Camptosar generics — when can they launch?
Camptosar (Irinotecan Hydrochloride) · Pfizer · 14 active US patents · 0 expired
Where Camptosar sits in the generic timeline
Imminent generic cliff: earliest active US patent for Camptosar 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 — 9 patents
- Formulation — 3 patents
- Composition of Matter — 2 patents
FDA U-codes carved out by Camptosar 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-1899 | (no description) |
U-1848 | (no description) |
U-1917 | (no description) |
U-2091 | (no description) |
U-1856 | (no description) |
U-3824 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the Camptosar drug page →
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Merrimack Pharmaceuticals Inc has developed liposome compositions that can contain a substituted ammonium and/or polyanion, and optionally a therapeutic or imaging entity.USPTO title: Liposomes useful for drug delivery
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This patent protects liposome compositions containing substituted ammonium and/or polyanion, and optionally with a desired therapeutic or imaging entity.USPTO title: Liposomes useful for drug delivery
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This patent protects methods for treating pancreatic cancer using liposomal irinotecan alone or in combination with other therapeutic agents.USPTO title: Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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This patent protects methods for treating pancreatic cancer using liposomal irinotecan alone or in combination with other therapeutic agents.USPTO title: Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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This patent protects methods for treating pancreatic cancer using liposomal irinotecan alone or in combination with other therapeutic agents.USPTO title: Methods for treating pancreatic cancer using combination therapies comprising liposomal irinotecan
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This patent protects methods for treating pancreatic cancer using liposomal irinotecan (MM-398) alone or in combination with other therapeutic agents.USPTO title: Methods for treating pancreatic cancer using combination therapies
Sources
- FDA Orange Book — patents listed against Camptosar (NDA filed 1996)
- Camptosar 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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