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Last Updated: July 14, 2020

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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 Pharms 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 twenty-nine patent family members in forty-two countries.

There are two drug master file entries for osimertinib mesylate. One supplier is listed for this compound.

Summary for osimertinib mesylate
International Patents:129
US Patents:3
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 2
Suppliers / Packagers: 1
Bulk Api Vendors: 54
Patent Applications: 6
DailyMed Link:osimertinib mesylate at DailyMed
Paragraph IV (Patent) Challenges for OSIMERTINIB MESYLATE
Tradename Dosage Ingredient NDA Submissiondate
TAGRISSO TABLET;ORAL osimertinib mesylate 208065 2019-11-13

US Patents and Regulatory Information for osimertinib mesylate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Pharms TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
AstraZeneca
Medtronic
Baxter
McKinsey

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