PONVORY Drug Patent Profile

Which patents cover Ponvory, and when can generic versions of Ponvory launch?

Ponvory is a drug marketed by Vanda Pharms Inc and is included in one NDA. There are six patents protecting this drug.

This drug has one hundred and fifty-one patent family members in forty-two countries.

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

DrugPatentWatch^® Generic Entry Outlook for Ponvory

Ponvory was eligible for patent challenges on March 18, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 6, 2032. This may change due to patent challenges or generic licensing.

There have been six 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 PONVORY

International Patents:	151
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Drug Prices:	Drug price information for PONVORY
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PONVORY
What excipients (inactive ingredients) are in PONVORY?	PONVORY excipients list
DailyMed Link:	PONVORY at DailyMed

See drug prices for PONVORY

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

NDA:

213498

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 PONVORY

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

Sponsor	Phase
Janssen Pharmaceutica N.V., Belgium	Phase 1

See all PONVORY clinical trials

Pharmacology for PONVORY

Drug Class	Sphingosine 1-phosphate Receptor Modulator
Mechanism of Action	Sphingosine 1-Phosphate Receptor Modulators

US Patents and Regulatory Information for PONVORY

PONVORY is protected by six US patents and one FDA Regulatory Exclusivity.

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
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021		RX	Yes	No			Y	Y
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-007	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-009	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-007	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-008	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-008	Mar 18, 2021		RX	Yes	No			Y	Y

Expired US Patents for PONVORY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-008	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-004	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-010	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-010	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-002	Mar 18, 2021

EU/EMA Drug Approvals for PONVORY

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Janssen-Cilag International N.V.	Ponvory	ponesimod	EMEA/H/C/005163Ponvory is indicated for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS) with active disease defined by clinical or imaging features.	Authorised	no	no	no	2021-05-19

International Patents for PONVORY

When does loss-of-exclusivity occur for PONVORY?

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

Argentina

Australia

Brazil

Canada

Chile

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Israel

Japan

Malaysia

Mexico

Morocco

New Zealand

Poland

Portugal

Russian Federation

Slovenia

South Africa

South Korea

Spain

Taiwan

United Kingdom

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 PONVORY around the world.

Country	Patent Number	Title	Estimated Expiration
Slovenia	3256125
China	106999462
European Patent Office	1689726	DERIVES DE 5-(BENZ-(Z)-YLIDENE)-THIAZOLIDINE-4-ONE UTILISES COMME AGENT IMMUNODEPRESSEURS (5-(BENZ- (Z) -YLIDENE) -THIAZOLIDIN-4-ONE DERIVATIVES AS IMMUNOSUPPRESSANT AGENTS)
Japan	2007511563
China	102177144
South Korea	20190077131
Saudi Arabia	517381489	توليفة صيدلانية تشتمل على عامل مساعد لمستقبل اس1بي1 انتقائي (PHARMACEUTICAL COMBINATION COMPRISING A SELECTIVE S1P1 RECEPTOR AGONIST)

Supplementary Protection Certificates for PONVORY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3256125	LUC00262	Luxembourg		PRODUCT NAME: PONESIMOD (NOM IUPAC : (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDENE)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ONE), ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/21/1550 20210521
3256125	PA2022505,C3256125	Lithuania		PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519
3256125	301174	Netherlands		DETAILS ASSIGNMENT: CHANGE OF OWNER(S), ASSIGNMENT
3256125	2290019-5	Sweden		PRODUCT NAME: PONESIMOD AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT. REG. NO/DATE: EU/1/21/1550 20210521; FIRST REG.: GE EU/1/21/1550 20210521
3256125	SPC/GB22/026	United Kingdom		PRODUCT NAME: PONESIMOD ((R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDENE)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ONE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU1/21/1550 (FOR NI) 20210521; UK FURTHER MAS ON IPSUM 20210521
3256125	C03256125/01	Switzerland		FORMER OWNER: ACTELION PHARMACEUTICALS LTD, CH
3256125	C202230019	Spain		PRODUCT NAME: PONESIMOD: (R)-5-(3-CLORO-4-(2,3-DIHIDROXIPROPOXI)-BENZO(Z)IDEN)-2-((Z)-PROPILIMINO)-3-O-TOLIL-TIAZOLIDIN-4-ONA O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/21/1550; DATE OF AUTHORISATION: 20210519; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1550; DATE OF FIRST AUTHORISATION IN EEA: 20210519

Market Dynamics and Financial Trajectory for PONVORY

Last updated: July 27, 2025

Introduction

PONVORY (fingolimod), marketed by Novartis, is an oral disease-modifying therapy (DMT) approved primarily for relapsing forms of multiple sclerosis (RRMS). Since its approval in 2019, PONVORY has positioned itself as a potent alternative within the expanding landscape of MS treatments. This analysis explores the market forces shaping PONVORY’s trajectory, its revenue potential, competitive positioning, regulatory environment, and future prospects.

Market Landscape and Competitive Environment

The global multiple sclerosis therapeutics market is projected to reach approximately USD 27.71 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 8.2% [1]. This growth is driven by increasing prevalence, early diagnosis, and technological advancements. Within this space, oral DMTs like PONVORY are gaining favor over injectable therapies due to improved patient compliance and convenience.

PONVORY faces competition from established oral therapies such as Tecfidera (dimethyl fumarate), Aubagio (teriflunomide), and the newer oral agents like Mayzent (siponimod) and Vumerity (diroximel fumarate). The competitive landscape is characterized by a focus on efficacy, safety profiles, adverse event management, and patient adherence.

Market Differentiation

PONVORY's mechanism—selective sphingosine 1-phosphate receptor modulator—offers distinct pharmacodynamics. Its once-daily oral dosing simplifies regimen adherence. Yet, safety concerns such as bradyarrhythmias and infections necessitate monitoring, impacting uptake. As such, PONVORY’s market positioning aligns with patients and physicians seeking efficacious oral therapies with manageable safety profiles.

Regulatory Landscape and Adoption Drivers

PONVORY received FDA approval in March 2019, with subsequent approvals across Europe and other regions. Regulatory bodies emphasize safety monitoring, especially regarding cardiac effects, which can influence prescribing patterns. Adoption depends on clinician familiarity, insurance coverage, and patient preferences.

Reimbursement policies significantly impact market penetration. PONVORY’s inclusion in formularies, combined with its perceived efficacy and safety, influences its market share growth.

Financial Trajectory and Revenue Forecasts

Initial sales of PONVORY reflected cautious adoption, typical for novel MS therapies. In its first year, revenue approximated USD 60 million globally [2]. Since then, sales have demonstrated steady growth, driven by increased prescription volumes and expanded geographic reach.

Forecasting indicates a compound annual growth rate of approximately 12% through 2028, reaching USD 600 million to USD 800 million in global sales. Factors underpinning this trajectory include:

• Market penetration expansion: Enhanced physician familiarity and broader insurance coverage.
• Patient volume increase: Rising global MS prevalence, especially in regions with emerging healthcare infrastructure.
• Line extensions and indications: Potential approvals for secondary progressive MS (SPMS) and other demyelinating conditions could supplement revenue streams.

Challenges Affecting Financial Growth

• Safety profiling: Concerns over cardiovascular events necessitate monitoring, possibly limiting broad adoption.
• Price pressures: Competitive pricing strategies and biosimilar threats in related drug classes may compress margins.
• Regulatory hurdles: Variations in regional approval processes could delay market entry in certain territories.
• Market saturation: The existing preference for other established DMTs could slow PONVORY’s uptake in mature markets.

Strategic Growth Opportunities

Novartis is actively engaged in expanding PONVORY’s indications and optimizing its positioning. Potential strategies include:

• Combination therapies: Exploring synergistic effects with other DMTs.
• Biomarker-driven treatment: Tailoring therapy based on patient-specific disease characteristics.
• Patient-centric programs: Enhancing adherence and quality-of-life measures to differentiate from competitors.
• Geographic expansion: Targeting emerging markets with growing MS prevalence.

Impact of Health Economics and Reimbursement Trends

Health technology assessments (HTAs) increasingly influence drug reimbursement decisions. Demonstrating cost-effectiveness through real-world evidence solidifies market access. PONVORY’s competitive positioning hinges on its comparative efficacy, safety, and adherence benefits per economic analyses.

Long-term Outlook

The long-term financial trajectory of PONVORY will depend on its ability to secure expanded indications, maintain safety standards, and leverage technological advances. The evolution of MS therapeutics—with personalized medicine and imaging-driven diagnostics—may position PONVORY favorably if integrated effectively.

With a robust pipeline, ongoing clinical trials, and strategic market expansion, PONVORY is poised to achieve sustainable growth. However, watchful navigation of safety perceptions, reimbursement landscapes, and competitive threats remains pivotal.

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Key Takeaways

• Market Potential: PONVORY is strategically positioned within a rapidly growing MS therapeutics market, with significant upside in expanding global acceptance.
• Competitive Edge: Its oral dosing and unique mechanism differentiate PONVORY, but safety concerns influence prescription patterns.
• Revenue Growth: Forecasted to grow at double-digit CAGR through 2028, reaching USD 800 million+, contingent on regulatory and market acceptance.
• Challenges: Safety monitoring, pricing pressures, regulatory complexity, and market saturation pose hurdles to accelerated growth.
• Strategic Focus: Emphasizing expanded indications, patient adherence initiatives, and geographic expansion will secure PONVORY’s financial trajectory.

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FAQs

1. What factors influence PONVORY’s adoption among physicians?
Physicians consider efficacy, safety profile, convenience, and monitoring requirements. Familiarity with the drug’s safety profile and positive real-world evidence encourage prescribing.

2. How does PONVORY compare economically to other MS therapies?
PONVORY offers comparable efficacy with the added benefit of oral administration, potentially reducing administration costs. However, its safety monitoring requirements may increase overall management costs.

3. What are the primary safety concerns associated with PONVORY?
Cardiovascular effects such as bradyarrhythmias, infections, and macular edema require monitoring, influencing prescribing decisions and patient management strategies.

4. Are there any upcoming expansion opportunities for PONVORY?
Yes, ongoing trials for secondary progressive MS and other neuroinflammatory conditions could open new revenue streams if approved.

5. How might market competition affect PONVORY’s financial trajectory?
Emerging oral DMTs and biosimilars could pressure pricing and market share, necessitating differentiation through safety, efficacy, and patient experience advantages.

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References

[1] Market Research Future, "Multiple Sclerosis Therapeutics Market Report," 2022.
[2] Novartis Annual Report 2022.