Amitiza generics — when can they launch?
Amitiza (LUBIPROSTONE) · Sucampo Pharma Llc · 6 active US patents · 0 expired
Where Amitiza sits in the generic timeline
Imminent generic cliff: earliest active US patent for Amitiza 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.
- Formulation — 6 patents
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Amitiza drug page →
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This patent protects a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which improves the compound's stability.USPTO title: Soft-gelatin capsule formulation
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This patent protects a soft gelatin capsule formulation of a 15-keto-prostaglandin compound.USPTO title: Soft-gelatin capsule formulation
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This patent protects a soft gelatin capsule formulation of a 15-keto-prostaglandin compound, which improves the compound's stability.USPTO title: Soft-gelatin capsule formulation
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This patent protects a soft gelatin capsule formulation of a 15-keto-prostaglandin compound.USPTO title: Soft-gelatin capsule formulation
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This patent protects a soft gelatin capsule formulation of a 15-keto-prostaglandin compound.USPTO title: Soft-gelatin capsule formulation
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This patent protects a soft gelatin capsule formulation of a 15-keto-prostaglandin compound.USPTO title: Soft-gelatin capsule formulation
Sources
- FDA Orange Book — patents listed against Amitiza (NDA filed 2006)
- Amitiza drug profile — full patent estate, indications, clinical trials, pricing
- Sucampo Pharma Llc 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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