Tryvio generics — when can they launch?
Tryvio (APROCITENTAN) · Idorsia · 6 active US patents · 0 expired
Where Tryvio sits in the generic timeline
Imminent generic cliff: earliest active US patent for Tryvio 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.
- Method of Use — 4 patents
- Formulation — 1 patent
- Composition of Matter — 1 patent
FDA U-codes carved out by Tryvio 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-3878 | (no description) |
U-3879 | (no description) |
U-3877 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Tryvio drug page →
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This patent protects a process for preparing a compound useful as an endothelin receptor antagonist, specifically a 4-pyrimidinesulfamide derivative.USPTO title: 4-pyrimidinesulfamide derivative
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This patent protects the use of aprocitentan, in combination with other active ingredients, for the treatment or prevention of certain endothelin-related diseases.USPTO title: Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases
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This patent protects novel crystalline forms of a specific chemical compound, aprocitentan, and its use as an endothelin receptor antagonist.USPTO title: Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan
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This patent protects novel crystalline forms of the drug aprocitentan, a 4-pyrimidinesulfamide derivative, and their use as endothelin receptor antagonists.USPTO title: Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan
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This patent protects the use of aprocitentan, in combination with other active ingredients, for the treatment or prevention of certain endothelin-related diseases.USPTO title: Combinations of a 4-pyrimidinesulfamide derivative with active ingredients for the treatment of endothelin related diseases
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This patent protects novel crystalline forms of aprocitentan, a drug used as an endothelin receptor antagonist, and its new uses in combination with other active ingredients or therapeutic agents.USPTO title: Crystalline forms of a 4-pyrimidinesulfamide derivative aprocitentan
Sources
- FDA Orange Book — patents listed against Tryvio (NDA filed 2025)
- Tryvio drug profile — full patent estate, indications, clinical trials, pricing
- Idorsia patent portfolio
- 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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