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Last Updated: November 7, 2024

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LUMAKRAS Drug Patent Profile


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Which patents cover Lumakras, 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
Drug Prices for LUMAKRAS

See drug prices for LUMAKRAS

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LUMAKRAS
Generic Entry Date for LUMAKRAS*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
National Cancer Institute (NCI)Phase 2
Vitrac Therapeutics, LLCPhase 1
WestatPhase 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

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
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-003 Jun 26, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  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

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.

Country Patent Number Title Estimated Expiration
South Korea 20230128589 KRas G12C 억제제 및 이의 사용 방법 (KRas G12C KRAS G12C INHIBITORS AND METHODS OF USING THE SAME) ⤷  Sign Up
Japan 2022058395 固体形態 ⤷  Sign Up
Costa Rica 20240126 INHIBIDORES DE KRAS G12C Y MÉTODOS PARA SU USO CAMPO DE LA INVENCIÓN (DIVISIONAL 2019-534) (KRAS G12C INHIBITORS AND METHODS OF USING THE SAME) ⤷  Sign Up
Chile 2020002405 Inhibidores de kras g12c y métodos para su uso (divisional de la solicitud no. 201903394) ⤷  Sign Up
European Patent Office 3972973 FORMES À L'ÉTAT SOLIDE (SOLID STATE FORMS) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.