Generic entry timeline

Sinemet Cr generics — when can they launch?

Sinemet Cr (CARBIDOPA) · Aton · 151 active US patents · 0 expired

Earliest patent expiry
2028-12-26
3 years remaining
Full patent estate to
2041-12-21
complete protection through 2041
FDA approval
1975
Aton

Where Sinemet Cr sits in the generic timeline

Imminent generic cliff: earliest active US patent for Sinemet Cr expires in 2028 (~3 years from today). ANDA filers are likely already preparing Paragraph IV certifications. Expect first-filer 180-day exclusivity competition imminently.

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 — 115 patents
  • Formulation — 36 patents

FDA U-codes carved out by Sinemet Cr 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-1645(no description)
U-1646(no description)
U-1649(no description)
U-219(no description)
U-3557(no description)
U-4005(no description)

Sample patent estate

Showing 6 of 151 active US patents. View full estate on the Sinemet Cr drug page →

  • US8557283 Method of Use · expires 2028-12-26
    This patent protects controlled release formulations of levodopa, including a multiparticulate formulation with a controlled release component, carboxylic acid component, and immediate release component.
    USPTO title: Controlled release formulations of levodopa and uses thereof
  • US8454998 Method of Use · expires 2028-12-26
    This patent protects controlled release formulations of levodopa, including a multiparticulate formulation with a controlled release component, carboxylic acid component, and immediate release component.
    USPTO title: Controlled release formulations of levodopa and uses thereof
  • US9089608 Formulation · expires 2028-12-26
    This patent protects controlled release formulations of levodopa, including multiparticulate oral solid formulations, that also contain a decarboxylase inhibitor and a carboxylic acid.
    USPTO title: Controlled release formulations of levodopa and uses thereof
  • US9089608 Formulation · expires 2028-12-26
    This patent protects controlled release formulations of levodopa, including multiparticulate oral solid formulations, that also contain a decarboxylase inhibitor and a carboxylic acid.
    USPTO title: Controlled release formulations of levodopa and uses thereof
  • US8454998 Method of Use · expires 2028-12-26
    This patent protects controlled release formulations of levodopa, including a multiparticulate formulation with a controlled release component, carboxylic acid component, and immediate release component.
    USPTO title: Controlled release formulations of levodopa and uses thereof
  • US9901640 Method of Use · expires 2028-12-26
    This patent protects a modified release dosage form of levodopa.
    USPTO title: Controlled release formulations of levodopa and uses thereof

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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