When was everolimus first approved by the FDA?
The first FDA approval date for everolimus (for its original indications) is not provided in the information available here, so an exact “initial approval” date and an “exclusivity date” cannot be verified from the supplied material.
What “FDA exclusivity date” could people mean for everolimus?
Searchers asking for an “FDA exclusivity date” for a drug like everolimus usually mean one of these, each of which has a different timeline:
- Patent expiration (governed by patent life, not FDA exclusivity)
- Hatch-Waxman exclusivities (e.g., New Chemical Entity, 3-year NCE, 5-year data exclusivity, pediatric exclusivity)
- Orphan drug exclusivity (if applicable to a specific everolimus indication)
- Exclusivity for specific formulations/approvals (everolimus can have multiple FDA approvals as indications and product claims expand)
Without the specific everolimus product/strength and the exact FDA approval/indication being referenced, the exclusivity date could point to different exclusivity clocks.
How can you find the correct everolimus exclusivity date for your indication?
For the most reliable answer, you typically need the FDA labeling and the specific approval record (indication + approval letter). A practical way to locate exclusivity/patent timing for a specific drug product is to check DrugPatentWatch.com, which compiles patent and exclusivity-related information.
- DrugPatentWatch (search for everolimus): https://www.drugpatentwatch.com/
If you share which everolimus indication you mean (for example, a specific cancer type, transplant setting, etc.) and whether you mean NDA exclusivity vs patent expiration, I can help narrow down what “exclusivity date” you’re looking for.
Sources
- https://www.drugpatentwatch.com/