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Generic Cymbalta Availability

Last updated on Sep 6, 2023.

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

CYMBALTA (duloxetine hydrochloride - capsule, delayed rel pellets;oral)

  • Manufacturer: LILLY
    Approval date: August 3, 2004
    Strength(s): EQ 20MG BASE [RLD] [AB], EQ 30MG BASE [RLD] [AB], EQ 60MG BASE [RLD] [AB]

Has a generic version of Cymbalta been approved?

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

duloxetine hydrochloride capsule, delayed rel pellets;oral

  • Manufacturer: ACTAVIS ELIZABETH
    Approval date: December 17, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: AJANTA PHARMA LTD
    Approval date: January 6, 2017
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: ALEMBIC
    Approval date: June 9, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: ALKEM LABS LTD
    Approval date: August 26, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: ANCHEN PHARMS
    Approval date: October 28, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: APOTEX
    Approval date: June 11, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: AUROBINDO PHARMA LTD
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: BRECKENRIDGE
    Approval date: June 11, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: CSPC OUYI
    Approval date: October 16, 2018
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: HETERO LABS LTD III
    Approval date: August 3, 2016
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: INVENTIA
    Approval date: October 28, 2015
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: LUPIN LTD
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: MACLEODS PHARMS LTD
    Approval date: March 23, 2017
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: MARKSANS PHARMA
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: PRINSTON INC
    Approval date: May 18, 2017
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: QINGDAO BAHEAL PHARM
    Approval date: April 17, 2019
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: SUN PHARM
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: SUNSHINE
    Approval date: February 11, 2021
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: TORRENT
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: ZYDUS HLTHCARE
    Approval date: January 8, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS
    Approval date: January 8, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Cymbalta. 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 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 20, 2023 - NEW PATIENT POPULATION

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.

Medical Disclaimer