Generic entry timeline

Crenessity generics — when can they launch?

Crenessity (CRINECERFONT) · Neurocrine · 16 active US patents · 0 expired

Earliest patent expiry
2035-01-21
9 years remaining
Full patent estate to
2041-06-09
complete protection through 2041
FDA approval
2024
Neurocrine

Where Crenessity sits in the generic timeline

Long-dated protection: earliest active US patent for Crenessity extends to 2035 (~9 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.

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 — 16 patents

FDA U-codes carved out by Crenessity 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-4049(no description)

Sample patent estate

Showing 6 of 16 active US patents. View full estate on the Crenessity drug page →

  • US11311544 Method of Use · expires 2035-01-21
    This patent protects a method of using CRF1 receptor antagonists to treat congenital adrenal hyperplasia.
    USPTO title: Treatment of congenital adrenal hyperplasia
  • US11311544 Method of Use · expires 2035-01-21
    This patent protects a method of using CRF1 receptor antagonists to treat congenital adrenal hyperplasia.
    USPTO title: Treatment of congenital adrenal hyperplasia
  • US11730739 Method of Use · expires 2035-01-21
    This patent protects a method of using CRF1 receptor antagonists to treat congenital adrenal hyperplasia.
    USPTO title: Treatment of congenital adrenal hyperplasia
  • US11730739 Method of Use · expires 2035-01-21
    This patent protects a method of using CRF1 receptor antagonists to treat congenital adrenal hyperplasia.
    USPTO title: Treatment of congenital adrenal hyperplasia
  • US10905690 Method of Use · expires 2035-01-21
    This patent protects a method of using CRF1 receptor antagonists to treat congenital adrenal hyperplasia.
    USPTO title: Treatment of congenital adrenal hyperplasia
  • US10905690 Method of Use · expires 2035-01-21
    This patent protects a method of using CRF1 receptor antagonists to treat congenital adrenal hyperplasia.
    USPTO title: Treatment of congenital adrenal hyperplasia

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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