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 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for LUMAKRAS
*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 |
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 | ||
| >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.
Make Better Decisions: Try a trial or see plans & pricing
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.
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