XALKORI Drug Patent Profile
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When do Xalkori patents expire, and what generic alternatives are available?
Xalkori is a drug marketed by Pf Prism Cv and is included in two NDAs. There are five patents protecting this drug.
This drug has one hundred and fifty-two patent family members in forty-eight countries.
The generic ingredient in XALKORI is crizotinib. One supplier is listed for this compound. Additional details are available on the crizotinib profile page.
DrugPatentWatch® Generic Entry Outlook for Xalkori
Xalkori was eligible for patent challenges on August 26, 2015.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be November 6, 2029. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for XALKORI
| International Patents: | 152 |
| US Patents: | 5 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 99 |
| Clinical Trials: | 51 |
| Patent Applications: | 2,843 |
| Drug Prices: | Drug price information for XALKORI |
| What excipients (inactive ingredients) are in XALKORI? | XALKORI excipients list |
| DailyMed Link: | XALKORI at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for XALKORI
*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 XALKORI
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Phase 2/Phase 3 |
| Zai Lab (Shanghai) Co., Ltd. | Phase 3 |
| Bristol-Myers Squibb | Phase 3 |
Pharmacology for XALKORI
US Patents and Regulatory Information for XALKORI
XALKORI is protected by seven US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of XALKORI is ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ 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.
Patents protecting XALKORI
Aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Method of treating abnormal cell growth
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE
Method of treating abnormal cell growth
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF REVERSING OR INHIBITING THE PROGRESS OF UNRESECTABLE, RECURRENT, OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ALK-POSITIVE IN ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER
Method of treating abnormal cell growth
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE
Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Polymorphs of a c-MET/HGFR inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
FDA Regulatory Exclusivity protecting XALKORI
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK) POSITIVE
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER AND YOUNG ADULTS WITH RELAPSED OR REFRACTORY, SYSTEMIC ANAPLASTIC LARGE CELL LYMPHOMA (ALCL) THAT IS ALK-POSITIVE
Exclusivity Expiration: ⤷ Sign Up
TREATMENT OF ADULT AND PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH UNRESECTABLE, RECURRENT, OR REFRACTORY INFLAMMATORY MYOFIBROBLASTIC TUMOR (IMT) THAT IS ALK-POSITIVE
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-002 | Aug 26, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-002 | Aug 26, 2011 | 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 |
EU/EMA Drug Approvals for XALKORI
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Pfizer Europe MA EEIG | Xalkori | crizotinib | EMEA/H/C/002489 XALKORI as monotherapy is indicated for:The first‑line treatment of adults with anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with previously treated anaplastic lymphoma kinase (ALK)‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of adults with ROS1‑positive advanced non‑small cell lung cancer (NSCLC)The treatment of paediatric patients (age ≥6 to |
Authorised | no | no | no | 2012-10-23 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for XALKORI
When does loss-of-exclusivity occur for XALKORI?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 7964
Patent: POLIMORFOS DE UN INHIBIDOR DE C-MET/HGFR
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 06323025
Patent: Polymorphs of a c-Met/HGFR inhibitor
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0619420
Patent: bases livres de polimorfos de um inibidor de c-met/hgfr, bem como uso das mesmas, composição farmacêutica, cápsula e uso da mesma
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 32283
Patent: POLYMORPHES D'UN INHIBITEUR DE C-MET/HGFR (POLYMORPHS OF A C-MET/HGFR INHIBITOR)
Estimated Expiration: ⤷ Sign Up
China
Patent: 1326175
Patent: Polymorphs of a C-MET/HGFR inhibitor
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 13843
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 63302
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 63302
Patent: POLYMORPHES D'UN INHIBITEUR DE C-MET/HGFR (POLYMORPHS OF A C-MET/HGFR INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 26477
Patent: POLYMORPHS OF A C-MET/HGFR INHIBITOR C-MET/HGFR
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 1971
Patent: פולימורפים של מעכב hgfr/met-c (Polymorphs of a c-met/hgfr inhibitor)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 63619
Estimated Expiration: ⤷ Sign Up
Patent: 07153893
Patent: POLYMORPH OF C-Met/HGFR INHIBITOR
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 8289
Patent: Polymorphs of (R)-3-[1-(2,6-dichloro-3-fluoro-phenyl)-ethoxy]-5-(1- piperidin-4-yl-1H-pyrazol-4-yl)-pyridin-2-ylamine
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 63302
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 63302
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 87650
Patent: ПОЛИМОРФЫ С-MET/HGFR ИНГИБИТОРА (C-MET/HGFR INHIBITOR POLYMORPHS)
Estimated Expiration: ⤷ Sign Up
Patent: 08120338
Patent: ПОЛИМОРФЫ С-MET/HGFR ИНГИБИТОРА
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 63302
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 0804374
Patent: Polymorphs of a C-MET/HGFR inhibitor
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1146852
Estimated Expiration: ⤷ Sign Up
Patent: 080074950
Patent: POLYMORPHS OF A C-MET/HGFR INHIBITOR
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 02419
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 89902
Estimated Expiration: ⤷ Sign Up
Patent: 0730522
Patent: Polymorphs of a C-MET/HGFR inhibitor
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 XALKORI around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Ecuador | SP055988 | COMPUESTOS DE AMINOHETEROARILO COMO INHIBIDORES DE LAS PROTEINQUINASAS | ⤷ Sign Up |
| Denmark | 1786785 | ⤷ Sign Up | |
| Brazil | PI0619420 | bases livres de polimorfos de um inibidor de c-met/hgfr, bem como uso das mesmas, composição farmacêutica, cápsula e uso da mesma | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XALKORI
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1786785 | 13C0015 | France | ⤷ Sign Up | PRODUCT NAME: CRIZOTINIB ET SES SELS, HYDRATES ET SOLVATES PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/12/793/001 20121026 |
| 1786785 | PA2013005 | Lithuania | ⤷ Sign Up | PRODUCT NAME: CRIZOTINIBUM; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023 |
| 1786785 | 1390008-9 | Sweden | ⤷ Sign Up | PRODUCT NAME: CRIZOTINIB INKLUSIVE ETT FARMACEUTISKT GODTAGBART SALT, SOLVAT ELLER HYDRAT DAERAV; REG. NO/DATE: EU/1/12/793/001 20121023; PERIOD OF VALIDITY (FROM - UNTIL): 2025-08-16 - 2027-10-25 |
| >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.
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