Ocaliva generics — when can they launch?
Ocaliva (OBETICHOLIC ACID) · Intercept Pharms Inc · 14 active US patents · 0 expired
Where Ocaliva sits in the generic timeline
Imminent generic cliff: earliest active US patent for Ocaliva 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
- Composition of Matter — 4 patents
- Method of Use — 4 patents
FDA U-codes carved out by Ocaliva 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-1854 | (no description) |
U-2945 | (no description) |
Sample patent estate
Showing 6 of 14 active US patents. View full estate on the Ocaliva drug page →
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This patent protects the composition of matter of the active drug substance Ocaliva.
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This patent protects the composition of matter of the active drug substance Ocaliva.
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This patent protects the molecule obeticholic acid and processes for its synthesis.USPTO title: Preparation and uses of obeticholic acid
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This patent protects a method for synthesizing obeticholic acid and its uses in treating various diseases and conditions.USPTO title: Preparation and uses of obeticholic acid
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This patent protects the molecule obeticholic acid and processes for its synthesis.USPTO title: Preparation and uses of obeticholic acid
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This patent protects a method for synthesizing obeticholic acid and its uses in treating various diseases and conditions.USPTO title: Preparation and uses of obeticholic acid
Sources
- FDA Orange Book — patents listed against Ocaliva (NDA filed 2016)
- Ocaliva drug profile — full patent estate, indications, clinical trials, pricing
- Intercept Pharms Inc 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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