Capmatinib hydrochloride - Generic Drug Details
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What are the generic drug 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*:
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
Sponsor | Phase |
---|---|
Sun Yat-sen University | Phase 2 |
Yonsei University | Phase 2 |
Southwest Oncology Group | Phase 2 |
Pharmacology 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 | ⤷ 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 | ||
>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 |
---|---|---|---|
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 | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for capmatinib hydrochloride
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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