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-seven patent family members in forty-four 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
Summary for TAGRISSO
| International Patents: | 177 |
| US Patents: | 4 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 74 |
| Clinical Trials: | 67 |
| Patent Applications: | 1,094 |
| 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
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
| Sponsor | Phase |
|---|---|
| Southwest Oncology Group | Phase 2 |
| Parexel | Phase 3 |
| Samsung Medical Center | Phase 2 |
Pharmacology for TAGRISSO
Anatomical Therapeutic Chemical (ATC) Classes 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 ten US patents and three FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of TAGRISSO is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2-(2,4,5-substituted-anilino) pyrimidine compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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
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: ⤷ Try a Trial
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: ⤷ Try a Trial
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: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Astrazeneca | TAGRISSO | osimertinib mesylate | TABLET;ORAL | 208065-002 | Nov 13, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| >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: ⤷ Try a Trial
Australia
Patent: 15204218
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 33403
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 16001609
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5848647
Estimated Expiration: ⤷ Try a Trial
Patent: 4712362
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 160310
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0210749
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 24848
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 89741
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 016000156
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 4243
Estimated Expiration: ⤷ Try a Trial
Patent: 1691242
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 89741
Estimated Expiration: ⤷ Try a Trial
Guatemala
Patent: 1600142
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 25655
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 54344
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 6186
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 88915
Estimated Expiration: ⤷ Try a Trial
Patent: 17501201
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 89741
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 3536
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 7358
Estimated Expiration: ⤷ Try a Trial
Patent: 16008744
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 1298
Estimated Expiration: ⤷ Try a Trial
Nicaragua
Patent: 1600098
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 161170
Estimated Expiration: ⤷ Try a Trial
Philippines
Patent: 016501310
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 89741
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 89741
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 927
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201605339Q
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 89741
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1605300
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 2336378
Estimated Expiration: ⤷ Try a Trial
Patent: 160101720
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 73226
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 02953
Estimated Expiration: ⤷ Try a Trial
Patent: 1609101
Estimated Expiration: ⤷ Try a Trial
United Kingdom
Patent: 1400034
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 933
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Philippines | 12015501326 | 2 - (2, 4, 5 - SUBSTITUTED -ANILINO) PYRIMIDINE DERIVATIVES AS EGFR MODULATORS USEFUL FOR TREATING CANCER | ⤷ Try a Trial |
| Hong Kong | 1221216 | -取代苯胺 嘧啶衍生物作為 調諧子用於治療癌症 (2-(2,4,5-SUBSTITUTED-ANILINO)PYRIMIDINE DERIVATIVES AS EGFR MODULATORS USEFUL FOR TREATING CANCER 2-(2,4,5-) EGFR) | ⤷ Try a Trial |
| Peru | 20161170 | COMPOSICIONES FARMACEUTICAS QUE COMPRENDEN AZD9291 | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for TAGRISSO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1848414 | CA 2016 00033 | Denmark | ⤷ Try a Trial | PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204 |
| 1848414 | C 2016 026 | Romania | ⤷ Try a Trial | 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 |
| 1848414 | CR 2016 00033 | Denmark | ⤷ Try a Trial | PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 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.
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