Details for New Drug Application (NDA): 200677

NDA 200677 describes SIGNIFOR, which is a drug marketed by Recordati Rare and is included in two NDAs. It is available from one supplier. There are three patents protecting this drug. Additional details are available on the SIGNIFOR profile page.

The generic ingredient in SIGNIFOR is pasireotide pamoate. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.

Summary for 200677

Tradename:	SIGNIFOR
Applicant:	Recordati Rare
Ingredient:	pasireotide diaspartate
Patents:	1

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 200677

Dosage:

SOLUTION;SUBCUTANEOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Pharmacology for NDA: 200677

Mechanism of Action

Somatostatin Receptor Agonists

Suppliers and Packaging for NDA: 200677

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677	NDA	Recordati Rare Diseases, Inc.	55292-131	55292-131-60	60 PACKAGE in 1 BOX (55292-131-60) / 6 AMPULE in 1 PACKAGE (55292-131-06) / 1 mL in 1 AMPULE (55292-131-01)
SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677	NDA	Recordati Rare Diseases, Inc.	55292-132	55292-132-60	60 PACKAGE in 1 BOX (55292-132-60) / 6 AMPULE in 1 PACKAGE (55292-132-06) / 1 mL in 1 AMPULE (55292-132-01)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
Approval Date:	Dec 14, 2012	TE:		RLD:	Yes
Patent:		Patent Expiration:	Dec 14, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
Approval Date:	Dec 14, 2012	TE:		RLD:	Yes
Patent:		Patent Expiration:	Dec 14, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
Approval Date:	Dec 14, 2012	TE:		RLD:	Yes
Patent:		Patent Expiration:	Dec 14, 2026	Product Flag?	Y	Substance Flag?	Y	Delist Request?

Expired US Patents for NDA 200677

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-002	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-001	Dec 14, 2012
Recordati Rare	SIGNIFOR	pasireotide diaspartate	SOLUTION;SUBCUTANEOUS	200677-003	Dec 14, 2012

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