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Generic Trulance Availability

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

TRULANCE (plecanatide - tablet;oral)

  • Manufacturer: SYNERGY PHARMS
    Approval date: January 19, 2017
    Strength(s): 3MG [RLD]

Has a generic version of Trulance been approved?

No. There is currently no therapeutically equivalent version of Trulance available in the United States.

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

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.

  • Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
    Patent 7,041,786
    Issued: May 9, 2006
    Inventor(s): Shailubhai; Kunwar & Nikiforovich; Gregory & Jacob; Gary S.
    Assignee(s): Callisto Pharmaceuticals
    A method of treatment of inflamed, pre-cancerous or cancerous tissue or polyps in a mammalian subject is disclosed. The treatment involves administration of a composition of at least one peptide agonist of a guanylate cyclase receptor and/or other small molecules that enhance intracellular production of cGMP. The at least one peptide agonist of a guanylate cyclase receptor may be administered either alone or in combination with an inhibitor of cGMP-dependent phosphodiesterase. The inhibitor may be a small molecule, peptide, protein or other compound that inhibits the degradation of cGMP. Without requiring a particular mechanism of action, this treatment may restore a healthy balance between proliferation and apoptosis in the subject's population of epithelial cells, and also suppress carcinogenesis. Thus, the method may be used to treat, inter alia, inflammation, including gastrointestinal inflammatory disorders, general organ inflammation and asthma, and carcinogenesis of the lung, gastrointestinal tract, bladder, testis, prostate and pancreas, or polyps.
    Patent expiration dates:
    • March 25, 2023
      ✓ 
      Drug substance
  • Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
    Patent 7,799,897
    Issued: September 21, 2010
    Inventor(s): Jacob; Gary S. & Nikiforovich; Gregory & Shailubhai; Kunwar
    Assignee(s): Synergy Pharmaceuticals, Inc.
    A method of treatment of inflamed, pre-cancerous or cancerous tissue or polyps in a mammalian subject is disclosed. The treatment involves administration of a composition of at least one peptide agonist of a guanylate cyclase receptor and/or other small molecules that enhance intracellular production of cGMP. The at least one peptide agonist of a guanylate cyclase receptor may be administered either alone or in combination with an inhibitor of cGMP-dependent phosphodiesterase. The inhibitor may be a small molecule, peptide, protein or other compound that inhibits the degradation of cGMP. Without requiring a particular mechanism of action, this treatment may restore a healthy balance between proliferation and apoptosis in the subject's population of epithelial cells, and also suppress carcinogenesis. Thus, the method may be used to treat, inter alia, inflammation, including gastrointestinal inflammatory disorders, general organ inflammation and asthma, and carcinogenesis of the lung, gastrointestinal tract, bladder, testis, prostate and pancreas, or polyps.
    Patent expiration dates:
    • June 9, 2022
      ✓ 
      Drug substance
  • Guanylate cyclase receptor agonists for the treatment of tissue inflammation and carcinogenesis
    Patent 8,637,451
    Issued: January 28, 2014
    Assignee(s): Synergy Pharmaceuticals Inc.
    A method of treatment of inflamed, pre-cancerous or cancerous tissue or polyps in a mammalian subject is disclosed. The treatment involves administration of a composition of at least one peptide agonist of a guanylate cyclase receptor and/or other small molecules that enhance intracellular production of cGMP. The at least one peptide agonist of a guanylate cyclase receptor may be administered either alone or in combination with an inhibitor of cGMP-dependent phosphodiesterase. The inhibitor may be a small molecule, peptide, protein or other compound that inhibits the degradation of cGMP. Without requiring a particular mechanism of action, this treatment may restore a healthy balance between proliferation and apoptosis in the subject's population of epithelial cells, and also suppress carcinogenesis. Thus, the method may be used to treat, inter alia, inflammation, including gastrointestinal inflammatory disorders, general organ inflammation and asthma, and carcinogenesis of the lung, gastrointestinal tract, bladder, testis, prostate and pancreas, or polyps.
    Patent expiration dates:
    • March 28, 2022
      ✓ 
      Patent use: ELEVATION OF INTRACELLULAR CGMP RESULTING IN INCREASED INTESTINAL FLUID AND ACCELERATED TRANSIT
  • Formulations of guanylate cyclase C agonists and methods of use
    Patent 9,610,321
    Issued: April 4, 2017
    Assignee(s): SYNERGY PHARMACEUTICALS, INC.
    The invention provides low-dose formulations of guanylate cyclase-C (“GCC”) agonist peptides and methods for their use. The formulations of the invention can be administered either alone or in combination with one or more additional therapeutic agents, preferably an inhibitor of cGMP-dependent phosphodiesterase or a laxative.
    Patent expiration dates:
    • September 15, 2031
      ✓ 
      Patent use: IRRITABLE BOWEL SYNDROME WITH CONSTIPATION
    • September 15, 2031
      ✓ 
      Patent use: CHRONIC IDIOPATHIC CONSTIPATION
  • Formulations of guanylate cyclase C agonists and methods of use
    Patent 9,616,097
    Issued: April 11, 2017
    Assignee(s): SYNERGY PHARMACEUTICALS, INC.
    The invention provides low-dose formulations of guanylate cyclase-C (“GCC”) agonist peptides and methods for their use. The formulations of the invention can be administered either alone or in combination with one or more additional therapeutic agents, preferably an inhibitor of cGMP-dependent phosphodiesterase or a laxative.
    Patent expiration dates:
    • July 2, 2032
      ✓ 
      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:
    • January 24, 2021 - TREATMENT IN ADULT PATIENTS FOR IRRITABLE BOWEL SYNDROME WITH CONSTIPATION (IBS-C)
    • January 19, 2022 - NEW CHEMICAL ENTITY
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.
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