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 forty-four patent family members in forty countries.

Two suppliers are listed for this compound.

Summary for PONESIMOD

International Patents:	144
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	9
Patent Applications:	93
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	213498-003	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No			Y	Y
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-007	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-003	Mar 18, 2021		RX	Yes	No
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	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	213498-002	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	213498-004	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-008	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-008	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/005163 Ponvory 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
Argentina	073904	FORMAS CRISTALINAS DE DERIVADOS DE TIAZOLIDINONA UTILES COMO INMUNOMODULADORES
Cyprus	2022011
Japan	2017538706	選択的Ｓ１Ｐ１レセプターアゴニストの投与法
World Intellectual Property Organization (WIPO)	2016092042
Cyprus	1125170
New Zealand	547962	5-(benz-(z)-ylidene)-thiazolidin-4-one derivatices as immunosuppressant agents
Hungary	S2200021

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	22C1021	France		PRODUCT NAME: PONESIMOD ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/21/1550 20210521
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); 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		PRODUCT NAME: PONESIMOD (IUPAC NAAM: (R)-5-(3-CHLOOR-4-(2,3-DIHYDROXY-PROPOXY)-BENZ(Z)YLIDEEN)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ON), DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/21/1550 20210521
3256125	C03256125/01	Switzerland		PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68114 16.11.2021
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

PONESIMOD Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ponesimod

Introduction

Ponesimod, a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator, has been approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Here, we delve into the market dynamics and financial trajectory of ponesimod, examining its impact on the healthcare market and the financial implications for both patients and healthcare providers.

Market Scenario Analysis

The introduction of ponesimod into the market has been analyzed under two primary scenarios: the current market scenario without ponesimod and the new market scenario with ponesimod.

Current Market Scenario

In the absence of ponesimod, the market for disease-modifying therapies (DMTs) for RMS is dominated by injectable and infusion therapies. This scenario reflects the existing treatment landscape where patients rely on these traditional DMTs[1].

New Market Scenario

With the introduction of ponesimod, the market dynamics shift slightly. Ponesimod is expected to capture a modest market share, with projected uptake rates of 1.0%, 2.5%, and 4.0% for the years 2021, 2022, and 2023, respectively. This uptake is anticipated to displace some of the existing injectable and infusion DMTs, leading to changes in drug acquisition and administrative costs[1].

Financial Impact on Healthcare Providers

The financial impact of ponesimod on healthcare providers is minimal but significant in certain aspects.

Total Annual Costs

The total annual costs for treating RMS patients with and without ponesimod show a slight increase. For instance, in 2021, the total annual cost in the new market scenario was estimated to be $96.4 million, compared to $96.3 million in the current market scenario. This increase is primarily driven by drug acquisition costs, which account for almost all of the total annual cost. Administrative costs, however, decrease due to the displacement of injectable/infusion DMTs by ponesimod[1].

Per Member Per Month (PMPM) Costs

The PMPM costs also reflect a minimal increase, with values ranging from $0.01 in 2021 to $0.03 in 2023. This indicates that the introduction of ponesimod does not significantly burden the healthcare system in terms of cost per member per month[1].

Market Drivers and Restraints

The market for ponesimod, like the broader multiple sclerosis drugs market, is influenced by several drivers and restraints.

Increasing Prevalence of Multiple Sclerosis

The rising prevalence of MS is a key driver for the demand of MS drugs, including ponesimod. As the burden of MS increases, so does the need for effective and diverse treatment options[3].

Advances in Drug Development

Continuous advancements in drug development, including the emergence of oral therapies like ponesimod, drive market growth. These innovations offer patients more treatment choices and improve the overall efficacy and safety of MS treatments[3].

Increased Medical Costs

Despite the benefits, increased medical costs remain a significant restraint. The high cost of DMTs, including ponesimod, can limit access to treatment for many patients. This is particularly challenging in regions where healthcare costs are not adequately covered by insurance or government initiatives[3].

Side Effects and Treatment-Associated Risks

Side effects and treatment-associated risks are another restraint. While ponesimod has a proven safety profile with over 10 years of data, any new therapy carries risks that can impact patient acceptance and adherence[4].

Regional Market Dynamics

The global multiple sclerosis drugs market, including ponesimod, varies significantly by region.

Asia Pacific Region

The Asia Pacific region is expected to register the highest CAGR during the forecast period. This growth is driven by increased government initiatives, improved distribution systems of pharmaceutical companies, and lower treatment costs in the region. For example, the joint venture between Biogen and Eisai Co., Ltd. to promote MS drugs in Japan has significantly boosted the market in this region[3].

Acquisition and Commercial Portfolio Expansion

The acquisition of ponesimod by Vanda Pharmaceuticals from Actelion Pharmaceuticals Ltd. (a Johnson & Johnson Company) marks a significant milestone. This acquisition expands Vanda's commercial portfolio and provides access to a versatile immune modulator, enhancing their market presence and capabilities in treating RMS[4].

Financial Performance of Pharmaceutical Companies

The financial performance of pharmaceutical companies involved in the MS market, including those marketing ponesimod, reflects strong growth. For instance, Johnson & Johnson reported strong sales growth in their pharmaceutical segment, which includes MS treatments. This growth is indicative of the overall demand and financial viability of MS drugs like ponesimod[2].

Key Takeaways

• Minimal Budget Impact: The introduction of ponesimod has a minimal impact on the annual budget of healthcare providers.
• Market Share Uptake: Ponesimod is expected to capture a modest market share, displacing some existing injectable and infusion DMTs.
• Regional Growth: The Asia Pacific region is expected to see the highest growth in the MS drugs market, driven by government initiatives and improved distribution.
• Financial Performance: Pharmaceutical companies involved in the MS market are experiencing strong financial growth.
• Market Drivers: Increasing prevalence of MS and advances in drug development are key drivers for the market.

FAQs

What is ponesimod and how is it used?

Ponesimod is a daily oral selective sphingosine-1-phosphate receptor 1 (S1P1R) modulator approved for the treatment of adults with relapsing forms of multiple sclerosis (RMS), including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease[4].

How does ponesimod affect the annual budget of healthcare providers?

The introduction of ponesimod results in a minimal increase in the annual budget of healthcare providers, primarily due to drug acquisition costs, while administrative costs decrease due to the displacement of injectable/infusion DMTs[1].

What are the key drivers for the multiple sclerosis drugs market?

The key drivers include the increasing prevalence of multiple sclerosis and advances in drug development, which offer patients more effective and diverse treatment options[3].

Which region is expected to see the highest growth in the MS drugs market?

The Asia Pacific region is expected to register the highest CAGR during the forecast period, driven by increased government initiatives, improved distribution systems, and lower treatment costs[3].

Who acquired the U.S. and Canadian rights to ponesimod?

Vanda Pharmaceuticals Inc. acquired the U.S. and Canadian rights to ponesimod from Actelion Pharmaceuticals Ltd. (a Johnson & Johnson Company)[4].

Sources

1. ISPOR: Budget Impact Analysis of Ponesimod for Relapsing Multiple Sclerosis.
2. Johnson & Johnson: 2021 First Quarter Sales.
3. SkyQuest: Multiple Sclerosis Drugs Market Analysis, Size, Share & Trends | 2031.
4. Vanda Pharmaceuticals: Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY® (ponesimod).