TRIHEPTANOIN generics — when can they launch?
TRIHEPTANOIN (TRIHEPTANOIN) · · 2 active US patents · 0 expired
Where TRIHEPTANOIN sits in the generic timeline
Imminent generic cliff: earliest active US patent for TRIHEPTANOIN 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 — 2 patents
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the TRIHEPTANOIN drug page →
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This patent protects a method for treating glycogen storage disease using a composition containing ketogenic odd carbon fatty acids.USPTO title: Glycogen or polysaccharide storage disease treatment method
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This patent protects solid compositions of triglycerides with one or more fatty acids, such as triheptanoin, and their therapeutic uses.USPTO title: Compositions of triglycerides and uses thereof
Sources
- FDA Orange Book — patents listed against TRIHEPTANOIN (NDA filed 2020)
- TRIHEPTANOIN drug profile — full patent estate, indications, clinical trials, pricing
- 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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