Generic Cymbalta Availability

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 [AB], EQ 30MG BASE [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: ALEMBIC PHARMS LTD
    Approval date: June 9, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: APOTEX INC
    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 PHARM
    Approval date: June 11, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: DR REDDYS LABS LTD
    Approval date: December 11, 2013
    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: SUN PHARMA GLOBAL
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: TEVA PHARMS USA
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: TORRENT PHARMS LTD
    Approval date: December 11, 2013
    Strength(s): EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG BASE [AB]
  • Manufacturer: ZYDUS PHARMS USA INC
    Approval date: January 8, 2014
    Strength(s): EQ 20MG BASE [AB], EQ 20MG BASE [AB], EQ 30MG BASE [AB], EQ 30MG BASE [AB], EQ 60MG 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: 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.

  • 3-aryloxy-3-substituted propanamines
    Patent 5,023,269
    Issued: June 11, 1991
    Inventor(s): Robertson; David W. & Wong; David T. & Krushinski, Jr.; Joseph H.
    Assignee(s): Eli Lilly and Company
    The present invention provides 3-aryloxy-3-substituted propanamines capable of inhibiting the uptake of serotonin and norepinephrine.
    Patent expiration dates:
    • December 11, 2013
      ✓ 
      Pediatric exclusivity
  • Duloxetine enteric pellets
    Patent 5,508,276
    Issued: April 16, 1996
    Inventor(s): Anderson; Neil R. & Oren; Peter L. & Ogura; Toshihiro & Fujii; Toshiro
    Assignee(s): Eli Lilly and Company Shionogi & Co.
    A superior enteric formulation of the antidepressant drug, duloxetine, is in the form of enteric pellets of which the enteric layer comprises hydroxypropylmethylcellulose acetate succinate.
    Patent expiration dates:
    • July 18, 2014
      ✓ 
      Drug product
    • January 18, 2015
      ✓ 
      Pediatric exclusivity
  • Treatment of fibromyalgia
    Patent 6,596,756
    Issued: July 22, 2003
    Inventor(s): David Joel; Goldstein & Smriti; Iyengar & Rosa Marie Ademe; Simmons
    Assignee(s): Eli Lilly and Company
    A method of using N-methyl-3-(1-naphthalenyloxy)-3-(2-thienyl)propanamine to treat persistent pain.
    Patent expiration dates:
    • September 10, 2019
      ✓ 
      Patent use: MANAGEMENT OF FIBROMYALGIA (FM)
    • March 10, 2020
      ✓ 
      Pediatric exclusivity

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:
    • November 4, 2013 - MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
    • May 4, 2014 -
    • October 18, 2015 - REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST
    • April 18, 2016 -

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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