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Last Updated: October 6, 2022

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-four patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and ninety-nine patent family members in thirty-two 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 fifteen 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
Sciwind Biosciences APAC CO Pty. Ltd.Phase 2
Hangzhou Sciwind Biosciences Co., Ltd.Phase 2
Milton S. Hershey Medical CenterPhase 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 recombinant 18 mg/3 mL prefilled syringe 206321 1 2021-08-16

US Patents and Regulatory Information for SAXENDA

SAXENDA is protected by twenty-four US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of SAXENDA is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with an end of dose feedback mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with a top release mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Syringe device with a dose limiting mechanism and an additional safety mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with a top release mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Derivatives of GLP-1 analogs
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with reset feature
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Propylene glycol-containing peptide formulations which are optimal for production and for use in injection devices
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Needle mounting system and a method for mounting a needle assembly
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with reset feature
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with torsion spring and rotatable display
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Stable formulation of modified GLP-1
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with a top release mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dial-down mechanism for wind-up pen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with an end of dose feedback mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with reset feature
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Automatic injection device with a top release mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with torsion spring and rotatable display
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dose mechanism for an injection device for limiting a dose setting corresponding to the amount of medicament left
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injection device with an end of dose feedback mechanism
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Liraglutide in cardiovascular conditions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Dial-down mechanism for wind-up pen
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting SAXENDA

NEW PATIENT POPULATION
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Novo SAXENDA liraglutide recombinant SOLUTION;SUBCUTANEOUS 206321-001 Dec 23, 2014 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SAXENDA

When does loss-of-exclusivity occur for SAXENDA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Patent: 04290862
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0416743
Estimated Expiration: See Plans and Pricing

Canada

Patent: 45034
Estimated Expiration: See Plans and Pricing

China

Patent: 82356
Estimated Expiration: See Plans and Pricing

Patent: 2784386
Estimated Expiration: See Plans and Pricing

Patent: 4826116
Estimated Expiration: See Plans and Pricing

Patent: 3304250
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 19723
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 94656
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 46683
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 38395
Estimated Expiration: See Plans and Pricing

Patent: 43210
Estimated Expiration: See Plans and Pricing

Japan

Patent: 58655
Estimated Expiration: See Plans and Pricing

Patent: 70373
Estimated Expiration: See Plans and Pricing

Patent: 07513084
Estimated Expiration: See Plans and Pricing

Patent: 12188424
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06005581
Estimated Expiration: See Plans and Pricing

Poland

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 21238
Estimated Expiration: See Plans and Pricing

Patent: 06116414
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 87019
Estimated Expiration: See Plans and Pricing

Patent: 00721
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1243648
Estimated Expiration: See Plans and Pricing

Patent: 060100428
Estimated Expiration: See Plans and Pricing

Spain

Patent: 60320
Estimated Expiration: See Plans and Pricing

Patent: 27854
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1906789
Estimated Expiration: See Plans and Pricing

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

See the table below for additional patents covering SAXENDA around the world.

Country Patent Number Title Estimated Expiration
Spain 2633917 See Plans and Pricing
South Korea 20070084393 DIAL-DOWN MECHANISM FOR WIND-UP PEN See Plans and Pricing
South Korea 100556067 See Plans and Pricing
Spain 2689536 See Plans and Pricing
Australia 2610699 See Plans and Pricing
Spain 2336827 See Plans and Pricing
Japan 2009502274 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for SAXENDA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2209800 14C0085 France See Plans and Pricing PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0944648 C00944648/01 Switzerland See Plans and Pricing PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
0944648 SPC034/2009 Ireland See Plans and Pricing SPC034/2009: 20101001, EXPIRES: 20220821
2209800 122014000114 Germany See Plans and Pricing PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
2209800 132014902311502 Italy See Plans and Pricing PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
2209800 C300698 Netherlands See Plans and Pricing PRODUCT NAME: INSULINE DEGLUDEC EN LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/94765041 2014120918
0944648 SPC/GB09/058 United Kingdom See Plans and Pricing PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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.