Drug

Rabies vaccine

As of the edition of 20 October 2026, Rabies vaccine is a vaccine component: marketed, first approved in 1997 (US); US protection ended in 2009.

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

The drug

Status
Marketed; latest approval 1997
Kind
Vaccine component
Brand name
Rabavert
First approved
20 October 1997 (US)
Approvals on record
3 in 1 region
Holder of the most recent approval
Sanofi; 3 holders in all
Registered trials
37, 0 stopped early
Disease areas
Infections; Animal diseases; Digestive system; Immune system; Blood and lymph; Cancer

US protection

US protection ended in 2009.

US protection ended in 2009, 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 Bavarian Nordic. 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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Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated8600
Phase 14400
Phase 211730
Phase 310730
Phase 44300
All trials37

Who has held its approvals

CompanyRoleYears
GSKEarlier holder1997 to now
Emergent BiosolutionsLater holder1998 to now
SanofiLater holder and Lead sponsor of trials2000 to now
Bavarian NordicAcquired holder2021 to now