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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 four patent family members in thirty-five 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:	104
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	60
Clinical Trials:	4
Patent Applications:	36
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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

Anatomical Therapeutic Chemical (ATC) Classes for LUMAKRAS

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

US Patents and Regulatory Information for LUMAKRAS

LUMAKRAS is protected by four US patents and two FDA Regulatory Exclusivities.

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

This potential generic entry date is based on patent ⤷ 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.

Patents protecting LUMAKRAS

KRAS G12C inhibitors and methods of using the same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Solid state forms
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

Dosing of KRAS inhibitor for treatment of cancers
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

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 LUMAKRAS

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

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
Estimated Expiration: ⤷ Try a Trial

Australia

Patent: 20280024
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2021023277
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 40392
Estimated Expiration: ⤷ Try a Trial

Patent: 25293
Estimated Expiration: ⤷ Try a Trial

Chile

Patent: 21003064
Estimated Expiration: ⤷ Try a Trial

China

Patent: 4144414
Estimated Expiration: ⤷ Try a Trial

Colombia

Patent: 21017366
Estimated Expiration: ⤷ Try a Trial

Costa Rica

Patent: 210665
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 72973
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 8077
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 92935
Estimated Expiration: ⤷ Try a Trial

Patent: 47071
Estimated Expiration: ⤷ Try a Trial

Patent: 21523216
Estimated Expiration: ⤷ Try a Trial

Patent: 22058395
Estimated Expiration: ⤷ Try a Trial

Jordan

Patent: 0210310
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 21014126
Estimated Expiration: ⤷ Try a Trial

Peru

Patent: 220504
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 202112855W
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 220011670
Estimated Expiration: ⤷ Try a Trial

Taiwan

Patent: 2110835
Estimated Expiration: ⤷ Try a Trial

Uruguay

Patent: 710
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 LUMAKRAS around the world.

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Country	Patent Number	Title	Estimated Expiration
Portugal	3630761		⤷ Try a Trial
Japan	7300076		⤷ Try a Trial
Japan	2023116708	癌を治療するためのＫＲＡＳ阻害剤の投与 (DOSING OF KRAS INHIBITOR FOR TREATMENT OF CANCERS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration