TARCEVA (nda021743)- (EQ 25MG BASE,EQ 100MG BASE,EQ 150MG BASE)

Generic Name	ERLOTINIB HYDROCHLORIDE	Innovator	OSI PHARMS
Dosage	EQ 25MG BASE,EQ 100MG BASE,EQ 150MG BASE
ParaIV Filing	Yes	505(b)2 Filing	No
Last Patent Expiry	2021-May-09	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	TARCEVA is a kinase inhibitor indicated for: • The 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) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. • First-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer, in combination with gemcitabine.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
12	0	8

Other Developers

Total Other Developers	8

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
EQ 25MG BASE	**	**	-	-	-
EQ 100MG BASE	**	**	-	-	-
EQ 150MG BASE	**	**	-	-	-

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	7

Manufacturing Details of TARCEVA