Generic entry timeline

Yorvipath generics — when can they launch?

Yorvipath (PALOPEGTERIPARATIDE) · Ascendis Pharma Bone · 27 active US patents · 0 expired

Earliest patent expiry
2031-04-30
5 years remaining
Full patent estate to
2042-11-12
complete protection through 2042
FDA approval
2025
Ascendis Pharma Bone

Where Yorvipath sits in the generic timeline

Mid-term cliff: earliest active US patent for Yorvipath expires in 2031 (~5 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.

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 — 18 patents
  • Composition of Matter — 6 patents
  • Formulation — 3 patents

FDA U-codes carved out by Yorvipath 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-3982(no description)

Sample patent estate

Showing 6 of 27 active US patents. View full estate on the Yorvipath drug page →

  • US8906847 Method of Use · expires 2031-04-30
    This patent protects a prodrug composition that includes a biologically active moiety attached to a non-active linker moiety through an amide bond.
    USPTO title: Prodrug comprising a drug linker conjugate
  • US8906847 Method of Use · expires 2031-04-30
    This patent protects a prodrug composition that includes a biologically active moiety attached to a non-active linker moiety through an amide bond.
    USPTO title: Prodrug comprising a drug linker conjugate
  • US8906847 Method of Use · expires 2031-04-30
    This patent protects a prodrug composition that includes a biologically active moiety attached to a non-active linker moiety through an amide bond.
    USPTO title: Prodrug comprising a drug linker conjugate
  • US11759504 Formulation · expires 2037-09-28
    This patent protects a pharmaceutical composition of a PTH compound with a pharmacokinetic profile that has a peak to trough ratio of less than 4 after subcutaneous administration.
    USPTO title: PTH compounds with low peak-to-trough ratios
  • US11590207 Method of Use · expires 2037-09-28
    This patent protects a dosage regimen for a controlled-release parathyroid hormone (PTH) compound used in treating or preventing a condition that can be treated with PTH.
    USPTO title: Dosage regimen for a controlled-release PTH compound
  • US11918628 Composition of Matter · expires 2037-09-28
    This patent protects a controlled-release compound made by reversibly conjugating parathyroid hormone (PTH(1-34)) to a branched polyethylene glycol.
    USPTO title: Controlled-release PTH compound

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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