Viewing data from:

KOSELUGO

NDA

SELUMETINIB SULFATE | N213756 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths8 unique patents3 unique exclusivities

Patent Timeline

8 unique patents, 3 exclusivities by expiration date

Expired (1)Expiring < 1yr (2)Active (5)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

Today

Mar. 13, 2028

Mar. 13, 2026

Dec. 12, 2026

Dec. 12, 2026

Mar. 26, 2029

Mar. 26, 2029

Mar. 26, 2029

Mar. 26, 2029

ODE-288

Apr. 10, 2027

NPP

Sep. 10, 2028

ODE-545

Nov. 19, 2032

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

1 trial from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Use of the Combination of Selumetinib and Olaparib or Selumetinib Alone Targeted Treatment for RAS Pathway Mutant Recurrent or Persistent Ovarian and Endometrial Cancers, A ComboMATCH Treatment Trial NCT05554328	Phase 2	Recruiting	National Cancer Institute (NCI)	165	2023-04-25 → 2028-10-01

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Medicare Part D Spending

CMS annual spending data for Koselugo (2023)

Total Spending

$14.9M

Total Claims

776

Beneficiaries

Avg Cost/Unit

$179.64

Spending Trend

$3.5M(2020)→$8.5M(2021)→$10.0M(2022)→$14.9M(2023)

YoY Change:+13.4%

5yr CAGR:+7.9%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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

6 letters from Drugs@FDA

Date	Submission	Document
May 27, 2026	SUPPL -7	View Letter (PDF)
Nov 21, 2025	SUPPL -6	View Letter (PDF)
Sep 17, 2025	SUPPL -5	View Letter (PDF)
Jan 25, 2024	SUPPL -4	View Letter (PDF)
Dec 23, 2021	SUPPL -3	View Letter (PDF)
Apr 13, 2020	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 10MG BASE

RLD

8 patents3 exclusivities▴

CAPSULE;ORAL | Approved: Apr 10, 2020

Patents (8)

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	—		—
11813246	Mar 26, 2029	—	—	Yes	—	—
12220403	Mar 26, 2029	—	—	Yes	—	—
12318367	Mar 26, 2029	—	—	Yes	—	—
12364684	Mar 26, 2029	—	—	—		—

Exclusivities (3)

Code	Date	Status
NPP	Sep 10, 2028	Active
ODE-288	Apr 10, 2027	< 1 year
ODE-545	Nov 19, 2032	Active

#002 — EQ 25MG BASE

RLD

8 patents3 exclusivities▾

CAPSULE;ORAL | Approved: Apr 10, 2020

Change History (3)

Recent changes detected for this application.

ADDED7/1/2026

AstraZeneca's KOSELUGO (selumetinib sulfate) gained orphan drug exclusivity designation for indication ODE-545, creating a seven-year regulatory exclusivity period from approval.

New: New record

ADDED7/1/2026

AstraZeneca's KOSELUGO (selumetinib sulfate) gained Orphan Drug exclusivity designation (ODE-545) for NDA 213756.

New: New record

MODIFIEDExclusivity Expiration7/1/2026

Old: Nov 19, 2028

New: Sep 10, 2028