Details for New Drug Application (NDA): 022074

NDA 022074 describes SOMATULINE DEPOT, which is a drug marketed by Ipsen Pharma and is included in one NDA. It is available from one supplier. Additional details are available on the SOMATULINE DEPOT profile page.

The generic ingredient in SOMATULINE DEPOT is lanreotide acetate. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the lanreotide acetate profile page.

Summary for 022074

Tradename:	SOMATULINE DEPOT
Applicant:	Ipsen Pharma
Ingredient:	lanreotide acetate
Patents:	0

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 022074

Constraining patent/regulatory exclusivity:

TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY

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: 022074

Mechanism of Action

Somatostatin Receptor Agonists

Suppliers and Packaging for NDA: 022074

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074	NDA	Ipsen Biopharmaceuticals, Inc.	15054-1060	15054-1060-4	1 POUCH in 1 CARTON (15054-1060-4) / 1 SYRINGE in 1 POUCH / .2 mL in 1 SYRINGE
SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074	NDA	Ipsen Biopharmaceuticals, Inc.	15054-1090	15054-1090-4	1 POUCH in 1 CARTON (15054-1090-4) / 1 SYRINGE in 1 POUCH / .3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
Approval Date:	Aug 30, 2007	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 15, 2024
Regulatory Exclusivity Use:	TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML)
Approval Date:	Aug 30, 2007	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 15, 2024
Regulatory Exclusivity Use:	TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY

Profile for product number 003

Active Rx/OTC/Discontinued:	RX	Dosage:	SOLUTION;SUBCUTANEOUS			Strength	EQ 120MG BASE/0.5ML (EQ 120MG BASE/0.5ML)
Approval Date:	Aug 30, 2007	TE:		RLD:	Yes
Regulatory Exclusivity Expiration:	Sep 15, 2024
Regulatory Exclusivity Use:	TREATMENT OF ADULTS WITH CARCINOID SYNDROME; WHEN USED, IT REDUCES THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY

Expired US Patents for NDA 022074

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-003	Aug 30, 2007
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-001	Aug 30, 2007
Ipsen Pharma	SOMATULINE DEPOT	lanreotide acetate	SOLUTION;SUBCUTANEOUS	022074-002	Aug 30, 2007

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