LUMAKRAS Drug Patent Profile
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Which patents cover Lumakras, and what generic alternatives are available?
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
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 |
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 |
Anatomical Therapeutic Chemical (ATC) Classes for LUMAKRAS
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
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 | ||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Israel | 270490 | מעכבי kras g12c ושיטות לשימוש בהם (Kras g12c inhibitors and methods of using the same) | ⤷ Try a Trial |
Australia | 2018273356 | KRAS G12C inhibitors and methods of using the same | ⤷ Try a Trial |
Argentina | 122784 | INHIBIDORES DE KRAS G12C Y MÉTODOS PARA SU USO | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2020236947 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |