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LUMAKRAS Drug Patent Profile

When do Lumakras patents expire, and when can generic versions of Lumakras launch?

Lumakras is a drug marketed by Amgen Inc and is included in one NDA. There are four patents protecting this drug.

This drug has one hundred and eighteen patent family members in thirty-six countries.

The generic ingredient in LUMAKRAS is sotorasib. One supplier is listed for this compound. Additional details are available on the sotorasib profile page.

DrugPatentWatch^® Generic Entry Outlook for Lumakras

Lumakras will be eligible for patent challenges on May 28, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 20, 2040. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LUMAKRAS

International Patents:	118
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	4
Patent Applications:	34
Drug Prices:	Drug price information for LUMAKRAS
What excipients (inactive ingredients) are in LUMAKRAS?	LUMAKRAS excipients list
DailyMed Link:	LUMAKRAS at DailyMed

See drug prices for LUMAKRAS

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LUMAKRAS

Constraining patent/regulatory exclusivity:

11,236,091

NDA:

214665

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LUMAKRAS

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
Vitrac Therapeutics, LLC	Phase 1
Westat	Phase 1

See all LUMAKRAS clinical trials

US Patents and Regulatory Information for LUMAKRAS

LUMAKRAS is protected by four US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 11,236,091.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	11,426,404
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No	11,827,635		Y	Y
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	10,519,146		Y	Y
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No	11,426,404

EU/EMA Drug Approvals for LUMAKRAS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Amgen Europe BV	Lumykras	sotorasib	EMEA/H/C/005522 Lumykras as monotherapy is indicated for the treatment of adults with advanced non-small cell lung cancer (NSCLC) with KRAS G12C mutation and who have progressed after at least one prior line of systemic therapy.	Authorised	no	no	no	2022-01-06

International Patents for LUMAKRAS

When does loss-of-exclusivity occur for LUMAKRAS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

European Patent Office

Israel

Japan

Jordan

Mexico

Peru

Singapore

South Korea

Taiwan

Uruguay

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LUMAKRAS around the world.

Country	Patent Number	Title	Estimated Expiration
Chile	2021003064	Formas en estado sólido
Japan	7092935
Argentina	122787	INHIBIDORES DE KRAS G12C Y MÉTODOS PARA SU USO
Brazil	112021022812	Dosagem de inibidor de kras para tratamento de cânceres
South Korea	20220011670	고체 상태 형태
Chile	2019003394	Inhibidores de kras g12c y métodos para su uso.

LUMAKRAS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUMAKRAS (Sotorasib)

Introduction to LUMAKRAS

LUMAKRAS, also known as sotorasib, is a groundbreaking drug developed by Amgen, marking a significant milestone in cancer treatment as the first approved KRAS G12C inhibitor. Approved by the FDA in May 2021, LUMAKRAS is used to treat adults with non-small cell lung cancer (NSCLC) that has spread or cannot be removed by surgery, and whose tumor has the KRAS G12C mutation[4].

Mechanism of Action and Clinical Significance

LUMAKRAS works by inhibiting the KRAS G12C protein, a mutation that is present in approximately 13% of NSCLC cases. This mutation has long been considered "undruggable," making LUMAKRAS a revolutionary treatment option. Its mechanism of action involves binding to the KRAS G12C protein, preventing it from interacting with other proteins and thereby inhibiting tumor growth[4].

Market Opportunity and Growth

The global market for KRAS inhibitors, led by LUMAKRAS, is poised for substantial growth. By 2028, the global KRAS inhibitors market is expected to surpass $4 billion, with the U.S. dominating the market with over 70% share due to the high prevalence of NSCLC and robust research and development activities[1].

Sales Performance

In the first quarter of 2022, LUMAKRAS sales were valued at approximately $62 million, representing a 38% increase from the previous quarter. This growth is attributed to its increasing adoption, with around 2,500 patients prescribed the drug by over 1,500 physicians in the first quarter of 2022[1].

As of the third quarter of 2024, LUMAKRAS sales have continued to rise, with an 88% year-over-year increase to $98 million, driven by volume growth and favorable changes in estimated sales deductions[2].

Clinical Trials and Pipeline

The KRAS inhibitor market is highly dynamic, with over 45 drugs currently in clinical trials. While LUMAKRAS is the only approved drug to date, other promising candidates like Adagrasib developed by Mirati Therapeutics are expected to gain approval in the near future. This robust pipeline ensures continued market growth despite potential competition[1].

Targeted Therapies and Solid Tumors

LUMAKRAS is primarily used in treating NSCLC but is also being evaluated for its efficacy in other solid tumors. Its high specificity and efficacy make it a favorable option for overcoming the limitations of conventional cancer therapies. Researchers are exploring its use in combination with other immunotherapeutic drugs, which is expected to further drive market growth[4].

Commercial Aspects

Dosage and Pricing

LUMAKRAS is administered as a once-daily oral prescription. The per-patient billing for LUMAKRAS is around $25,000, reflecting its high cost, which is a significant factor in the market dynamics[1].

Patent and Market Exclusivity

LUMAKRAS enjoys market exclusivity, which is crucial for its commercial success. However, the entry of other KRAS inhibitors in the market may impact its sales in the coming years. Despite this, the drug's unique mechanism and efficacy are expected to maintain its market position[1].

Regional Market Dominance

North America, particularly the U.S., is expected to dominate the global LUMAKRAS market due to the high prevalence of NSCLC and the presence of large pharmaceutical companies actively involved in research and development. This regional dominance is anticipated to continue in the foreseeable future[3][4].

Challenges and Limiting Factors

High Cost of Therapy

One of the major limiting factors for the growth of the LUMAKRAS market is the high cost of cancer therapy. This financial toxicity can restrict patient access to the drug. However, increasing initiatives by governments and pharmaceutical companies to develop favorable reimbursement policies are expected to help mitigate this issue[3][4].

Competition from Emerging Drugs

The entry of other KRAS inhibitors, such as Adagrasib, into the market could pose a competitive threat to LUMAKRAS. However, the robust research and development activities and the promising clinical pipeline of drugs are expected to sustain the growth of the KRAS inhibitors market[1].

Financial Projections

By 2026, the LUMAKRAS market is expected to surpass $1.5 billion, driven by its efficacy in managing NSCLC and its potential use in other solid tumors. The global KRAS inhibitors market is projected to reach over $4 billion by 2028, indicating a strong financial trajectory for LUMAKRAS and other KRAS inhibitors[1][3][4].

Key Takeaways

• Market Growth: The global KRAS inhibitors market, led by LUMAKRAS, is expected to reach over $4 billion by 2028.
• Sales Performance: LUMAKRAS sales have shown significant growth, with an 88% year-over-year increase in the third quarter of 2024.
• Clinical Significance: LUMAKRAS is the first approved KRAS G12C inhibitor, offering a new treatment option for NSCLC patients.
• Regional Dominance: North America, particularly the U.S., is expected to dominate the market due to high NSCLC prevalence and robust R&D activities.
• Challenges: High therapy costs and potential competition from emerging drugs are key challenges.

FAQs

Q: What is LUMAKRAS and how does it work?

A: LUMAKRAS (sotorasib) is a KRAS G12C inhibitor used to treat NSCLC. It works by binding to the KRAS G12C protein, preventing tumor growth.

Q: How much is the LUMAKRAS market expected to grow by 2028?

A: The global KRAS inhibitors market, led by LUMAKRAS, is expected to surpass $4 billion by 2028.

Q: What are the main challenges facing the LUMAKRAS market?

A: High therapy costs and potential competition from emerging KRAS inhibitors are the main challenges.

Q: In which regions is LUMAKRAS expected to dominate the market?

A: North America, particularly the U.S., is expected to dominate the global LUMAKRAS market.

Q: What is the current sales performance of LUMAKRAS?

A: As of the third quarter of 2024, LUMAKRAS sales have increased by 88% year-over-year to $98 million.

Sources

1. GlobeNewswire: "KRAS G12C Inhibitor Lumakras Sotorasib Drug Sales Forecast"
2. AMGEN: "AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS"
3. PR Newswire: "Global Lumakras Drug Clinical Insight & Sales Forecast Report"
4. Business Wire: "2021 Lumakras Drug Clinical Insight & Sales Forecast Market Report"