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Last Updated: December 12, 2019

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Insulin degludec; liraglutide - Generic Drug Details

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

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

Identify potential brand extensions & 505(b)(2) entrants

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   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   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   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   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
2107069 122013000061 Germany   Start Trial PRODUCT NAME: INSULIN DEGLUDEC IN ALLEN DURCH DAS BASISPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/12/807/001 EU/1/12/807/004-005 EU/1/12/807/007-009 EU/1/12/807/012-013 EU/1/12/807/015 20130121
0885961 SPC/GB05/024 United Kingdom   Start Trial PRODUCT NAME: INSULIN GLULISINE OR A PHYSIOLOGICALLY TOLERABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/04/285/001 - 020 20040929
0705275 32/2000 Austria   Start Trial PRODUCT NAME: INSULIN ASPART/PROTAMIN; NAT. REGISTRATION NO/DATE: EU/1/00/142/001-008 20000801; FIRST REGISTRATION: LI 55414-55416 20000623
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
2597103 19/2017 Austria   Start Trial PRODUCT NAME: KOMBINATION VON INSULIN DEGLUTEC UND LIRAGLUTID; NAT. REGISTRATION NO/DATE: EU/1/14/947/001-4 20140918; FIRST REGISTRATION: LI 65041 (CH) 20140912
0368187 SZ 34/2000 Austria   Start Trial PRODUCT NAME: LANTUS - INSULIN GLARGIN
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
McKesson
Mallinckrodt
McKinsey
Medtronic

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