Drug

Eladocagene exuparvovec

As of the edition of 20 October 2026, Eladocagene exuparvovec is a gene: marketed, first approved in 2022 (EU); US protection ends in 2036.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2024
Kind
Gene
Brand name
Kebilidi
First approved
18 July 2022 (EU)
Approvals on record
2 in 2 regions
Holder of the most recent approval
PTC Therapeutics; 2 holders in all

US protection

US protection ends in 2036.

US protection ends in 2036, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by PTC Therapeutics. The date is computed, not published.

This is the US only, and it is not the date generics or biosimilars can enter.

The exact date and the listings behind it

In the product

2 listings count towards this date. The exact date and each listing are in the product.

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Who has held its approvals

CompanyRoleYears
PTC TherapeuticsApplicant2022 to now