Drug

Zopapogene imadenovec

As of the edition of 20 October 2026, Zopapogene imadenovec is a gene: marketed, first approved in 2025 (US); US protection ends in 2037.

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

The drug

Status
Marketed; latest approval 2025
Kind
Gene
Brand name
Papzimeos
First approved
14 August 2025 (US)
Approvals on record
1 in 1 region
Holder of the most recent approval
Precigen
Registered trials
1, 0 stopped early
Disease areas
Infections; Urinary and reproductive

US protection

US protection ends in 2037.

US protection ends in 2037, 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 Precigen. 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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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase 41010
All trials1

Who has held its approvals

CompanyRoleYears
PrecigenOriginator and Lead sponsor of trials2024 to now