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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Summary for TAGRISSO
| International Patents: | 176 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 69 |
| Patent Applications: | 43 |
| Drug Prices: | Drug price information for TAGRISSO |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for TAGRISSO |
| What excipients (inactive ingredients) are in TAGRISSO? | TAGRISSO excipients list |
| DailyMed Link: | TAGRISSO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for TAGRISSO
*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
| Sponsor | Phase |
|---|---|
| Jonathan Riess | Phase 1 |
| TYK Medicines, Inc | Phase 2 |
| Southwest Oncology Group | Phase 2 |
Pharmacology for TAGRISSO
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 | ||||
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-001 | Nov 13, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-001 | Nov 13, 2015 | RX | Yes | No | ⤷ 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 |
|---|---|---|---|
| Eurasian Patent Organization | 034243 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ AZD9291, ДЛЯ ЛЕЧЕНИЯ РАКА (PHARMACEUTICAL COMPOSITIONS COMPRISING AZD9291 FOR TREATING CANCER) | ⤷ Sign Up |
| Argentina | 087336 | COMPUESTOS DE 2-(2,4,5-ANILINO SUSTITUIDO)PIRIMIDINA | ⤷ Sign Up |
| Brazil | 122014026114 | compostos de fórmula (i), composição farmacêutica e uso do composto | ⤷ Sign Up |
| China | 105254616 | 2-(2,4,5-SUBSTITUTED-ANILINO)PYRIMIDINE COMPOUNDS and salts thereof | ⤷ Sign Up |
| Hungary | E026429 | ⤷ Sign Up | |
| Lithuania | 3009431 | ⤷ Sign Up | |
| Portugal | 3686193 | ⤷ 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 | CR 2016 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204 |
| 1848414 | 122016000056 | Germany | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202 |
| 1848414 | 132016000078445 | Italy | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB(TAGRISSO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1086, 20160204 |
| 1848414 | 93160 | Luxembourg | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB (TAGRISSO); FIRST REGISTRATION DATE: 20160204 |
| 1848414 | 300824 | Netherlands | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204 |
| 1848414 | CA 2016 00033 | Denmark | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204 |
| 1848414 | C 2016 026 | Romania | ⤷ Sign Up | PRODUCT NAME: OSIMERTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1086; DATE OF NATIONAL AUTHORISATION: 20160202; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1086; DATE OF FIRST AUTHORISATION IN EEA: 20160202 |
| >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.
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