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 twenty-three patent family members in thirty-seven 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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Questions you can ask:
- What is the 5 year forecast for LUMAKRAS?
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Summary for LUMAKRAS
International Patents: | 123 |
US Patents: | 4 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 60 |
Clinical Trials: | 4 |
Patent Applications: | 52 |
Drug Prices: | Drug price information for LUMAKRAS |
What excipients (inactive ingredients) are in LUMAKRAS? | LUMAKRAS excipients list |
DailyMed Link: | LUMAKRAS at DailyMed |


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
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
Westat | Phase 1 |
Vitrac Therapeutics, LLC | Phase 1 |
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 ⤷ Try for Free.
This potential generic entry date is based on patent ⤷ Try for Free.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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: ⤷ Try for Free
Australia
Patent: 20280024
Patent: Solid state forms
Estimated Expiration: ⤷ Try for Free
Brazil
Patent: 2021023277
Patent: Formas em estado sólido
Estimated Expiration: ⤷ Try for Free
Canada
Patent: 40392
Patent: FORMES A L'ETAT SOLIDE (SOLID STATE FORMS)
Estimated Expiration: ⤷ Try for Free
Patent: 25293
Patent: SOLID STATE FORMS
Estimated Expiration: ⤷ Try for Free
Chile
Patent: 21003064
Patent: Formas en estado sólido
Estimated Expiration: ⤷ Try for Free
Patent: 23003098
Estimated Expiration: ⤷ Try for Free
China
Patent: 4144414
Patent: 固态形式 (Solid state forms)
Estimated Expiration: ⤷ Try for Free
Patent: 8834208
Estimated Expiration: ⤷ Try for Free
Colombia
Patent: 21017366
Patent: Formas en estado sólido
Estimated Expiration: ⤷ Try for Free
Costa Rica
Patent: 210665
Patent: FORMAS EN ESTADO SÓLIDO (SOLID STATE FORMS)
Estimated Expiration: ⤷ Try for Free
European Patent Office
Patent: 72973
Patent: FORMES À L'ÉTAT SOLIDE (SOLID STATE FORMS)
Estimated Expiration: ⤷ Try for Free
Israel
Patent: 8077
Patent: צורות מצב מוצק (Solid state forms)
Estimated Expiration: ⤷ Try for Free
Japan
Patent: 92935
Estimated Expiration: ⤷ Try for Free
Patent: 47071
Estimated Expiration: ⤷ Try for Free
Patent: 21523216
Patent: 固体形態
Estimated Expiration: ⤷ Try for Free
Patent: 22058395
Patent: 固体形態
Estimated Expiration: ⤷ Try for Free
Patent: 24059626
Patent: 固体形態
Estimated Expiration: ⤷ Try for Free
Jordan
Patent: 0210310
Patent: أشكال الحالة الصلبة (SOLID STATE FORMS)
Estimated Expiration: ⤷ Try for Free
Mexico
Patent: 21014126
Patent: FORMAS EN ESTADO SOLIDO. (SOLID STATE FORMS.)
Estimated Expiration: ⤷ Try for Free
New Zealand
Patent: 2284
Estimated Expiration: ⤷ Try for Free
Peru
Patent: 220504
Patent: FORMAS EN ESTADO SOLIDO
Estimated Expiration: ⤷ Try for Free
Saudi Arabia
Patent: 1430905
Estimated Expiration: ⤷ Try for Free
Singapore
Patent: 202112855W
Patent: SOLID STATE FORMS
Estimated Expiration: ⤷ Try for Free
South Korea
Patent: 220011670
Patent: 고체 상태 형태
Estimated Expiration: ⤷ Try for Free
Taiwan
Patent: 2110835
Patent: Solid state forms
Estimated Expiration: ⤷ Try for Free
Uruguay
Patent: 710
Patent: FORMAS EN ESTADO SÓLIDO
Estimated Expiration: ⤷ Try for Free
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 |
---|---|---|---|
Taiwan | I824148 | ⤷ Try for Free | |
Australia | 2020280024 | ⤷ Try for Free | |
Singapore | 11202112432P | DOSING OF KRAS INHIBITOR FOR TREATMENT OF CANCERS | ⤷ Try for Free |
Canada | 3140392 | FORMES A L'ETAT SOLIDE (SOLID STATE FORMS) | ⤷ Try for Free |
Japan | 2022009090 | 癌を治療するためのKRAS阻害剤の投与 | ⤷ Try for Free |
Canada | 3139519 | ⤷ Try for Free | |
Spain | 2905676 | ⤷ Try for Free | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for LUMAKRAS (Sotorasib)
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