SOTORASIB - Generic Drug Details

What are the generic drug sources for sotorasib and what is the scope of freedom to operate?

Sotorasib is the generic ingredient in one branded drug marketed by Amgen Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for SOTORASIB

International Patents:	118
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	33
Patent Applications:	68
What excipients (inactive ingredients) are in SOTORASIB?	SOTORASIB excipients list
DailyMed Link:	SOTORASIB at DailyMed

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

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 SOTORASIB

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

Sponsor	Phase
NYU Langone Health	Phase 2
Eisai Inc.	Phase 2
ETOP IBCSG Partners Foundation	Phase 2

See all SOTORASIB clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for SOTORASIB

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for SOTORASIB

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
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes			Y	Y
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No			Y	Y
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No			Y	Y

EU/EMA Drug Approvals for SOTORASIB

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 SOTORASIB

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

SOTORASIB Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sotorasib (Lumakras)

Introduction to Sotorasib (Lumakras)

Sotorasib, marketed as Lumakras, is a groundbreaking prescription drug designed to treat adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery. It specifically targets tumors with the abnormal KRAS G12C gene, a mutation common in NSCLC[1].

Market Drivers

The growth of the sotorasib market is driven by several key factors:

• Increasing Prevalence of Cancer: The rising number of cancer cases, particularly NSCLC, has created an unmet need for innovative and effective treatments. Sotorasib fills this gap by offering a targeted therapy for patients with the KRAS G12C mutation[1].
• Limitations of Traditional Treatments: Sotorasib overcomes the limitations of traditional cancer treatments by providing a more targeted approach, reducing the side effects associated with broader-spectrum therapies[1].
• Government and Pharmaceutical Support: Preferential reimbursement policies and increased investment in cancer research by governments and pharmaceutical companies are expected to boost the market. These policies help reduce the economic burden on patients, making advanced treatments more accessible[1].

Market Segmentation

The sotorasib market is segmented in several ways:

• By Dose: The market is divided into 960 mg, 480 mg, and 240 mg doses, catering to different patient needs and treatment protocols[1].
• By Application: The drug is used in various healthcare settings, including hospitals, drug centers, clinics, and others[1].
• By Geography: The market is segmented into North America, Europe, Asia-Pacific, and the Rest of the World. North America, particularly the United States, holds a significant share due to the high prevalence of NSCLC and the presence of large pharmaceutical companies[1].

Geographical Performance

North America

North America dominates the sotorasib market, driven by the high incidence of NSCLC and the active participation of major pharmaceutical companies in marketing and research activities. The U.S. is a key market within this region[1].

Asia-Pacific

The Asia-Pacific region is expected to show steady growth due to the increasing number of lung cancer cases. Approximately 59% of the world’s lung cancer cases occur in Asia, and there is a growing demand for advanced treatment options in this region[1].

Financial Performance

Sales Growth

Sotorasib has demonstrated strong sales growth. In the third quarter of 2024, sales of Lumakras increased by 88% year-over-year to $98 million, driven by volume growth and favorable market conditions[2].

Revenue Projections

The global KRAS inhibitors market, which includes sotorasib, is projected to surpass $4 billion by 2028. Sotorasib itself is forecasted to achieve significant revenue, with sales expected to reach around $1 billion by 2028[4].

Market Impact

The introduction of sotorasib has transformed the lung cancer treatment landscape. In the first quarter of 2022, the drug saw a 38% increase in sales from the previous quarter, valued at around $62 million. It has been prescribed to over 2,500 patients by more than 1,500 physicians, indicating strong adoption rates[4].

Clinical and Commercial Challenges

Despite its success, sotorasib faces some challenges:

• Side Effects: The drug is associated with side effects such as diarrhea, vomiting, and nausea, which can limit market growth to some extent[1].
• Competition: The entry of other KRAS inhibitors, such as adagrasib developed by Mirati Therapeutics, is expected to impact sotorasib's sales. However, the robust research and development in this domain are likely to sustain market growth[4].

Future Opportunities

Several factors point to lucrative opportunities for sotorasib in the future:

• Combined Therapies: Researchers are evaluating the combined use of sotorasib with other immunotherapy drugs, which could expand its therapeutic applications[1].
• Other Solid Tumors: The potential use of sotorasib in treating other solid tumors is being explored, further broadening its market potential[1].
• Collaborations: Collaborations, such as the one between Boehringer Ingelheim and Amgen to evaluate the combination of BI 1701963 and sotorasib, are expected to drive innovation and growth[1].

Financial Highlights from Amgen

Amgen, the company behind sotorasib, reported significant financial growth in the third quarter of 2024:

• Total Revenues: Increased by 23% to $8.5 billion, driven by a 24% growth in product sales and a 29% volume growth[2].
• GAAP EPS: Increased by 62% to $5.22, reflecting strong business momentum[2].
• Free Cash Flow: Increased to $3.3 billion, driven by business performance and working capital items[2].

Key Takeaways

• Sotorasib is a critical drug in the treatment of NSCLC with the KRAS G12C mutation.
• The market is driven by increasing cancer cases, government support, and pharmaceutical investments.
• North America dominates the market, but Asia-Pacific is expected to show significant growth.
• Despite side effects and competition, sotorasib's sales are strong, with projections indicating continued growth.
• Future opportunities include combined therapies and expanded use in other solid tumors.

FAQs

What is sotorasib used for?

Sotorasib is used to treat adult patients with non-small cell lung cancer (NSCLC) that has spread to other parts of the body or cannot be removed by surgery, specifically those with the KRAS G12C gene mutation[1].

How is the sotorasib market segmented?

The market is segmented by dose (960 mg, 480 mg, and 240 mg), application (hospitals, drug centers, clinics, and others), and geography (North America, Europe, Asia-Pacific, and the Rest of the World)[1].

What are the key drivers of the sotorasib market?

Key drivers include the increasing prevalence of cancer, the limitations of traditional treatments, and government and pharmaceutical support for preferential reimbursement policies and research investments[1].

How has sotorasib performed financially?

In the third quarter of 2024, sotorasib sales increased by 88% year-over-year to $98 million. The global KRAS inhibitors market, including sotorasib, is projected to surpass $4 billion by 2028[2][4].

What challenges does sotorasib face?

Sotorasib faces challenges such as side effects like diarrhea, vomiting, and nausea, and competition from other KRAS inhibitors. However, ongoing research and development are expected to sustain market growth[1][4].

What are the future opportunities for sotorasib?

Future opportunities include the combined use with other immunotherapy drugs and potential use in treating other solid tumors. Collaborations between pharmaceutical companies are also expected to drive innovation and growth[1].

Sources

1. Nextmsc.com: Lumakras (Sotorasib) Market Analysis Report | 2030
2. Stocktitan.net: AMGEN REPORTS THIRD QUARTER 2024 FINANCIAL RESULTS
3. Bluematterconsulting.com: Oncology Market Outlook for 2024
4. Globenewswire.com: KRAS G12C Inhibitor Lumakras Sotorasib Drug Sales Forecast
5. ScienceDirect.com: Positive advanced NSCLC patients previously treated with immune ...