Generic entry timeline

Advil generics — when can they launch?

Advil (ibuprofen) · Generic (originally Boots Group) · 14 active US patents · 0 expired

Earliest patent expiry
2029-09-30
3 years remaining
Full patent estate to
2032-03-16
complete protection through 2032
FDA approval
1969-01-15
Generic (originally Boots Group)

Where Advil sits in the generic timeline

Imminent generic cliff: earliest active US patent for Advil 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 — 14 patents

FDA U-codes carved out by Advil 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-1756(no description)
U-981(no description)
U-1735(no description)
U-2018(no description)
U-3746(no description)
U-2266(no description)
U-2264(no description)

Sample patent estate

Showing 6 of 14 active US patents. View full estate on the Advil drug page →

  • US9295639 Method of Use · expires 2029-09-30
    This patent protects a method of treating critically ill patients with intravenous ibuprofen to achieve a similar effect as administering it to non-critically ill patients.
    USPTO title: Treating critically ill patients with intravenous ibuprofen
  • US8871810 Method of Use · expires 2029-09-30
    This patent protects a method of treating critically ill patients with intravenous ibuprofen to achieve a similar effect as administering it to non-critically ill patients.
    USPTO title: Treating critically ill patients with intravenous ibuprofen
  • US9138404 Method of Use · expires 2029-09-30
    This patent protects a method of treating critically ill patients with intravenous ibuprofen to achieve a similar effect as administering it to non-critically ill patients.
    USPTO title: Treating critically ill patients with intravenous ibuprofen
  • US9114068 Method of Use · expires 2029-09-30
    This patent protects a method of treating critically ill patients with intravenous ibuprofen to alleviate pain, inflammation, and fever without significantly increasing their blood pressure.
    USPTO title: Treating patients with intravenous ibuprofen
  • US8735452 Method of Use · expires 2029-09-30
    This patent protects a method of treating critically ill patients with intravenous ibuprofen to alleviate pain, inflammation, and fever without significantly increasing their blood pressure.
    USPTO title: Treating patients with intravenous ibuprofen
  • US9649284 Method of Use · expires 2029-09-30
    This patent protects a method of treating critically ill patients with intravenous ibuprofen to achieve a similar effect as non-critically ill patients.
    USPTO title: Treating critically ill patients with intravenous ibuprofen

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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