Selumetinib sulfate - Generic Drug Details
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What are the generic drug sources for selumetinib sulfate and what is the scope of freedom to operate?
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 |
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 | 213756-001 | Apr 10, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Astrazeneca | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-002 | Apr 10, 2020 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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 |
|---|---|---|---|
| Australia | 2009229204 | Pharmaceutical composition 271 | ⤷ Try a Trial |
| Brazil | PI0909267 | composição farmacêutica, processo para a preparação de uma composição farmacêutica, e, métodos para tratar um animal de sangue quente que sofre de um a condição e para tratar o câncer em um animal de sangue quente | ⤷ Try a Trial |
| Australia | 2003218157 | N3 ALKYLATED BENZIMIDAZOLE DERIVATIVES AS MEK INHIBITORS | ⤷ Try a Trial |
| South Africa | 200407220 | N3 alkylated benzimidazole derivatives as MEK inhibitors | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for selumetinib sulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1482932 | 300974 | Netherlands | ⤷ Try a Trial | DETAILS ASSIGNMENT: CHANGE OF OWNER(S), CHANGE OF OWNER(S) NAME |
| 1482932 | CA 2019 00011 | Denmark | ⤷ Try a Trial | PRODUCT NAME: BINIMETINIB I ALLE FORMER BESKYTTET AF GRUNDPATENTET; REG. NO/DATE: EU/1/18/1315 20180924 |
| 1482932 | C 2019 008 | Romania | ⤷ Try a Trial | PRODUCT NAME: BINIMETINIB; NATIONAL AUTHORISATION NUMBER: EU/1/18/1315; DATE OF NATIONAL AUTHORISATION: 20180920; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/18/1315; DATE OF FIRST AUTHORISATION IN EEA: 20180920 |
| 1968948 | C202130063 | Spain | ⤷ Try a Trial | PRODUCT NAME: SELUMETINIB HIDROGENOSULFATO, INCLUYENDO SOLVATOS Y FORMAS ANHIDRAS DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/21/1552; DATE OF AUTHORISATION: 20210617; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1552; DATE OF FIRST AUTHORISATION IN EEA: 20210617 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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.
ISSN: 2162-2639
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