Rapamune generics — when can they launch?
Rapamune (sirolimus) · Pfizer · 7 active US patents · 0 expired
Where Rapamune sits in the generic timeline
Imminent generic cliff: earliest active US patent for Rapamune 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.
- Formulation — 4 patents
- Method of Use — 3 patents
FDA U-codes carved out by Rapamune 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-3259 | (no description) |
U-3258 | (no description) |
U-4040 | (no description) |
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the Rapamune drug page →
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This patent protects methods for treating cancer using nanoparticles that contain rapamycin or a derivative thereof.USPTO title: Nanoparticle comprising rapamycin and albumin as anticancer agent
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This patent protects prion-free compositions of nanoparticles containing albumin and a substantially water-insoluble drug, such as Rapamune.USPTO title: Prion free nanoparticle compositions and methods of making thereof
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This patent protects methods for assessing the suitability of a pharmaceutical composition containing nanoparticles of rapamycin coated with albumin and a non-nanoparticle portion of albumin and rapamycin.USPTO title: Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
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This patent protects methods for assessing the suitability of a pharmaceutical composition containing nanoparticles of rapamycin coated with albumin and a non-nanoparticle portion of albumin and rapamycin.USPTO title: Methods of assessing suitability of use of pharmaceutical compositions of albumin and poorly water soluble drug
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This patent protects methods for treating epithelioid cell tumors by administering a composition of nanoparticles containing an mTOR inhibitor and albumin.USPTO title: Methods of treating epithelioid cell tumors comprising administering a composition comprising nanoparticles comprising an mTOR inhibitor and an albumin
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This patent protects methods for treating epithelioid cell tumors, such as PEComa, using nanoparticles containing an mTOR inhibitor and albumin.USPTO title: Methods of treating epithelioid cell tumors
Sources
- FDA Orange Book — patents listed against Rapamune (NDA filed 1999)
- Rapamune drug profile — full patent estate, indications, clinical trials, pricing
- Pfizer patent portfolio
- Patent cliff 2029 — 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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