Generic entry timeline

TELOTRISTAT ETIPRATE generics — when can they launch?

TELOTRISTAT ETIPRATE (TELOTRISTAT ETIPRATE) · · 5 active US patents · 0 expired

Earliest patent expiry
2027-12-11
2 years remaining
Full patent estate to
2031-02-28
complete protection through 2031
FDA approval
2017
—

Where TELOTRISTAT ETIPRATE sits in the generic timeline

Imminent generic cliff: earliest active US patent for TELOTRISTAT ETIPRATE expires in 2027 (~2 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.

Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.

Patent estate by type — active patents

Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.

  • Method of Use — 3 patents
  • Composition of Matter — 2 patents

FDA U-codes carved out by TELOTRISTAT ETIPRATE patents

Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.

U-codeDescription
U-1979(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the TELOTRISTAT ETIPRATE drug page →

  • US7553840 Composition of Matter · expires 2027-12-11
    This patent protects compounds of formula I, including the molecule telotristat etiprate, and methods of their use to treat, prevent, and/or manage diseases and disorders.
    USPTO title: 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use
  • US7968559 Method of Use · expires 2027-12-11
    This patent protects methods of using compounds, including telotristat etiprate, to treat, prevent, and/or manage diseases and disorders.
    USPTO title: Methods of using 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds
  • US8653094 Method of Use · expires 2028-12-19
    This patent protects solid forms of the drug telotristat etiprate and methods of using them.
    USPTO title: 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
  • US8193204 Composition of Matter · expires 2031-02-27
    This patent protects solid forms of the molecule (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 its salts.
    USPTO title: 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
  • US7709493 Method of Use · expires 2031-02-28
    This patent protects compounds of formula I and methods of their use to treat, prevent, and/or manage diseases and disorders.
    USPTO title: 4-phenyl-6-(2,2,2-trifluoro-1-phenylethoxy)pyrimidine-based compounds and methods of their use

Sources

Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.

Get generic entry alerts

Free Pharma CI alerts on TELOTRISTAT ETIPRATE — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.

Subscribe free →