Vyndaqel generics — when can they launch?
Vyndaqel (Tafamidis Meglumine) · Foldrx Pharms · 2 active US patents · 0 expired
Where Vyndaqel sits in the generic timeline
Imminent generic cliff: earliest active US patent for Vyndaqel expires in 2026 (~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 — 1 patent
- Composition of Matter — 1 patent
FDA U-codes carved out by Vyndaqel 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-2524 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the Vyndaqel drug page →
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This patent protects methods and compounds for stabilizing the protein transthyretin and preventing its misfolding.USPTO title: Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
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This patent protects compositions and methods for stabilizing the protein transthyretin and preventing its misfolding.USPTO title: Compositions and methods for stabilizing transthyretin and inhibiting transthyretin misfolding
Sources
- FDA Orange Book — patents listed against Vyndaqel (NDA filed 2019)
- Vyndaqel drug profile — full patent estate, indications, clinical trials, pricing
- Foldrx Pharms patent portfolio
- Patent cliff 2026 — 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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