Velcade generics — when can they launch?
Velcade (bortezomib) · Shilpa · 7 active US patents · 0 expired
Where Velcade sits in the generic timeline
Mid-term cliff: earliest active US patent for Velcade expires in 2032 (~6 years). Generic developers typically begin ANDA bioequivalence studies 3-4 years ahead of this date. Paragraph IV filings + Hatch-Waxman 30-month stays may shift the effective entry by another 18-36 months.
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 — 3 patents
FDA U-codes carved out by Velcade 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-3632 | (no description) |
Sample patent estate
Showing 6 of 7 active US patents. View full estate on the Velcade drug page →
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This patent protects a bortezomib composition that includes bortezomib and boric acid in a specific mass ratio, which can be prepared as a solid through lyophilization.USPTO title: Bortezomib formulations
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This patent protects ready-to-use liquid aqueous bortezomib compositions and methods for preparing and using them in therapeutic applications.USPTO title: Bortezomib compositions
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This patent protects ready-to-use liquid aqueous bortezomib compositions and methods for preparing and using them in therapeutic applications.USPTO title: Bortezomib compositions
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This patent protects ready-to-use liquid aqueous bortezomib compositions and methods of preparing and using them in therapeutic applications.USPTO title: Bortezomib compositions
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This patent protects ready-to-use liquid aqueous bortezomib compositions and methods of preparing and using them in therapeutic applications.USPTO title: Bortezomib compositions
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This patent protects ready-to-use liquid aqueous bortezomib compositions and methods of preparing and using them in therapeutic applications.USPTO title: Bortezomib compositions
Sources
- FDA Orange Book — patents listed against Velcade (NDA filed 2003)
- Velcade drug profile — full patent estate, indications, clinical trials, pricing
- Shilpa patent portfolio
- Patent cliff 2032 — 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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