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Last Updated: May 24, 2024

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saxenda Drug Patent Profile


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When do Saxenda patents expire, and what generic alternatives are available?

Saxenda is a drug marketed by Novo and is included in one NDA. There are nineteen patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in SAXENDA is liraglutide. There are seven drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the liraglutide 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 2021 were $439mm indicating the motivation for generic entry.

There have been twenty 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 Loss of Exclusivity (LOE) 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
Hangzhou Sciwind Biosciences Co., Ltd.Phase 2
Sciwind Biosciences APAC CO Pty. Ltd.Phase 2
National Institute on Drug Abuse (NIDA)Phase 1/Phase 2

See all saxenda clinical trials

Pharmacology for saxenda
Paragraph IV (Patent) Challenges for SAXENDA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
SAXENDA Injection liraglutide 18 mg/3 mL prefilled syringe 206321 1 2021-08-16

US Patents and Regulatory Information for saxenda

saxenda is protected by nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of saxenda is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting saxenda

Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Needle mounting system and a method for mounting a needle assembly
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with torsion spring and rotatable display
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dial-down mechanism for wind-up pen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Automatic injection device with a top release mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with torsion spring and rotatable display
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Injection device with an end of dose feedback mechanism
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Liraglutide in cardiovascular conditions
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Dial-down mechanism for wind-up pen
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

International Patents for saxenda

See the table below for patents covering saxenda around the world.

Country Patent Number Title Estimated Expiration
China 116327897 用于心血管病况的利拉鲁肽 (Liraglutide for cardiovascular conditions) ⤷  Sign Up
Portugal 3300721 ⤷  Sign Up
Hungary 9903714 ⤷  Sign Up
China 102196835 Dial-down mechanism for wind-up pen ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006045526 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for saxenda

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0944648 C00944648/01 Switzerland ⤷  Sign Up PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
0944648 SPC/GB09/058 United Kingdom ⤷  Sign Up PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
0944648 CA 2009 00041 Denmark ⤷  Sign Up
2209800 SPC/GB14/079 United Kingdom ⤷  Sign Up 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 09C0054 France ⤷  Sign Up PRODUCT NAME: LIRAGLUTIDE; REGISTRATION NO/DATE IN FRANCE: EU/1/09/529/001 DU 20090630; REGISTRATION NO/DATE AT EEC: EU/1/09/529/001 DU 20090630
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.