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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Chubb
Federal Trade Commission
McKesson
Fuji
US Department of Justice
Teva
Johnson and Johnson
Julphar

Generated: December 16, 2018

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Insulin degludec - Generic Drug Details

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

Insulin degludec is the generic ingredient in two branded drugs marketed by Novo Nordisk Inc and is included in two NDAs. There are seventeen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Insulin degludec has one hundred and thirty-five patent family members in twenty-three countries.

There are forty drug master file entries for insulin degludec. Two suppliers are listed for this compound.

Pharmacology for insulin degludec
Drug ClassInsulin Analog
Synonyms for insulin degludec
(1A-21A),(1B-29B)-Insulin (human), 29B-(N6-(N-(15-carboxy-1-oxopentadecyl)-L-gamma- glutamyl)-L-lysine)-
54Q18076QB
844439-96-9
886983-20-6
B29N(epsilon)-omega-carboxypentadecanoyl-gamma-L-glutamyl desB30 human insulin
Degludec
Insulin degludec [USAN:INN]
NN 1250
NN1250
Tresiba
UNII-54Q18076QB

US Patents and Regulatory Information for 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 Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Supplementary Protection Certificates for insulin degludec

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0885961/01 Switzerland ➤ Sign Up PRODUCT NAME: INSULIN GLULISIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 57013 02.05.2005
C0009 France ➤ Sign Up PRODUCT NAME: INSULINE GLULISINE; REGISTRATION NO/DATE IN FRANCE: EU/1/04/258/001 DU 20040927; REGISTRATION NO/DATE AT EEC: EU/1/04/285/001 DU 20040927
2/2005 Austria ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE
91020-8 0090020-9 Sweden ➤ Sign Up PRODUCT NAME: LANTUS - INSULIN GLARGIN; REGISTRATION NO/DATE: EU/1/00/134/001 20000609
C/GB05/024 United Kingdom ➤ Sign Up PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
00698 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Chubb
Federal Trade Commission
McKesson
Fuji
US Department of Justice
Teva
Johnson and Johnson
Julphar

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