Adagrasib - Generic Drug Details

What are the generic drug sources for adagrasib and what is the scope of patent protection?

Adagrasib is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Adagrasib has forty patent family members in thirty-one countries.

One supplier is listed for this compound.

Summary for adagrasib

International Patents:	40
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	20
Patent Applications:	41
What excipients (inactive ingredients) are in adagrasib?	adagrasib excipients list
DailyMed Link:	adagrasib at DailyMed

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

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULT PATIENTS WITH KRAS G12C-MUTATED LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC), AS DETERMINED BY AN FDA-APPROVED TEST, WHO HAVE RECEIVED AT LEAST ONE PRIOR SYSTEMIC THERAPY

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 adagrasib

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

Sponsor	Phase
Incyte Corporation	Phase 1
Bristol-Myers Squibb	Phase 1/Phase 2
AstraZeneca	Phase 1

See all adagrasib clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for adagrasib

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

US Patents and Regulatory Information for adagrasib

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes			Y	Y
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes

International Patents for adagrasib

Country	Patent Number	Title	Estimated Expiration
European Patent Office	3880208
Canada	3082579
Croatia	P20230377
Taiwan	201938555
Finland	3710439
South Korea	20200100632

Supplementary Protection Certificates for adagrasib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3710439	LUC00350	Luxembourg		PRODUCT NAME: ADAGRASIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/23/1744 20240109
3710439	2024C/525	Belgium		PRODUCT NAME: ADAGRASIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/23/1744 20240109
3710439	301279	Netherlands		PRODUCT NAME: ADAGRASIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1744 20240109
3710439	CR 2024 00024	Denmark		PRODUCT NAME: ADAGRASIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1744 20240109
3710439	PA2024517	Lithuania		PRODUCT NAME: ADAGRASIBAS ARBA FARMACINIU POZIURIU PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/23/1744 20240105
3710439	122024000035	Germany		PRODUCT NAME: ADAGRASIB ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/23/1744 20240105

Adagrasib Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Adagrasib

Introduction to Adagrasib

Adagrasib, a targeted therapy medication, has been making significant waves in the cancer treatment landscape by inhibiting the KRAS G12C mutant protein. This protein is commonly associated with various types of cancer, including non-small cell lung cancer (NSCLC) and colorectal cancer. Here, we delve into the market dynamics and financial trajectory of adagrasib.

Market Overview

The adagrasib market is projected to grow at a compound annual growth rate (CAGR) of a significant percentage from 2024 to 2034, reaching a substantial market size by the end of the forecast period[1].

Regional Market Performance

• North America: This region dominates the adagrasib market, accounting for more than 47% of the revenue. The high frequency of KRAS G12C mutations in NSCLC patients, particularly in the United States and Canada, coupled with FDA approval, has accelerated the adoption of adagrasib in this region[1].
• Europe: Europe is the second-largest market, driven by increased awareness of precision medicine, favorable government initiatives, and the presence of major pharmaceutical companies. Collaborations between academic institutions and pharmaceutical companies further bolster research activities in this region[1].
• Asia Pacific: This region is expected to be the fastest-growing segment during the forecast period, fueled by a large population base, rising cancer incidence, improved healthcare infrastructure, and increased investments in biotechnology and pharmaceutical sectors[1].

Key Market Players

The adagrasib market is primarily dominated by a few large companies:

• Mirati Therapeutics: A commercial-stage biotechnology company that has been at the forefront of adagrasib development. Mirati Therapeutics has reported significant financial and clinical updates, including ongoing Phase 3 clinical studies like KRYSTAL-12[2].
• Amgen: Another major player in the KRAS inhibitor market, although specific details on their adagrasib-related activities are less prominent compared to Mirati Therapeutics.

Market Drivers

Several factors are driving the growth of the adagrasib market:

• Increasing Incidence of Cancer: The rising incidence of cancers with KRAS G12C mutations, particularly NSCLC, is a key driver. The United States alone accounts for approximately 46% of all KRAS mutation cases in NSCLC among the 7 major markets (7MM)[4].
• Advancements in Precision Medicine: Growing awareness and access to precision medicine are enhancing the adoption of targeted therapies like adagrasib.
• Government Initiatives and Research Collaborations: Favorable government initiatives and collaborations between academic institutions and pharmaceutical companies are fostering research and development in this area[1].

Market Restraints

Despite the positive outlook, there are several challenges:

• Competition: The KRAS inhibitor market is becoming increasingly competitive, with other therapies like LUMAKRAS (sotorasib) also vying for market share[4].
• High Development Costs: The development of targeted therapies is costly, which can be a barrier to entry for new players and a financial strain on existing ones[2][3].

Financial Performance and Projections

Revenue and Market Size

The adagrasib market was valued at USD XX Million in 2024 and is expected to grow significantly by 2034. Mirati Therapeutics, for instance, reported net product revenue of $13.4 million and $19.7 million for the three and six months ended June 30, 2023, respectively, indicating a growing commercial presence[2].

Research and Development Expenses

Companies like Mirati Therapeutics and Kura Oncology are investing heavily in research and development. Mirati Therapeutics reported R&D expenses of $124.2 million and $250.9 million for the three and six months ended June 30, 2023, respectively. Kura Oncology also reported significant R&D expenses of $39.7 million in Q2 2024, highlighting the ongoing investment in clinical trials and pipeline development[2][3].

Cash Position and Funding

Mirati Therapeutics had cash, cash equivalents, and short-term investments of approximately $779.4 million as of June 30, 2023. Kura Oncology reported a strong cash position of $491.5 million, providing a runway into 2027. These financial resources are crucial for sustaining the costly process of drug development and clinical trials[2][3].

Clinical Trials and Pipeline Updates

• KRYSTAL-12 Trial: Mirati Therapeutics is enrolling patients in the KRYSTAL-12 Phase 3 clinical study, comparing adagrasib to docetaxel in second-line NSCLC patients[2].
• Combination Studies: Kura Oncology has initiated a study combining KO-2806 with adagrasib in KRAS G12C-mutated NSCLC, supported by a clinical collaboration and supply agreement with Mirati Therapeutics (now part of Bristol Myers Squibb)[3].

Impact of External Factors

COVID-19 Pandemic

The COVID-19 pandemic has had a mixed impact on the adagrasib market. While it presented challenges in terms of clinical trial enrollment and supply chain disruptions, it also accelerated the adoption of telemedicine and remote patient monitoring, which could benefit long-term market growth[1].

Economic Downturn

Economic downturns can affect healthcare spending and research investments. However, the critical nature of cancer treatment and the potential of adagrasib to address unmet medical needs may mitigate some of these effects[1].

Porter’s Five Forces Analysis

• Bargaining Power of Suppliers: Moderate to high due to the specialized nature of the ingredients and services required for targeted therapies.
• Bargaining Power of Buyers: Moderate, as patients and healthcare providers have some flexibility in choosing treatments but are also constrained by regulatory approvals and insurance coverage.
• Threat of Substitutes: High, given the competitive landscape of KRAS inhibitors.
• Threat of New Entrants: Moderate, due to the high barriers to entry in terms of research, development, and regulatory approvals.
• Competitive Rivalry: High, with multiple players vying for market share in the KRAS inhibitor space[1].

Key Takeaways

• The adagrasib market is poised for significant growth driven by increasing cancer incidence, advancements in precision medicine, and favorable government initiatives.
• Major players like Mirati Therapeutics and Amgen are driving the market forward with substantial investments in R&D.
• Clinical trials, such as the KRYSTAL-12 study, and combination studies with other therapies are key to the future success of adagrasib.
• Financial stability, as evidenced by the cash positions of key players, is crucial for sustaining long-term market growth.

FAQs

What is Adagrasib and How Does it Work?

Adagrasib is a targeted therapy medication that blocks the KRAS G12C mutant protein, which is associated with various types of cancer. It works by preventing the mutant KRAS protein from acting, thereby slowing down or stopping the proliferation of cancer cells carrying this mutation.

Which Companies are Leading the Adagrasib Market?

The adagrasib market is primarily dominated by companies like Mirati Therapeutics and Amgen.

What are the Key Drivers of the Adagrasib Market?

Key drivers include the increasing incidence of cancers with KRAS G12C mutations, advancements in precision medicine, and favorable government initiatives.

What are the Major Challenges Facing the Adagrasib Market?

Challenges include competition from other KRAS inhibitors, high development costs, and the impact of external factors like economic downturns.

What is the Current Financial Status of Key Players in the Adagrasib Market?

Companies like Mirati Therapeutics and Kura Oncology have significant cash reserves, with Mirati Therapeutics holding approximately $779.4 million and Kura Oncology having $491.5 million as of their latest financial reports.

Cited Sources

1. We Market Research: Adagrasib Market Report | Size, Growth, Segmentation and Statistics[1].
2. PR Newswire: Mirati Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Updates[2].
3. Stock Titan: Kura Oncology Reports Second Quarter 2024 Financial Results[3].
4. GlobeNewswire: KRAS Inhibitors Market: New Treatments Are Set to Change Cancer Care[4].