Generic entry timeline

OxyContin generics — when can they launch?

OxyContin (oxycodone) · Purdue Pharma · 40 active US patents · 0 expired

Earliest patent expiry
2028-10-09
2 years remaining
Full patent estate to
2036-09-02
complete protection through 2036
FDA approval
—
Purdue Pharma

Where OxyContin sits in the generic timeline

Imminent generic cliff: earliest active US patent for OxyContin expires in 2028 (~2 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 — 35 patents
  • Formulation — 5 patents

FDA U-codes carved out by OxyContin 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-1556(no description)

Sample patent estate

Showing 6 of 40 active US patents. View full estate on the OxyContin drug page →

  • US7771707 Formulation · expires 2028-10-09
    This patent protects an abuse-deterrent pharmaceutical composition that reduces the likelihood of improper administration of drugs, especially opioids, by modifying the drug's lipophilicity.
    USPTO title: Abuse-deterrent drug formulations
  • US7771707 Formulation · expires 2028-10-09
    This patent protects an abuse-deterrent pharmaceutical composition that reduces the likelihood of improper administration of drugs, especially opioids, by modifying the drug's lipophilicity.
    USPTO title: Abuse-deterrent drug formulations
  • US7771707 Formulation · expires 2028-10-09
    This patent protects an abuse-deterrent pharmaceutical composition that reduces the likelihood of improper administration of drugs, especially opioids, by modifying the drug's lipophilicity.
    USPTO title: Abuse-deterrent drug formulations
  • US7771707 Formulation · expires 2028-10-09
    This patent protects an abuse-deterrent pharmaceutical composition that reduces the likelihood of improper administration of drugs, especially opioids, by modifying the drug's lipophilicity.
    USPTO title: Abuse-deterrent drug formulations
  • US7771707 Formulation · expires 2028-10-09
    This patent protects an abuse-deterrent pharmaceutical composition that reduces the likelihood of improper administration of drugs, especially opioids, by modifying the drug's lipophilicity.
    USPTO title: Abuse-deterrent drug formulations
  • US9682075 Method of Use · expires 2030-12-10
    This patent protects tamper-resistant pharmaceutical compositions that slow the release of a drug, such as an opioid, even if the formulation is compromised.
    USPTO title: Tamper-resistant pharmaceutical compositions of opioids and other drugs

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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