Generic entry timeline

Celebrex generics — when can they launch?

Celebrex (celecoxib) · Pfizer Inc. (originally Searle/Pharmacia) · 13 active US patents · 0 expired

Earliest patent expiry

2030-04-19

4 years remaining

Full patent estate to

2036-05-27

complete protection through 2036

FDA approval

1998-12-31

Pfizer Inc. (originally Searle/Pharmacia)

Where Celebrex sits in the generic timeline

Mid-term cliff: earliest active US patent for Celebrex 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.

Method of Use — 9 patents
Composition of Matter — 3 patents
Formulation — 1 patent

FDA U-codes carved out by Celebrex 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-3244`	(no description)
`U-2718`	(no description)

Sample patent estate

Showing 6 of 13 active US patents. View full estate on the Celebrex drug page →

US11478488 Method of Use · expires 2030-04-19

This patent protects co-crystals of tramadol and coxibs, such as Celebrex, for use in treating pain.

USPTO title: Co-crystals of tramadol and coxibs
US8598152 Composition of Matter · expires 2030-04-19

This patent protects co-crystals of tramadol combined with co-crystal formers selected from NSAIDs or coxibs, and processes for their preparation.

USPTO title: Co-crystals of tramadol and coxibs
US9012440 Composition of Matter · expires 2030-04-19

This patent protects co-crystals of tramadol and coxibs, including their preparation and use as medicaments for treating pain.

USPTO title: Co-crystals of tramadol and coxibs
US10548909 Method of Use · expires 2030-04-19

This patent protects co-crystals of tramadol and coxibs, such as Celebrex, for use in treating pain.

USPTO title: Co-crystals of tramadol and coxibs
US10238668 Method of Use · expires 2030-04-19

This patent protects co-crystals of tramadol and coxibs, and their uses in medicaments or pharmaceutical formulations for pain treatment.

USPTO title: Co-crystals of tramadol and coxibis
US10245276 Composition of Matter · expires 2030-04-19

This patent protects co-crystals of tramadol and coxibs, including their preparation and use as medicaments for treating pain.

USPTO title: Co-crystals of tramadol and coxibs

Sources

FDA Orange Book — patents listed against Celebrex (NDA filed 1998)
Celebrex drug profile — full patent estate, indications, clinical trials, pricing
Pfizer Inc. (originally Searle/Pharmacia) patent portfolio
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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