SELUMETINIB SULFATE - Generic Drug Details
✉ Email this page to a colleague
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 |
Sarcoma Alliance for Research through Collaboration | Phase 2 |
United States Department of Defense | 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 | ||||
>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 |
>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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
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.