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SAXENDA Drug Patent Profile

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 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. Three 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-one 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

Summary for SAXENDA

International Patents:	188
US Patents:	19
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
Hangzhou Sciwind Biosciences Co., Ltd.	Phase 2
Sciwind Biosciences APAC CO Pty. 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	7,762,994*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

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
European Patent Office	1843809	DISPOSITIF D'INJECTION AUTOMATIQUE MUNI D'UN MECANISME DE LIBERATION SUPERIEUR (AN AUTOMATIC INJECTION DEVICE WITH A TOP RELEASE MECHANISM)
Australia	2610799
Germany	69942307
Japan	2000517308

Supplementary Protection Certificates for SAXENDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2209800	122014000114	Germany		PRODUCT NAME: KOMBINATION VON INSULIN DEGLUDEC UND LIRAGLUTIDE; REGISTRATION NO/DATE: EU/1/14/947 20140918
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
0944648	SPC/GB09/058	United Kingdom		PRODUCT NAME: LIRAGLUTIDE; REGISTERED: UK EU/1/09/529/001 20090630
0944648	C00944648/01	Switzerland		PRODUCT NAME: LIRAGLUTID; REGISTRATION NO/DATE: SWISSMEDIC 59329 11.12.2009

SAXENDA Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for SAXENDA (Liraglutide)

Introduction to SAXENDA (Liraglutide)

SAXENDA, also known as liraglutide, is a glucagon-like peptide-1 (GLP-1) receptor agonist developed by Novo Nordisk. It is primarily used for the treatment of obesity and has also been approved for managing type 2 diabetes under the brand name Victoza.

Mechanism of Action and Clinical Use

SAXENDA works by mimicking the action of the natural hormone GLP-1, which helps regulate blood sugar levels and appetite. This mechanism makes it effective in promoting weight loss and improving glycemic control[1].

Market Landscape

The market for GLP-1 medications, including SAXENDA, is highly competitive and rapidly evolving. Novo Nordisk's SAXENDA and Ozempic have established strong market positions due to their efficacy in both diabetes management and weight loss. Other key players, such as Eli Lilly with Trulicity and Mounjaro, are also making significant strides in this market[4].

Competitive Landscape

• Marketed Therapies: SAXENDA competes with other GLP-1 receptor agonists like Ozempic (semaglutide) from Novo Nordisk, Trulicity (dulaglutide) from Eli Lilly, and Mounjaro (tirzepatide), a dual-agonist combining GLP-1 and GIP receptors[4].
• Emerging Therapies: The market is expected to see the introduction of new therapies, including oral GLP-1s, which could potentially disrupt the current market dynamics. These oral therapies are in clinical trials and show promising results in terms of efficacy and tolerability[3].

Market Forecast and Size

The global GLP-1 market, which includes SAXENDA, is projected to grow significantly. Here are some key points:

• Global Market Size: The GLP-1 market is estimated to reach $100 billion by 2030, driven by the expanding use of these drugs for weight loss and other health conditions[3].
• Regional Market Size: Detailed market size forecasts for SAXENDA are available for the 7MM (United States, EU5, and Japan) from 2019 to 2032. For instance, the market size in the US and EU5 countries like Germany, France, Italy, Spain, and the UK is expected to grow steadily over this period[1].

Financial Performance of Novo Nordisk

Novo Nordisk, the manufacturer of SAXENDA, has seen significant financial growth driven by the success of its GLP-1 products.

• Revenue Growth: Novo Nordisk's sales increased by 24% in Danish kroner and by 25% at constant exchange rates (CER) for the first six months of 2024 compared to the same period in 2023[5].
• Operating Profit: The company's operating profit increased by 18% to DKK 57.8 billion in the first half of 2024, reflecting the strong performance of its GLP-1 products[5].
• Research and Development: Novo Nordisk has significantly increased its research and development costs, which rose by 79% in the first half of 2024 compared to the same period in 2023. This investment is crucial for maintaining market leadership and developing new therapies[5].

Regulatory and Developmental Activities

SAXENDA has undergone extensive regulatory and developmental activities:

• Regulatory Milestones: The drug has achieved several regulatory milestones, including approvals for obesity treatment in various markets. Ongoing research and development activities are focused on expanding its indications and improving patient outcomes[1].
• Clinical Trials: Studies such as the SELECT cardiovascular outcomes study have demonstrated the efficacy of GLP-1 drugs, including semaglutide, in reducing major cardiovascular events. Such studies support the continued growth and acceptance of SAXENDA and similar drugs[3].

Challenges and Opportunities

Challenges

• Competition: The market is highly competitive, with several other GLP-1 receptor agonists available. The launch of late-stage emerging therapies will continue to challenge SAXENDA's market position[1].
• Cost and Access: Despite the potential for lower-cost oral GLP-1s, the current high cost of injectable GLP-1s can limit access for some patients. This could impact market penetration and growth[3].

Opportunities

• Expanding Indications: GLP-1 drugs, including SAXENDA, are being studied for their potential benefits in other serious health conditions such as kidney disease and sleep-related breathing disorders. This could expand the patient population and market size[3].
• Oral Therapies: The development of oral GLP-1s could make these treatments more accessible and affordable, potentially increasing market size and penetration[3].

Economic Implications

The success of GLP-1 drugs like SAXENDA has broader economic implications:

• Market Valuations: Leading manufacturers have achieved unprecedented market valuations, impacting national economies and the global stock market landscape[4].
• Healthcare Delivery: The widespread adoption of these drugs could significantly influence healthcare delivery, consumer behaviors, and investment strategies in the healthcare sector[4].

Key Takeaways

• Market Growth: The GLP-1 market, including SAXENDA, is projected to reach $100 billion by 2030.
• Competitive Landscape: SAXENDA faces competition from other GLP-1 receptor agonists but remains a strong player.
• Financial Performance: Novo Nordisk's financials reflect the strong performance of its GLP-1 products.
• Regulatory and Developmental Activities: Ongoing research and regulatory milestones support the continued growth of SAXENDA.
• Challenges and Opportunities: The market faces challenges from competition and cost but has opportunities for expansion through new indications and oral therapies.

FAQs

Q: What is SAXENDA used for?

SAXENDA (liraglutide) is used for the treatment of obesity and is also approved for managing type 2 diabetes under the brand name Victoza.

Q: How does SAXENDA work?

SAXENDA works by mimicking the action of the natural hormone GLP-1, which helps regulate blood sugar levels and appetite.

Q: What is the projected market size for GLP-1 drugs by 2030?

The global GLP-1 market is estimated to reach $100 billion by 2030.

Q: Who are the main competitors of SAXENDA in the GLP-1 market?

The main competitors include other GLP-1 receptor agonists like Ozempic (semaglutide) from Novo Nordisk, Trulicity (dulaglutide) from Eli Lilly, and Mounjaro (tirzepatide) from Eli Lilly.

Q: What are the potential new developments in the GLP-1 market?

The development of oral GLP-1s and the expansion of indications to other serious health conditions are potential new developments that could impact the market.

Sources

1. ResearchAndMarkets: "SAXENDA (Liraglutide), Drug Insight and Market Forecast - 2032"
2. Novo Nordisk: "Financial report for the period 1 January 2021 to 31 December 2021"
3. Goldman Sachs: "Weighing the GLP-1 market"
4. IQVIA: "Decoding the Buzz Around Weight-loss Medications"
5. GlobeNewswire: "Novo Nordisk's sales increased by 24% in Danish kroner and by 25% at constant exchange rates (CER) for the first six months of 2024"