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 one NDA. There are five patents protecting this drug.
This drug has one hundred and fifty patent family members in forty-seven 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
Summary for XALKORI
International Patents: | 150 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 99 |
Clinical Trials: | 48 |
Patent Applications: | 212 |
Formulation / Manufacturing: | see details |
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
Generic Entry Date for XALKORI*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;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 XALKORI
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
GlaxoSmithKline | Phase 2 |
Ulrik Lassen | Phase 2 |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 2 |
Pharmacology for XALKORI
Anatomical Therapeutic Chemical (ATC) Classes 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 ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Method of treating abnormal cell growth
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
Method of treating abnormal cell growth
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) THAT IS ANAPLASTIC LYMPHOMA KINASE (ALK)-POSITIVE
Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Polymorphs of a c-MET/HGFR inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting XALKORI
TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS ARE ROS-1 POSITIVE.
Exclusivity Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-002 | Aug 26, 2011 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | 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 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
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 06323025
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0619420
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 32283
Estimated Expiration: ⤷ Try a Trial
China
Patent: 1326175
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 13843
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 63302
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 63302
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 26477
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 1971
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 63619
Estimated Expiration: ⤷ Try a Trial
Patent: 07153893
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 8289
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 63302
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 63302
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 87650
Estimated Expiration: ⤷ Try a Trial
Patent: 08120338
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 63302
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 0804374
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1146852
Estimated Expiration: ⤷ Try a Trial
Patent: 080074950
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 02419
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 89902
Estimated Expiration: ⤷ Try a Trial
Patent: 0730522
Estimated Expiration: ⤷ Try a Trial
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 |
---|---|---|---|
South Korea | 20070038562 | ENANTIOMERICALLY PURE AMINOHETEROARYL COMPOUNDS AS PROTEIN KINASE INHIBITORS | ⤷ Try a Trial |
Japan | 4663619 | ⤷ Try a Trial | |
African Regional IP Organization (ARIPO) | 2373 | Enantiomerically pure aminoheteroaryl compounds asprotein kinase inhibitors. | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for XALKORI
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1786785 | SPC/GB13/018 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: CRIZOTINIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, HYDRATE OR SOLVATE THEREOF.; REGISTERED: UK EU/1/12/793/001 20121026; UK EU/1/12/793/002 20121026; UK EU/1/12/793/003 20121026; UK EU/1/12/793/004 20121026 |
1786785 | 167 5008-2013 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: KRIZOTINIB; REGISTRATION NO/DATE: EU/1/12/793/001 - EU/1/12/793/004 20121023 |
1786785 | 92155 | Luxembourg | ⤷ Try a Trial | PRODUCT NAME: CRIZOTINIB, EVENTUELLEMENT SOUS LA FORME D UN SEL, HYDRATE OU SOLVATE PHARMACEUTIQUEMENT ACCEPTABLE |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |