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Last Updated: November 7, 2024

SOTORASIB - Generic Drug Details


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What are the generic drug sources for sotorasib and what is the scope of freedom to operate?

Sotorasib is the generic ingredient in one branded drug marketed by Amgen Inc and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Sotorasib has one hundred and eighteen patent family members in thirty-six countries.

One supplier is listed for this compound.

Summary for SOTORASIB
International Patents:118
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 60
Clinical Trials: 33
Patent Applications: 68
What excipients (inactive ingredients) are in SOTORASIB?SOTORASIB excipients list
DailyMed Link:SOTORASIB at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for SOTORASIB
Generic Entry Date for SOTORASIB*:
Constraining patent/regulatory exclusivity:
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 SOTORASIB

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

SponsorPhase
NYU Langone HealthPhase 2
Eisai Inc.Phase 2
ETOP IBCSG Partners FoundationPhase 2

See all SOTORASIB clinical trials

US Patents and Regulatory Information for SOTORASIB

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 214665-003 Jun 26, 2024 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  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 214665-001 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 Y Y ⤷  Sign Up
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-002 Jan 20, 2023 RX Yes Yes ⤷  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 ⤷  Sign Up
Amgen Inc LUMAKRAS sotorasib TABLET;ORAL 214665-003 Jun 26, 2024 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 SOTORASIB

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 SOTORASIB

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
Japan 7095052 ⤷  Sign Up
Japan 2022009090 癌を治療するためのKRAS阻害剤の投与 ⤷  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.