Osimertinib mesylate - Generic Drug Details

What are the generic sources for osimertinib mesylate and what is the scope of patent protection?

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

Osimertinib mesylate has one hundred and seventy-one patent family members in forty-four 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:	171
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	67
Clinical Trials:	5
Patent Applications:	3,150
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for osimertinib mesylate
DailyMed Link:	osimertinib mesylate at DailyMed

Recent Clinical Trials for osimertinib mesylate

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

Sponsor	Phase
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.	Phase 1/Phase 2
Wuhan Union Hospital, China	Phase 2
Sichuan Baili Pharmaceutical Co., Ltd.	Phase 2/Phase 3

See all osimertinib mesylate clinical trials

Generic filers with tentative approvals for OSIMERTINIB MESYLATE

Applicant	Application No.	Strength	Dosage Form
		80MG	TABLET;ORAL
		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

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

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			Y	Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-001	Nov 13, 2015		RX	Yes	No			Y
Astrazeneca	TAGRISSO	osimertinib mesylate	TABLET;ORAL	208065-002	Nov 13, 2015		RX	Yes	Yes			Y

International Patents for osimertinib mesylate

Country	Patent Number	Title	Estimated Expiration
South Korea	101422619
Peru	20141700	COMPUESTOS DE 2-(2,4,5-ANILINO SUSTITUIDO) PIRIMIDINA
Spain	2873226
China	105175396	Substituted 4-methoxy-N3-(pyrimidine-2-yl)phenyl-1,3-diamine compound and salt thereof
Japan	2013544273

Supplementary Protection Certificates for osimertinib mesylate

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