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KRAZATI Drug Patent Profile

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

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

This drug has thirty-four patent family members in twenty-eight 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

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Summary for KRAZATI

International Patents:	34
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	38
Clinical Trials:	2
Patent Applications:	20
Drug Prices:	Drug price information for KRAZATI
What excipients (inactive ingredients) are in KRAZATI?	KRAZATI excipients list
DailyMed Link:	KRAZATI at DailyMed

Drug patent expirations by year for KRAZATI

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

Generic Entry Date for KRAZATI^: ⤷ Try a Trial* 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
Aadi Bioscience, Inc.	Phase 1/Phase 2
Mirati Therapeutics Inc.	Phase 1/Phase 2
Mirati Therapeutics Inc.	Phase 2

See all KRAZATI clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for KRAZATI

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

US Patents and Regulatory Information for KRAZATI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of KRAZATI is ⤷ Try a Trial.

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.

Patents protecting KRAZATI

KRas G12C inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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

FDA Regulatory Exclusivity protecting KRAZATI

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial

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
Exclusivity Expiration: ⤷ Try a Trial

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Glossary

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

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

Patent: 18369759
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2020009818
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 82579
Estimated Expiration: ⤷ Try a Trial

Chile

Patent: 20001271
Estimated Expiration: ⤷ Try a Trial

China

Patent: 1989321
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 20007244
Estimated Expiration: ⤷ Try a Trial

Croatia

Patent: 0230377
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 10439
Estimated Expiration: ⤷ Try a Trial

Eurasian Patent Organization

Patent: 2091186
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 10439
Estimated Expiration: ⤷ Try a Trial

Patent: 80208
Estimated Expiration: ⤷ Try a Trial

Finland

Patent: 10439
Estimated Expiration: ⤷ Try a Trial

Hungary

Patent: 61599
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 4601
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 22019
Estimated Expiration: ⤷ Try a Trial

Patent: 46565
Estimated Expiration: ⤷ Try a Trial

Patent: 21502993
Estimated Expiration: ⤷ Try a Trial

Patent: 22508108
Estimated Expiration: ⤷ Try a Trial

Lithuania

Patent: 10439
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 20005063
Estimated Expiration: ⤷ Try a Trial

Philippines

Patent: 020550622
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 10439
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 10439
Estimated Expiration: ⤷ Try a Trial

Serbia

Patent: 182
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 202004427T
Estimated Expiration: ⤷ Try a Trial

Slovenia

Patent: 10439
Estimated Expiration: ⤷ Try a Trial

South Africa

Patent: 2002105
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 200100632
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 44547
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 09005
Estimated Expiration: ⤷ Try a Trial

Patent: 1938555
Estimated Expiration: ⤷ Try a Trial

Ukraine

Patent: 5802
Estimated Expiration: ⤷ Try a Trial

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.

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Country	Patent Number	Title	Estimated Expiration
Denmark	3710439		⤷ Try a Trial
South Africa	202002105	KRAS G12C INHIBITORS	⤷ Try a Trial
South Korea	20200100632	ＫＲＡＳＧ12Ｃ 억제제	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for KRAZATI

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

Recent Clinical Trials for KRAZATI

Anatomical Therapeutic Chemical (ATC) Classes for KRAZATI

Patents protecting KRAZATI

FDA Regulatory Exclusivity protecting KRAZATI

When does loss-of-exclusivity occur for KRAZATI?

Make Better Decisions: Try a trial or see plans & pricing

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