Onpattro generics — when can they launch?
Onpattro (PATISIRAN SODIUM) · Alnylam Pharmaceuticals · 13 active US patents · 0 expired
Where Onpattro sits in the generic timeline
Imminent generic cliff: earliest active US patent for Onpattro 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 — 4 patents
FDA U-codes carved out by Onpattro 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-2378 | (no description) |
Sample patent estate
Showing 6 of 13 active US patents. View full estate on the Onpattro drug page →
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This patent protects lipid-containing formulations for administering nucleic acid-based therapies, such as liposomes and lipoplexes.USPTO title: Lipid containing formulations
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This patent protects novel, stable lipid particles for delivering and/or administering nucleic acids, such as interfering RNA.USPTO title: Lipid formulations for nucleic acid delivery
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This patent protects novel, stable lipid particles for delivering nucleic acids, such as interfering RNA, and methods for making and administering them.USPTO title: Lipid formulations for nucleic acid delivery
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This patent protects novel, stable lipid particles for delivering nucleic acids, such as interfering RNA, and methods for making and administering them.USPTO title: Lipid formulations for nucleic acid delivery
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This patent protects novel, stable lipid particles for delivering nucleic acids, such as interfering RNA, and methods for making and administering them.USPTO title: Lipid formulations for nucleic acid delivery
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This patent protects novel, stable lipid particles for delivering and/or administering nucleic acids, such as interfering RNA.USPTO title: Lipid formulations for nucleic acid delivery
Sources
- FDA Orange Book — patents listed against Onpattro (NDA filed 2018)
- Onpattro drug profile — full patent estate, indications, clinical trials, pricing
- Alnylam Pharmaceuticals 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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