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Last Updated: August 11, 2020

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SAXENDA Drug Profile

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Which patents cover Saxenda, and what generic alternatives are available?

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-six 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 25, 2014.

Annual sales in 2018 were $341mm indicating the motivation for generic entry.

There have been four patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for SAXENDA
Drug Prices for SAXENDA

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Drug Sales Revenue Trends for SAXENDA

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Recent Clinical Trials for SAXENDA

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

SponsorPhase
National Institute on Drug Abuse (NIDA)Phase 1/Phase 2
National Institutes of Health (NIH)Phase 1/Phase 2
Milton S. Hershey Medical CenterPhase 1/Phase 2

See all SAXENDA clinical trials

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
>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 132014902311502 Italy   Start Trial PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
2209800 C02209800/01 Switzerland   Start Trial PRODUCT NAME: INSULIN DEGLUDEC + LIRAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC 65041 12.09.2014
0944648 C00944648/01 Switzerland   Start Trial PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
2209800 1490067-4 Sweden   Start Trial PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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