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Last Updated: December 8, 2019

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INSULIN ASPART; INSULIN DEGLUDEC - Generic Drug Details

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What are the generic drug sources for insulin aspart; insulin degludec and what is the scope of patent protection?

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-eight 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

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

See all INSULIN ASPART; INSULIN DEGLUDEC clinical trials

Recent Litigation for INSULIN ASPART; INSULIN DEGLUDEC

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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 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   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
2107069 138 5015-2013 Slovakia   Start Trial PRODUCT NAME: INZULIN DEGLUDEK; REGISTRATION NO/DATE: EU/1/12/807/001 - EU/1/12/807/015 20130121
0792290 04C0020 France   Start Trial PRODUCT NAME: INSULIN DETEMIR; NAT. REGISTRATION NO/DATE: EU/1/04/278/001 20040601; FIRST REGISTRATION: LI - 56370 20031110
2498802 122017000039 Germany   Start Trial PRODUCT NAME: SULIQUA (FIRMENEIGENER NAME DES MEDIZINISCHEN PRODUKTS) BZW. WIRKSTOFFZUSAMMENSETZUNG UMFASSEND INSULIN GLARGIN / LIXISENATID UND IHRE PHARMAZEUTISCH ANNEHMBAREN SALZE (INTERNATIONALER, NICHT FIRMENEIGENER NAME); REGISTRATION NO/DATE: EU/1/16/1157 20170111
0885961 SPC/GB05/024 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
2107069 C02107069/02 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + INSULIN ASPART; REGISTRATION NO/DATE: SWISSMEDIC 62648 12.09.2013
2498802 26/2017 Austria   Start Trial PRODUCT NAME: INSULIN GLARGIN UND LIXISENATID; REGISTRATION NO/DATE: EU/1/16/1157 (MITTEILUNG) 20170113
0383472 C960026 Netherlands   Start Trial PRODUCT NAME: INSULINUM LISPRUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/007/001 - EU/1/96/007/003 19960430
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Mallinckrodt
Merck
Medtronic
Baxter
AstraZeneca

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