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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Questions you can ask:
- What is the 5 year forecast for LUMAKRAS?
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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
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 ⤷ Subscribe.
This potential generic entry date is based on patent 11,236,091.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
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 | 11,426,404 | ⤷ Subscribe | ⤷ Subscribe | ||||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-003 | Jun 26, 2024 | RX | Yes | No | 11,827,635 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-001 | May 28, 2021 | RX | Yes | No | 10,519,146 | ⤷ Subscribe | Y | Y | ⤷ Subscribe | ||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-003 | Jun 26, 2024 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-003 | Jun 26, 2024 | RX | Yes | No | 11,426,404 | ⤷ Subscribe | ⤷ Subscribe | ||||
>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: ⤷ Subscribe
Australia
Patent: 20280024
Patent: Solid state forms
Estimated Expiration: ⤷ Subscribe
Brazil
Patent: 2021023277
Patent: Formas em estado sólido
Estimated Expiration: ⤷ Subscribe
Canada
Patent: 40392
Patent: FORMES A L'ETAT SOLIDE (SOLID STATE FORMS)
Estimated Expiration: ⤷ Subscribe
Patent: 25293
Patent: SOLID STATE FORMS
Estimated Expiration: ⤷ Subscribe
Chile
Patent: 21003064
Patent: Formas en estado sólido
Estimated Expiration: ⤷ Subscribe
China
Patent: 4144414
Patent: 固态形式 (Solid state forms)
Estimated Expiration: ⤷ Subscribe
Colombia
Patent: 21017366
Patent: Formas en estado sólido
Estimated Expiration: ⤷ Subscribe
Costa Rica
Patent: 210665
Patent: FORMAS EN ESTADO SÓLIDO (SOLID STATE FORMS)
Estimated Expiration: ⤷ Subscribe
European Patent Office
Patent: 72973
Patent: FORMES À L'ÉTAT SOLIDE (SOLID STATE FORMS)
Estimated Expiration: ⤷ Subscribe
Israel
Patent: 8077
Patent: צורות מצב מוצק (Solid state forms)
Estimated Expiration: ⤷ Subscribe
Japan
Patent: 92935
Estimated Expiration: ⤷ Subscribe
Patent: 47071
Estimated Expiration: ⤷ Subscribe
Patent: 21523216
Patent: 固体形態
Estimated Expiration: ⤷ Subscribe
Patent: 22058395
Patent: 固体形態
Estimated Expiration: ⤷ Subscribe
Jordan
Patent: 0210310
Patent: أشكال الحالة الصلبة (SOLID STATE FORMS)
Estimated Expiration: ⤷ Subscribe
Mexico
Patent: 21014126
Patent: FORMAS EN ESTADO SOLIDO. (SOLID STATE FORMS.)
Estimated Expiration: ⤷ Subscribe
Peru
Patent: 220504
Patent: FORMAS EN ESTADO SOLIDO
Estimated Expiration: ⤷ Subscribe
Singapore
Patent: 202112855W
Patent: SOLID STATE FORMS
Estimated Expiration: ⤷ Subscribe
South Korea
Patent: 220011670
Patent: 고체 상태 형태
Estimated Expiration: ⤷ Subscribe
Taiwan
Patent: 2110835
Patent: Solid state forms
Estimated Expiration: ⤷ Subscribe
Uruguay
Patent: 710
Patent: FORMAS EN ESTADO SÓLIDO
Estimated Expiration: ⤷ Subscribe
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 |
---|---|---|---|
Chile | 2021003064 | Formas en estado sólido | ⤷ Subscribe |
Japan | 7092935 | ⤷ Subscribe | |
Argentina | 122787 | INHIBIDORES DE KRAS G12C Y MÉTODOS PARA SU USO | ⤷ Subscribe |
Brazil | 112021022812 | Dosagem de inibidor de kras para tratamento de cânceres | ⤷ Subscribe |
South Korea | 20220011670 | 고체 상태 형태 | ⤷ Subscribe |
Chile | 2019003394 | Inhibidores de kras g12c y métodos para su uso. | ⤷ Subscribe |
>Country | >Patent Number | >Title | >Estimated Expiration |
LUMAKRAS Market Analysis and Financial Projection Experimental
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