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Generic Singulair Availability

Last updated on Mar 9, 2023.

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

SINGULAIR (montelukast sodium - granule;oral)

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

SINGULAIR (montelukast sodium - tablet, chewable;oral)

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

SINGULAIR (montelukast sodium - tablet;oral)

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

Has a generic version of Singulair been approved?

Yes. The following products are equivalent to Singulair:

montelukast sodium granule;oral

  • Manufacturer: AJANTA PHARMA LTD
    Approval date: July 31, 2015
    Strength(s): EQ 4MG BASE/PACKET [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: February 18, 2020
    Strength(s): EQ 4MG BASE/PACKET [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: September 17, 2012
    Strength(s): EQ 4MG BASE/PACKET [AB]
  • Manufacturer: TEVA PHARMS
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE/PACKET [AB]
  • Manufacturer: TORRENT
    Approval date: July 31, 2018
    Strength(s): EQ 4MG BASE/PACKET [AB]

montelukast sodium tablet, chewable;oral

  • Manufacturer: AMNEAL PHARMS
    Approval date: September 4, 2020
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: ANBISON LAB
    Approval date: November 5, 2015
    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: CHARTWELL MOLECULAR
    Approval date: December 6, 2018
    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: GRAVITI PHARMS
    Approval date: April 18, 2017
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: May 22, 2015
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: LANNETT CO INC
    Approval date: August 3, 2012
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: March 12, 2015
    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: UNICHEM
    Approval date: July 2, 2018
    Strength(s): EQ 4MG BASE [AB], EQ 5MG BASE [AB]
  • Manufacturer: UNIMARK REMEDIES LTD
    Approval date: October 30, 2014
    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: AMNEAL PHARMS
    Approval date: September 4, 2015
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: ANBISON LAB
    Approval date: January 12, 2016
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: CHARTWELL MOLECULAR
    Approval date: August 3, 2012
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: CIPLA
    Approval date: October 28, 2016
    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: GRAVITI PHARMS
    Approval date: April 24, 2017
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: HETERO LABS LTD V
    Approval date: September 10, 2014
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: September 11, 2014
    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: UNICHEM
    Approval date: October 8, 2015
    Strength(s): EQ 10MG BASE [AB]
  • Manufacturer: UNIMARK REMEDIES LTD
    Approval date: October 30, 2014
    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: Generic Drug FAQ.

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.

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