KRAZATI Drug Patent Profile
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When do Krazati patents expire, and what generic alternatives are available?
Krazati is a drug marketed by Bristol and is included in one NDA. There is one patent protecting this drug.
This drug has thirty-six patent family members in twenty-nine countries.
The generic ingredient in KRAZATI is adagrasib. One supplier is listed for this compound. Additional details are available on the adagrasib profile page.
DrugPatentWatch® Generic Entry Outlook for Krazati
Krazati will be eligible for patent challenges on December 12, 2026. 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 December 12, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for KRAZATI
| International Patents: | 36 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 38 |
| Clinical Trials: | 4 |
| Patent Applications: | 20 |
| Drug Prices: | Drug price information for KRAZATI |
| What excipients (inactive ingredients) are in KRAZATI? | KRAZATI excipients list |
| DailyMed Link: | KRAZATI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for KRAZATI
Generic Entry Date for KRAZATI*:
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 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 KRAZATI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Incyte Corporation | Phase 1 |
| Kura Oncology, Inc. | Phase 1 |
| Mirati Therapeutics Inc. | Phase 1 |
US Patents and Regulatory Information for KRAZATI
KRAZATI is protected by two US patents and two FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of KRAZATI is ⤷ Sign Up.
This potential generic entry date is based on 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.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting KRAZATI
KRas G12C inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: 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
KRas G12C inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT, IN COMBINATION WITH CETUXIMAB, OF ADULT PATIENTS WITH KRAS G12C-MUTED LOCALLY ADVANCED OR METASTATIC COLORECTAL CANCER, PER FDA APPROVED TEST, WHERE PRIOR TREATMENT WITH FLUOROPYRIMIDINE-, OXALIPLATIN-, AND IRINOTECAN-BASED CHEMOTHERAPY
FDA Regulatory Exclusivity protecting KRAZATI
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
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
Exclusivity Expiration: ⤷ Sign Up
| 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 | Y | Y | ⤷ 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 | ⤷ 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 KRAZATI
When does loss-of-exclusivity occur for KRAZATI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Australia
Patent: 18369759
Patent: KRas G12C inhibitors
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2020009818
Patent: inibidores kras g12c
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 82579
Patent: INHIBITEURS DE KRAS G12C (KRAS G12C INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 20001271
Patent: Inhibidores de kras g12c
Estimated Expiration: ⤷ Sign Up
China
Patent: 1989321
Patent: KRAS G12C抑制剂 (KRAS G12C INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 20007244
Patent: Inhibidores de kras g12c
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0230377
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 10439
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2091186
Patent: ИНГИБИТОРЫ KRas G12C
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 10439
Patent: INHIBITEURS DE KRAS G12C (KRAS G12C INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Patent: 80208
Patent: INHIBITEURS DE KRAS G12C (KRAS G12C INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Finland
Patent: 0240021
Estimated Expiration: ⤷ Sign Up
Patent: 10439
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 61599
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 4601
Patent: מעכבי kras g12c (Kras g12c inhibitors)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 22019
Estimated Expiration: ⤷ Sign Up
Patent: 46565
Estimated Expiration: ⤷ Sign Up
Patent: 21502993
Patent: ＫＲＡＳ Ｇ１２Ｃ阻害剤
Estimated Expiration: ⤷ Sign Up
Patent: 22508108
Patent: ＫＲＡＳ Ｇ１２Ｃ阻害剤
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 10439
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 20005063
Patent: INHIBIDORES DE KRAS G12C. (KRAS G12C INHIBITORS.)
Estimated Expiration: ⤷ Sign Up
Philippines
Patent: 020550622
Patent: KRAS G12C INHIBITORS
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 10439
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 10439
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 0411982
Patent: 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)
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 182
Patent: INHIBITORI KRAS G12C (KRAS G12C INHIBITORS)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 202004427T
Patent: KRAS G12C INHIBITORS
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 10439
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 2002105
Patent: KRAS G12C INHIBITORS
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 200100632
Patent: ＫＲＡＳ Ｇ12Ｃ 억제제
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 44547
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 09005
Estimated Expiration: ⤷ Sign Up
Patent: 1938555
Patent: KRAS G12C inhibitors
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 5802
Patent: ІНГІБІТОРИ KRAS G12C (KRAS G12C INHIBITORS)
Estimated Expiration: ⤷ Sign Up
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 KRAZATI around the world.
| 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 |
| Japan | 2021502993 | ＫＲＡＳ Ｇ１２Ｃ阻害剤 | ⤷ Sign Up |
| Finland | 3710439 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for KRAZATI
| 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
ISSN: 2162-2639
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