Wednesday, September 28, 2016

Cymbalta


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, EQ 30MG BASE, EQ 60MG BASE [RLD]

Has a generic version of Cymbalta been approved?


No. There is currently no therapeutically equivalent version of Cymbalta available.


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:

    • June 11, 2013
      ✓ 
      Patent use: METHOD FOR INHIBITING SEROTONIN UPTAKE
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
      ✓ 
      Patent use: MANAGEMENT OF FIBROMYALGIA (FM)
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
      ✓ 
      Patent use: TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
      ✓ 
      Patent use: MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
      ✓ 
      Patent use: METHOD OF TREATING ANXIETY
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
      ✓ 
      Patent use: METHOD OF TREATING DEPRESSION
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
      ✓ 
      Patent use: METHOD FOR INHIBITING NOREPINEPHRINE UPTAKE
      ✓ 
      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
      ✓ 
      Patent use: TREATMENT OF GENERALIZED ANXIETY DISORDER
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      Drug substance
      ✓ 
      Drug product


    • June 11, 2013
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      Patent use: TREATMENT OF MAJOR DEPRESSIVE DISORDER(MDD);ALTHOUGH THE MEHCHANISM OF THE ANTIDEPRESSANT ACTION OF DULOXETINE IN HUMANS IS UNKNOWN, IT IS BELIEVED TO BE RELATED TO ITS POTENTIATION OF SERATONERGIC AND NORADRENERGIC ACTIVITY IN THE CNS
      ✓ 
      Drug substance
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      Drug product




  • 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




  • 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)



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 28, 2010 - REVISIONS TO PROVIDE FOR RESULTS OF MAINTENANCE DATA IN ADULT PATIENTS WITH MAJOR DEPRESSIVE DISORDER

    • June 13, 2011 - MANAGEMENT OF FIBROMYALGIA

    • November 19, 2012 - MAINTENANCE OF GENERALIZED ANXIETY DISORDER (GAD)

    • November 4, 2013 - MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN

See also...

  • Cymbalta Consumer Information (Drugs.com)
  • Cymbalta Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Cymbalta Consumer Information (Cerner Multum)
  • Cymbalta Advanced Consumer Information (Micromedex)
  • Cymbalta AHFS DI Monographs (ASHP)
  • Duloxetine Delayed-Release Capsules Consumer Information (Wolters Kluwer)
  • Duloxetine Consumer Information (Cerner Multum)
  • Duloxetine Advanced Consumer Information (Micromedex)
  • Duloxetine AHFS DI Monographs (ASHP)

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