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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

12 trials from ClinicalTrials.gov — 7 recruiting, 2 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Use of AMG 510 (Sotorasib) and Panitumumab as a Targeted Treatment for KRAS G12C Mutant Solid Tumor Cancers (A ComboMATCH Treatment Trial)NCT05638295	Phase 2	Active	National Cancer Institute (NCI)	105	2024-08-01 → 2028-12-31
A Study Evaluating the Efficacy and Safety of Divarasib Versus Sotorasib or Adagrasib in Participants With Previously Treated KRAS G12C-positive Advanced or Metastatic Non-Small Cell Lung Cancer NCT06497556	Phase 3	Active	Hoffmann-La Roche	338	2024-09-23 → 2029-11-30
CIMAvax-EGF With KRAS G12C Inhibitor for the Treatment of Advanced, KRAS G12C Mutated Non Small Cell Lung Cancer NCT07543172	Phase 2	Not Yet Recruiting	Roswell Park Cancer Institute	29	2026-10-15 → 2029-06-01
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
Pre-operative Targeted Treatments in Molecularly Selected Resectable Colorectal Cancer (UNICORN)NCT05845450	Phase 2	Recruiting	Gruppo Oncologico del Nord-Ovest	197	2023-05-11 → 2028-05
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 Study of Sotorasib in People With Non-Small Cell Lung Cancer NCT06582771	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center	39	2024-08-30 → 2027-08
A Rollover Study Evaluating Sotorasib With or Without Panitumumab in Participants With KRAS p.G12C Mutation NCT07172919	Phase 2	Recruiting	Amgen	14	2026-01-02 → 2028-07-01
A Study Evaluating Sotorasib Platinum Doublet Combination Versus Pembrolizumab Platinum Doublet Combination as a Front-Line Therapy in Participants With Stage IV or Advanced Stage IIIB/C Nonsquamous Non-Small Cell Lung Cancers (CodeBreaK 202)NCT05920356	Phase 3	Recruiting	Amgen	750	2023-11-16 → 2032-06-29
Expanded Access of Sotorasib NCT04667234	—	NO_LONGER_AVAILABLE	Amgen	—	—

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

VA Federal Supply Schedule

Government-negotiated contract prices | 6 NDCs (3 FSS, 3 Big4)

Lowest Price

$15481.99

Highest Price

$21421.66

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
55513-0488-24LUMAKRAS 120MG TAB	$15481.99	Big4	Amgen USA, Inc.	07/31/2026
55513-0488-24LUMAKRAS 120MG TAB	$20362.88	FSS	Amgen USA, Inc.	07/31/2026
55513-0504-50LUMAKRAS 320MG TAB	$15795.23	Big4	Amgen USA, Inc.	07/31/2026
55513-0504-50LUMAKRAS 320MG TAB	$20794.88	FSS	Amgen USA, Inc.	07/31/2026
55513-0512-60LUMAKRAS 240MG TAB	$16194.92	Big4	Amgen USA, Inc.	07/31/2026
55513-0512-60LUMAKRAS 240MG TAB	$21421.66	FSS	Amgen USA, Inc.	07/31/2026

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

Medicare Part D Spending

CMS annual spending data for Lumakras (2024)

Total Spending

$153.6M

Total Claims

8,675

Beneficiaries

1,563

Avg Cost/Unit

$146.16

Spending Trend

$35.8M(2021)→$123.6M(2022)→$140.2M(2023)→$153.6M(2024)

YoY Change:+31.1%

5yr CAGR:+23.4%

Source: CMS Medicare Part D Spending by Drug (2024). 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

10 patents4 exclusivities▴

TABLET;ORAL | Approved: May 28, 2021

Patents (10)

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

10 patents4 exclusivities▾

TABLET;ORAL | Approved: Jan 20, 2023

#003 — 240MG

RLD

10 patents4 exclusivities▾

TABLET;ORAL | Approved: Jun 26, 2024