Indocin Sr generics — when can they launch?
Indocin Sr (INDOMETHACIN) · · 6 active US patents · 0 expired
Where Indocin Sr sits in the generic timeline
Mid-term cliff: earliest active US patent for Indocin Sr expires in 2030 (~4 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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.
- Formulation — 4 patents
- Method of Use — 2 patents
FDA U-codes carved out by Indocin Sr 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-code | Description |
|---|---|
U-55 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Indocin Sr drug page →
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This patent protects methods for producing indomethacin particles using dry milling processes and compositions containing these particles.USPTO title: Formulation of indomethacin
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This patent protects methods for producing indomethacin particles and compositions, as well as methods of treatment using a therapeutically effective amount of indomethacin.USPTO title: Formulation of indomethacin
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This patent protects methods for producing indomethacin particles and compositions, as well as methods of treatment using a therapeutically effective amount of indomethacin.USPTO title: Formulation of indomethacin
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This patent protects methods for producing indomethacin particles using dry milling processes and compositions containing these particles.USPTO title: Formulation of indomethacin
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This patent protects methods for producing indomethacin particles using dry milling processes and compositions containing these particles.USPTO title: Formulation of indomethacin
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This patent protects methods for producing indomethacin particles using dry milling processes and compositions containing these particles.USPTO title: Formulation of indomethacin
Sources
- FDA Orange Book — patents listed against Indocin Sr (NDA filed 1965)
- Indocin Sr drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2030 — every drug losing US exclusivity that year
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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