Drug

Prabotulinumtoxin a

As of the edition of 20 October 2026, Prabotulinumtoxin a is a drug: marketed, first approved in 2018 (CA); acts on SNAP25; US protection ends in 2031.

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

The drug

Status
Marketed; latest approval 2019
Kind
Unknown
Brand name
Jeuveau
First approved
16 August 2018 (CA)
Approvals on record
2 in 2 regions
Holder of the most recent approval
Evolus
Registered trials
17, 1 stopped early
Disease areas
Nervous system; Bones, joints and muscles; Mental health; Mouth and teeth

US protection

US protection ends in 2031.

US protection ends in 2031, 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 Evolus. 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

1 listing counts towards this date. The exact date and each listing are in the product.

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Target

GeneProteinUniProt
SNAP25Synaptosomal-associated protein 25P60880

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated3300
Phase 12100
Phase 27601
Phase 33210
Phase 42010
All trials17

Who has held its approvals

CompanyRoleYears
EvolusApplicant and Lead sponsor of trials2014 to now