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Last Updated: October 4, 2024

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 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: 25
DailyMed Link:capmatinib hydrochloride at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for capmatinib hydrochloride
Generic Entry Date for capmatinib hydrochloride*:
Constraining patent/regulatory exclusivity:
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

SponsorPhase
Sun Yat-sen UniversityPhase 2
Yonsei UniversityPhase 2
Southwest Oncology GroupPhase 2

See all capmatinib hydrochloride clinical trials

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

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

Country Patent Number Title Estimated Expiration
Australia 2018207947 Tablet formulation of 2-fluoro-N-methyl-4-(7-(quinolin-6-ylmethyl)imidazo(1,2-b)(1,2,4)triazin-2-yl)Benzamide ⤷  Sign Up
Singapore 10201900648S TABLET FORMULATION OF 2-FLUORO-N-METHYL-4-[7-(QUINOLIN-6-YLMETHYL)IMIDAZO[1,2-B][1,2,4]TRIAZIN-2-YL]BENZAMIDE ⤷  Sign Up
China 113248510 2-氟-N-甲基-4-[7-(喹啉-6-基甲基)咪唑并[1,2-b][1,2,4]三嗪-2-基]苯甲酰胺的盐及与其相关的制备方法 (Salts of 2-fluoro-n-methyl-4-[7-(quinolin-6-ylmethyl) imidazo [1, 2-b] [1, 2, 4] triazin-2-yl] benzamide and processes related thereto) ⤷  Sign Up
Tunisia 2010000530 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 ⤷  Sign Up
Eurasian Patent Organization 032254 ИМИДАЗОТРИАЗИНЫ И ИМИДАЗОПИРИМИДИНЫ В КАЧЕСТВЕ ИНГИБИТОРОВ КИНАЗЫ (IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS) ⤷  Sign Up
Guatemala 201700007 FORMULACIÓN EN FORMA DE TABLETA DE 2-FLUOR-N-METIL-4-[7-(QUINOLIN-6-YLMETIL)IMIDAZO[1,2-B] [1,2,4]TRIAZIN-2-IL]BENZAMIDA ⤷  Sign Up
Malaysia 188338 IMIDAZOTRIAZINES AND IMIDAZOPYRIMIDINES AS KINASE INHIBITORS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for capmatinib hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2099447 301209 Netherlands ⤷  Sign Up PRODUCT NAME: CAPMATINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/22/1650 20220621
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 122022000083 Germany ⤷  Sign Up PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH UNBEDENKLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
3172209 22C1058 France ⤷  Sign Up PRODUCT NAME: CAPMATINIB OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, EN PARTICULIER LE SEL DE DICHLORHYDRATE; REGISTRATION 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
3172209 122022000076 Germany ⤷  Sign Up PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 20220620
3172209 51/2022 Austria ⤷  Sign Up PRODUCT NAME: CAPMATINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/22/1650 (MITTEILUNG) 20220621
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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