Adagrasib - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug sources for adagrasib and what is the scope of patent protection?
Adagrasib
is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.One supplier is listed for this compound.
Summary for adagrasib
| International Patents: | 90 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 31 |
| What excipients (inactive ingredients) are in adagrasib? | adagrasib excipients list |
| DailyMed Link: | adagrasib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for adagrasib
Generic Entry Date for adagrasib*:
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 adagrasib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| City of Hope Medical Center | PHASE2 |
| National Cancer Institute (NCI) | PHASE2 |
| M.D. Anderson Cancer Center | EARLY_PHASE1 |
Anatomical Therapeutic Chemical (ATC) Classes for adagrasib
US Patents and Regulatory Information for adagrasib
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol | KRAZATI | adagrasib | TABLET;ORAL | 216340-001 | Dec 12, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | Y | ⤷ Start Trial | ||
| Bristol | KRAZATI | adagrasib | TABLET;ORAL | 216340-001 | Dec 12, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Bristol | KRAZATI | adagrasib | TABLET;ORAL | 216340-001 | Dec 12, 2022 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for adagrasib
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Australia | 2018369759 | ⤷ Start Trial | |
| Brazil | 112020009818 | ⤷ Start Trial | |
| Canada | 3082579 | ⤷ Start Trial | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for adagrasib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3710439 | CA 2024 00024 | Denmark | ⤷ Start Trial | PRODUCT NAME: ADAGRASIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1744 20240109 |
| 3710439 | CR 2024 00024 | Denmark | ⤷ Start Trial | PRODUCT NAME: ADAGRASIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/23/1744 20240109 |
| 3710439 | 24C1026 | France | ⤷ Start Trial | PRODUCT NAME: ADAGRASIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/23/1744 20240109 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
