OSIMERTINIB MESYLATE - Generic Drug Details

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What are the generic drug sources for osimertinib mesylate and what is the scope of freedom to operate?

Osimertinib mesylate is the generic ingredient in one branded drug marketed by Astrazeneca and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Osimertinib mesylate has one hundred and seventy-six patent family members in forty-three countries.

There are two drug master file entries for osimertinib mesylate. One supplier is listed for this compound. There is one tentative approval for this compound.

Summary for OSIMERTINIB MESYLATE

International Patents:	176
US Patents:	4
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	75
Clinical Trials:	7
Patent Applications:	2,701
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for OSIMERTINIB MESYLATE
DailyMed Link:	OSIMERTINIB MESYLATE at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for OSIMERTINIB MESYLATE

Generic Entry Date for OSIMERTINIB MESYLATE^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 OSIMERTINIB MESYLATE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Sichuan Baili Pharmaceutical Co., Ltd.	Phase 2
Klus Pharma Inc.	Phase 2
Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.	Phase 2

See all OSIMERTINIB MESYLATE clinical trials

Generic filers with tentative approvals for OSIMERTINIB MESYLATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	80MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	40MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for OSIMERTINIB MESYLATE

Drug Class	Kinase Inhibitor
Mechanism of Action	Breast Cancer Resistance Protein Inhibitors Cytochrome P450 1A2 Inducers Cytochrome P450 3A Inhibitors Cytochrome P450 3A4 Inducers Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for OSIMERTINIB MESYLATE

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for OSIMERTINIB MESYLATE

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 OSIMERTINIB MESYLATE

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Glossary

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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				⤷ 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	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 OSIMERTINIB MESYLATE

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Country	Patent Number	Title	Estimated Expiration
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
Poland	3009431		⤷ Sign Up
European Patent Office	2736895	DERUVES DE 2-(2,4,5-SUBSTITUTED-ANILINO) PYRIMIDINE COMME MODULATUERS DU EGFR UTILES DANS LE TRAITEMENT DU CANCER (2-(2,4,5-SUBSTITUTED-ANILINO) PYRIMIDINE DERIVATIVES AS EGFR MODULATORS USEFUL FOR TREATING CANCER)	⤷ Sign Up
Ecuador	SP13013033	DERIVADOS DE 2-(2,4,5-ANILINO SUSTITUIDO)PIRIMIDINA COMO MODULADORES DE EGFR ÚTILES PARA EL TRATAMIENTO DEL CÁNCER	⤷ Sign Up
Japan	5977779		⤷ Sign Up
Croatia	P20211682		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for OSIMERTINIB MESYLATE

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

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