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 four patent family members in thirty-five countries.
One supplier is listed for this compound.
Summary for SOTORASIB
| International Patents: | 104 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 29 |
| 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
Generic Entry Date for SOTORASIB*:
Constraining patent/regulatory exclusivity:
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 SOTORASIB
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| NYU Langone Health | Phase 2 |
| NYU Langone Health | Phase 1 |
| Gustave Roussy, Cancer Campus, Grand Paris | Phase 2 |
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 | 214665-002 | Jan 20, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| 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 | 214665-001 | 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 | Y | Y | ⤷ Try a Trial | ||
| 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 | 214665-001 | May 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Amgen Inc | LUMAKRAS | sotorasib | TABLET;ORAL | 214665-001 | May 28, 2021 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ 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 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 |
|---|---|---|---|
| European Patent Office | 3738593 | DOSAGE D'INHIBITEUR DE KRAS POUR LE TRAITEMENT DE CANCERS (DOSING OF KRAS INHIBITOR FOR TREATMENT OF CANCERS) | ⤷ Try a Trial |
| Poland | 3630761 | ⤷ Try a Trial | |
| Uruguay | 37744 | INHIBIDORES DE KRAS G12C Y MÉTODOS PARA SU USO | ⤷ Try a Trial |
| Singapore | 11202112432P | DOSING OF KRAS INHIBITOR FOR TREATMENT OF CANCERS | ⤷ Try a Trial |
| Japan | 7092935 | ⤷ Try a Trial | |
| China | 115626923 | KRAS G12C抑制剂及其使用方法 (KRAS G12C inhibitors and methods of use thereof) | ⤷ Try a Trial |
| Argentina | 122789 | INHIBIDORES DE KRAS G12C Y MÉTODOS PARA SU USO | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
