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TEPMETKO

NDA

TEPOTINIB HYDROCHLORIDE | N214096 | EMD SERONO INC

1 strength8 unique patents2 unique exclusivities

Patent Timeline

8 unique patents, 2 exclusivities by expiration date

Active (8)TodayExclusivity

2026

2027

2028

2029

2030

Today

Oct. 30, 2029

Mar. 19, 2030

Jul. 4, 2028

May. 30, 2028

Jul. 21, 2028

Jul. 4, 2028

Apr. 29, 2028

Jul. 4, 2028

NCE

Feb. 3, 2026

ODE-325

Feb. 3, 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

Medicare Part D Spending

CMS annual spending data for Tepmetko (2023)

Total Spending

$22.5M

Total Claims

1,056

Beneficiaries

249

Avg Cost/Unit

$399.67

Spending Trend

$5.4M(2021)→$12.2M(2022)→$22.5M(2023)

YoY Change:+5.8%

5yr CAGR:+5.5%

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Feb 16, 2024	SUPPL -3	View Letter (PDF)
Mar 24, 2023	SUPPL -1	View Letter (PDF)
Mar 24, 2023	SUPPL -2	View Letter (PDF)
Feb 5, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 225MG BASE

RLD

8 patents2 exclusivities▴

TABLET;ORAL | Approved: Feb 3, 2021

Patents (8)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8329692	Oct 30, 2029	—	Yes	Yes	—	—
8580781	Mar 19, 2030	—	Yes	Yes	—	—
8658643	Jul 4, 2028	—	—	—		—
8921357	May 30, 2028	—	Yes	Yes	—	—
8927540	Jul 21, 2028	—	—	—		—
9062029	Jul 4, 2028	—	—	Yes	—	—
9284300	Apr 29, 2028	—	—	Yes	—	—
9403799	Jul 4, 2028	—	—	—		—

Exclusivities (2)

Code	Date	Status
NCE	Feb 3, 2026	Expired
ODE-325	Feb 3, 2028	Active