RYBELSUS Drug Patent Profile

When do Rybelsus patents expire, and when can generic versions of Rybelsus launch?

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

This drug has one hundred and eighty-seven patent family members in thirty-eight countries.

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

DrugPatentWatch^® Generic Entry Outlook for Rybelsus

Rybelsus 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 March 15, 2033. 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 RYBELSUS

International Patents:	187
US Patents:	12
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	9
Patent Applications:	702
Drug Prices:	Drug price information for RYBELSUS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for RYBELSUS
What excipients (inactive ingredients) are in RYBELSUS?	RYBELSUS excipients list
DailyMed Link:	RYBELSUS at DailyMed

See drug prices for RYBELSUS

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

Constraining patent/regulatory exclusivity:

10,933,120

NDA:

213051

Dosage:

TABLET;ORAL

^*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 RYBELSUS

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

Sponsor	Phase
Rutgers, The State University of New Jersey	Phase 2
Alzheimer's Association	Phase 2
National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2

See all RYBELSUS clinical trials

Pharmacology for RYBELSUS

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

Paragraph IV (Patent) Challenges for RYBELSUS

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
RYBELSUS	Tablets	semaglutide	3 mg, 7 mg and 14 mg	213051	1	2024-07-15

US Patents and Regulatory Information for RYBELSUS

RYBELSUS is protected by twelve US patents.

This potential generic entry date is based on patent 10,933,120.

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	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes	11,759,503		Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes	8,536,122		Y	Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes	10,960,052		Y

EU/EMA Drug Approvals for RYBELSUS

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 RYBELSUS

When does loss-of-exclusivity occur for RYBELSUS?

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

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hungary

Israel

Japan

Lithuania

Malaysia

Mexico

Poland

Portugal

Russian Federation

Serbia

Slovenia

South Africa

South Korea

Spain

Ukraine

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 RYBELSUS around the world.

Country	Patent Number	Title	Estimated Expiration
Mexico	345501	COMPOSICIONES SOLIDAS QUE COMPRENDEN AGONISTA DE GLP-1 Y SAL DEL ACIDO N-(8-(2-HIDROXIBENZOIL)AMINO)CAPRILICO. (SOLID COMPOSITIONS COMPRISING A GLP-1 AGONIST AND A SALT OF N-(8-(2-HYDROXYBENZOYL)AMINO)CAPRYLIC ACID.)
Peru	20210453	COMPOSICIONES SOLIDAS QUE COMPRENDEN UN AGONISTA DE GLP-1, UNA SAL DEL ACIDO N-(8-(2-HIDROXIBENZOIL)AMINO)CAPRILICO Y UN LUBRICANTE
San Marino	T201800117

Supplementary Protection Certificates for RYBELSUS

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1863839	132018000000262	Italy		PRODUCT NAME: SEMAGLUTIDE(OZEMPIC); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/17/1251, 20180212
1863839	22/2018	Austria		PRODUCT NAME: SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180212
1863839	661	Finland

Market Dynamics and Financial Trajectory for Rybelsus

Introduction

Rybelsus, the oral semaglutide medication developed by Novo Nordisk, has been making significant strides in the pharmaceutical market, particularly in the treatment of type 2 diabetes and, to some extent, obesity. Here, we delve into the market dynamics and financial trajectory of Rybelsus, highlighting its growth, challenges, and future prospects.

Market Growth and Sales Performance

Rybelsus has experienced substantial growth since its launch. In 2022, the drug's sales more than doubled, reaching approximately 11.29 billion Danish kroner (about $1.7 billion), making it Novo Nordisk's second-largest growth driver after Ozempic[1].

Global Expansion

Much of the momentum behind Rybelsus came from its launches in various international markets, including Italy, Japan, and Spain. This global expansion has been a key factor in the drug's increased sales and market presence[1].

Financial Performance

Revenue Growth

The financial performance of Rybelsus is closely tied to Novo Nordisk's overall financial health. In 2022, Novo Nordisk's total sales increased by 16% at constant exchange rates to 177 billion Danish kroner (about $26 billion). Rybelsus played a significant role in this growth, contributing to the company's robust financial performance[1].

Operating Profit and Net Profit

For the period from 2022 to 2023, Novo Nordisk saw a significant increase in operating profit and net profit. The operating profit grew by 37% to 102.574 billion Danish kroner, and the net profit increased by 51% to 83.683 billion Danish kroner. These figures reflect the overall success of Rybelsus and other GLP-1 products in the company's portfolio[2].

Competitive Landscape

GLP-1 Market

The GLP-1 (Glucagon-Like Peptide-1) market is highly competitive, with Novo Nordisk and Eli Lilly being major players. Rybelsus, along with other Novo Nordisk products like Ozempic and Wegovy, dominates the market. However, Eli Lilly's Mounjaro and Zepbound are rapidly gaining ground, indicating a dynamic and evolving competitive landscape[4].

Market Share and Growth

Despite the competition, Rybelsus continues to show strong growth. In Q2 2024, Rybelsus led Novo Nordisk's portfolio with a 49% year-over-year increase in sales. This growth is part of a broader trend where GLP-1 products are becoming increasingly popular for diabetes and obesity treatment[4].

Challenges and Opportunities

Supply Chain Issues

In the past, Rybelsus and its counterpart, Wegovy, faced supply chain issues, particularly with contract manufacturers. However, these issues have largely been resolved, with all dose strengths of Wegovy becoming available again in the U.S. by December 2022. This resolution has led to accelerated prescription trends for Wegovy and continued strong sales for Rybelsus[1].

Formulation and Administration

While Rybelsus is the first oral GLP-1 medication, it is less effective compared to its injectable counterparts and has specific administration requirements that some patients find cumbersome. However, this also presents an opportunity for further innovation, such as the development of more effective oral GLP-1s, which could significantly expand the market[3].

Future Prospects

Market Expansion and Innovation

Novo Nordisk is expected to continue scaling up manufacturing capacity for its GLP-1 products, including Rybelsus. With additional production lines set to start running in 2024, the company is well-positioned for sustained growth. The anticipated release of more effective oral GLP-1s by 2026 could further boost Rybelsus's market presence and appeal[1][3].

Financial Outlook

For 2024, Novo Nordisk expects sales growth to be in the range of 22-28% at constant exchange rates, with operating profit growth expected to be between 20-28%. This outlook is supported by the strong performance of Rybelsus and other GLP-1 products, indicating a bright financial future for the drug[5].

Regulatory Updates

Cardiovascular Benefits

Recent updates to the Wegovy label in the EU to reflect the risk reduction of major adverse cardiovascular events highlight the broader benefits of GLP-1 medications, including Rybelsus. Such regulatory approvals can enhance the market appeal and prescription rates of these drugs[5].

Conclusion

Rybelsus has established itself as a significant player in the GLP-1 market, driven by its global expansion, robust sales performance, and Novo Nordisk's strong financial health. Despite competitive pressures and past supply chain issues, the drug's future looks promising, with ongoing innovation and regulatory approvals set to further boost its market presence.

Key Takeaways

• Substantial Sales Growth: Rybelsus sales more than doubled in 2022, reaching $1.7 billion.
• Global Expansion: Launches in Italy, Japan, and Spain have driven international growth.
• Financial Performance: Contributed to Novo Nordisk's 16% sales growth and 37% operating profit increase in 2022.
• Competitive Landscape: Faces competition from Eli Lilly's Mounjaro and Zepbound but remains a market leader.
• Future Prospects: Expected to benefit from increased manufacturing capacity and potential new oral GLP-1 formulations.
• Regulatory Updates: Recent label updates highlighting cardiovascular benefits could enhance market appeal.

FAQs

What is Rybelsus used for?

Rybelsus is used for the treatment of type 2 diabetes and, to some extent, obesity. It is an oral semaglutide medication.

How has Rybelsus performed in terms of sales?

Rybelsus sales more than doubled in 2022, reaching approximately $1.7 billion, making it Novo Nordisk's second-largest growth driver after Ozempic.

What are the main challenges faced by Rybelsus?

Past supply chain issues and the drug's lower efficacy compared to injectable counterparts are key challenges. However, these issues are being addressed.

How does Rybelsus compare to other GLP-1 products?

Rybelsus is less effective than its injectable counterparts but offers the convenience of oral administration. It remains a market leader despite growing competition from Eli Lilly's products.

What are the future prospects for Rybelsus?

Rybelsus is expected to benefit from increased manufacturing capacity, potential new oral GLP-1 formulations, and recent regulatory updates highlighting cardiovascular benefits.

Sources

1. FiercePharma: "Rybelsus by Novo gains steam as Wegovy shakes off supply woes"
2. Novo Nordisk Annual Report 2023: Financial performance and market data
3. T. Rowe Price: "New diabetes and obesity drugs show promise for patients and investors"
4. Drug Discovery Trends: "Lilly's GLP-1 portfolio gains ground on Novo Nordisk"
5. GlobeNewswire: "Novo Nordisk's sales increased by 24% in Danish kroner and by 25% at CER"