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Last Updated: October 23, 2019

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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 nineteen patents protecting this drug.

This drug has one hundred and eighty-seven 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.

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
>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
0792290 28/2004 Austria   Start Trial PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
2107069 CA 2013 00030 Denmark   Start Trial
2107069 13C0035 France   Start Trial PRODUCT NAME: INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/12/807/001 20130121
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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