saxenda Drug Patent Profile

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 eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and sixty-six patent family members in twenty-nine countries.

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

DrugPatentWatch^® Litigation and Generic Entry Outlook for Saxenda

A generic version of saxenda was approved as liraglutide by HIKMA on December 23^rd, 2024.

Summary for saxenda

International Patents:	166
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	33
Patent Applications:	2,996
Drug Prices:	Drug price information for saxenda
Drug Sales Revenues:	Drug sales revenues for saxenda
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for saxenda
What excipients (inactive ingredients) are in saxenda?	saxenda excipients list
DailyMed Link:	saxenda at DailyMed

See drug prices for saxenda

See drug sales revenues for saxenda

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for saxenda

Constraining patent/regulatory exclusivity:

8,114,833*PED

NDA:

206321

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

Sponsor	Phase
University of Chicago	Early Phase 1
Sciwind Biosciences APAC CO Pty. Ltd.	Phase 2
Hangzhou Sciwind Biosciences Co., Ltd.	Phase 2

See all saxenda clinical trials

Pharmacology for saxenda

Drug Class	GLP-1 Receptor Agonist
Mechanism of Action	Glucagon-like Peptide-1 (GLP-1) Agonists

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 eighteen US patents.

This potential generic entry date is based on patent 8,114,833.

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

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	11,097,063		Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	10,220,155*PED				Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	RE46363*PED				Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	10,376,652		Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	9,775,953*PED				Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	9,457,154*PED				Y
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014		RX	Yes	Yes	8,684,969*PED				Y

Expired US Patents for saxenda

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	6,458,924
Novo	SAXENDA	liraglutide	SOLUTION;SUBCUTANEOUS	206321-001	Dec 23, 2014	7,235,627

International Patents for saxenda

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

Country	Patent Number	Title	Estimated Expiration
Denmark	1909870
Denmark	1909871
Germany	602006020453
Israel	182613	מנגנון למחזיק דמוי-עט הניתן להעלאה והורדה של הכמות המוזרקת המדודה (Dial-down mechanism for wind-up pen)
Japan	5558477
Portugal	3300721
Russian Federation	2401133	АВТОМАТИЧЕСКОЕ ИНЪЕКЦИОННОЕ УСТРОЙСТВО С ВЕРХНИМ РАЗБЛОКИРУЮЩИМ МЕХАНИЗМОМ (AUTOMATIC INJECTION DEVICE WITH UPPER UNLOCK MECHANISM)

Supplementary Protection Certificates for saxenda

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0944648	09C0054	France		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
2209800	132014902311502	Italy		PRODUCT NAME: INSULINA DEGLUDEC/LIRAGLUTIDE(XULTOPHY); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/14/947, 20140918
2209800	1490067-4	Sweden		PRODUCT NAME: COMBINATION OF INSULIN DEGLUDEC AND LIRAGLUTIDE; REG. NO/DATE: EU/1/14/974 20140918
2209800	14C0085	France		PRODUCT NAME: LIRAGLUTIDE ET INSULINE DEGLUDEC; REGISTRATION NO/DATE: EU/1/14/947 20140918
0944648	C00944648/01	Switzerland		PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009
0944648	CA 2009 00041	Denmark
0944648	SPC/GB09/058	United Kingdom		PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630

Saxenda Market Dynamics and Financial Trajectory: A Comprehensive Analysis

The Saxenda market has emerged as a critical component of the global anti-obesity pharmaceutical sector, driven by escalating obesity rates, advancements in GLP-1 receptor agonist therapies, and strategic maneuvers by key industry players. This report examines the market dynamics, competitive landscape, financial performance, and future outlook for Saxenda, contextualizing its role within broader healthcare trends and economic forces.

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Overview of Saxenda and Its Therapeutic Role

Saxenda (liraglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk for chronic weight management. Approved for individuals with a body mass index (BMI) ≥30 kg/m² or ≥27 kg/m² with weight-related comorbidities, Saxenda operates by mimicking the GLP-1 hormone to regulate appetite and promote satiety[1][5]. Its daily subcutaneous injection regimen differentiates it from newer weekly alternatives like Wegovy (semaglutide), also produced by Novo Nordisk[5][10].

Mechanism of Action and Clinical Efficacy

Liraglutide binds to GLP-1 receptors in the brain, slowing gastric emptying and reducing hunger signals. Clinical trials demonstrate an average weight loss of 5–10% over 56 weeks when combined with lifestyle modifications[5][7]. Despite its efficacy, Saxenda faces challenges from patient preference for less frequent dosing and the emergence of generics, such as Biocon’s MHRA-approved liraglutide in the UK[1][6].

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Market Segmentation and Growth Drivers

Segmentation by Indication and Dosage

The Saxenda market is segmented into:

• Indication: Obesity management (BMI ≥30 kg/m²) and overweight management (BMI ≥27 kg/m² with comorbidities)[6].
• Dosage Form: Pre-filled pens dominate due to convenience, though injection-based formats remain prevalent in clinical settings[1][6].
• Distribution Channels: Retail pharmacies account for the largest share, followed by online platforms, which have gained traction post-pandemic[1][6].
• End Users: Hospitals/clinics lead utilization, though homecare settings are expanding with increased patient self-administration[6].

Key Growth Drivers

1. Obesity Pandemic: Global obesity rates have surged, with over 650 million adults classified as obese. This prevalence drives demand for pharmacological interventions, contributing to Saxenda’s historic CAGR of XX% (2019–2024)[1][7].
2. Healthcare Accessibility: Expanded insurance coverage and awareness campaigns, particularly in North America and Europe, have improved patient access[1][5].
3. Non-Surgical Alternatives: Amid rising interest in minimally invasive treatments, Saxenda’s non-surgical profile positions it as a preferred option[3][6].

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Competitive Landscape and Financial Performance

Market Position and Competitors

Saxenda once dominated the GLP-1 obesity market but now contends with:

• Wegovy (semaglutide): Novo Nordisk’s weekly injection, achieving superior weight loss (15–20% in trials) and generating $8.44 billion in 2024[10][11].
• Tirzepatide (Eli Lilly): A dual GIP/GLP-1 agonist poised for obesity approval, projected to capture significant market share[5][7].
• Generics: Biocon’s liraglutide and other biosimilars threaten Saxenda’s pricing power, particularly in cost-sensitive regions[1][5].

Financial Trajectory of Novo Nordisk

Novo Nordisk’s 2024 financials underscore the shifting dynamics:

• Obesity Care Sales: Grew 57% to DKK 65.1 billion ($9.45 billion), driven by Wegovy’s 56% surge, while Saxenda contributed DKK 6.94 billion ($1.01 billion)[4][11].
• Regional Performance: North America accounted for 70% of obesity drug sales, though Asia-Pacific is the fastest-growing region (CAGR 19%)[1][6].
• 2025 Outlook: Anticipated 16–24% sales growth, fueled by GLP-1 volume increases and产能 expansion investments exceeding DKK 80 billion[8][9].

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Regional Market Dynamics

North America: Dominance and Pricing Pressures

North America held 48% of the Saxenda market in 2024, driven by high obesity rates (42.4% in the U.S.) and robust healthcare spending[5][7]. However, list prices of $1,349/month have spurred patient reliance on savings programs (e.g., Novo’s $25/month offer) and accelerated generic encroachment[5][7].

Asia-Pacific: Emerging Growth Frontier

With a projected CAGR of XX% (2025–2030), Asia-Pacific’s growth is fueled by urbanization, sedentary lifestyles, and improving healthcare infrastructure. China and India, facing obesity rates of 16% and 40%, respectively, represent key markets for Saxenda and its generics[1][6].

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Challenges and Regulatory Considerations

Supply Chain and Manufacturing

Novo Nordisk’s 2024 supply constraints for Wegovy highlighted production scalability issues, though the company is investing DKK 80 billion in new facilities to alleviate bottlenecks[8][9]. Saxenda’s manufacturing, while stable, faces competition from generics requiring fewer regulatory hurdles[1][5].

Regulatory Milestones and Patent Cliffs

Saxenda’s U.S. patent expiration in 2024 opens the door for generics, prompting Novo Nordisk to prioritize Wegovy and next-generation therapies like CagriSema (a GLP-1/amylin analog)[9][10]. Regulatory approvals for cardiovascular benefits (e.g., Wegovy’s 2024 label expansion) further reshape the competitive landscape[4][9].

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Future Outlook and Strategic Recommendations

Market Projections

The global anti-obesity drug market is projected to reach $4.8 billion by 2030, with Saxenda’s segment growing at a moderated CAGR of XX% amid generics and therapeutic innovations[7][5]. Novo Nordisk’s obesity portfolio, however, is expected to dominate, targeting $44 billion in sales by 2030[5][10].

Strategic Imperatives for Novo Nordisk

1. Differentiate Through Innovation: Accelerate development of oral GLP-1s (e.g., oral semaglutide) and combination therapies to offset Saxenda’s decline[9][10].
2. Optimize Pricing Strategies: Expand patient assistance programs and negotiate formulary placements to maintain Saxenda’s accessibility amid generic competition[5][7].
3. Leverage Digital Health Tools: Integrate Saxenda with digital platforms for adherence monitoring, enhancing outcomes in homecare settings[1][6].

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Conclusion

Saxenda’s journey reflects the rapid evolution of the obesity therapeutics market. While its growth is tempered by generics and next-generation alternatives, its foundational role in establishing GLP-1 agonists as viable obesity treatments remains undisputed. Novo Nordisk’s strategic pivot toward Wegovy and pipeline innovations ensures its leadership, yet Saxenda’s legacy persists in expanding access to life-changing weight management solutions. As the market evolves, the emphasis will shift toward personalized, cost-effective therapies that align with global health priorities.

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Key Takeaways

• Saxenda’s market share is challenged by weekly GLP-1 agonists and generics, yet it remains a revenue cornerstone in Novo Nordisk’s portfolio.
• Regional disparities in obesity prevalence and healthcare access dictate divergent growth trajectories, with Asia-Pacific emerging as a critical battleground.
• Strategic investments in manufacturing and R&D are essential to sustain competitiveness in an increasingly crowded market.

FAQs

1. How does Saxenda compare to Wegovy?
   Saxenda requires daily injections and offers moderate weight loss (~5–10%), whereas Wegovy’s weekly dosing and superior efficacy (~15–20%) drive its dominance[5][10].

2. What is Saxenda’s cost without insurance?
   The average monthly cost is $1,806, though Novo Nordisk’s savings programs reduce this to $25 for eligible patients[5].

3. Will generics replace Saxenda?
   Generics like Biocon’s liraglutide will erode Saxenda’s market share, particularly in price-sensitive regions, but Novo’s innovation pipeline mitigates this risk[1][5].

4. Which regions drive Saxenda’s growth?
   North America leads in revenue, but Asia-Pacific’s CAGR outpaces other regions due to rising obesity rates and healthcare investments[1][6].

5. What are the emerging trends in obesity treatment?
   Combination therapies, digital health integration, and oral GLP-1 formulations are reshaping the landscape, emphasizing convenience and personalized care[1][9].

References

1. https://www.einpresswire.com/article/783890557/saxenda-global-market-report-2025-a-comprehensive-outlook-on-future-growth-and-trends
2. https://www.einpresswire.com/article/793408470/comprehensive-insights-of-the-global-saxenda-market-key-drivers-growth-opportunities-and-forecast-for-2025-2034
3. https://www.openpr.com/news/3878900/saxenda-market-forecast-2025-2034-evaluating-growth-factors
4. https://www.pearceip.law/2025/02/05/novo-nordisks-sales-increase-26-in-2024-led-by-56-growth-in-wegovy-saxenda/
5. https://www.drugpatentwatch.com/p/drug-price/drugname/SAXENDA
6. https://www.thebusinessresearchcompany.com/report/saxenda-global-market-report
7. https://www.globenewswire.com/news-release/2024/05/07/2876922/28124/en/Anti-Obesity-Drugs-Global-Strategic-Business-Report-2024-Market-to-Reach-4-8-Billion-by-2030-Saxenda-Commands-the-AOM-Market-Newer-Drugs-to-Provide-Impetus-to-Market-Growth.html
8. https://www.novonordisk.com/content/dam/nncorp/global/en/investors/irmaterial/annual_report/2025/novo-nordisk-annual-report-2024.pdf
9. https://ml-eu.globenewswire.com/Resource/Download/365675dd-10f3-4293-9aec-ede9f63375c6
10. https://www.fiercepharma.com/pharma/novo-nordisks-wegovy-lifts-2025-obesity-sales-target-37b
11. https://www.echemi.com/cms/2241570.html