent expiration dates:
    • September 24, 2019
      ✓ 
      Patent use: METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET
  • Pharmaceutical formulations useful in the treatment of insomnia
    Patent 9,265,720
    Issued: February 23, 2016
    Assignee(s): Orexo AB
    There is provided a formulation suitable for transmucosal administration comprising a short acting hypnotic drug, which formulation provides a measurable plasma concentration of drug within 10 minutes of administration. The formulation is capable of providing sleep on demand, and preferably comprises particles of drug, for example zolpidem or a pharmaceutically-acceptable salt thereof and a mucoadhesion promoting agent, such as sodium carboxymethylcellulose, which particles of drug and mucoadhesive are presented upon the surface of larger carrier particles.
    Patent expiration dates:
    • May 13, 2030
      ✓ 
      Patent use: METHOD OF TREATING INSOMNIA CHARACTERIZED BY DIFFICULTY WITH SLEEP ONSET

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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