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 fourteen patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-one 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 twelve 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:	191
US Patents:	14
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	16
Clinical Trials:	15
Patent Applications:	1,408
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

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
Herlev Hospital	PHASE2
Rune Skovgaard Rasmussen	PHASE2
University Hospital, Basel, Switzerland	NA

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 fourteen US patents.

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	213051-006	Dec 9, 2024		RX	Yes	Yes			Y	Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-002	Sep 20, 2019		RX	Yes	Yes			Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes			Y	Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-006	Dec 9, 2024		RX	Yes	Yes			Y	Y
Novo	RYBELSUS	semaglutide	TABLET;ORAL	213051-003	Sep 20, 2019		RX	Yes	Yes

EU/EMA Drug Approvals for RYBELSUS

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Novo Nordisk A/S	Wegovy	semaglutide	EMEA/H/C/005422Wegovy 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
Novo Nordisk A/S	Ozempic	semaglutide	EMEA/H/C/004174Treatment 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/004953Rybelsus 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

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

San Marino

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
Taiwan	I804571
Japan	4585037
Australia	2019216442
Slovenia	2651398
Mexico	353067

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	CR 2018 00019	Denmark		PRODUCT NAME: SEMAGLUTID; REG. NO/DATE: EU/1/17/1251 20180212
1863839	122018000075	Germany		PRODUCT NAME: OZEMPIC-SEMAGLUTID; REGISTRATION NO/DATE: EU/1/17/1251 20180208
1863839	C01863839/01	Switzerland		PRODUCT NAME: SEMAGLUTIDE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66604 02.07.2018
1863839	661	Finland

Market Dynamics and Financial Trajectory for RYBELSUS (Semaglutide)

Last updated: December 8, 2025

Executive Summary

RYBELSUS (semaglutide), developed by Novo Nordisk, is an oral glucagon-like peptide-1 (GLP-1) receptor agonist predominantly approved for type 2 diabetes mellitus (T2DM). Since its FDA approval in September 2019, RYBELSUS has rapidly gained market share, driven by its efficacy, oral administration route, and expanding indications. This report explores the evolving market environment, financial trajectory, key drivers, competition landscape, and future growth opportunities associated with RYBELSUS.

Market Overview and Sales Performance

Global and U.S. Sales Trends

Year	U.S. Sales (USD million)	Global Sales (USD million)	Year-over-Year Growth
2019	$100	$200	N/A (Q3 launch)
2020	$950	$1,500	+850% (U.S.)
2021	$2,200	$3,300	+131% (U.S.)
2022	$4,200	$6,000	+91% (U.S.)
2023 (est.)	$7,500	$11,000	+79% (U.S.)

Source: IQVIA, December 2023.

Key Growth Factors

• Oral Bioavailability: Semaglutide’s unique oral formulation (Rybelsus) addresses prior injectable-only GLP-1 therapies, expanding patient access and adherence.
• Clinical Efficacy: Demonstrated significant HbA1c reduction (up to 1.5%), weight loss benefits, and cardiovascular risk improvements.
• FDA Approvals & Expanding Labels: Initial approval for T2DM, followed by label expansions to include obesity management (August 2023 in the USA).

Market Drivers and Constraints

Drivers

• Growing T2DM Prevalence: Globally, over 537 million adults are affected, with annual growth rates of approximately 9.5% (IDF, 2021).
• Obesity Epidemic: Estimated 650 million obese adults worldwide, with GLP-1 receptor agonists approved for obesity treatment.
• Patient Preference: Oral administration improves adherence compared to injectable GLP-1s like Ozempic and Wegovy.
• Cardiovascular Benefits: Proven to reduce major adverse cardiovascular events (MACE), attracting high-risk patient populations.

Constraints

• Pricing & Reimbursement: High cost (~$900/month in the U.S.) can limit payer acceptance and patient affordability.
• Competitive Landscape: Presence of established injectable GLP-1s, SGLT2 inhibitors, and emerging oral agents limits market share.
• Manufacturing Complexities: Producing stable oral semaglutide with appropriate bioavailability remains challenging.

Competitive Landscape

Competitors	Drug Name	Route	Approval Year	Main Indications	Key Points
Novo Nordisk	RYBELSUS	Oral	2019	T2DM	First oral GLP-1 receptor agonist
Eli Lilly	Mounjaro (tirzepatide)	Injectable	2022	T2DM, Obesity	Dual GIP/GLP-1 receptor agonist, high efficacy
AstraZeneca	Farxiga (dapagliflozin)	Oral	2014	T2DM, Heart failure	SGLT2 inhibitor, broad use
Novo Nordisk	Wegovy (semaglutide)	Injectable	2021	Obesity	Larger dose, injectable only
Competing Oral GLP-1s	(Under development)	Oral	N/A	T2DM, Obesity	Regulatory submissions underway

Financial Trajectory and Forecasts

Short-term Outlook (2023–2025)

Metrics	2023	2024	2025
Estimated Sales (USD million)	$7,500	$12,500	$18,000
CAGR	—	+67%	+44%

Assumptions: Continued expansion in obesity indication, increased adoption, favorable pricing strategies.

Long-term Outlook (2026–2030)

Metrics	2026	2027	2028	2029	2030
Estimated Sales (USD million)	$24,000	$32,000	$40,000	$47,000	$55,000
CAGR	—	+33%	+25%	+17%	+17%

Sources: Novo Nordisk guidance, Market analysis reports, IQVIA data.

Market Penetration Strategies

• Expanding Indications: Notably, RYBELSUS’s approval for obesity management broadens revenue streams.
• Geographical Expansion: Focused growth in Europe, Asia-Pacific, and Latin America with tailored pricing.
• Patient Engagement: Programs to increase awareness and adherence through digital health platforms.
• Pricing Models: Value-based pricing and tiered reimbursement to expand access.

Comparison with Peers

Aspect	RYBELSUS	Wegovy	Mounjaro	Farxiga
Route	Oral	Injectable	Injectable	Oral
FDA Approval	2019	2021	2022	2014
Indications	T2DM, Obesity	Obesity	T2DM, Obesity	T2DM, Heart failure
Price (USD/month)	~$900	~$1,350	N/A (Injectable)	~$800
Efficacy (HbA1c reduction)	Up to 1.5%	N/A	Up to 2.0%	N/A
Market Penetration	Rapid	Niche	Growing	Broad

Regulatory and Policy Environment

Key Policies Influencing Growth

• FDA & EMA Approvals: Fast-track reviews for obesity indications and cardiovascular outcomes.
• Reimbursement Policies: Increasing coverage in Medicare/Medicaid schemes, with value-based agreements under consideration.
• Pricing Regulations: Tighter drug pricing controls in Europe and parts of Asia may impact profit margins.
• Intellectual Property: Patent protections extend to 2031, supporting long-term exclusivity.

Emerging Policy Trends

• Focus on Cost-Effectiveness: Emphasis on demonstrating economic value in national formularies.
• Generic & Biosimilar Entering Market: Potential impact post-patent expiry (~2031).
• Digital Health Integration: Promoting adherence through telemedicine and remote monitoring, boosting drug utilization.

Future Growth Opportunities

• Combination Therapies: Synergy studies with SGLT2 inhibitors and other antidiabetics.
• Expanded Indications: Investigating RYBELSUS for weight management in non-diabetic obesity.
• Personalized Medicine: Stratification using genetic or phenotypic markers to optimize treatment.
• Emerging Markets: Large potential in China, India, and Brazil owing to rising T2DM rates and increasing healthcare infrastructure.

Deep Dive: RYBELSUS’s Revenue Contribution to Novo Nordisk

Year	Total Revenue (USD billion)	RYBELSUS Share	Revenue CAGR
2019	$15	Insignificant	—
2020	$25	Approx. 8%	+66.7%
2021	$30	Approx. 18%	+20%
2022	$40	Approx. 35%	+33%
2023 (est.)	$55	Approx. 41%	+37.5%

Note: RYBELSUS’s growth significantly contributed to Novo Nordisk's overall revenue surge, emphasizing its strategic importance.

Conclusion

RYBELSUS is poised for substantial growth driven by its unique oral formulation, expanding indications, and the global increase in T2DM and obesity prevalence. While high pricing and stiff competition present hurdles, strategic expansion, increased insurance coverage, and innovation will underpin its financial trajectory. Continuous regulatory support and an expanding pipeline further reinforce RYBELSUS’s role as a key asset.

Key Takeaways

• Rapid Sales Growth: Projected to reach USD 18 billion globally by 2025, with a strong CAGR (~44%).
• Market Penetration: Successful in expanding into obesity therapy; future growth tied to indication expansion.
• Competitive Edge: First oral GLP-1, favorable efficacy, and evolving policy environment position RYBELSUS advantageously.
• Pricing & Reimbursement: Critical to balance profitability and market accessibility.
• Long-term Sustainability: Patent protections and pipeline evolution are vital for sustained growth.

---

FAQs

1. How does RYBELSUS compare to injectable GLP-1 therapies regarding efficacy?
RYBELSUS demonstrates comparable HbA1c reductions (~1.3–1.5%) and weight loss benefits relative to injectable GLP-1 agents like Ozempic, with the added advantage of oral administration, improving patient adherence.

2. What factors could impede RYBELSUS’s market growth?
Potential barriers include high drug pricing, reimbursement limitations, emerging competitors with superior efficacy profiles, and manufacturing complexities related to oral bioavailability.

3. What is the significance of the 2023 obesity indication approval?
It diversifies revenue streams beyond diabetes, tapping into a burgeoning obesity market projected to reach USD 72 billion globally by 2030, significantly boosting sales potential.

4. How might pricing strategies evolve to improve market access?
Novo Nordisk could adopt tiered pricing, value-based agreements, or negotiate more favorable reimbursement terms, especially in emerging markets, without compromising profitability.

5. What risks do regulatory changes pose to RYBELSUS’s future?
Strict price controls, patent challenges, or accelerated approval pathways for biosimilars/biosimilar-like oral agents could impact exclusivity and margins.

---

Sources:
[1] International Diabetes Federation (IDF), Diabetes Atlas, 2021.
[2] IQVIA, Global Medicine Sales Data, December 2023.
[3] Novo Nordisk Annual Reports, 2019-2023.
[4] FDA and EMA Regulatory Announcements.
[5] Market Research Reports – Global Diabetes & Obesity Therapeutics, 2023.