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Last Updated: December 5, 2019

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INSULIN DEGLUDEC; LIRAGLUTIDE - Generic Drug Details

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

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

Insulin degludec; liraglutide has two hundred and ninety-eight patent family members in twenty-seven countries.

There are forty drug master file entries for insulin degludec; liraglutide. One supplier is listed for this compound.

Summary for INSULIN DEGLUDEC; LIRAGLUTIDE
Recent Clinical Trials for INSULIN DEGLUDEC; LIRAGLUTIDE

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SponsorPhase
Emory UniversityPhase 3
Novo Nordisk A/SN/A
Novo Nordisk A/SPhase 3

See all INSULIN DEGLUDEC; LIRAGLUTIDE clinical trials

Recent Litigation for INSULIN DEGLUDEC; LIRAGLUTIDE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Novo Nordisk Inc. v. Teva Pharmaceuticals USA, Inc.2017-03-03
SMITH v. NOVO NORDISK INC.2016-08-08

See all INSULIN DEGLUDEC; LIRAGLUTIDE litigation

Pharmacology for INSULIN DEGLUDEC; LIRAGLUTIDE

US Patents and Regulatory Information for INSULIN DEGLUDEC; LIRAGLUTIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016 RX Yes Yes   Start Trial   Start Trial Y 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

Expired US Patents for INSULIN DEGLUDEC; LIRAGLUTIDE

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016   Start Trial   Start Trial
Novo XULTOPHY 100/3.6 insulin degludec; liraglutide SOLUTION;SUBCUTANEOUS 208583-001 Nov 21, 2016   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for INSULIN DEGLUDEC; LIRAGLUTIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
2107069 C20130014 00133 Estonia   Start Trial PRODUCT NAME: DEGLUDEKINSULIIN/ASPARTINSULIIN;REG NO/DATE: K(2013)368 (LOPLIK) 23.01.2013
0792290 0491022-0 Sweden   Start Trial PRODUCT NAME: N EPSILONB29 MYRISTOYL- ELLER N EPSILONB29 TETRADEKANOYL-DES(B30) HUMANT INSULIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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