PENTASA (nda020049)- (250MG,500MG)

Generic Name	MESALAMINE	Innovator	TAKEDA PHARMS USA
Dosage	250MG,500MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2007-Dec-25	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	PENTASA is indicated for the induction of remission and for the treatment of adult patients with mildly to moderately active ulcerative colitis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
1	0	1

Other Developers

Total Other Developers	55

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
250MG	**	**	Down	-	-
500MG	**	**	Up	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of PENTASA