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Osimertinib mesylateis the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.
Osimertinib mesylate has one hundred and fifty-one patent family members in forty-two countries.
There are two drug master file entries for osimertinib mesylate. One supplier is listed for this compound. There is one tentative approval for this compound.
Summary for osimertinib mesylate
|Drug Master File Entries:||2|
|Finished Product Suppliers / Packagers:||1|
|Raw Ingredient (Bulk) Api Vendors:||61|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for osimertinib mesylate|
|DailyMed Link:||osimertinib mesylate at DailyMed|
Recent Clinical Trials for osimertinib mesylate
Identify potential brand extensions & 505(b)(2) entrants
|Sichuan Baili Pharmaceutical Co., Ltd.||Phase 2/Phase 3|
|TYK Medicines, Inc||Phase 1|
Generic filers with tentative approvals for OSIMERTINIB MESYLATE
The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.
Pharmacology for osimertinib mesylate
|Drug Class||Kinase Inhibitor |
|Mechanism of Action||Kinase Inhibitors |
Cytochrome P450 3A Inhibitors
Cytochrome P450 3A4 Inducers
Cytochrome P450 1A2 Inducers
Breast Cancer Resistance Protein Inhibitors
|Country||Patent Number||Estimated Expiration|
|Serbia||54653||⤷ Free Forever Trial|
|Philippines||12016501310||⤷ Free Forever Trial|
|Cyprus||1117431||⤷ Free Forever Trial|
|Hungary||E026429||⤷ Free Forever Trial|
|Eurasian Patent Organization||024421||⤷ Free Forever Trial|
|Israel||246186||⤷ Free Forever Trial|
|>Country||>Patent Number||>Estimated Expiration|
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