Capmatinib hydrochloride - Generic Drug Details

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 five patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

One supplier is listed for this compound.

Summary for capmatinib hydrochloride

International Patents:	175
US Patents:	5
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	24
DailyMed Link:	capmatinib hydrochloride at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for capmatinib hydrochloride

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
Yonsei University	Phase 2
Southwest Oncology Group	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

US Patents and Regulatory Information for capmatinib hydrochloride

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
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes			Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No			Y	Y
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes			Y	Y

International Patents for capmatinib hydrochloride

Country	Patent Number	Title	Estimated Expiration
Spain	2398843
Japan	2020114852	２−フルオロ−Ｎ−メチル−４−［７−（キノリン−６−イルメチル）イミダゾ［１，２−Ｂ］［１，２，４］トリアジン−２−イル］ベンズアミドの錠剤 (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL) IMIDAZO [1,2-B] [1,2,4] TRIAZIN-2-YL] BENZAMIDE)
Malaysia	188338	IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS
China	103288833	Imidazo triazines and imidazo pyrimidines as kinase inhibitors
Poland	2099447

Supplementary Protection Certificates for capmatinib hydrochloride

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3172209	CA 2022 00056	Denmark		PRODUCT NAME: CAPMATINIB ELER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	22C1060	France		PRODUCT NAME: CAPMATINIB OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/22/1650 20220621
2099447	122022000083	Germany		PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
3172209	2022C/558	Belgium		PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621
2099447	PA2022527	Lithuania		PRODUCT NAME: KAPMATINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/22/1650 20220620