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Serving hundreds of leading biopharmaceutical companies globally:

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

Generated: September 23, 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.

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

Pharmacology for insulin degludec
Ingredient-typeInsulin
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 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novo Nordisk Inc TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 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
226 Luxembourg ➤ Sign Up PRODUCT NAME: COMBINATION D'INSULINE DEGLUDEC ET INSULINE ASPARTE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; FIRST REGISTRATION DATE: 20130121
00597 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN INSULINE ASPART; REGISTRATION NO/DATE: EU/1/12/806/001EU/1/12/806/004EU/1/12/806/005EU/1/12/806/007EU/1/12/806/008 2013210121
60026 Netherlands ➤ Sign Up 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
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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