Welireg generics — when can they launch?
Welireg (BELZUTIFAN) · Merck & Co. · 3 active US patents · 0 expired
Where Welireg sits in the generic timeline
Long-dated protection: earliest active US patent for Welireg extends to 2034 (~8 years out). Generic competition is at least 4 years away. Lifecycle moves (new formulations, label extensions, combination filings) typically execute 18-36 months ahead of cliff.
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 — 2 patents
- Formulation — 1 patent
FDA U-codes carved out by Welireg 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-4195 | (no description) |
Sample patent estate
Showing 3 of 3 active US patents. View full estate on the Welireg drug page →
-
This patent protects a method of using Welireg.
-
This patent protects methods of using HIF-2α inhibitors, such as certain aryl ethers, for treating cancer.USPTO title: Aryl ethers and uses thereof
-
This patent protects solid dispersions and pharmaceutical compositions containing a HIF-2α inhibitor for treating HIF-2α-mediated diseases and conditions.USPTO title: Solid dispersions and pharmaceutical compositions comprising a substituted indane and methods for the preparation and use thereof
Sources
- FDA Orange Book — patents listed against Welireg (NDA filed 2021)
- Welireg drug profile — full patent estate, indications, clinical trials, pricing
- Merck & Co. patent portfolio
- Patent cliff 2034 — 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.
Get generic entry alerts
Free Pharma CI alerts on Welireg — get notified the moment an ANDA Paragraph IV certification is filed, a 30-month stay is triggered, or a generic launches. First 2 drugs free.
Subscribe free →