CAPMATINIB HYDROCHLORIDE - Generic Drug Details

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What are the generic sources for capmatinib hydrochloride and what is the scope of freedom to operate?

Capmatinib hydrochloride is the generic ingredient in one branded drug marketed by Novartis Pharm and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Capmatinib hydrochloride has one hundred and seventy-eight patent family members in forty-five countries.

One supplier is listed for this compound.

Summary for CAPMATINIB HYDROCHLORIDE

International Patents:	178
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	25
DailyMed Link:	CAPMATINIB HYDROCHLORIDE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for CAPMATINIB HYDROCHLORIDE

Generic Entry Date for CAPMATINIB HYDROCHLORIDE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 CAPMATINIB HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sun Yat-sen University	Phase 2
Yonsei University	Phase 2
National Cancer Institute (NCI)	Phase 2

See all CAPMATINIB HYDROCHLORIDE clinical trials

Pharmacology for CAPMATINIB HYDROCHLORIDE

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inhibitors Mesenchymal Epithelial Transition Inhibitors Multidrug and Toxin Extrusion Transporter 1 Inhibitors Multidrug and Toxin Extrusion Transporter 2 K Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for CAPMATINIB HYDROCHLORIDE

L01EX	Other protein kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for CAPMATINIB HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TABRECTA	Tablets	capmatinib hydrochloride	150 mg and 200 mg	213591	1	2024-05-06

US Patents and Regulatory Information for CAPMATINIB HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		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 CAPMATINIB HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2099447	IMIDAZOTRIAZINES ET IMIDAZOPYRIMIDINES UTILISÉES EN TANT QU'INHIBITEURS DE KINASES (IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS)	⤷ Sign Up
Denmark	3034075		⤷ Sign Up
Hungary	E053346		⤷ Sign Up
France	22C1058		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2009143211		⤷ Sign Up
Ecuador	SP10010685	SALES DE 2-FLUORO-N-METIL-4-[7-(QUINOLIN-6-IL-METIL)-IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA Y PROCESOS RELACIONADOS CON LA PREPARACIÓN DE LAS MISMAS	⤷ Sign Up
Argentina	071873	SALES DE 2-FLUORO-N-METIL-4-[7-(QUINOLIN-6-IL-METIL)-IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-IL]BENZAMIDA, UN HIDRATO DE LA SAL, UN METODO DE PREPARACION DEL COMPUESTO, UNA COMPOSICION QUE LO COMPRENDE, UN METODO PARA INHIBIR LA ACTIVIDAD DE LA TIROSINA QUINASA, UN METODO PARA TRATAR UNA ENFERMEDAD Y UN PROC	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for CAPMATINIB HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2099447	CA 2022 00053	Denmark	⤷ Sign Up	PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	301209	Netherlands	⤷ Sign Up	PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1650 20220621
2099447	CR 2022 00053	Denmark	⤷ Sign Up	PRODUCT NAME: CAPMATINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
3172209	CA 2022 00056	Denmark	⤷ Sign Up	PRODUCT NAME: CAPMATINIB ELER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	PA2022527	Lithuania	⤷ Sign Up	PRODUCT NAME: KAPMATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/22/1650 20220620
3172209	C202230060	Spain	⤷ Sign Up	PRODUCT NAME: CAPMATINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/22/1650; DATE OF AUTHORISATION: 20220620; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/22/1650; DATE OF FIRST AUTHORISATION IN EEA: 20220620
2099447	C20220044 00389	Estonia	⤷ Sign Up	PRODUCT NAME: KAPMATINIIB;REG NO/DATE: EU/1/22/1650; 21.06.2022
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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