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Last Updated: October 12, 2024

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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 four patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and seventy-six patent family members in forty-three 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

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Jonathan RiessPhase 1
TYK Medicines, IncPhase 2
Southwest Oncology GroupPhase 2

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 thirteen US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAGRISSO is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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

Pharmaceutical compositions comprising AZD9291
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY

2-(2,4,5-substituted-anilino)pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

2-(2,4,5-substituted-anilino) pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY

2-(2,4,5-substituted-anilino)pyrimidine compounds
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY

FDA Regulatory Exclusivity protecting TAGRISSO

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: ⤷  Sign Up

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: ⤷  Sign Up

IN COMBINATION WITH PEMETREXED AND PLATINUM-BASED CHEMOTHERAPY FOR THE FIRST-LINE TREATMENT OF ADULT PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE EGFR EXON 19 DELETIONS OR EXON 21 L858R MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-001 Nov 13, 2015 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca TAGRISSO osimertinib mesylate TABLET;ORAL 208065-002 Nov 13, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Patent: COMPOSICIONES FARMACÉUTICAS QUE COMPRENDEN AZD9291
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 15204218
Patent: Pharmaceutical compositions comprising AZD9291
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 33403
Patent: COMPOSITIONS PHARMACEUTIQUES COMPRENANT AZD9291 (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291)
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 16001609
Patent: Composiciones farmacéuticas que comprenden azd9291.
Estimated Expiration: ⤷  Sign Up

China

Patent: 5848647
Patent: 包含AZD9291的药用组合物 (Pharmaceutical compositions comprising AZD9291)
Estimated Expiration: ⤷  Sign Up

Patent: 4712362
Patent: 包含AZD9291的药用组合物 (Pharmaceutical composition comprising AZD9291)
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 160310
Patent: COMPOSICIONES FARMACPEUTICAS QUE COMPRENDEN AZD9291
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0210749
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 24848
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 89741
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 016000156
Patent: COMPOSICIONES FARMACÿUTICAS QUE COMPRENDEN AZD9291.
Estimated Expiration: ⤷  Sign Up

Eurasian Patent Organization

Patent: 4243
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ AZD9291, ДЛЯ ЛЕЧЕНИЯ РАКА (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291 FOR TREATING CANCER)
Estimated Expiration: ⤷  Sign Up

Patent: 1691242
Patent: ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ AZD9291
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 89741
Patent: COMPOSITIONS PHARMACEUTIQUES COMPRENANT AZD9291 (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291)
Estimated Expiration: ⤷  Sign Up

Guatemala

Patent: 1600142
Patent: COMPOSICIONES FARMACÉUTICAS QUE COMPRENDEN AZD9291
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 25655
Patent: 包含AZD9291的藥用組合物 (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 54344
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6186
Patent: תכשירים רוקחיים המכילים azd9291 (Pharmaceutical compositions comprising azd9291)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 88915
Estimated Expiration: ⤷  Sign Up

Patent: 17501201
Patent: AZD9291を含む医薬組成物
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 89741
Estimated Expiration: ⤷  Sign Up

Malaysia

Patent: 3536
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 7358
Patent: COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN AZD9291. (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291.)
Estimated Expiration: ⤷  Sign Up

Patent: 16008744
Patent: COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN AZD9291. (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291.)
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 1298
Patent: Pharmaceutical compositions comprising azd9291
Estimated Expiration: ⤷  Sign Up

Nicaragua

Patent: 1600098
Patent: COMPOSICIONES FARMACÉUTICAS QUE COMPRENDEN AZD9291
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 161170
Patent: COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN AZD9291
Estimated Expiration: ⤷  Sign Up

Philippines

Patent: 016501310
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 89741
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 89741
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 927
Patent: FARMACEUTSKE SUPSTANCE KOJE SADRŽE AZD9291 (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291)
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201605339Q
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 89741
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1605300
Patent: PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 2336378
Estimated Expiration: ⤷  Sign Up

Patent: 160101720
Patent: AZD9291을 포함하는 제약 조성물 (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291)
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 73226
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 02953
Estimated Expiration: ⤷  Sign Up

Patent: 1609101
Patent: Pharmaceutical compositions comprising AZD9291
Estimated Expiration: ⤷  Sign Up

United Kingdom

Patent: 1400034
Estimated Expiration: ⤷  Sign Up

Uruguay

Patent: 933
Patent: COMPOSICIONES FARMACÉUTICAS QUE COMPRENDEN AZD9291
Estimated Expiration: ⤷  Sign Up

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
Spain 2873226 ⤷  Sign Up
Canada 2843109 DERIVES DE 2-(ANILINO 2,4,5-SUBSTITUE)PYRIMIDINE UTILISES COMME MODULATEURS DE L'EGFR UTILES POUR LE TRAITEMENT D'UN CANCER (2 -(2,4,5-SUBSTITUTED -ANILINO) PYRIMIDINE DERIVATIVES AS EGFR MODULATORS USEFUL FOR TREATING CANCER) ⤷  Sign Up
New Zealand 721298 Pharmaceutical compositions comprising azd9291 ⤷  Sign Up
Slovenia 2736895 ⤷  Sign Up
Ukraine 109736 ПОЛІМОРФНА ФОРМА МЕЗИЛАТНОЇ СОЛІ 2-(2,4,5-ЗАМІЩЕНОГО АНІЛІНО)ПІРИМІДИНУ (ВАРІАНТИ) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TAGRISSO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1848414 93160 Luxembourg ⤷  Sign Up PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204
1848414 122016000056 Germany ⤷  Sign Up PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
1848414 CR 2016 00033 Denmark ⤷  Sign Up PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1848414 132016000078445 Italy ⤷  Sign Up PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204
1848414 300824 Netherlands ⤷  Sign Up PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.