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Last Updated: April 4, 2020

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RYZODEG 70/30 Drug Profile


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When do Ryzodeg 70/30 patents expire, and when can generic versions of Ryzodeg 70/30 launch?

Ryzodeg 70/30 is a drug marketed by Novo and is included in one NDA. There are twenty patents protecting this drug.

This drug has one hundred and ninety-three patent family members in twenty-three countries.

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.

US ANDA Litigation and Generic Entry Outlook for Ryzodeg 70/30

Ryzodeg 70/30 was eligible for patent challenges on September 25, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 28, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Drug patent expirations by year for RYZODEG 70/30
Generic Entry Opportunity Date for RYZODEG 70/30
Generic Entry Date for RYZODEG 70/30*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for RYZODEG 70/30

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Novo Nordisk A/SN/A

See all RYZODEG 70/30 clinical trials

Recent Litigation for RYZODEG 70/30

Identify potential future generic entrants

District Court Litigation
Case NameDate
SMITH v. NOVO NORDISK INC.2016-08-08

See all RYZODEG 70/30 litigation

US Patents and Regulatory Information for RYZODEG 70/30

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No   Start Trial   Start Trial   Start Trial
Novo RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Novo RYZODEG 70/30 insulin aspart; insulin degludec SOLUTION;SUBCUTANEOUS 203313-001 Sep 25, 2015 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for RYZODEG 70/30

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2107069 C20130014 00133 Estonia   Start Trial PRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
2107069 472 Finland   Start Trial
2107069 C 2013 019 Romania   Start Trial PRODUCT NAME: INSULINA DEGLUDECIN TOATE FORMELE SALE ASA CUM SUNT PROTEJATE IN BREVETUL DEBAZA; NATIONAL AUTHORISATION NUMBER: EU/1/12/807/001; DATE OF NATIONAL AUTHORISATION: 20130121; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/807/001; DATE OF FIRST AUTHORISATION IN EEA: 20130121
2597103 2017/015 Ireland   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; NAT REGISTRATION NO/DATE: EU/1/14/947 20140918; FIRST REGISTRATION NO/DATE: 65041 20140912
2498802 132017000077235 Italy   Start Trial PRODUCT NAME: COMPOSIZIONE FARMACEUTICA COMPRENDENTE INSULINA GLARGINA E LIXISENATIDE(SULIQUA); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1157, 20170113
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Dow
McKinsey
Moodys
Colorcon
AstraZeneca
Merck

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 verification 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.