Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Serving leading biopharmaceutical companies globally:

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Last Updated: October 23, 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 patent protection?

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

Insulin degludec has one hundred and seventy-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.

Recent Clinical Trials for insulin degludec

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SponsorPhase
University of Colorado, DenverPhase 4
Population Health Research InstitutePhase 3
Eli Lilly and CompanyPhase 1

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Recent Litigation for insulin degludec

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

See all insulin degludec litigation

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 203314-002 Sep 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo TRESIBA insulin degludec SOLUTION;SUBCUTANEOUS 203314-002 Sep 25, 2015 RX Yes Yes   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 degludec

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0792290 28/2004 Austria   Start Trial PRODUCT NAME: INSULIN-DETEMIR UND PHARMAZEUTISCH ANNEHMBARE ZN-SALZE DAVON; NAT. REGISTRATION NO/DATE: EU/1/04/278/001-009 20040601; FIRST REGISTRATION: LI 56370 56371 56372 20031110
2107069 CA 2013 00030 Denmark   Start Trial
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:

Moodys
Baxter
McKinsey
Dow
Medtronic
AstraZeneca

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