Crizotinib - Generic Drug Details
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What are the generic sources for crizotinib and what is the scope of patent protection?
Crizotinib
is the generic ingredient in one branded drug marketed by Pf Prism Cv and is included in two NDAs. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Crizotinib has one hundred and fifty-two patent family members in forty-eight countries.
One supplier is listed for this compound.
Summary for crizotinib
International Patents: | 152 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 99 |
Clinical Trials: | 155 |
Patent Applications: | 339 |
What excipients (inactive ingredients) are in crizotinib? | crizotinib excipients list |
DailyMed Link: | crizotinib at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for crizotinib
Generic Entry Dates for crizotinib*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for crizotinib*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE, PELLETS;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 crizotinib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Hunan Province Tumor Hospital | Phase 1/Phase 2 |
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB Chair | Phase 2/Phase 3 |
Bristol-Myers Squibb | Phase 3 |
Pharmacology for crizotinib
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 | 202570-002 | Aug 26, 2011 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | ⤷ 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 | ⤷ Sign Up | ||||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE;ORAL | 202570-001 | Aug 26, 2011 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Pf Prism Cv | XALKORI | crizotinib | CAPSULE, PELLETS;ORAL | 217581-003 | Sep 7, 2023 | 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 |
EU/EMA Drug Approvals for crizotinib
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 crizotinib
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
New Zealand | 568654 | Method of treating abnormal cell growth | ⤷ Sign Up |
Russian Federation | 2384331 | СПОСОБ ЛЕЧЕНИЯ АНОМАЛЬНОГО РОСТА КЛЕТОК (METHOD OF TREATING ABNORMAL CELL EXPANSION) | ⤷ Sign Up |
Spain | 2353821 | ⤷ Sign Up | |
China | 101023064 | Enantiomerically pure aminoheteroaryl compounds as protein kinase inhibitors | ⤷ Sign Up |
Uruguay | 29081 | COMPUESTOS DE AMINOHETEROARILO ENANTIOMÉRICAMENTE PUROS COMO INHIBIDORES DE PROTEÍNA QUINASA | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for crizotinib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1786785 | C01786785/01 | Switzerland | ⤷ Sign Up | FORMER OWNER: PFIZER INC., US |
1786785 | C 2013 011 | Romania | ⤷ Sign Up | PRODUCT NAME: CRIZOTINIB, OPTIONAL IN FORMA DE SARE ACCEPTABILAFARMACEUTIC, HIDRAT SAU SOLVAT AL ACE EU/1/12/793/004; DATE OF NATIONAL AUTHORISATION: 20121023; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/12/793/001, EMEA EU/1/12/793/002, EMEA EU/1/12/793/003, EMEA EU/1/12/793/004; DATE OF FIRST AUTHORISATION IN EEA: 20121023 STUIA; NATIONAL AUTHORISATION NUMBER: RO EU/1/12/793/001, RO EU/1/12/793/002, RO EU/1/12/793/003, RO |
1786785 | C300587 | Netherlands | ⤷ Sign Up | PRODUCT NAME: CRIZOTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, HYDRAAT OF SOLVAAT; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023 |
1786785 | SPC/GB13/018 | United Kingdom | ⤷ Sign Up | 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 | 122013000027 | Germany | ⤷ Sign Up | PRODUCT NAME: CRIZOTINIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, HYDRATS ODER SOLVATS DAVON; REGISTRATION NO/DATE: EU/1/12/793/001-004 20121023 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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