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Express Scripts
Baxter
Cerilliant
Moodys
Citi
Fish and Richardson
Covington
Dow
Teva

Generated: November 16, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200677

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

The generic ingredient in SIGNIFOR is pasireotide pamoate. One supplier is listed for this compound. Additional details are available on the pasireotide pamoate profile page.
Summary for 200677
Tradename:SIGNIFOR
Applicant:Novartis
Ingredient:pasireotide diaspartate
Patents:2
Generic Entry Opportunity Date for 200677
Generic Entry Date for 200677*:
Constraining patent/regulatory exclusivity:
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
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 Novartis Pharmaceuticals Corporation 0078-0633 0078-0633-20 60 PACKAGE in 1 BOX (0078-0633-20) > 6 AMPULE in 1 PACKAGE (0078-0633-06) > 1 mL in 1 AMPULE (0078-0633-61)
SIGNIFOR pasireotide diaspartate SOLUTION;SUBCUTANEOUS 200677 NDA Novartis Pharmaceuticals Corporation 0078-0634 0078-0634-20 60 PACKAGE in 1 BOX (0078-0634-20) > 6 AMPULE in 1 PACKAGE (0078-0634-06) > 1 mL in 1 AMPULE (0078-0634-61)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrengthEQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
Approval Date:Dec 14, 2012TE:RLD:Yes
Regulatory Exclusivity Expiration:Dec 14, 2019
Regulatory Exclusivity Use:TREATMENT OF ADULT PATIENTS WITH CUSHING'S DISEASE FOR WHOM PITUITARY SURGERY IS NOT AN OPTION OR HAS NOT BEEN CURATIVE
Patent:➤ Sign UpPatent Expiration:Dec 14, 2026Product Flag?YSubstance Flag?YDelist Request?
Patent:➤ Sign UpPatent Expiration:Dec 27, 2025Product Flag?YSubstance Flag?YDelist Request?

Expired US Patents for NDA 200677

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

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