Marinol generics — when can they launch?
Marinol (DRONABINOL) · Wellhouse Pharma · 4 active US patents · 0 expired
Where Marinol sits in the generic timeline
Imminent generic cliff: earliest active US patent for Marinol expires in 2028 (~2 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.
- Composition of Matter — 4 patents
Sample patent estate
Showing 4 of 4 active US patents. View full estate on the Marinol drug page →
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This patent protects oral formulations of a cannabinoid, specifically dronabinol, that are stable at room or refrigerated temperatures.USPTO title: Oral cannabinoid formulations
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This patent protects liquid formulations of the active substance dronabinol, which is used in the drug Marinol.USPTO title: Liquid cannabinoid formulations
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This patent protects oral formulations of dronabinol, including an aqueous-based solution, that are stable at room or refrigerated temperatures.USPTO title: Oral cannabinoid formulations
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This patent protects oral formulations of dronabinol, including an aqueous-based solution, that are stable at room or refrigerated temperatures.USPTO title: Oral cannabinoid formulations
Sources
- FDA Orange Book — patents listed against Marinol (NDA filed 1985)
- Marinol drug profile — full patent estate, indications, clinical trials, pricing
- Wellhouse Pharma patent portfolio
- Patent cliff 2028 — 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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