BUPHENYL (nda020572)- (500MG)

Generic Name	SODIUM PHENYLBUTYRATE	Innovator	HORIZON THERAP US
Dosage	500MG
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2004-Aug-20	NCE Excl Expiry	Expired
ODE Expiry	None	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	BUPHENYL® is indicated as adjunctive therapy in the chronic management of patients with urea cycle disorders involving deficiencies of carbamylphosphate synthetase (CPS), ornithine transcarbamylase (OTC), or argininosuccinic acid synthetase (AS). It is indicated in all patients with neonatal-onset deficiency (complete enzymatic deficiency, presenting within the first 28 days of life). It is also indicated in patients with late-onset disease (partial enzymatic deficiency, presenting after the first month of life) who have a history of hyperammonemic encephalopathy.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
2	0	2

Other Developers

Total Other Developers	2

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

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

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	2

Manufacturing Details of BUPHENYL