ATAZANAVIR SULFATE generics — when can they launch?
ATAZANAVIR SULFATE (ATAZANAVIR SULFATE) · · 2 active US patents · 0 expired
Where ATAZANAVIR SULFATE sits in the generic timeline
Imminent generic cliff: earliest active US patent for ATAZANAVIR SULFATE 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 — 1 patent
- Formulation — 1 patent
FDA U-codes carved out by ATAZANAVIR SULFATE 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-1279 | (no description) |
Sample patent estate
Showing 2 of 2 active US patents. View full estate on the ATAZANAVIR SULFATE drug page →
-
This patent protects a compound and its therapeutic methods, including administration with at least one additional therapeutic agent.USPTO title: Modulators of pharmacokinetic properties of therapeutics
-
This patent protects a composition of a pharmaceutical agent, specifically atazanavir sulfate, combined with solid carrier particles to improve processability.USPTO title: Use of solid carrier particles to improve the processability of a pharmaceutical agent
Sources
- FDA Orange Book — patents listed against ATAZANAVIR SULFATE (NDA filed 2003)
- ATAZANAVIR SULFATE drug profile — full patent estate, indications, clinical trials, pricing
- 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.
Get generic entry alerts
Free Pharma CI alerts on ATAZANAVIR SULFATE — 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 →