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Last Updated: September 27, 2021

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TAGRISSO Drug Patent Profile


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

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

This drug has one hundred and forty-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.

DrugPatentWatch® 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.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There is one tentative approval for the generic drug (osimertinib mesylate), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

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Drug patent expirations by year for TAGRISSO
Drug Prices for TAGRISSO

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for TAGRISSO
Generic Entry Date for TAGRISSO*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*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

SponsorPhase
M.D. Anderson Cancer CenterPhase 1/Phase 2
Beijing Cancer Prevention & Treatment SocietyPhase 2
Sun Yat-sen UniversityPhase 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 TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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:

Medtronic
Boehringer Ingelheim
Harvard Business School
McKinsey
Merck
Colorcon

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.