Generic entry timeline

Aubagio generics — when can they launch?

Aubagio (TERIFLUNOMIDE) · Sanofi · 12 active US patents · 0 expired

Earliest patent expiry
2026-09-12
expired
Full patent estate to
2034-08-04
complete protection through 2034
FDA approval
2012
Sanofi

Where Aubagio sits in the generic timeline

All listed Orange Book patents for Aubagio have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.

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.

  • Other — 6 patents
  • Method of Use — 4 patents
  • Formulation — 2 patents

FDA U-codes carved out by Aubagio 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-1285(no description)
U-1786(no description)

Sample patent estate

Showing 6 of 12 active US patents. View full estate on the Aubagio drug page →

  • US6794410 Method of Use · expires 2026-09-12
    This patent protects the use of a specific compound for treating the symptoms of multiple sclerosis.
    USPTO title: Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
  • US6794410 Method of Use · expires 2026-09-12
    This patent protects the use of a specific compound for treating the symptoms of multiple sclerosis.
    USPTO title: Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
  • US6794410 Other · expires 2027-03-12
    This patent protects the use of a specific compound for treating the symptoms of multiple sclerosis.
    USPTO title: Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
  • US6794410 Other · expires 2027-03-12
    This patent protects the use of a specific compound for treating the symptoms of multiple sclerosis.
    USPTO title: Use of (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4′-trifluoromethylphenyl)-amide for treating multiple sclerosis
  • US8802735 Formulation · expires 2030-09-14
    This patent protects tablet formulations of a specific amide compound, used to treat autoimmune diseases such as multiple sclerosis.
    USPTO title: (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability
  • US8802735 Formulation · expires 2030-09-14
    This patent protects tablet formulations of a specific amide compound, used to treat autoimmune diseases such as multiple sclerosis.
    USPTO title: (Z)-2-cyano-3-hydroxy-but-2-enoic acid-(4'-trifluormethylphenyl)-amide tablet formulations with improved stability

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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