CERITINIB — Competitive Intelligence Brief

CERITINIB (CERITINIB) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Kinase Inhibitor [EPC].

marketed Kinase Inhibitor [EPC] ALK, IGF-1R, InsR, ROS1 Small molecule

Target snapshot

CERITINIB (CERITINIB). Ceritinib inhibits ALK, IGF-1R, InsR, and ROS1 kinases, particularly effective against ALK, blocking its autophosphorylation and downstream signaling.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
CERITINIB TARGET	CERITINIB		marketed	Kinase Inhibitor [EPC]	ALK, IGF-1R, InsR, ROS1	2014-01-01
Wayrilz	RILZABRUTINIB	Genzyme Corp	marketed	Kinase Inhibitor [EPC]		2025-01-01
Hernexeos	ZONGERTINIB	Boehringer Ingelheim	marketed	Kinase Inhibitor [EPC]		2025-01-01
Romvimza	VIMSELTINIB	Deciphera Pharms	marketed	Kinase Inhibitor [EPC]		2025-01-01
Itovebi	INAVOLISIB	Genentech Inc	marketed	Kinase Inhibitor [EPC]		2025-01-01
LAZERTINIB	LAZERTINIB		marketed	Kinase Inhibitor [EPC]		2024-01-01
Itovebi	inavolisib	Pfizer	marketed	Kinase Inhibitor [EPC]	phosphatidylinositol 3-kinase (PI3K) alpha (PIK3CA)	2024-01-01

Recent regulatory actions (last 90 days)

• 2026-02-26 — Hernexeos · FDA · approved · US · Boehringer Ingelheim

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Kinase Inhibitor [EPC] class)

1. · 12 drugs in this class
2. Pfizer · 7 drugs in this class
3. Novartis · 3 drugs in this class
4. Bayer · 2 drugs in this class
5. Boehringer Ingelheim · 2 drugs in this class
6. AstraZeneca · 2 drugs in this class
7. Beigene Usa Inc · 1 drug in this class
8. BeiGene · 1 drug in this class
9. AbbVie · 1 drug in this class
10. Bristol · 1 drug in this class