Generic entry timeline

Xerava generics — when can they launch?

Xerava (ERAVACYCLINE DIHYDROCHLORIDE) · Tetraphase Pharms · 8 active US patents · 0 expired

Earliest patent expiry
2029-08-07
3 years remaining
Full patent estate to
2037-10-19
complete protection through 2037
FDA approval
2018
Tetraphase Pharms

Where Xerava sits in the generic timeline

Imminent generic cliff: earliest active US patent for Xerava expires in 2029 (~3 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.

  • Composition of Matter — 4 patents
  • Method of Use — 2 patents
  • Formulation — 2 patents

FDA U-codes carved out by Xerava 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-2380(no description)

Sample patent estate

Showing 6 of 8 active US patents. View full estate on the Xerava drug page →

  • US8796245 Method of Use · expires 2029-08-07
    This patent protects a compound represented by Structural Formula (A) and its therapeutic use, as well as a pharmaceutical composition comprising the compound.
    USPTO title: C7-fluoro substituted tetracycline compounds
  • US8796245 Method of Use · expires 2029-08-07
    This patent protects a compound represented by Structural Formula (A) and its therapeutic use, as well as a pharmaceutical composition comprising the compound.
    USPTO title: C7-fluoro substituted tetracycline compounds
  • US8906887 Formulation · expires 2030-12-28
    This patent protects a compound represented by Structural Formula (A) and its pharmaceutical composition, including its therapeutic use.
    USPTO title: C7-fluoro substituted tetracycline compounds
  • US8906887 Formulation · expires 2030-12-28
    This patent protects a compound represented by Structural Formula (A) and its pharmaceutical composition, including its therapeutic use.
    USPTO title: C7-fluoro substituted tetracycline compounds
  • US11578044 Composition of Matter · expires 2037-10-19
    This patent protects crystalline forms of the bis-HCl salt of eravacycline, specifically Forms I, J, A, and B, and pharmaceutical compositions containing these forms.
    USPTO title: Crystalline forms of eravacycline
  • US10961190 Composition of Matter · expires 2037-10-19
    This patent protects crystalline forms of the bis-HCl salt of eravacycline, specifically Forms I, J, A, and B, and pharmaceutical compositions containing these forms.
    USPTO title: Crystalline forms of eravacycline

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.

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