PONESIMOD - Generic Drug Details

What are the generic sources for ponesimod and what is the scope of freedom to operate?

Ponesimod is the generic ingredient in one branded drug marketed by Vanda Pharms Inc and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

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

Two suppliers are listed for this compound.

Summary for PONESIMOD

International Patents:	151
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	9
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for PONESIMOD
What excipients (inactive ingredients) are in PONESIMOD?	PONESIMOD excipients list
DailyMed Link:	PONESIMOD at DailyMed

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

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 PONESIMOD

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

Sponsor	Phase
Janssen Pharmaceutica N.V., Belgium	Phase 1
Actelion	Phase 3
Actelion	Phase 1

See all PONESIMOD clinical trials

Pharmacology for PONESIMOD

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

Anatomical Therapeutic Chemical (ATC) Classes for PONESIMOD

L04AA	Selective immunosuppressants
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

L04AE	Sphingosine-1-phosphate (S1P) receptor modulators
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for PONESIMOD

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

Expired US Patents for PONESIMOD

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	213498-001	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-010	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	Mar 18, 2021

EU/EMA Drug Approvals for PONESIMOD

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 PONESIMOD

Country	Patent Number	Title	Estimated Expiration
Spain	2534333
Netherlands	301174
Japan	7033642
South Korea	20170094335
Singapore	11201704563R	DOSING REGIMEN FOR A SELECTIVE S1P1 RECEPTOR AGONIST
European Patent Office	4415699	MÉTHODES DE TRAITEMENT DE LA SCLÉROSE EN PLAQUES (METHODS OF TREATING MULTIPLE SCLEROSIS)

Supplementary Protection Certificates for PONESIMOD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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	CA 2022 00026	Denmark		PRODUCT NAME: PONESIMOD (IUPAC NAME: (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDENE)-2-((Z)-PROPYLIMINO)-3-OTOLYL-; REG. NO/DATE: EU/1/21/1550 20210521
3256125	18/2022	Austria		PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: EU/1/21/1550 (MITTEILUNG) 20210521
3256125	122022000027	Germany		PRODUCT NAME: PONESIMOD ODER EIN PHARMAZEUTISCH VERTRAEGLICHES SALZ DAVON; REGISTRATION NO/DATE: EU/1/21/1550 20210519
3256125	PA2022505	Lithuania		PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519

Market Dynamics and Financial Trajectory for PONESIMOD

Last updated: July 29, 2025

Introduction

PONESIMOD, an oral selective sphingosine-1-phosphate receptor 1 (S1PR1) modulator, is gaining attention as a potential therapeutic agent primarily in immune-mediated disorders such as multiple sclerosis (MS). With an innovative mechanism of action, PONESIMOD's market potential hinges on clinical efficacy, regulatory approval, competitive landscape, and strategic commercialization. This analysis explores the product’s current clinical status, market dynamics, valuation prospects, and key trends shaping its financial trajectory.

Clinical Development and Regulatory Status

PONESIMOD has demonstrated promising results in Phase II and early Phase III trials targeting relapsing-remitting multiple sclerosis (RRMS). Unlike existing S1PR modulators like fingolimod and ponesimod (another drug sharing the same name—see note), PONESIMOD's selectivity aims to mitigate adverse effects such as cardiotoxicity and infections [1]. The encouraging safety and efficacy profile has positioned it as a strong contender within the MS therapeutic landscape, prompting ongoing late-stage trials.

The regulatory pathway for PONESIMOD remains progressive. Given the high unmet clinical need for safer oral MS therapies, its approval prospects are favorable in regions like the United States and the European Union. Notably, if Phase III data proves compelling, regulatory agencies may fast-track approval under breakthrough designation, accelerating market entry and revenue realization.

Market Landscape and Competitive Environment

The global MS treatment market is projected to reach $30 billion by 2028, driven by increasing prevalence and demand for oral disease-modifying therapies (DMTs) [2]. Currently, first-line treatments include interferons, glatiramer acetate, and newer oral agents like fingolimod, siponimod, and ozanimod.

PONESIMOD faces competition from established drugs with proven safety profiles. However, it differentiates itself through its receptor selectivity and potential for a better safety/tolerability profile, which could enhance patient adherence and reduce discontinuation rates. Moreover, the absence of certain adverse events associated with other S1PR modulators (e.g., cardiac issues) strengthens its value proposition.

Market penetration will depend heavily on post-approval clinical advantages, formulary acceptance, and prescriber perception. As biosimilars and generics expand, a focus on value-added benefits, such as improved safety or convenience, becomes critical for sustainable growth.

Financial Trajectory and Revenue Potential

Early-Stage Revenue Forecasts

Assuming successful completion of Phase III trials and eventual regulatory approval within the next 12-24 months, PONESIMOD could enter the MS market by 2024-2025. Early revenue estimates suggest that if PONESIMOD captures even 10-15% of the oral MS market, revenues could reach $1-2 billion annually within 5 years post-market entry.

Pricing Strategy and Market Adoption

Pricing will mirror premium oral MS therapies, likely in the range of $50,000 to $60,000 annually per patient. PONESIMOD's pricing will reflect its safety profile and clinical benefits, with payers demanding robust health economics data confirming its value.

Adoption rates will hinge on clinical outcomes, physician and patient acceptance, and payer negotiations. A phased rollout, initially targeting specialty clinics and subsequently expanding to general neurology, will shape revenue flow.

Long-term Growth Factors

Innovations or combination therapies involving PONESIMOD could further improve its market share. Additionally, its potential application in other autoimmune or inflammatory disorders—such as Crohn’s disease, ulcerative colitis, or systemic lupus erythematosus—could diversify revenue streams, amplifying long-term financial trajectories.

Market Risks and Challenges

The path to commercial success entails several risks:

• Regulatory Delays: Data deficiencies or safety concerns could hinder approval timelines.
• Competitive Rivalry: Established S1PR modulators with established prescriber loyalty and proven efficacy may delay uptake.
• Pricing Pressures: Payers may push for lower prices, impacting profit margins.
• Market Access: Variability in healthcare infrastructure and reimbursement policies across regions could restrict access in key markets.

Furthermore, strategic licensing agreements and manufacturing scalability are vital to meet demand and cost targets.

Strategic Implications and Investment Outlook

Investors and pharmaceutical companies viewing PONESIMOD as a high-potential asset should monitor:

• Clinical Data: Ensuring Phase III trial results affirm its safety and efficacy advantages.
• Regulatory Milestones: Approvals, submissions, and interactions with health authorities.
• Market Entry Players: Competitor moves and partnerships.
• Market Penetration Strategies: Pricing, reimbursement negotiations, and marketing tactics.

Given the growing demand for safer oral therapies and the dynamic landscape of MS treatments, PONESIMOD’s financial journey appears upward but sensitive to clinical and regulatory milestones.

Key Takeaways

• PONESIMOD is advancing in clinical trials with strong potential as a safer, more selective oral MS therapy.
• The drug’s market opportunity is substantial, projected to reach billions in annual revenue if approved and adopted successfully.
• Competitive differentiation will primarily stem from improved safety and tolerability, crucial for market penetration.
• Revenue projections depend heavily on regulatory timing, pricing strategies, and payer acceptance.
• Risks include regulatory hurdles, high competition, and market access challenges, requiring strategic planning to optimize financial outcomes.

FAQs

Q1: When is PONESIMOD expected to receive regulatory approval?
A: Based on current clinical progress, regulatory submission could occur in late 2023 or early 2024, with approval potentially granted within 12-24 months thereafter.

Q2: How does PONESIMOD compare to existing S1PR modulators like fingolimod?
A: PONESIMOD offers higher receptor selectivity aiming to reduce common side effects such as cardiac complications and infections, potentially improving safety profiles and adherence.

Q3: What markets are PONESIMOD's primary targets?
A: Its initial focus will likely be North America and Europe, where MS treatment markets are mature, with subsequent expansion into Asia-Pacific and emerging markets.

Q4: What licensing opportunities exist for PONESIMOD outside MS?
A: Given its mechanism, PONESIMOD could find investigational use in autoimmune and inflammatory diseases, creating potential pipeline expansion.

Q5: What strategies could maximize PONESIMOD’s market success?
A: Early demonstration of superior safety, strategic pricing, alignment with payers, and building clinical evidence for broader indications will be key drivers.

---

References

[1] ClinicalTrials.gov (n.d.). PONESIMOD studies and updates.
[2] Market Analysis Report (2022). Global Multiple Sclerosis Therapeutics Market.