Drug

Susoctocog alfa

As of the edition of 20 October 2026, Susoctocog alfa is a protein: marketed, first approved in 2014 (US); US protection ends in 2026.

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

The drug

Status
Marketed; latest approval 2024
Kind
Protein
Brand name
Obizur
First approved
23 October 2014 (US)
Approvals on record
3 in 3 regions
Holder of the most recent approval
Takeda; 2 holders in all
Registered trials
5, 1 stopped early
Disease areas
Blood and lymph; Inherited and neonatal

US protection

US protection ends in 2026.

US protection ends in 2026, 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 Takeda. 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 not stated4220
Phase 31001
All trials5

Who has held its approvals

CompanyRoleYears
TakedaApplicant and Lead sponsor of trials2015 to now