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Generated: November 21, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203255

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NDA 203255 describes SIGNIFOR LAR KIT, which is a drug marketed by Novartis Pharms Corp and is included in one NDA. It is available from one supplier. There are four patents protecting this drug. Additional details are available on the SIGNIFOR LAR KIT profile page.

The generic ingredient in SIGNIFOR LAR KIT is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.
Summary for 203255
Tradename:SIGNIFOR LAR KIT
Applicant:Novartis Pharms Corp
Ingredient:pasireotide pamoate
Patents:4
Generic Entry Opportunity Date for 203255
Generic Entry Date for 203255*:
Constraining patent/regulatory exclusivity:
Dosage:
POWDER;INTRAMUSCULAR

*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.

Suppliers and Packaging for NDA: 203255
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255 NDA Novartis Pharmaceuticals Corporation 0078-0641 0078-0641-81 1 KIT in 1 KIT (0078-0641-81) * 6 mL in 1 VIAL, SINGLE-USE (0078-0762-61) * 2 mL in 1 SYRINGE
SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255 NDA Novartis Pharmaceuticals Corporation 0078-0642 0078-0642-81 1 KIT in 1 KIT (0078-0642-81) * 6 mL in 1 VIAL, SINGLE-USE (0078-0776-61) * 2 mL in 1 SYRINGE

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:FOR SUSPENSION;INTRAMUSCULARStrengthEQ 20MG BASE/VIAL
Approval Date:Dec 15, 2014TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 29, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
Regulatory Exclusivity Expiration:Dec 15, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTSWITH ACROMEGALY WHO HAVE HAD AN INADEQUATE RESPONSE TO SURGERY AND/OR FOR WHOM SURGERY IS NOT AN OPTION
Patent:➤ Try a Free TrialPatent Expiration:Dec 14, 2026Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 203255

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis Pharms Corp SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-003 Dec 15, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-001 Dec 15, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis Pharms Corp SIGNIFOR LAR KIT pasireotide pamoate FOR SUSPENSION;INTRAMUSCULAR 203255-002 Dec 15, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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