Yupelri generics — when can they launch?
Yupelri (REVEFENACIN) · Mylan Ireland Ltd · 10 active US patents · 0 expired
Where Yupelri sits in the generic timeline
Imminent generic cliff: earliest active US patent for Yupelri 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.
- Method of Use — 5 patents
- Composition of Matter — 4 patents
- Formulation — 1 patent
FDA U-codes carved out by Yupelri 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-2440 | (no description) |
Sample patent estate
Showing 6 of 10 active US patents. View full estate on the Yupelri drug page →
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This patent protects a class of biphenyl compounds that act as muscarinic receptor antagonists.USPTO title: Biphenyl compounds useful as muscarinic receptor antagonists
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This patent protects crystalline freebase forms of a biphenyl compound and methods for preparing and using them to treat a pulmonary disorder.USPTO title: Crystalline freebase forms of a biphenyl compound
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This patent protects crystalline freebase forms of a biphenyl compound and methods of using them to treat a pulmonary disorder.USPTO title: Crystalline freebase forms of a biphenyl compound
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This patent protects crystalline freebase forms of a biphenyl compound and methods of using them to treat a pulmonary disorder.USPTO title: Crystalline freebase forms of a biphenyl compound
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This patent protects crystalline freebase forms of a biphenyl compound used to treat a pulmonary disorder.USPTO title: Crystalline freebase forms of a biphenyl compound
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This patent protects crystalline freebase forms of a biphenyl compound used to treat a pulmonary disorder.USPTO title: Crystalline freebase forms of a biphenyl compound
Sources
- FDA Orange Book — patents listed against Yupelri (NDA filed 2018)
- Yupelri drug profile — full patent estate, indications, clinical trials, pricing
- Mylan Ireland Ltd 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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