Arthrotec generics — when can they launch?
Arthrotec (Diclofenac Sodium) · Pfizer · 24 active US patents · 0 expired
Where Arthrotec sits in the generic timeline
Imminent generic cliff: earliest active US patent for Arthrotec expires in 2027 (~1 year 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 — 23 patents
- Formulation — 1 patent
FDA U-codes carved out by Arthrotec 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-1659 | (no description) |
U-1614 | (no description) |
U-1488 | (no description) |
U-1489 | (no description) |
U-1477 | (no description) |
U-1435 | (no description) |
U-1248 | (no description) |
Sample patent estate
Showing 6 of 24 active US patents. View full estate on the Arthrotec drug page →
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This patent protects a pharmaceutical composition containing a low dose of diclofenac and beta-cyclodextrin for inducing analgesia in a subject.USPTO title: Formulations of low dose diclofenac and beta-cyclodextrin
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This patent protects a gel formulation of diclofenac sodium for topical treatment of pain, such as in osteoarthritis.USPTO title: Diclofenac topical formulation
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This patent protects a gel formulation of diclofenac sodium for topical treatment of pain, such as in osteoarthritis.USPTO title: Diclofenac topical formulation
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This patent protects methods of using diclofenac for pain relief, including compositions such as solution and gel formulations.USPTO title: Treatment of pain with topical diclofenac
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This patent protects a gel formulation of diclofenac sodium for topical treatment of pain, such as in osteoarthritis.USPTO title: Diclofenac topical formulation
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This patent protects a gel formulation of diclofenac sodium for topical treatment of pain, such as in osteoarthritis.USPTO title: Diclofenac topical formulation
Sources
- FDA Orange Book — patents listed against Arthrotec (NDA filed 1988)
- Arthrotec drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2027 — 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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