Mulpleta generics — when can they launch?
Mulpleta (LUSUTROMBOPAG) · Vancocin Italia · 3 active US patents · 0 expired
Where Mulpleta sits in the generic timeline
Imminent generic cliff: earliest active US patent for Mulpleta 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 — 2 patents
- Formulation — 1 patent
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Mulpleta drug page →
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This patent protects a pharmaceutical composition containing an optically active compound with thrombopoietin receptor agonist activity.USPTO title: Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
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This patent protects a pharmaceutical composition containing an optically active compound with thrombopoietin receptor agonist activity, specifically a 4-phenylthiazole derivative.USPTO title: Pharmaceutical composition containing optically active compound having thrombopoietin receptor agonist activity, and intermediate therefor
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This patent protects a solubility-improving preparation for enhancing the oral absorption of a poorly soluble drug with an acidic group.USPTO title: Preparation for improving solubility of poorly soluble drug
Sources
- FDA Orange Book — patents listed against Mulpleta (NDA filed 2018)
- Mulpleta drug profile — full patent estate, indications, clinical trials, pricing
- Vancocin Italia 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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