ADAGRASIB - Generic Drug Details
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What are the generic drug sources for adagrasib and what is the scope of freedom to operate?
Adagrasib
is the generic ingredient in one branded drug marketed by Bristol and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Adagrasib has thirty-six patent family members in twenty-nine countries.
One supplier is listed for this compound.
Summary for ADAGRASIB
| International Patents: | 36 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 20 |
| Patent Applications: | 41 |
| 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:
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 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 |
|---|---|
| Incyte Corporation | Phase 1 |
| Bristol-Myers Squibb | Phase 1/Phase 2 |
| AstraZeneca | Phase 1 |
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | KRAZATI | adagrasib | TABLET;ORAL | 216340-001 | Dec 12, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Bristol | KRAZATI | adagrasib | TABLET;ORAL | 216340-001 | Dec 12, 2022 | RX | Yes | Yes | ⤷ 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 |
International Patents for ADAGRASIB
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2019099524 | ⤷ Sign Up | |
| Saudi Arabia | 520411982 | Kirsten 2 مثبطات نظير الجين الورمي الفيروسي لساركوما جرذ (KRas) واستخدامها لعلاج السرطان (Kirsten Rat Sarcoma 2 Viral Oncogene Homolog (KRAS) Inhibitors And Their Use for Treatment of Cancer) | ⤷ Sign Up |
| Colombia | 2020007244 | Inhibidores de kras g12c | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ADAGRASIB
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 3710439 | 301279 | Netherlands | ⤷ Sign Up | PRODUCT NAME: ADAGRASIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/23/1744 20240109 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
