Drug

Trastuzumab emtansine

As of the edition of 20 October 2026, Trastuzumab emtansine is an antibody drug conjugate: marketed, first approved in 2013 (US); acts on ERBB2, TUBB and TUBB1 and 7 more; US protection ended in 2025.

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

The drug

Status: Marketed; latest approval 2013
Kind: Antibody drug conjugate
Brand name: Kadcyla
First approved: 22 February 2013 (US)
Approvals on record: 7 in 4 regions
Holder of the most recent approval: Roche; 4 holders in all
Registered trials: 115, 21 stopped early
Disease areas: Cancer; Skin and connective tissue; Digestive system; Urinary and reproductive; Lungs and airways; Pregnancy and women's health

US protection

US protection ended in 2025.

US protection ended in 2025, 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 Roche. 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.

See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.

Targets

Gene	Protein	UniProt
TUBB4A	Tubulin beta-4A chain	P04350
ERBB2	Receptor tyrosine-protein kinase erbB-2	P04626
TUBB	Tubulin beta chain	P07437
TUBB4B	Tubulin beta-4B chain	P68371
TUBB3	Tubulin beta-3 chain	Q13509
TUBB2A	Tubulin beta-2A chain	Q13885
TUBB8	Tubulin beta-8 chain	Q3ZCM7
TUBB6	Tubulin beta-6 chain	Q9BUF5
TUBB2B	Tubulin beta-2B chain	Q9BVA1
TUBB1	Tubulin beta-1 chain	Q9H4B7

Gene

Protein

UniProt

TUBB4A

Tubulin beta-4A chain

P04350

ERBB2

Receptor tyrosine-protein kinase erbB-2

P04626

TUBB

Tubulin beta chain

P07437