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KRAZATI Drug Patent Profile

When do Krazati patents expire, and what generic alternatives are available?

Krazati is a drug marketed by Bristol and is included in one NDA. There is one patent protecting this drug.

This drug has forty patent family members in thirty-one countries.

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

DrugPatentWatch^® Generic Entry Outlook for Krazati

Krazati will be eligible for patent challenges on December 12, 2026. 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 December 12, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for KRAZATI

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	4
Patent Applications:	31
Drug Prices:	Drug price information for KRAZATI
What excipients (inactive ingredients) are in KRAZATI?	KRAZATI excipients list
DailyMed Link:	KRAZATI at DailyMed

See drug prices for KRAZATI

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

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

NDA:

216340

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 KRAZATI

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

Sponsor	Phase
Incyte Corporation	Phase 1
Kura Oncology, Inc.	Phase 1
Mirati Therapeutics Inc.	Phase 1

See all KRAZATI clinical trials

US Patents and Regulatory Information for KRAZATI

KRAZATI is protected by two US patents and two FDA Regulatory Exclusivities.

This potential generic entry date is based on 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.

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
Bristol	KRAZATI	adagrasib	TABLET;ORAL	216340-001	Dec 12, 2022		RX	Yes	Yes	10,689,377		Y	Y
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

International Patents for KRAZATI

When does loss-of-exclusivity occur for KRAZATI?

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

Australia

Brazil

Canada

Chile

China

Colombia

Croatia

Denmark

Eurasian Patent Organization

European Patent Office

Finland

France

Hungary

Israel

Japan

Lithuania

Mexico

Netherlands

Philippines

Poland

Portugal

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Ukraine

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 KRAZATI around the world.

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

Supplementary Protection Certificates for KRAZATI

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

KRAZATI Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for KRAZATI

Introduction to KRAZATI

KRAZATI (adagrasib), developed by Mirati Therapeutics, is a groundbreaking small-molecule KRAS G12C inhibitor that has revolutionized the treatment of non-small cell lung cancer (NSCLC) and other solid tumors. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

FDA Approval and Market Entry

KRAZATI received accelerated approval from the U.S. Food and Drug Administration (FDA) in December 2022 for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic NSCLC who have received at least one prior systemic therapy[5].

Market Size and Growth Projections

The global market for KRAS-targeting therapies is expected to exceed $4 billion by 2029, with KRAZATI poised to be a significant player in this market. According to GlobalData, Mirati Therapeutics is anticipated to lead this market, with KRAZATI projected to secure a 30.7% market share and generate $1.2 billion in worldwide sales by 2029[1].

Revenue Performance

In its first full quarter on the market, KRAZATI generated $6.3 million in revenue, surpassing Wall Street expectations of $3.4 million. This strong start indicates a high level of interest and adoption among healthcare providers and patients[3].

For the three and six months ended June 30, 2023, KRAZATI's net product revenue was $13.4 million and $19.7 million, respectively. This revenue includes both commercial sales and sales to third-party commercial customers for clinical trials[2].

Competitive Landscape

KRAZATI competes primarily with Amgen's Lumakras, another KRAS G12C inhibitor. While Lumakras was the first to market, KRAZATI has quickly gained traction. In the first quarter of 2023, KRAZATI captured a third of new patient starts, and 80% of the top 50 targeted doctors prescribed KRAZATI. Some patients even switched from Lumakras due to liver toxicity issues or brain metastasis, further solidifying KRAZATI's position[3].

Clinical and Regulatory Milestones

The FDA approval of KRAZATI was based on the positive results from the Phase 2 registration-enabling cohort of the KRYSTAL-1 study, which demonstrated an objective response rate (ORR) of 43% and a disease control rate of 80% in patients with KRAS G12C-mutated advanced NSCLC[5].

In addition to its approval for NSCLC, KRAZATI is being explored in combination therapies. For instance, Mirati is conducting phase 3 trials pairing KRAZATI with Keytruda and chemotherapies, and also seeking accelerated approval for a combination of KRAZATI and Eli Lilly’s Erbitux in third-line colorectal cancer[3].

International Approvals and Expansion

KRAZATI has received conditional marketing authorization from the European Commission for the treatment of KRAS G12C-mutated advanced NSCLC. It has also been approved in Japan for treating KRAS G12C-mutated, unresectable, advanced, and/or recurrent NSCLC[4].

Financial Performance and Outlook

Mirati Therapeutics reported a net loss of $176.9 million for the three months ended June 30, 2023, and $361.5 million for the six months ended June 30, 2023. However, the company's cash, cash equivalents, and short-term investments stood at approximately $779.4 million as of June 30, 2023, indicating a robust financial position to support ongoing research and commercial activities[2].

The company expects a net cash burn of $560 million to $580 million for 2023, which is manageable given its current financial resources.

Cost Structure and Expenses

The cost of product revenue for KRAZATI includes manufacturing and distribution costs, royalties, and non-cash amortization expenses. For the three and six months ended June 30, 2023, these costs were $1.3 million and $2.1 million, respectively[2].

Selling, general, and administrative expenses increased due to higher headcount-related costs and commercial-related expenses to support the marketing and sales of KRAZATI. These expenses were $75.5 million and $149.0 million for the three and six months ended June 30, 2023, respectively[2].

Future Prospects and Combination Therapies

KRAZATI's future prospects are promising, with ongoing and planned combination studies in KRAS G12C-mutated solid tumors. The addition of chemotherapies to the KRAZATI and Keytruda regimen is expected to enhance efficacy, although it faces a high bar set by previous trials like KEYNOTE-189[3].

Key Takeaways

• Market Leadership: KRAZATI is projected to lead the KRAS-targeting therapy market with a 30.7% market share by 2029.
• Revenue Growth: Strong revenue performance in its initial quarters, exceeding market expectations.
• Competitive Edge: Gaining traction over competitors like Lumakras due to its safety profile and efficacy.
• Global Expansion: Approved in the U.S., Europe, and Japan, with ongoing efforts for further international approvals.
• Financial Stability: Robust cash reserves to support ongoing research and commercial activities.

FAQs

1. What is KRAZATI and how is it used? KRAZATI (adagrasib) is a small-molecule KRAS G12C inhibitor used for the treatment of adult patients with KRAS G12C-mutated locally advanced or metastatic non-small cell lung cancer (NSCLC) who have received at least one prior systemic therapy.

2. Who developed KRAZATI? KRAZATI was developed by Mirati Therapeutics.

3. What are the key financial projections for KRAZATI? KRAZATI is projected to generate $1.2 billion in worldwide sales by 2029, securing a 30.7% market share in the KRAS-targeting therapy market.

4. How does KRAZATI compare to its competitors? KRAZATI has gained significant traction over its primary competitor, Amgen's Lumakras, due to its safety profile and efficacy, particularly in patients with brain metastasis or those experiencing liver toxicity with Lumakras.

5. What are the ongoing and future clinical trials for KRAZATI? KRAZATI is being explored in combination therapies, including phase 3 trials pairing it with Keytruda and chemotherapies, and a combination with Eli Lilly’s Erbitux in third-line colorectal cancer.

Sources

1. GlobalData: "Oncology KRAS-targeting therapy market to exceed $4 billion by 2029"[1]
2. Mirati Therapeutics: "Mirati Therapeutics Reports Second Quarter 2023 Financial Results and Recent Corporate Updates"[2]
3. FiercePharma: "Mirati's KRAS drug Krazati beat estimates in first full quarter, Keytruda combo strategy remains unclear"[3]
4. GlobeNewswire: "KRAS Inhibitors Market: New Treatments Are Set to Change Cancer Care"[4]
5. PR Newswire: "Mirati Therapeutics Announces U.S. FDA Accelerated Approval of KRAZATI (adagrasib) as a Targeted Treatment Option for Patients with Locally Advanced or Metastatic Non-Small Cell Lung Cancer (NSCLC) with a KRAS G12C Mutation"[5]