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Generated: April 20, 2019

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Insulin degludec - Generic Drug Details

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

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

Insulin degludec has one hundred and fifty-eight 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 TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-001 Sep 25, 2015 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo 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 TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novo TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes ➤ Sign Up ➤ Sign Up Y 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

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 PA2004005,C0792290 Lithuania ➤ Sign Up PRODUCT NAME: INSULIN DETEMIR; REGISTRATION NO/DATE: EU/1/04/278/001, EU/1/04/278/002, EU/1/04/278/003, EU/1/04/278/004, EU/1/04/278/005, EU/1/04/278/006, EU/1/04/278/007, EU/1/04/278/008, EU/1/04/278/00 20040601
2498802 122017000039 Germany ➤ Sign Up 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
2209800 C300698 Netherlands ➤ Sign Up PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
2498802 C201730022 Spain ➤ Sign Up PRODUCT NAME: SULIQUA-INSULINA GLARGINA/ LIXISENATIDA; NATIONAL AUTHORISATION NUMBER: EU/1/16/1157; DATE OF AUTHORISATION: 20170111; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1157; DATE OF FIRST AUTHORISATION IN EEA: 20170111
2107069 C20130014 00133 Estonia ➤ Sign Up PRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
2107069 CA 2013 00033 Denmark ➤ Sign Up
2498802 300883 Netherlands ➤ Sign Up PRODUCT NAME: INSULIN GLARGINE/LIXISENATIDE; REGISTRATION NO/DATE: EU/1/16/1157 20170113
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Moodys
Baxter
Cipla
Chinese Patent Office
Federal Trade Commission

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