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Generic Xermelo Availability

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

XERMELO (telotristat etiprate - tablet;oral)

  • Manufacturer: LEXICON PHARMS INC
    Approval date: February 28, 2017
    Strength(s): EQ 250MG BASE [RLD]

Has a generic version of Xermelo been approved?

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

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

  • 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
    Patent 7,553,840
    Issued: June 30, 2009
    Inventor(s): Devasagayaraj; Arokiasamy & Jin; Haihong & Shi; Zhi-Cai & Tunoori; Ashok & Wang; Ying & Zhang; Chengmin
    Assignee(s): Lexicon Pharmaceuticals, Inc.

    Compounds of formula I are disclosed, as well as compositions comprising them and methods of their use to treat, prevent and/or manage diseases and disorders:

    Patent expiration dates:

    • December 11, 2027
      ✓ 
      Drug substance
  • 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
    Patent 7,709,493
    Issued: May 4, 2010
    Inventor(s): Devasagayaraj; Arokiasamy & Jin; Haihong & Shi; Zhi-Cai & Tunoori; Ashok & Wang; Ying & Zhang; Chengmin
    Assignee(s): Lexicon Pharmaceuticals, Inc.

    Compounds of formula I are disclosed, as well as compositions comprising them and methods of their use to treat, prevent and/or manage diseases and disorders:

    Patent expiration dates:

    • December 11, 2027
      ✓ 
      Patent use: THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY
      ✓ 
      Drug substance
  • Methods of using 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds
    Patent 7,968,559
    Issued: June 28, 2011
    Inventor(s): Devasagayaraj; Arokiasamy & Jin; Haihong & Shi; Zhi-Cai & Tunoori; Ashok & Wang; Ying & Zhang; Chengmin
    Assignee(s): Lexicon Pharmaceuticals, Inc.

    Compounds of formula I are disclosed, as well as compositions comprising them and methods of their use to treat, prevent and/or manage diseases and disorders:

    Patent expiration dates:

    • December 11, 2027
      ✓ 
      Patent use: THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY
  • Solid forms of (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1- (4-chloro-2-(3-methyl-1H-pyrazol-1-YL)phenyl)2,2,2-trifluoroethoxy)-pyrimidin-4-YL)phenyl)propanoate and methods of their use
    Patent 8,193,204
    Issued: June 5, 2012
    Inventor(s): Bednarz; Mark S. & De Paul; Susan & Kanamarlapudi; Ramanaiah C. & Perlberg; Anett & Zhang; Haiming
    Assignee(s): Lexicon Pharmaceuticals, Inc.

    Solid forms of (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate and salts thereof are disclosed.

    Patent expiration dates:

    • February 27, 2031
      ✓ 
      Drug substance
  • Solid forms of (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)-pyrimidin-4-yl)phenyl)propanoate and methods of their use
    Patent 8,653,094
    Issued: February 18, 2014
    Assignee(s): Lexicon Pharmaceuticals, Inc.

    Solid forms of (S)-ethyl 2-amino-3-(4-(2-amino-6-((R)-1-(4-chloro-2-(3-methyl-1H-pyrazol-1-yl)phenyl)-2,2,2-trifluoroethoxy)pyrimidin-4-yl)phenyl)propanoate and salts thereof are disclosed.

    Patent expiration dates:

    • December 19, 2028
      ✓ 
      Patent use: THE TREATMENT OF CARCINOID SYNDROME DIARRHEA IN COMBINATION WITH SOMATOSTATIN ANALOG (SSA) THERAPY IN ADULTS INADEQUATELY CONTROLLED BY SSA THERAPY

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:

    • February 28, 2022 - NEW CHEMICAL ENTITY
    • February 28, 2024 -

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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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