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KOSELUGO

NDA

SELUMETINIB SULFATE | N219943 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths4 unique patents3 unique exclusivities

Patent Timeline

4 unique patents, 3 exclusivities by expiration date

Expired (1)Expiring < 1yr (2)Active (1)TodayExclusivity

2027

2028

2029

Today

Mar. 13, 2028

Mar. 13, 2026

Dec. 12, 2026

Dec. 12, 2026

ODE*

Apr. 10, 2027

Sep. 10, 2028

NPP

Nov. 19, 2028

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDSELUMETINIB SULFATE

DMF 414922025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 27, 2026	SUPPL -3	View Letter (PDF)
Nov 21, 2025	SUPPL -2	View Letter (PDF)
Sep 17, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 5MG BASE

RLD

4 patents3 exclusivities▴

GRANULE;ORAL | Approved: Sep 10, 2025

Patents (4)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7425637	Mar 13, 2028	—	Yes	—	—	—
8178693	Mar 13, 2026	—	Yes	Yes	—	—
9156795	Dec 12, 2026	—	Yes	Yes	—	—
9562017	Dec 12, 2026	—	Yes	—		—

Exclusivities (3)

Code	Date	Status
NP	Sep 10, 2028	Active
NPP	Nov 19, 2028	Active
ODE*	Apr 10, 2027	< 1 year

#002 — EQ 7.5MG BASE

RLD

4 patents3 exclusivities▾

GRANULE;ORAL | Approved: Sep 10, 2025

Change History (2)

Recent changes detected for this application.

MODIFIEDrs7/1/2026

AstraZeneca's KOSELUGO (selumetinib sulfate) received rare pediatric disease designation, triggering potential pediatric exclusivity eligibility.

Old: No

New: Yes

MODIFIEDrs7/1/2026

AstraZeneca's KOSELUGO (selumetinib sulfate) lost its rare-disease designation status in NDA 219943.

Old: Yes

New: No