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Last Updated: August 2, 2021

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SAXENDA Drug Patent 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-seven patent family members in thirty 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.

DrugPatentWatch® Generic Entry Outlook for Saxenda

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

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be February 13, 2026. This may change due to patent challenges or generic licensing.

Annual sales in 2019 were $202mm indicating the motivation for generic entry (peak sales were $341mm in 2018).

There have been six 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

See drug prices for SAXENDA

Drug Sales Revenue Trends for SAXENDA

See drug sales revenues for SAXENDA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for SAXENDA
Generic Entry Date for SAXENDA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
SOLUTION;SUBCUTANEOUS

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for SAXENDA

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

SponsorPhase
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Phase 2
Anders Fink-Jensen, MD, DMSciPhase 4
Zuyderland Medisch CentrumN/A

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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 SAXENDA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for SAXENDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0944648 SPC034/2009 Ireland ⤷  Free Forever Trial SPC034/2009: 20101001, EXPIRES: 20220821
2209800 SPC/GB14/079 United Kingdom ⤷  Free Forever 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
2209800 14C0085 France ⤷  Free Forever Trial PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0944648 C00944648/01 Switzerland ⤷  Free Forever Trial PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Express Scripts
Moodys
Colorcon
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.