Generic entry timeline

Col-Probenecid generics — when can they launch?

Col-Probenecid (probenecid) · Pfizer Inc. · 5 active US patents · 0 expired

Earliest patent expiry
2029-06-03
3 years remaining
Full patent estate to
2039-12-23
complete protection through 2039
FDA approval
1951
Pfizer Inc.

Where Col-Probenecid sits in the generic timeline

Imminent generic cliff: earliest active US patent for Col-Probenecid expires in 2029 (~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 — 5 patents

FDA U-codes carved out by Col-Probenecid 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-4026(no description)

Sample patent estate

Showing 5 of 5 active US patents. View full estate on the Col-Probenecid drug page →

  • US7795243 Method of Use · expires 2029-06-03
    This patent protects orally bioavailable prodrugs of sulopenem, such as Col-Probenecid, and their preparation, formulation, and use to treat and prevent infections in mammals.
    USPTO title: Penem prodrugs
  • US12109197 Method of Use · expires 2039-04-01
    This patent protects combinations of beta-lactam compounds and probenecid, and methods of treating or preventing a disease using these combinations.
    USPTO title: Combinations of β-lactam compounds and probenecid and uses thereof
  • US11554112 Method of Use · expires 2039-04-01
    This patent protects combinations of beta-lactam compounds and probenecid, and methods of treating or preventing a disease using these combinations.
    USPTO title: Combinations of β-lactam compounds and probenecid and uses thereof
  • US12544337 Method of Use · expires 2039-12-23
    This patent protects the use of bilayer tablets containing a beta-lactam compound and probenecid for treating or preventing a disease.
    USPTO title: Combinations of beta-lactam compounds and probenecid and uses thereof
  • US11478428 Method of Use · expires 2039-12-23
    This patent protects the use of bilayer tablets containing a beta-lactam compound and probenecid for treating or preventing a disease.
    USPTO title: Combinations of beta-lactam compounds and probenecid 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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