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Last Updated: December 12, 2019

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SAXENDA Drug Profile

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When do Saxenda patents expire, and when can generic versions of Saxenda launch?

Saxenda is a drug marketed by Novo and is included in one NDA. There are twenty-two patents protecting this drug.

This drug has two hundred and eighty patent family members in twenty-nine countries.

The generic ingredient in SAXENDA is liraglutide recombinant. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the liraglutide recombinant profile page.

US ANDA Litigation and Generic Entry Outlook for Saxenda

Saxenda was eligible for patent challenges on January 25th, 2014.

Annual sales in 2017 were $49mm indicating the motivation for generic entry.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch.

Drug patent expirations by year for SAXENDA
Drug Prices for SAXENDA

See drug prices for SAXENDA

Drug Sales Revenue Trends for SAXENDA

See drug sales revenues for SAXENDA

Recent Clinical Trials for SAXENDA

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

SponsorPhase
Federico II UniversityPhase 4
Texas Tech UniversityN/A
Rebecca AsharePhase 2

See all SAXENDA clinical trials

Recent Litigation for SAXENDA

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 SAXENDA litigation

Pharmacology for SAXENDA

US Patents and Regulatory Information for SAXENDA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 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 SAXENDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 C300698 Netherlands   Start Trial PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
0944648 SPC034/2009 Ireland   Start Trial SPC034/2009: 20101001, EXPIRES: 20220821
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
0944648 SPC/GB09/058 United Kingdom   Start Trial PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
2209800 SPC/GB14/079 United Kingdom   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF, AND LIRAGLUTIDE, OR PHARMACEUTICALLY ACCEPTABLE SOLVATES, HYDRATES, OR SALTS THEREOF; REGISTERED: CH 65041 20140912; UK EU/1/14/947 20140922
0944648 CA 2009 00041 Denmark   Start Trial
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Mallinckrodt
Boehringer Ingelheim
McKinsey
Baxter
Dow

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