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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Fish and Richardson

Generated: December 16, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203313

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NDA 203313 describes RYZODEG 70/30, which is a drug marketed by Novo Nordisk Inc and is included in one NDA. There are thirteen patents protecting this drug. Additional details are available on the RYZODEG 70/30 profile page.

The generic ingredient in RYZODEG 70/30 is insulin aspart; insulin degludec. There are thirty-eight drug master file entries for this compound. Additional details are available on the insulin aspart; insulin degludec profile page.

Summary for 203313

Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;SUBCUTANEOUSStrength90 UNITS/3ML;210 UNITS/3ML (30 UNITS/ML;70 UNITS/ML)
Approval Date:Sep 25, 2015TE:RLD:Yes
Regulatory Exclusivity Expiration:Sep 25, 2020
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Dec 16, 2019
Regulatory Exclusivity Use:NEW PATIENT POPULATION
Patent:► SubscribePatent Expiration:Jun 20, 2017Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 203313

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo Nordisk IncRYZODEG 70/30insulin aspart; insulin degludecSOLUTION;SUBCUTANEOUS203313-001Sep 25, 2015► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Farmers Insurance
US Army
Express Scripts
US Department of Justice

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