Viewing data from:

KOSELUGO

NDA

SELUMETINIB SULFATE | N213756 | ASTRAZENECA PHARMACEUTICALS LP

2 strengths8 unique patents4 unique exclusivities

Patent Timeline

8 unique patents, 4 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

NPP

Nov. 19, 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

59 trials from ClinicalTrials.gov — 3 recruiting, 10 active, 34 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
SAFIR02_Breast - Efficacy of Genome Analysis as a Therapeutic Decision Tool for Patients With Metastatic Breast Cancer NCT02299999	Phase 2	Active	UNICANCER	1,460	2014-04-07 → 2025-12
Maintenance With Olaparib or Selumetinib + Durvaluma for m-PDAC Guided by BRCAness and KRAS Status.NCT04348045	Phase 2	Active	GERCOR - Multidisciplinary Oncology Cooperative Group	307	2020-12-07 → 2025-12
Targeted Therapy Directed by Genetic Testing in Treating Pediatric Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphomas, or Histiocytic Disorders (The Pediatric MATCH Screening Trial)NCT03155620	Phase 2	Active	National Cancer Institute (NCI)	1,377	2017-07-31 → 2027-01-06
A Study of the Drugs Selumetinib Versus Carboplatin/Vincristine in Patients With Neurofibromatosis and Low-Grade Glioma NCT03871257	Phase 3	Active	National Cancer Institute (NCI)	165	2020-01-15 → 2027-12-31
A Study of Different Dosing Schedules of Selumetinib With Cisplatin/Gemcitabine (CIS/GEM) Versus CIS/GEM Alone in Biliary Cancer NCT02151084	Phase 2	Active	University Health Network, Toronto	57	2014-11 → 2027-09
Selumetinib and Olaparib in Solid Tumors NCT03162627	Phase 1	Active	M.D. Anderson Cancer Center	90	2017-08-04 → 2026-08-30
Assess Efficacy & Safety of Selumetinib in Combination With Docetaxel in Patients Receiving 2nd Line Treatment for v-Ki-ras2 Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) Positive NSCLC NCT01933932	Phase 3	Active	AstraZeneca	510	2013-09-25 → 2025-12-31
Cediranib Maleate and Selumetinib Sulfate in Treating Patients With Solid Malignancies NCT01364051	Phase 1	Active	National Cancer Institute (NCI)	19	2011-05-25 → 2027-03-31
MEK 1/2 Inhibitor Selumetinib (AZD6244 Hydrogen Sulfate) in Adults With Neurofibromatosis Type 1 (NF1) and Inoperable Plexiform Neurofibromas NCT02407405	Phase 2	Active	National Cancer Institute (NCI)	36	2016-01-07 → 2030-01-01
Phase 2 Platform Study in Patients With Advanced Non-Small Lung Cancer Who Progressed on First-Line Osimertinib Therapy (ORCHARD)NCT03944772	Phase 2	Active	AstraZeneca	247	2019-06-25 → 2025-05-06

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

VA Federal Supply Schedule

Government-negotiated contract prices | 8 NDCs (4 FSS, 4 Big4)

Lowest Price

$2044.13

Highest Price

$13100.98

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00310-0625-28KOSELUGO 25MG CAP	$6211.84	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-0625-28KOSELUGO 25MG CAP	$4952.12	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-0610-28KOSELUGO 10MG CAP	$2484.79	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-0610-28KOSELUGO 10MG CAP	$2044.13	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-0610-60KOSELUGO 10MG CAP	$5240.39	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-0610-60KOSELUGO 10MG CAP	$4326.95	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-0625-60KOSELUGO 25MG CAP	$13100.98	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-0625-60KOSELUGO 25MG CAP	$10808.71	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data across 2 drug listings matched to this application (2024)

Koselugo — Selumetinib Sulfate (2024)

Total Spending

$22.4M

Total Claims

1,175

Beneficiaries

157

Avg Cost/Unit

$182.85

Spending Trend

$3.5M(2020)→$8.5M(2021)→$10.0M(2022)→$14.9M(2023)→$22.4M(2024)

YoY Change:+1.8%

5yr CAGR:+6.3%

Koselugo — Selumetinib/Vitamin E Tpgs (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 (2024). Shows gross drug cost under Part D.

API Supply Chain3 active DMFs

3 active API suppliers hold Drug Master Files for this ingredient.

CHUNGHWA CHEMICAL SYNTHESIS AND BIOTECH CO LTDSELUMETINIB SULFATE

DMF 414922025

MSN LABORATORIES PRIVATE LTDSELUMETINIB SULFATE

DMF 438332026

ALIVUS LIFE SCIENCES LTDSELUMETINIB SULFATE

DMF 439362026

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 patents4 exclusivities▴

CAPSULE;ORAL | Approved: Apr 10, 2020

Patents (8) · 2 use codes

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 (4)

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

#002 — EQ 25MG BASE

RLD

8 patents4 exclusivities▾

CAPSULE;ORAL | Approved: Apr 10, 2020