Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 14, 2019

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 and is included in one NDA. There are nineteen 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 forty drug master file entries for this compound. Additional details are available on the insulin aspart; insulin degludec profile page.
Summary for 203313
Tradename:RYZODEG 70/30
Ingredient:insulin aspart; insulin degludec
Generic Entry Opportunity Date for 203313
Generic Entry Date for 203313*:
Constraining patent/regulatory exclusivity:

*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.

Profile for product number 001

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:  Start TrialPatent Expiration:Jul 17, 2026Product Flag?YSubstance Flag?Delist Request?

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.