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Last Updated: December 5, 2020

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TAGRISSO Drug Profile

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Which patents cover Tagrisso, and when can generic versions of Tagrisso launch?

Tagrisso is a drug marketed by Astrazeneca Pharms and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and thirty-eight patent family members in forty-two countries.

The generic ingredient in TAGRISSO is osimertinib mesylate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the osimertinib mesylate profile page.

US ANDA Litigation and Generic Entry Outlook for Tagrisso

Tagrisso was eligible for patent challenges on November 13, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 2, 2035. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for TAGRISSO
Drug patent expirations by year for TAGRISSO
Drug Prices for TAGRISSO

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Generic Entry Opportunity Date for TAGRISSO
Generic Entry Date for TAGRISSO*:
Constraining patent/regulatory exclusivity:

*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 TAGRISSO

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

Genprex, Inc.Phase 1/Phase 2
National Cancer Institute (NCI)Phase 3
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2

See all TAGRISSO clinical trials

Paragraph IV (Patent) Challenges for TAGRISSO
Tradename Dosage Ingredient NDA Submissiondate
TAGRISSO TABLET;ORAL osimertinib mesylate 208065 2019-11-13

US Patents and Regulatory Information for TAGRISSO

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 208065-001 Nov 13, 2015 RX Yes No   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
Harvard Business School

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