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Last Updated: October 26, 2021

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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 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.

Recent Clinical Trials for osimertinib mesylate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Sichuan Baili Pharmaceutical Co., Ltd.Phase 2/Phase 3
TYK Medicines, IncPhase 1

See all osimertinib mesylate clinical trials

Generic filers with tentative approvals for OSIMERTINIB MESYLATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial80MGTABLET;ORAL
⤷  Free Forever Trial⤷  Free Forever Trial40MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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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