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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 Pharms and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.Selumetinib sulfate has one hundred and fifty-five patent family members in thirty-eight countries.
One supplier is listed for this compound.
Summary for selumetinib sulfate
| International Patents: | 155 |
| US Patents: | 4 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 11 |
| Clinical Trials: | 32 |
| Patent Applications: | 5 |
| DailyMed Link: | selumetinib sulfate at DailyMed |
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 |
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 Pharms | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start Trial | |||
| Astrazeneca Pharms | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Astrazeneca Pharms | KOSELUGO | selumetinib sulfate | CAPSULE;ORAL | 213756-001 | Apr 10, 2020 | RX | Yes | No | Start Trial | Start Trial | Y | Start 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 | Estimated Expiration |
|---|---|---|
| Hong Kong | 1141976 | Start Trial |
| Japan | 2009521487 | Start Trial |
| World Intellectual Property Organization (WIPO) | 03077914 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for selumetinib sulfate
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1482932 | LUC00100 | Luxembourg | Start Trial | PRODUCT NAME: BINIMETINIB SOUS TOUTES SES FORMES TELLES QUE PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/18/1315 20180924 |
| 1482932 | PA2019007,C1482932 | Lithuania | Start Trial | PRODUCT NAME: BINIMETINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA ARBA SOLVATAS; REGISTRATION NO/DATE: EU/1/18/1315 20180920 |
| 1482932 | C20190010 00281 | Estonia | Start Trial | PRODUCT NAME: BINIMETINIIB;REG NO/DATE: EU/1/18/1315 24.09.2018 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
