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Generated: November 21, 2018

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Details for New Drug Application (NDA): 022074

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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. There is one patent protecting this drug. 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. One supplier is 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:1
Generic Entry Opportunity Date for 022074
Generic Entry 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
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 15054-1060-3 1 POUCH in 1 CARTON (15054-1060-3) > 1 SYRINGE in 1 POUCH > .2 mL in 1 SYRINGE
SOMATULINE DEPOT lanreotide acetate SOLUTION;SUBCUTANEOUS 022074 NDA Ipsen Biopharmaceuticals, Inc. 15054-1090 15054-1090-3 1 POUCH in 1 CARTON (15054-1090-3) > 1 SYRINGE in 1 POUCH > .3 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML)
Approval Date:Aug 30, 2007TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 15, 2020
Regulatory Exclusivity Use:TO REDUCE THE FREQUENCY OF SHORT-ACTING SOMATOSTATIN ANALOG RESCUE THERAPY WHEN USED FOR THE TREATMENT OF ADULTS WITH CARCINOID SYNDROME
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
Regulatory Exclusivity Expiration:Dec 16, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH UNRESECTABLE,WELL- OR MODERATELY-DIFFERENTIATED LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS TO IMPROVE PROGRESSION-FREE SURVIVAL

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Medtronic
Daiichi Sankyo
Federal Trade Commission
Harvard Business School
Colorcon
Merck
Argus Health
Chubb

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