Generic entry timeline

Onfi generics — when can they launch?

Onfi (CLOBAZAM) · Lundbeck Pharms Llc · 7 active US patents · 0 expired

Earliest patent expiry
2039-09-05
13 years remaining
Full patent estate to
2040-01-31
complete protection through 2040
FDA approval
2011
Lundbeck Pharms Llc

Where Onfi sits in the generic timeline

Long-dated protection: earliest active US patent for Onfi extends to 2039 (~13 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 — 7 patents

FDA U-codes carved out by Onfi 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-724(no description)

Sample patent estate

Showing 6 of 7 active US patents. View full estate on the Onfi drug page →

  • US12403090 Method of Use · expires 2039-09-05
    This patent protects oral film compositions for delivering active ingredients, including clobazam, for treating conditions such as epilepsy and seizures.
    USPTO title: Oral film compositions and dosage forms having precise active dissolution profiles
  • US12403090 Method of Use · expires 2039-09-05
    This patent protects oral film compositions for delivering active ingredients, including clobazam, for treating conditions such as epilepsy and seizures.
    USPTO title: Oral film compositions and dosage forms having precise active dissolution profiles
  • US12290597 Method of Use · expires 2039-09-05
    This patent protects oral film compositions for delivering active ingredients, including clobazam, for treating conditions such as epilepsy and seizures.
    USPTO title: Oral film compositions and dosage forms having precise active dissolution profiles
  • US12290597 Method of Use · expires 2039-09-05
    This patent protects oral film compositions for delivering active ingredients, including clobazam, for treating conditions such as epilepsy and seizures.
    USPTO title: Oral film compositions and dosage forms having precise active dissolution profiles
  • US11541002 Method of Use · expires 2040-01-31
    This patent protects oral film compositions for delivering active ingredients, including clobazam, for treating conditions such as epilepsy and seizures.
    USPTO title: Oral film compositions and dosage forms having precise active dissolution profiles
  • US11541002 Method of Use · expires 2040-01-31
    This patent protects oral film compositions for delivering active ingredients, including clobazam, for treating conditions such as epilepsy and seizures.
    USPTO title: Oral film compositions and dosage forms having precise active dissolution profiles

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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