Generic Singulair Availability

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

SINGULAIR (montelukast sodium - granule;oral)

  • Manufacturer: MERCK
    Approval date: July 26, 2002
    Strength(s): EQ 4MG BASE/PACKET [RLD] [AB]

SINGULAIR (montelukast sodium - tablet, chewable;oral)

  • Manufacturer: MERCK
    Approval date: February 20, 1998
    Strength(s): EQ 5MG BASE [RLD] [AB]
  • Manufacturer: MERCK
    Approval date: March 3, 2000
    Strength(s): EQ 4MG BASE [AB]

SINGULAIR (montelukast sodium - tablet;oral)

  • Manufacturer: MERCK
    Approval date: February 20, 1998
    Strength(s): EQ 10MG BASE [RLD] [AB]

Has a generic version of Singulair been approved?

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

montelukast sodium granule;oral

  • Manufacturer: DR REDDYS LABS LTD
    Approval date: September 17, 2012
    Strength(s): EQ 4MG BASE/PACKET [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: December 18, 2012
    Strength(s): EQ 4MG BASE/PACKET [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE/PACKET [AB]

montelukast sodium tablet, chewable;oral

  • Manufacturer: APOTEX INC
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: August 6, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: KUDCO IRELAND
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: ROXANE
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: SANDOZ INC
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: VINTAGE PHARMS LLC
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]

montelukast sodium tablet;oral

  • Manufacturer: ACCORD HLTHCARE
    Approval date: September 21, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: APOTEX CORP
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: August 6, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: GLENMARK GENERICS
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: KUDCO IRELAND
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: MYLAN PHARMS INC
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: ROXANE
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: SANDOZ INC
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: VINTAGE PHARMS LLC
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]

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

  • Granule formation
    Patent 8,007,830
    Issued: August 30, 2011
    Inventor(s): Down; Brian
    Assignee(s): Merck Frosst Canada & Co.
    The present invention relates to oral granules of montelukast sodium.
    Patent expiration dates:
    • October 24, 2022
      ✓ 
      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:
    • March 26, 2015 - NEW PATIENT POPULATION

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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