TAGRISSO (nda208065)- (EQ 40MG BASE,EQ 80MG BASE)

Generic Name	OSIMERTINIB MESYLATE	Innovator	ASTRAZENECA
Dosage	EQ 40MG BASE,EQ 80MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2035-Jan-02	NCE Excl Expiry	2020-Nov-13
ODE Expiry	2022-Nov-13	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TAGRISSO is a kinase inhibitor indicated for: • 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 • the first-line treatment of adult patients with metastatic NSCLC whose tumors have EGFR exon 19 deletions or exon 21 L858R mutations, as detected by an FDA-approved test. • the treatment of adult patients with metastatic EGFR T790M mutation-positive NSCLC, as detected by an FDA-approved test, whose disease has progressed on or after EGFR TKI therapy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
0	3	0

Other Developers

Total Other Developers	3

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 40MG BASE	**	**	-	-	-
EQ 80MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	0

Manufacturing Details of TAGRISSO