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Last Updated: November 18, 2019

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Insulin aspart; insulin degludec - Generic Drug Details

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What are the generic sources for insulin aspart; insulin degludec and what is the scope of freedom to operate?

Insulin aspart; insulin degludec is the generic ingredient in one branded drug marketed by Novo and is included in one NDA. There are twenty patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin aspart; insulin degludec has one hundred and eighty-seven patent family members in twenty-three countries.

There are forty drug master file entries for insulin aspart; insulin degludec.

Summary for insulin aspart; insulin degludec
Recent Clinical Trials for insulin aspart; insulin degludec

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

SponsorPhase
University of Colorado, DenverPhase 4
Merete Bechmann ChristensenPhase 4
Novo Nordisk A/SPhase 4

See all insulin aspart; insulin degludec clinical trials

Recent Litigation for insulin aspart; insulin degludec

Identify potential future generic entrants

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

See all insulin aspart; insulin degludec litigation

US Patents and Regulatory Information for insulin aspart; insulin degludec

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 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   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 insulin aspart; insulin degludec

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0705275 32/2000 Austria   Start Trial PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2597103 CR 2017 00013 Denmark   Start Trial PRODUCT NAME: KOMBINATION AF INSULIN DEGLUDEC OG LIRAGLUTID; NAT. REG. NO/DATE: EU/1/14/947 20140922; FIRST REG. NO/DATE: CH 65041 20140912
2107069 CA 2013 00030 Denmark   Start Trial
0705275 41/2005 Austria   Start Trial PRODUCT NAME: NOVOMIX 70 - SUSPENSION, ENTHALTEND LOESLICHES INSULIN ASPART UND PROTAMINKRISTALLISIERTES INSULIN ASPART IM VERHAELTNIS 70:30; REGISTRATION NO/DATE: EU/1/00/142/017 - EU/1/00/142/022 20051005
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
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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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
Johnson and Johnson
Express Scripts
Medtronic
Baxter

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