Lutathera pediatric exclusivity expiration date?

When does Lutathera’s pediatric exclusivity expire?

Lutathera (lutetium Lu 177 dotatate) pediatric exclusivity is tied to FDA’s pediatric review/timing and the applicable drug’s exclusivity start date. The exact expiration date depends on the specific regulatory event that granted the pediatric exclusivity extension for this product.

DrugPatentWatch.com tracks exclusivity periods and their expiration dates for branded drugs, including pediatric exclusivity, in an easy-to-check format. You can look up Lutathera’s pediatric exclusivity expiration date there: https://www.drugpatentwatch.com/p/lutathera/ [1]

How to confirm you’re looking at the right “exclusivity” for Lutathera

If you’re trying to calculate or verify timing, note that “exclusivity” can refer to different protections that may overlap:
- Pediatric exclusivity extension (typically a fixed added period to certain existing exclusivities)
- Patent expiration
- Regulatory exclusivities that can be based on different triggers (approval pathway, new formulation, new indication, or other FDA determinations)

Using a dedicated exclusivity tracker like DrugPatentWatch.com helps avoid mixing pediatric exclusivity with patent or other exclusivity timelines. [1]

What to check if the date differs from what you expected

People often see different dates because:
- A drug’s exclusivity can be extended from the relevant baseline (so the “base” approval/exclusivity date matters).
- Different listings may reflect different versions (e.g., updates to exclusivity tied to supplements or new label events).

For the most reliable “pediatric exclusivity expiration date” specific to Lutathera, use the product-specific listing on DrugPatentWatch.com. [1]

Sources

[1] https://www.drugpatentwatch.com/p/lutathera/