RAPAMUNE (nda021083)- (1MG/ML)

Generic Name	SIROLIMUS	Innovator	PF PRISM CV
Dosage	1MG/ML
ParaIV Filing	No	505(b)2 Filing	No
Last Patent Expiry	2014-Mar-30	NCE Excl Expiry	Expired
ODE Expiry	2022-May-28	NP Expiry	None
GAIN Expiry	None	Drug Complexity	No
Indication	• Rapamune is an mTOR inhibitor immunosuppressant indicated for the prophylaxis of organ rejection in patients aged ≥13 years receiving renal transplants: o Patients at low-to moderate-immunologic risk: Use initially with cyclosporine (CsA) and corticosteroids. CsA withdrawal is recommended 2-4 months after transplantation. o Patients at high-immunologic risk: Use in combination with CsA and corticosteroids for the first 12 months following transplantation. Safety and efficacy of CsA withdrawal has not been established in high risk patients. • Rapamune is an mTOR inhibitor indicated for the treatment of patients with lymphangioleiomyomatosis.

Approvals and Launches

Final Approvals	Tentative Approvals	Generic Launches
6	0	6

Other Developers

Total Other Developers	5

Drugs with Suitability

Drugs with Suitability	No

Drug Pricing

	NDA			ANDA
Dosage	Weekly	Monthly	Yearly	Yearly Up	Yearly Down
1MG/ML	**	**	-	-	4

Drug Sales

NDA Sales Available	Total Generic Sales Available
Yes	4

Manufacturing Details of RAPAMUNE