STALEVO 100 (nda021485)- (25MG;200MG;100MG)

Generic Name	CARBIDOPA; ENTACAPONE; LEVODOPA	Innovator	ORION PHARMA
Dosage	25MG;200MG;100MG
ParaIV Filing	Yes	505(b)2 Filing	Yes
Last Patent Expiry	2020-Jun-29	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	Stalevo, a combination drug consisting of levodopa (aromatic amino acid), carbidopa (aromatic amino acid decarboxylation inhibitor), and entacapone (catechol-O-methyltransferase (COMT) inhibitor) is indicated for the treatment of Parkinson’s disease. Stalevo is to be used: • To substitute (with equivalent strengths of each of the three components) for carbidopa/levodopa and entacapone previously administered as individual products • To replace carbidopa/levodopa therapy (without entacapone) when patients experience the signs and symptoms of end-of-dose “wearingoff” and when they have been taking a total daily dose of levodopa of 600 mg or less and have not been experiencing dyskinesias.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	1

Other Developers

Total Other Developers	None

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
25MG;200MG;100MG	**	**	-	-	1

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	1

Manufacturing Details of STALEVO 100