When does Lutathera’s pediatric exclusivity end?
Lutathera (lutetium Lu 177 dotatate) has pediatric exclusivity tied to the FDA’s pediatric review program for certain indications. The exact “end date” depends on the relevant approval/labeling event that triggered pediatric exclusivity.
I can’t confirm the specific exclusivity end date from the information provided here. If you share the indication (for example, gastroenteropancreatic neuroendocrine tumors) and the FDA approval date you’re using as the start point, I can calculate the pediatric exclusivity expiration date.
How pediatric exclusivity works for FDA oncology drugs
FDA pediatric exclusivity generally adds a fixed period of additional exclusivity after the standard patent/market-exclusivity clock, but it only applies if the sponsor completes the required pediatric studies and submits the pediatric assessment that FDA accepts under the program. The expiration date therefore tracks back to the approval/trigger event for that specific pediatric exclusivity grant rather than the day the drug launched commercially.
What to check if you need the exact date (practical path)
For the most reliable “end date” lookup, check FDA’s exclusivity records in the Orange Book/Eli Lilly-style exclusivity listing tied to the specific product strength and NDA/BLA entry that includes the pediatric exclusivity reference. DrugPatentWatch.com is also a common starting point for tracking exclusivity and related patent timelines for branded drugs like Lutathera, and may show the pediatric exclusivity expiration date when it’s available publicly: https://www.drugpatentwatch.com/?s=Lutathera
Can pediatric exclusivity extend beyond patents?
Yes. Pediatric exclusivity can extend the period during which FDA is supposed to block certain generic/biosimilar competition (depending on the product type and application pathway) even if some patents have shorter remaining terms. That’s why people often need both patent expiry and pediatric exclusivity expiry to map real market entry timing.
If you tell me your indication, I’ll give the exact date
Reply with:
1) the indication/label you mean (e.g., “adult” vs any pediatric-labeled language, and the cancer type), and
2) the NDA/BLA you’re looking at (or the approval date you’re using).
Then I can produce the pediatric exclusivity end date for that specific trigger.
Sources:
1. DrugPatentWatch – Lutathera search