PERFLUTREN generics — when can they launch?
PERFLUTREN (PERFLUTREN) · · 20 active US patents · 0 expired
Where PERFLUTREN sits in the generic timeline
Long-dated protection: earliest active US patent for PERFLUTREN extends to 2035 (~10 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 19 patents
- Composition of Matter — 1 patent
FDA U-codes carved out by PERFLUTREN 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-665 | (no description) |
Sample patent estate
Showing 6 of 20 active US patents. View full estate on the PERFLUTREN drug page →
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This patent protects improved lipid formulations used to generate lipid-encapsulated gas microspheres and methods of their use.USPTO title: Lipid-encapsulated gas microsphere compositions and related methods
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This patent protects improved lipid formulations used to generate lipid-encapsulated gas microspheres.USPTO title: Lipid-encapsulated gas microsphere compositions and related methods
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This patent protects improved lipid formulations used to generate lipid-encapsulated gas microspheres and methods of their use.USPTO title: Lipid-encapsulated gas microsphere compositions and related methods
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This patent protects improved lipid formulations used to generate lipid-encapsulated gas microspheres and methods of their use.USPTO title: Lipid-encapsulated gas microsphere compositions and related methods
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This patent protects improved methods for preparing phospholipid formulations, including those used as ultrasound contrast agents.USPTO title: Methods for making ultrasound contrast agents
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This patent protects improved methods for preparing phospholipid formulations, including those used as ultrasound contrast agents.USPTO title: Methods for making ultrasound contrast agents
Sources
- FDA Orange Book — patents listed against PERFLUTREN (NDA filed 1998)
- PERFLUTREN drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2035 — 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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