Selumetinib sulfate - Generic Drug Details
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What are the generic sources for selumetinib sulfate and what is the scope of patent protection?
Selumetinib sulfate
is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are five patents protecting this compound. Additional information is available in the individual branded drug profile pages.Selumetinib sulfate has one hundred and ninety-eight patent family members in forty-four countries.
One supplier is listed for this compound.
Summary for selumetinib sulfate
International Patents: | 198 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 24 |
Clinical Trials: | 37 |
Patent Applications: | 42 |
DailyMed Link: | selumetinib sulfate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for selumetinib sulfate
Generic Entry Date for selumetinib sulfate*:
Constraining patent/regulatory exclusivity:
INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH NEUROFIBROMATOSIS TYPE 1 (NF1) WHO HAVE SYMPTOMATIC, INOPERABLE PLEXIFORM NEUROFIBROMAS (PN) Dosage:
CAPSULE;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 selumetinib sulfate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 3 |
United States Department of Defense | Phase 2 |
Sarcoma Alliance for Research through Collaboration | Phase 2 |
Pharmacology for selumetinib sulfate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Mitogen-Activated Protein Kinase Kinase 1 Inhibitors Mitogen-Activated Protein Kinase Kinase 2 Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for selumetinib sulfate
US Patents and Regulatory Information for selumetinib sulfate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 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 selumetinib sulfate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Hong Kong | 1153139 | 作為 抑制劑的 烷基化苯並咪唑衍生物 (N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS MEK N3) | ⤷ Sign Up |
Lithuania | C1482932 | ⤷ Sign Up | |
Saudi Arabia | 109300195 | تركيبة صيدلانية جديدة مضادة للسرطان (A Novel Anti-Cancer Pharmaceutical Composition) | ⤷ Sign Up |
Japan | 2009521487 | ⤷ Sign Up | |
China | 101633644 | N3 alkylated benzimidazole derivatives as mek inhibitors | ⤷ Sign Up |
Denmark | 1482932 | ⤷ Sign Up | |
Taiwan | I343377 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for selumetinib sulfate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1968948 | 2021C/549 | Belgium | ⤷ Sign Up | PRODUCT NAME: SELUMETINIB (Y COMPRIS TOUS SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER HYDROGENOSULFATE), ESTERS, SOLVATES OU ENANTIOMERES DE CEUX-CI); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619 |
1482932 | PA2019007,C1482932 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
1482932 | 122019000022 | Germany | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB EINSCHLIESSLICH BINIMETINIB IN FORM EINES PHARMAZEUTISCH VERTRAEGLICHEN SALZES ODER SOLVATS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
1482932 | 14/2019 | Austria | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB UND PHARMAZEUTISCH ANNEHMBAREN SALZE ODER SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/18/1315 (MITTEILUNG) 20180924 |
1482932 | C01482932/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: BINIMETINIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66907 01.11.2019 |
1482932 | PA2019007 | Lithuania | ⤷ Sign Up | PRODUCT NAME: BINIMETINIBAS BET KOKIOMIS FORMOMIS, KURIOMS TAIKOMA PAGRINDINIO PATENTO APSAUGA; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
1968948 | LUC00234 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: SELUMETINIB (INCLUANT TOUS SES SELS PHARMACEUTIQUEMENT ACCEPTABLES (EN PARTICULIER LE SULFATE D'HYDROGENE), SES ESTERS, SOLVATES ET ENANTIOMERES); AUTHORISATION NUMBER AND DATE: EU/1/21/1552 20210619 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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