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LUMAKRAS

NDA

SOTORASIB | N214665 | AMGEN INC

3 strengths6 unique patents5 unique exclusivities

Patent Timeline

6 unique patents, 5 exclusivities by expiration date

Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

Today

May. 21, 2038

May. 20, 2040

Sep. 15, 2040

May. 20, 2040

Nov. 18, 2039

May. 20, 2040

NCE

May. 28, 2026

I-962

Jan. 16, 2028

ODE-352

May. 28, 2028

ODE*

May. 28, 2028

ODE-507

Jan. 16, 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

6 trials from ClinicalTrials.gov — 4 recruiting, 1 active, 1 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Phase II Study of Neoadjuvant Sotorasib in Combination With Cisplatin or Carboplatin and Pemetrexed for Surgically Resectable Stage IIA-IIIB Non-Squamous Non-Small Cell Lung Cancer With a KRAS p.G12C Mutation NCT05118854	Phase 2	Active	M.D. Anderson Cancer Center	13	2022-03-30 → 2027-10-20
Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation NCT06252649	Phase 3	Recruiting	Amgen	450	2024-07-17 → 2032-04-25
A Phase I Study of BAY3498264 Given Together With Sotorasib in Participants Who Have Advanced Solid Cancers With Specific Genetic Changes Called KRASG12C Mutation NCT06659341	Phase 1	Recruiting	Bayer	104	2024-11-08 → 2027-06-15
Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial NCT05564377	Phase 2	Recruiting	National Cancer Institute (NCI)	2,900	2023-04-07 → 2030-07-01
Sotorasib in Combination With Trastuzumab Deruxtecan for the Treatment of Locally Advanced and Metastatic Non-small Cell Lung Cancer With a KRAS G12C Mutation NCT07012031	Phase 1/2	Recruiting	National Cancer Institute (NCI)	37	2026-06-17 → 2027-06-14
A Phase 1/2, Study Evaluating the Safety, Tolerability, PK, and Efficacy of Sotorasib (AMG 510) in Subjects With Solid Tumors With a Specific KRAS Mutation (CodeBreaK 100)NCT03600883	Phase 1/2	Completed	Amgen	713	2018-08-27 → 2026-05-29

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

Medicare Part D Spending

CMS annual spending data for Lumakras (2023)

Total Spending

$140.2M

Total Claims

7,447

Beneficiaries

1,527

Avg Cost/Unit

$111.46

Spending Trend

$35.8M(2021)→$123.6M(2022)→$140.2M(2023)

YoY Change:+34.9%

5yr CAGR:+19.7%

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

API Supply Chain2 active DMFs

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

TAPI NL BVSOTORASIB

DMF 400382025

HETERO LABS LTDSOTORASIB (FORM-III)

DMF 412702025

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Feb 24, 2025	SUPPL -9	View Letter (PDF)
Oct 1, 2024	SUPPL -12	View Letter (PDF)
Apr 25, 2023	SUPPL -4	View Letter (PDF)
Mar 20, 2023	SUPPL -7	View Letter (PDF)
Jan 23, 2023	SUPPL -3	View Letter (PDF)
Nov 22, 2022	SUPPL -2	View Letter (PDF)
Jun 1, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — 120MG

RLD

6 patents4 exclusivities▴

TABLET;ORAL | Approved: May 28, 2021

Patents (6)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
10519146	May 21, 2038	—	Yes	Yes	—	—
11236091	May 20, 2040	—	Yes	Yes		—
11426404	Sep 15, 2040	—	—	—		—
11827635	May 20, 2040	—	Yes	Yes		—
12280056	Nov 18, 2039	—	—	—		—
12398133	May 20, 2040	—	Yes	Yes		—

Exclusivities (4)

Code	Date	Status
I-962	Jan 16, 2028	Active
NCE	May 28, 2026	Expired
ODE-352	May 28, 2028	Active
ODE-507	Jan 16, 2032	Active

#002 — 320MG

RLD

6 patents4 exclusivities▾

TABLET;ORAL | Approved: Jan 20, 2023

#003 — 240MG

RLD

6 patents4 exclusivities▾

TABLET;ORAL | Approved: Jun 26, 2024