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Osimertinib mesylate - Generic Drug Details

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

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

Osimertinib mesylate has eighty-one patent family members in thirty-eight countries.

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

Summary for osimertinib mesylate

International Patents:	81
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	40
Patent Applications:	3
DailyMed Link:	osimertinib mesylate at DailyMed

Pharmacology for osimertinib mesylate

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

Synonyms for osimertinib mesylate

1421373-66-1

2-Propenamide, N-(2-((2-(dimethylamino)ethyl)methylamino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)-2-pyrimidinyl)amino)phenyl)-, methanesulfonate (1:1)

AK198680

AKOS026673944

AZD 9291 mesylate

AZD-9291 (Mesylate)

AZD-9291 mesylate

AZD-9291 mesylate pound Osimertinib Mereletinib)

AZD9291 mesylate

AZD9291 Ms salt, Osimertinib Ms salt; Mereletinib Ms salt

BC600811

CHEBI:90948

CHEMBL3545063

D10766

EX-A1577

FT-0699962

HY-15772A

KS-00000SU8

Mereletinib mesylate

MFCD28137994

MolPort-044-560-736

N-(2-((2-(dimethylamino)ethyl)(methyl)amino)-4-methoxy-5-((4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl)amino)phenyl)acrylamide methanesulfonate

N-(2-{[2-(dimethylamino)ethyl](methyl)amino}-4-methoxy-5-{[4-(1-methyl-1H-indol-3-yl)pyrimidin-2-yl]amino}phenyl)prop-2-enamide methanesulfonate

Osimertinib mesilate (JAN)

Osimertinib mesylate (USAN)

Osimertinib mesylate [USAN]

osimertinib methanesulfonate

osimertinib monomesylate

RDL94R2A16

SCHEMBL14661152

Tagrisso (TN)

UNII-RDL94R2A16

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

International Patents for osimertinib mesylate

Country	Patent Number	Estimated Expiration
Israel	242285
Taiwan	201319057
Taiwan	I555743
Ecuador	SP13013033
Portugal	3009431