Mobocertinib Succinate

Sold as Exkivity. Every FDA application for this active ingredient.

As of Nov 15, 2026, FDA lists 1 application for Mobocertinib Succinate (sold as Exkivity), first approved Sep 15, 2021, with 0 new uses approved and 0 published complete response letters.

First approved: Sep 15, 2021
Applications: 1
New uses approved: 0
Complete response letters: 0
Medicare spending, 2025: $0K

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name

Product	Part	Spending, 2025	Change	Beneficiaries
Exkivity	Part D	$0K	-100%	0

Orphan Designations (FDA)

One designation, 1 approved for the designated use; see all orphan designations

Treatment of non-small cell lung cancer with genetic alterations in EGFR including EGFR mutations and/or EGFR gene…Takeda Development Center Americas, Inc. · designated Dec 17, 2019 · approved Sep 15, 2021

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history

Approved	Application	Sponsor	Supplements	Marketing
Sep 15, 2021	ExkivityNDA 215310 · New molecular entity	Takeda Pharms USA	2	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA