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
*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
| Sponsor | Phase |
|---|---|
| NYU Langone Health | Phase 2 |
| ETOP IBCSG Partners Foundation | Phase 2 |
| Eisai Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for SOTORASIB
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 | ⤷ 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 | 214665-002 | 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 | ||
| >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 |
|---|---|---|---|
| Canada | 3140392 | FORMES A L'ETAT SOLIDE (SOLID STATE FORMS) | ⤷ Sign Up |
| Colombia | 2021017366 | Formas en estado sólido | ⤷ Sign Up |
| World Intellectual Property Organization (WIPO) | 2018217651 | ⤷ Sign Up | |
| Australia | 2020275845 | Dosing of KRAS inhibitor for treatment of cancers | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
