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LUMAKRAS Drug Patent Profile

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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

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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

Drug patent expirations by year for LUMAKRAS

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

Generic Entry Date for LUMAKRAS^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of LUMAKRAS is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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 LUMAKRAS

KRAS G12C inhibitors and methods of using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Solid state forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Dosing of KRAS inhibitor for treatment of cancers
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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

Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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 LUMAKRAS

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

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: ⤷ Sign Up

FDA HAS NOT RECOGNIZED ORPHAN-DRUG EXCLUSIVITY (ODE) FOR THIS DRUG, BUT IT CONTAINS THE SAME ACTIVE MOIETY OR MOIETIES AS ANOTHER DRUG(S) THAT WAS ELIGIBLE FOR ODE, AND ALSO SHARES ODE-PROTECTED USE(S) OR INDICATION(S) WITH THAT DRUG(S).AN APPLICATION SEEKING APPROVAL FOR THE SAME ACTIVE MOIETY OR MOIETIES, INCLUDING AN ANDA THAT CITES THIS NDA AS ITS BASIS OF SUBMISSION, MAY NOT BE APPROVED FOR SUCH ODE-PROTECTED USE(S) AND INDICATION(S)
Exclusivity Expiration: ⤷ Sign Up

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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
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-002	Jan 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-003	Jun 26, 2024		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Amgen Inc	LUMAKRAS	sotorasib	TABLET;ORAL	214665-001	May 28, 2021		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

EU/EMA Drug Approvals for LUMAKRAS

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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
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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

Patent: 8978
Patent: FORMAS EN ESTADO SÓLIDO
Estimated Expiration: ⤷ Sign Up

Australia

Patent: 20280024
Patent: Solid state forms
Estimated Expiration: ⤷ Sign Up

Brazil

Patent: 2021023277
Patent: Formas em estado sólido
Estimated Expiration: ⤷ Sign Up

Canada

Patent: 40392
Patent: FORMES A L'ETAT SOLIDE (SOLID STATE FORMS)
Estimated Expiration: ⤷ Sign Up

Patent: 25293
Patent: SOLID STATE FORMS
Estimated Expiration: ⤷ Sign Up

Chile

Patent: 21003064
Patent: Formas en estado sólido
Estimated Expiration: ⤷ Sign Up

China

Patent: 4144414
Patent: 固态形式 (Solid state forms)
Estimated Expiration: ⤷ Sign Up

Colombia

Patent: 21017366
Patent: Formas en estado sólido
Estimated Expiration: ⤷ Sign Up

Costa Rica

Patent: 210665
Patent: FORMAS EN ESTADO SÓLIDO (SOLID STATE FORMS)
Estimated Expiration: ⤷ Sign Up

European Patent Office

Patent: 72973
Patent: FORMES À L'ÉTAT SOLIDE (SOLID STATE FORMS)
Estimated Expiration: ⤷ Sign Up

Israel

Patent: 8077
Patent: צורות מצב מוצק (Solid state forms)
Estimated Expiration: ⤷ Sign Up

Japan

Patent: 92935
Estimated Expiration: ⤷ Sign Up

Patent: 47071
Estimated Expiration: ⤷ Sign Up

Patent: 21523216
Patent: 固体形態
Estimated Expiration: ⤷ Sign Up

Patent: 22058395
Patent: 固体形態
Estimated Expiration: ⤷ Sign Up

Jordan

Patent: 0210310
Patent: أشكال الحالة الصلبة (SOLID STATE FORMS)
Estimated Expiration: ⤷ Sign Up

Mexico

Patent: 21014126
Patent: FORMAS EN ESTADO SOLIDO. (SOLID STATE FORMS.)
Estimated Expiration: ⤷ Sign Up

Peru

Patent: 220504
Patent: FORMAS EN ESTADO SOLIDO
Estimated Expiration: ⤷ Sign Up

Singapore

Patent: 202112855W
Patent: SOLID STATE FORMS
Estimated Expiration: ⤷ Sign Up

South Korea

Patent: 220011670
Patent: 고체 상태 형태
Estimated Expiration: ⤷ Sign Up

Taiwan

Patent: 2110835
Patent: Solid state forms
Estimated Expiration: ⤷ Sign Up

Uruguay

Patent: 710
Patent: FORMAS EN ESTADO SÓLIDO
Estimated Expiration: ⤷ Sign Up

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.

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Country	Patent Number	Title	Estimated Expiration
Canada	3140392	FORMES A L'ETAT SOLIDE (SOLID STATE FORMS)	⤷ Sign Up
Colombia	2021017366	Formas en estado sólido	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2018217651		⤷ Sign Up
Australia	2020275845	Dosing of KRAS inhibitor for treatment of cancers	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration