Xarelto generics — when can they launch?
Xarelto (rivaroxaban) · Johnson & Johnson · 6 active US patents · 0 expired
Where Xarelto sits in the generic timeline
Long-dated protection: earliest active US patent for Xarelto 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 — 3 patents
- Other — 3 patents
FDA U-codes carved out by Xarelto 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-1955 | (no description) |
U-1957 | (no description) |
U-1953 | (no description) |
Sample patent estate
Showing 6 of 6 active US patents. View full estate on the Xarelto drug page →
-
This patent protects a method of treating thromboembolic disorders by administering a direct factor Xa inhibitor once daily in oral form.USPTO title: Prevention and treatment of thromboembolic disorders
-
This patent protects a method of treating thromboembolic disorders by administering a direct factor Xa inhibitor once daily in oral form.USPTO title: Prevention and treatment of thromboembolic disorders
-
This patent protects a method of treating thromboembolic disorders by administering a direct factor Xa inhibitor once daily in oral form.USPTO title: Prevention and treatment of thromboembolic disorders
-
This patent protects a method of treating thromboembolic disorders by administering a direct factor Xa inhibitor once daily in oral form.USPTO title: Prevention and treatment of thromboembolic disorders
-
This patent protects a method of treating thromboembolic disorders by administering a direct factor Xa inhibitor once daily in oral form.USPTO title: Prevention and treatment of thromboembolic disorders
-
This patent protects a method of treating thromboembolic disorders by administering a direct factor Xa inhibitor once daily in oral form.USPTO title: Prevention and treatment of thromboembolic disorders
Sources
- FDA Orange Book — patents listed against Xarelto (NDA filed 2011)
- Xarelto drug profile — full patent estate, indications, clinical trials, pricing
- Johnson & Johnson 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 Xarelto — 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 →