Generic entry timeline

Lioresal generics — when can they launch?

Lioresal (BACLOFEN) · · 18 active US patents · 0 expired

Earliest patent expiry
2037-09-08
11 years remaining
Full patent estate to
2041-09-29
complete protection through 2041
FDA approval
1977
—

Where Lioresal sits in the generic timeline

Long-dated protection: earliest active US patent for Lioresal extends to 2037 (~11 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 — 11 patents
  • Formulation — 7 patents

FDA U-codes carved out by Lioresal 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-3433(no description)
U-3263(no description)
U-2779(no description)
U-3489(no description)
U-3488(no description)

Sample patent estate

Showing 6 of 18 active US patents. View full estate on the Lioresal drug page →

  • US11446246 Method of Use · expires 2037-09-08
    This patent protects suspensions of metronidazole or baclofen, including various additives, for use as a formulation.
    USPTO title: Suspensions and diluents for metronidazole and baclofen
  • US11324696 Formulation · expires 2037-09-29
    This patent protects formulations for suspensions of metronidazole or baclofen, including various additives such as stabilizers and preservatives.
    USPTO title: Suspensions and diluents for metronidazole and baclofen
  • US11654124 Formulation · expires 2039-07-29
    This patent protects stabilized formulations of the active ingredient 4-amino-3-substituted butanoic acid derivatives, including baclofen and its salts.
    USPTO title: Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
  • US11931328 Formulation · expires 2039-07-29
    This patent protects stabilized formulations of the active ingredient 4-amino-3-substituted butanoic acid derivatives, including baclofen and its salts.
    USPTO title: Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
  • US10792262 Method of Use · expires 2039-07-29
    This patent protects stabilized formulations of 4-amino-3-substituted butanoic acid derivatives, including methods of manufacture and use.
    USPTO title: Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives
  • US11931328 Formulation · expires 2039-07-29
    This patent protects stabilized formulations of the active ingredient 4-amino-3-substituted butanoic acid derivatives, including baclofen and its salts.
    USPTO title: Stabilized formulations of 4-amino-3-substituted butanoic acid derivatives

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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