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Last Updated: September 26, 2022

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 sixty-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 have been four patent litigation cases 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

See drug prices for TAGRISSO

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
Karen Reckamp, MD, MSPhase 1
Enviro Therapeutics, Inc.Phase 1
TYK Medicines, IncPhase 3

See all TAGRISSO clinical trials

Paragraph IV (Patent) Challenges for TAGRISSO
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 TAGRISSO

TAGRISSO is protected by nine US patents and four FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAGRISSO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting TAGRISSO

Pharmaceutical compositions comprising AZD9291
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY

Pharmaceutical compositions comprising AZD9291
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS

Pharmaceutical compositions comprising AZD9291
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS

2-(2,4,5-substituted-anilino) pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY

2-(2,4,5-substituted-anilino) pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS

2-(2,4,5-substituted-anilino) pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS

2-(2,4,5-substituted-anilino)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY

2-(2,4,5-substituted-anilino)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21L858R MUTATIONS

2-(2,4,5-substituted-anilino)pyrimidine compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: ADJUVANT THERAPY AFTER TUMOR RESECTION IN PATIENTS WITH NON-SMALL CELL LUNG CANCER(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19DELETIONS OR EXON 21 L858R MUTATIONS

FDA Regulatory Exclusivity protecting TAGRISSO

FOR TREATMENT OF PATIENTS WITH METASTATIC EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) T790M MUTATION-POSITIVE NON-SMALL CELL LUNG CANCER (NSCLC), AS DETECTED BY AN FDA-APPROVED TEST, WHO HAVE PROGRESSED ON OR AFTER EGFR TKI THERAPY
Exclusivity Expiration: See Plans and Pricing

INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

FOR ADJUVANT THERAPY AFTER TUMOR RESECTION IN ADULT PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

INDICATION OF OSIMERTINIB AS ADJUVANT THERAPY AFTER TUMOR RESECTION IN ADULT PATIENTS WITH NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: See Plans and Pricing

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

International Patents for TAGRISSO

When does loss-of-exclusivity occur for TAGRISSO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8989
Estimated Expiration: See Plans and Pricing

Australia

Patent: 15204218
Estimated Expiration: See Plans and Pricing

Canada

Patent: 33403
Estimated Expiration: See Plans and Pricing

Chile

Patent: 16001609
Estimated Expiration: See Plans and Pricing

China

Patent: 5848647
Estimated Expiration: See Plans and Pricing

Patent: 4712362
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 160310
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0210749
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 89741
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 016000156
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 4243
Estimated Expiration: See Plans and Pricing

Patent: 1691242
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 89741
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 1600142
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 25655
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 54344
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6186
Estimated Expiration: See Plans and Pricing

Japan

Patent: 88915
Estimated Expiration: See Plans and Pricing

Patent: 17501201
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 89741
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3536
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7358
Estimated Expiration: See Plans and Pricing

Patent: 16008744
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 1298
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 1600098
Estimated Expiration: See Plans and Pricing

Peru

Patent: 161170
Estimated Expiration: See Plans and Pricing

Philippines

Patent: 016501310
Estimated Expiration: See Plans and Pricing

Poland

Patent: 89741
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 89741
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 927
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201605339Q
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 89741
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 2336378
Estimated Expiration: See Plans and Pricing

Patent: 160101720
Estimated Expiration: See Plans and Pricing

Spain

Patent: 73226
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 02953
Estimated Expiration: See Plans and Pricing

Patent: 1609101
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 1400034
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 933
Estimated Expiration: See Plans and Pricing

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TAGRISSO around the world.

Country Patent Number Title Estimated Expiration
Chile 2016001609 Composiciones farmacéuticas que comprenden azd9291. See Plans and Pricing
Japan 2014139226 2-(2,4,5-SUBSTITUTED-ANILINO)PYRIMIDINE COMPOUND See Plans and Pricing
Colombia 6811863 Compuestos de 2-(2,4,5-anilino sustituido)pirimidina See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAGRISSO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1848414 132016000078445 Italy See Plans and Pricing PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204
1848414 300824 Netherlands See Plans and Pricing PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204
1848414 93160 Luxembourg See Plans and Pricing PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.