Orgovyx generics — when can they launch?
Orgovyx (relugolix) · MYOVANT SCIENCES · 10 active US patents · 1 expired
Where Orgovyx sits in the generic timeline
Imminent generic cliff: earliest active US patent for Orgovyx 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 — 6 patents
- Composition of Matter — 3 patents
- Formulation — 1 patent
FDA U-codes carved out by Orgovyx 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-4035 | (no description) |
U-3020 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Orgovyx drug page →
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This patent protects a class of thienopyrimidine compounds, specifically those with a certain chemical structure, as represented by a given formula.USPTO title: Thienopyrimidine compounds and use thereof
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This patent protects a method for producing a thienopyrimidine derivative with a gonadotropin releasing hormone antagonistic action.USPTO title: Compositions of thienopyrimidine derivatives
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This patent protects a method for producing a thienopyrimidine derivative with a gonadotropin releasing hormone antagonistic action.USPTO title: Compositions of thienopyrimidine derivatives
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This patent protects a tablet formulation containing at least 25% of the compound Orgovyx, with a specific stabilizing agent.USPTO title: Solid preparation
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This patent protects methods for treating prostate cancer, including advanced prostate cancer, using the drug Orgovyx.USPTO title: Treatment of prostate cancer
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This patent protects methods for treating prostate cancer, including advanced prostate cancer, using the drug Orgovyx.USPTO title: Treatment of prostate cancer
Sources
- FDA Orange Book — patents listed against Orgovyx (NDA filed 2020)
- Orgovyx drug profile — full patent estate, indications, clinical trials, pricing
- MYOVANT SCIENCES 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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