WEGOVY Drug Patent Profile

Which patents cover Wegovy, and what generic alternatives are available?

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

This drug has one hundred and fifty-four patent family members in thirty-three countries.

The generic ingredient in WEGOVY is semaglutide. Two suppliers are listed for this compound. Additional details are available on the semaglutide profile page.

DrugPatentWatch^® Generic Entry Outlook for Wegovy

Wegovy was eligible for patent challenges on December 5, 2021.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 5, 2031. This may change due to patent challenges or generic licensing.

There have been seven 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 WEGOVY

International Patents:	154
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	12
Patent Applications:	702
Drug Prices:	Drug price information for WEGOVY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for WEGOVY
What excipients (inactive ingredients) are in WEGOVY?	WEGOVY excipients list
DailyMed Link:	WEGOVY at DailyMed

See drug prices for WEGOVY

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

Constraining patent/regulatory exclusivity:

8,129,343

NDA:

215256

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 WEGOVY

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Phase 2
Neurobiology Research Unit	Phase 2
Psychiatric Centre Rigshospitalet	Phase 2

See all WEGOVY clinical trials

Pharmacology for WEGOVY

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

Paragraph IV (Patent) Challenges for WEGOVY

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
WEGOVY	Injection	semaglutide	0.25 mg/0.5 mL 0.5 mg/0.5 mL 1 mg/0.5 mL 1.7 mg/0.75 mL 2.4 mg/0.75 mL	215256	1	2022-10-20

US Patents and Regulatory Information for WEGOVY

WEGOVY is protected by eight US patents and three FDA Regulatory Exclusivities.

This potential generic entry date is based on patent 8,129,343.

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	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes	9,764,003
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes	12,214,017		Y
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-004	Jun 4, 2021		RX	Yes	Yes	8,536,122		Y	Y
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-005	Jun 4, 2021		RX	Yes	Yes	9,764,003
Novo	WEGOVY	semaglutide	SOLUTION;SUBCUTANEOUS	215256-005	Jun 4, 2021		RX	Yes	Yes	8,536,122		Y	Y

EU/EMA Drug Approvals for WEGOVY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novo Nordisk A/S	Ozempic	semaglutide	EMEA/H/C/004174 Treatment of adults with insufficiently controlled type 2 diabetes mellitus as an adjunct to diet and exercise:as monotherapy when metformin is considered inappropriate due to intolerance or contraindications;in addition to other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2018-02-08
Novo Nordisk A/S	Rybelsus	semaglutide	EMEA/H/C/004953 Rybelsus is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exerciseas monotherapy when metformin is considered inappropriate due to intolerance or contraindicationsin combination with other medicinal products for the treatment of diabetes.For study results with respect to combinations, effects on glycaemic control and cardiovascular events, and the populations studied, see sections 4.4, 4.5 and 5.1.	Authorised	no	no	no	2020-04-03
Novo Nordisk A/S	Wegovy	semaglutide	EMEA/H/C/005422 Wegovy is indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management, including weight loss and weight maintenance, in adults with an initial Body Mass Index (BMI) of- ≥30 kg/m² (obesity), or- ≥27 kg/m² to	Authorised	no	no	no	2022-01-06

International Patents for WEGOVY

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

Country	Patent Number	Title	Estimated Expiration
Brazil	112022013746	FORMULAÇÃO AQUOSA DE CAGRILINTIDA, FORMULAÇÃO AQUOSA DE SEMAGLUTIDA, DISPOSITIVO MÉDICO, E, COMBINAÇÃO DE DOSE FIXA
China	101133082	Acylated GLP-1 compounds
Japan	7132441
Mexico	2019008148	USO DE PEPTIDOS GLP-1 DE ACCION PROLONGADA. (USE OF LONG-ACTING GLP-1 PEPTIDES.)
Russian Federation	2015101826	ПРИМЕНЕНИЕ ДОЛГОДЕЙСТВУЮЩИХ ПЕПТИДОВ GLP-1

Supplementary Protection Certificates for WEGOVY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	2018/017	Ireland		PRODUCT NAME: OZEMPIC-SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	22/2018	Austria		PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	300936	Netherlands		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	661	Finland
1863839	C01863839/01	Switzerland		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018

Market Dynamics and Financial Trajectory for Wegovy

Introduction

Wegovy, developed by Novo Nordisk, is a groundbreaking weight loss medication that has been making significant waves in the pharmaceutical industry. Here, we delve into the market dynamics and financial trajectory of this drug, exploring its impact, challenges, and future prospects.

Market Overview

The market for Wegovy is part of the broader GLP-1 (Glucagon-Like Peptide-1) market, which is projected to reach a total addressable market of $100 billion globally by 2030[3].

Market Size and Growth

As of 2024, the Wegovy market is estimated to be around $1.82 billion and is expected to grow at a CAGR of more than 7% to reach $2.67 billion by 2029[4]. This growth is driven by increasing demand for effective weight loss treatments and the drug's expanding availability in various markets.

Sales Performance

Q1 2024 Sales

In the first quarter of 2024, Wegovy sales surged, generating over $1.34 billion, a 107% increase from the same period in 2023. Despite this strong growth, sales were slightly impacted by lower realized prices and ongoing supply constraints[5].

Q3 2024 Sales

In the third quarter, Wegovy continued its robust performance, with sales jumping 79% year-on-year to $2.5 billion, exceeding analyst expectations. This growth was partly driven by new international market launches[2].

Competitive Landscape

Competition from Eli Lilly's Zepbound

The approval of Eli Lilly's Zepbound in November 2023 introduced a new competitor in the obesity treatment market. While Zepbound's new prescriptions are tracking slightly ahead of Wegovy, Novo Nordisk's drug still maintains a larger market share. Both companies are working to expand their manufacturing capabilities to meet the high demand for these medications[1].

Supply Constraints

Both Novo Nordisk and Eli Lilly are facing significant supply constraints due to the complex nature of these biologic drugs. Novo Nordisk has been working to boost supply, including the gradual increase of Wegovy "starter" doses and the acquisition of additional production plants through a deal with Catalent[1].

Pricing and Insurance Coverage

Net Prices and Insurance

Novo Nordisk has been working to gain better insurance coverage for Wegovy in the U.S., resulting in lower net prices. Despite this, the drug is now available to 50 million people with obesity in the U.S. through various insurers, including Medicaid programs in 15 states and some Medicare coverage[1].

Cost to Patients

For many insured patients in the U.S., the cost of Wegovy is significantly reduced, with some paying less than $25 per month, despite the list price being around $1,350 per month[4].

Financial Impact

Revenue and Profit Guidance

Novo Nordisk's overall revenue in Q1 2024 grew 24% year-over-year, driven largely by the strong performance of Wegovy and Ozempic. The company has adjusted its full-year guidance, expecting sales growth of 23% to 27% and operating profit growth of 21% to 27%[2][5].

Net Profit

In Q1 2024, Novo Nordisk reported a net profit of over $3.64 billion, up 29% year-over-year, reflecting the strong demand for its GLP-1-based treatments[5].

Future Prospects

Oral GLP-1s

The potential introduction of oral GLP-1s, which are less complex and capital-intensive to produce, could significantly expand the market. These oral therapies are expected to be more cost-effective and could increase the patient population beyond the current estimates[3].

Expanding Indications

Studies have shown that GLP-1s, including Wegovy, offer significant benefits for patients with other serious health conditions, such as cardiovascular events and kidney disease. This could further increase the market size and potential revenue for these drugs[3].

Regulatory Environment

FDA Approvals and Reimbursement

Wegovy gained limited Medicare reimbursement in March 2024 for reducing the risk of cardiovascular events in obese people with heart disease. This approval, while limited, marks a significant step in expanding the drug's reach[1].

Industry Segmentation

Geography

The Wegovy market is segmented geographically, with North America expected to witness the highest growth rate over the forecast period. Other regions, including Europe, Asia-Pacific, Middle East and Africa, and Latin America, also contribute to the market's growth[4].

Key Takeaways

• Strong Sales Growth: Wegovy has seen significant sales growth, despite challenges from lower prices and supply constraints.
• Competitive Landscape: The market is competitive, with Eli Lilly's Zepbound emerging as a new player, but Novo Nordisk maintains a larger market share.
• Pricing and Insurance: Efforts to improve insurance coverage have reduced costs for many patients, making the drug more accessible.
• Future Prospects: The potential introduction of oral GLP-1s and expanding indications could further boost the market.
• Regulatory Environment: Recent FDA approvals and reimbursement changes are crucial for market expansion.

FAQs

Q: What is the current market size of Wegovy?

A: As of 2024, the Wegovy market is estimated to be around $1.82 billion[4].

Q: How has Wegovy's sales performance been in 2024?

A: In Q1 2024, Wegovy sales surged by 107% year-on-year, and in Q3, sales jumped 79% year-on-year, exceeding analyst expectations[2][5].

Q: What are the main challenges facing Wegovy's sales growth?

A: The main challenges include lower realized prices and ongoing supply constraints due to the complex nature of the drug[1][5].

Q: How does Wegovy compare to its competitor, Zepbound?

A: While Zepbound's new prescriptions are tracking slightly ahead of Wegovy, Novo Nordisk's drug maintains a larger market share[1].

Q: What are the future prospects for Wegovy and the GLP-1 market?

A: The potential introduction of oral GLP-1s and expanding indications for other serious health conditions could significantly expand the market and increase revenue[3].

Sources

1. Biopharma Dive: "Novo sees Wegovy sales dip on lower price, tight supply"
2. BioSpace: "Novo Misses Overall Q3 Revenue Despite Beating Wegovy Sales Forecast, Narrows 2024 Outlook"
3. Goldman Sachs: "Weighing the GLP-1 market"
4. Mordor Intelligence: "Wegovy Market Size & Share Analysis - Industry Research Report"
5. BioSpace: "Novo's Q1 Revenue Grows 24%, Raises Guidance as Wegovy Sales Surge"