Osimertinib mesylate - Generic Drug Details
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What are the generic sources for osimertinib mesylate and what is the scope of patent protection?
Osimertinib mesylate
is 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 seventy-one patent family members in forty-four 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
International Patents: | 171 |
US Patents: | 3 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 67 |
Clinical Trials: | 5 |
Patent Applications: | 3,150 |
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
Sponsor | Phase |
---|---|
Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | Phase 1/Phase 2 |
Wuhan Union Hospital, China | Phase 2 |
Sichuan Baili Pharmaceutical Co., Ltd. | Phase 2/Phase 3 |
Generic filers with tentative approvals for OSIMERTINIB MESYLATE
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 80MG | TABLET;ORAL |
See Plans and Pricing | See Plans and Pricing | 40MG | TABLET;ORAL |
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 | Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inducers Kinase Inhibitors |
Paragraph IV (Patent) Challenges for OSIMERTINIB MESYLATE
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
TAGRISSO | Tablets | osimertinib mesylate | 40 mg and 80 mg | 208065 | 3 | 2019-11-13 |
US Patents and Regulatory Information for osimertinib mesylate
International Patents for osimertinib mesylate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
South Korea | 101422619 | See Plans and Pricing | |
Peru | 20141700 | COMPUESTOS DE 2-(2,4,5-ANILINO SUSTITUIDO) PIRIMIDINA | See Plans and Pricing |
Spain | 2873226 | See Plans and Pricing | |
China | 105175396 | Substituted 4-methoxy-N3-(pyrimidine-2-yl)phenyl-1,3-diamine compound and salt thereof | See Plans and Pricing |
Japan | 2013544273 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for osimertinib mesylate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1848414 | 93160 | Luxembourg | See Plans and Pricing | PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204 |
1848414 | 300824 | Netherlands | See Plans and Pricing | PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204 |
1848414 | CA 2016 00033 | Denmark | See Plans and Pricing | PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204 |
1848414 | 132016000078445 | Italy | See Plans and Pricing | PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204 |
1848414 | 122016000056 | Germany | See Plans and Pricing | PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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