Generic entry timeline

Ravicti generics — when can they launch?

Ravicti (GLYCEROL PHENYLBUTYRATE) · Horizon Therap Us · 15 active US patents · 0 expired

Earliest patent expiry
2030-09-22
4 years remaining
Full patent estate to
2032-03-09
complete protection through 2032
FDA approval
2013
Horizon Therap Us

Where Ravicti sits in the generic timeline

Mid-term cliff: earliest active US patent for Ravicti expires in 2030 (~4 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 — 15 patents

FDA U-codes carved out by Ravicti 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-1816(no description)
U-1383(no description)

Sample patent estate

Showing 6 of 15 active US patents. View full estate on the Ravicti drug page →

  • US10183005 Method of Use · expires 2030-09-22
    This patent protects methods for evaluating daily ammonia exposure and adjusting the dosage of a nitrogen scavenging drug, such as Ravicti.
    USPTO title: Methods of therapeutic monitoring of nitrogen scavenging drugs
  • US10183004 Method of Use · expires 2030-09-22
    This patent protects methods for evaluating daily ammonia exposure and adjusting the dosage of a nitrogen scavenging drug, such as Ravicti.
    USPTO title: Methods of therapeutic monitoring of nitrogen scavenging drugs
  • US10183006 Method of Use · expires 2030-09-22
    This patent protects methods for evaluating daily ammonia exposure and adjusting the dosage of a nitrogen scavenging drug, such as Ravicti.
    USPTO title: Methods of therapeutic monitoring of nitrogen scavenging drugs
  • US10045959 Method of Use · expires 2030-09-22
    This patent protects methods for evaluating daily ammonia exposure and adjusting the dosage of a nitrogen scavenging drug, such as Ravicti.
    USPTO title: Methods of therapeutic monitoring of nitrogen scavenging drugs
  • US8642012 Method of Use · expires 2030-09-22
    This patent protects methods for determining and adjusting the dose of ammonia-scavenging drugs, such as Ravicti, based on patient factors like dietary protein intake and urinary nitrogen levels.
    USPTO title: Methods of treatment using ammonia-scavenging drugs
  • US9999608 Method of Use · expires 2030-09-22
    This patent protects methods for evaluating daily ammonia exposure and adjusting the dosage of a nitrogen scavenging drug, such as Ravicti.
    USPTO title: Methods of therapeutic monitoring of nitrogen scavenging drugs

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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