Capmatinib hydrochloride - Generic Drug Details

✉ Email this page to a colleague

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^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: ⤷ Subscribe 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
Southwest Oncology Group	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

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Subscribe
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	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-002	May 6, 2020		RX	Yes	Yes	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Novartis Pharm	TABRECTA	capmatinib hydrochloride	TABLET;ORAL	213591-001	May 6, 2020		RX	Yes	No	⤷ Subscribe	⤷ Subscribe	Y	Y		⤷ Subscribe
>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

Subscribe to access the full database, or Subscribe
Country	Patent Number	Title	Estimated Expiration
Norway	344864		⤷ Subscribe
Israel	229229	מלחים של 2 - פלואורו - n - מתיל - 4 - [7 - (קווינולין - 6 - איל - מתיל) - אימידזו[[2,1-b [4,2,1]] טריאזינ- 2 - איל] בנזאמיד ותהליכים הקשורים להכנתם (Salts of 2-fluoro-n-methyl-4-[7-(quinolin-6-yl-methyl)-imidazo[1,2-b][1,2,4]triazin-2-yl]benzamide and processes related to preparing the same)	⤷ Subscribe
Canada	2954840	FORMULATION DE COMPRIME DE 2-FLUORO-N-METHYL-4-[7-(QUINOLINE -6-YLMETHYL) IMIDAZO[1,2-B] [1,2,4]TRIAZINE -2-YL]BENZAMIDE (TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE)	⤷ Subscribe
Israel	198716	אימידזוטריאזינים ואימידזופירימידינים כמעכבי קינאז (Imidazotriazines and imidazopyrimidines as kinase inhibitors)	⤷ Subscribe
Chile	2017000180	Formulacion en forma de tableta de 2-fluor-n-metil-4-[7-(quinolin-6-ilmetil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida.	⤷ Subscribe
Brazil	112017000953	formulação de comprimido de 2-flúor-n-metil-4-[7-(quinolin-6-il-metil)imidazo[1,2-b][1,2,4]triazin-2-il]benzamida	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for capmatinib hydrochloride

Subscribe to access the full database, or Subscribe
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3172209	122022000076	Germany	⤷ Subscribe	PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
2099447	122022000083	Germany	⤷ Subscribe	PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
3172209	2022C/558	Belgium	⤷ Subscribe	PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621
3172209	CA 2022 00056	Denmark	⤷ Subscribe	PRODUCT NAME: CAPMATINIB ELER ET FARMACEUTISK ACCEPTABLET SALT DERAF; REG. NO/DATE: EU/1/22/1650 20220621
2099447	2022C/557	Belgium	⤷ Subscribe	PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: EU/1/22/1650 20220621
3172209	301208	Netherlands	⤷ Subscribe	PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1650 20220621
>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.