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PONVORY Drug Patent Profile

When do Ponvory patents expire, and what generic alternatives are available?

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 forty-four patent family members in forty 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 will be eligible for patent challenges on March 18, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for PONVORY

International Patents:	144
US Patents:	6
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	1
Patent Applications:	75
Drug Prices:	Drug price information 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

Constraining patent/regulatory exclusivity:

9,062,014

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 seven US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on patent 9,062,014.

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	RE43728		Y	Y
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-005	Mar 18, 2021		RX	Yes	No	10,220,023
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	9,000,018
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-007	Mar 18, 2021		RX	Yes	No	8,273,779
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-008	Mar 18, 2021		RX	Yes	No	11,951,097
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-008	Mar 18, 2021		RX	Yes	No	RE43728		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	213498-009	Mar 18, 2021	9,000,018
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-010	Mar 18, 2021	RE43728
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-007	Mar 18, 2021	9,000,018
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-006	Mar 18, 2021	RE43728
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-004	Mar 18, 2021	9,000,018
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-001	Mar 18, 2021	9,000,018
Vanda Pharms Inc	PONVORY	ponesimod	TABLET;ORAL	213498-007	Mar 18, 2021	RE43728

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/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 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
Austria	483698
Eurasian Patent Organization	036075	СХЕМА ДОЗИРОВАНИЯ ДЛЯ СЕЛЕКТИВНОГО АГОНИСТА РЕЦЕПТОРА S1P1 (DOSING REGIMEN FOR A SELECTIVE S1P1 RECEPTOR AGONIST)
South Korea	20170094335	선택적 S1P1 수용체 효능제에 대한 투약 섭생 (S1P1 DOSING REGIMEN FOR A SELECTIVE S1P1 RECEPTOR AGONIST)
South Korea	20190077131	선택적 S1P1 수용체 아고니스트를 포함하는 약학 조합물 (S1P1 PHARMACEUTICAL COMBINATION COMPRISING A SELECTIVE S1P1 RECEPTOR AGONIST)
Hungary	E057865
Morocco	41139	COMBINAISON PHARMACEUTIQUE COMPORTANT UN AGONISTE SÉLECTIF DU RÉCEPTEUR SIP1
South Korea	20110071133	CRYSTALLINE FORMS OF (R)-5-[3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)-BENZ[Z]YLIDENE]-2-([Z]-PROPYLIMINO)-3-0-TOLYL-THIAZOLIDIN-4-ONE

Supplementary Protection Certificates for PONVORY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
3256125	C03256125/01	Switzerland		PRODUCT NAME: PONESIMOD; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 68114 16.11.2021
3256125	2022C/515	Belgium		PRODUCT NAME: PONESIMOD (IUPAC NAAM: (R)-5-(3-CHLORO-4-(2,3-DIHYDROXY-PROPOXY)- BENZ(Z)YLIDEEN)-2-((Z)-PROPYLIMINO)-3-O-TOLYL-THIAZOLIDIN-4-ON); AUTHORISATION NUMBER AND DATE: EU/1/21/1550 20210521
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	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	PA2022505	Lithuania		PRODUCT NAME: PONEZIMODAS; REGISTRATION NO/DATE: EU/1/21/1550 20210519

PONVORY Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for PONVORY

Introduction

PONVORY, a selective S1P1 receptor modulator, has been approved by the U.S. Food and Drug Administration (FDA) and Health Canada to treat adults with relapsing forms of multiple sclerosis (MS). Despite being the fourth in its class and the ninth branded oral drug in the MS market, PONVORY has shown promising potential. Here, we delve into the market dynamics and financial trajectory of this drug.

Market Position and Competition

PONVORY entered a crowded MS market, where it competes with established drugs like Roche's Ocrevus, Bristol Myers Squibb’s Zeposia, and Novartis’ Mayzent. Despite this, a Spherix Global Insights survey indicated that physicians project a 4.5% market share for PONVORY six months after its launch, placing it on par with Zeposia and ahead of Mayzent[1].

Physician and Patient Perspectives

Physicians have expressed positive opinions about PONVORY, particularly for its unique pharmacokinetic profile. Unlike most other MS drugs, PONVORY clears out of the system within a week, making it a preferred option for patients planning to start families. This differentiation is crucial, as half of the specialists surveyed by Spherix indicated that PONVORY could become a preferred oral therapy for such patients[1].

Sales and Uptake

The initial uptake of PONVORY has been relatively slow. After three months on the market, only 14% of neurologists were contacted about PONVORY by J&J sales reps, significantly lower than other MS drug launches at the same stage. This low detailing rate is a key factor in the slow prescription growth[1].

However, patient requests have played a significant role in driving prescriptions. Neurologists cited patient requests as the second most common reason for prescribing PONVORY, which is unusual since patient requests typically rank lower in such surveys[1].

Financial Performance

Vanda Pharmaceuticals acquired the U.S. and Canadian rights to PONVORY from Janssen on December 7, 2023. Since then, the drug has shown mixed financial results.

• In the second quarter of 2024, PONVORY net product sales were $8.6 million, a 26% increase from the first quarter of 2024 but a 15% decrease compared to the second quarter of 2023 due to generic competition[2].
• In the third quarter of 2024, PONVORY net product sales dropped to $5.9 million, a 32% decrease from the second quarter of 2024[5].

For the first nine months of 2024, PONVORY net product sales totaled $21.3 million. Despite this, Vanda Pharmaceuticals reported a net loss of $14.0 million for the same period, compared to a net income of $4.9 million in the first nine months of 2023[5].

Operational Highlights and Challenges

The acquisition of PONVORY has expanded Vanda's commercial portfolio, but it also comes with operational challenges.

• Cash Position: As of September 30, 2024, Vanda's cash, cash equivalents, and marketable securities stood at $376.3 million, representing a decrease from the previous quarter[5].
• Operating Expenses: Vanda's operating expenses have increased, with significant costs in research and development, selling, general and administrative, and intangible asset amortization[5].

Differentiation and Market Strategy

Differentiation is crucial for PONVORY's success in a crowded market. The drug's unique pharmacokinetic profile and its superiority over other MS drugs like Aubagio in clinical studies are key differentiators. For instance, PONVORY was associated with fewer T2 and T1 MRI lesions and showed a lower annual rate of relapse compared to Aubagio[4].

Future Outlook

The future of PONVORY hinges on how effectively Vanda can differentiate it and present compelling data to physicians. As Virginia Schobel from Spherix noted, "If Janssen can differentiate and lay out where they’re going to play, present the data and explain why it makes sense, then yes, it will be interesting to watch"[1].

Key Takeaways

• Market Share Potential: PONVORY is projected to achieve a 4.5% market share six months after its launch.
• Unique Selling Points: Its rapid clearance from the system makes it a preferred option for patients planning families.
• Financial Performance: Mixed results with increasing sales in some quarters but overall net losses.
• Operational Challenges: High operating expenses and the need for effective differentiation.
• Future Strategy: Differentiation and presenting compelling data to physicians are critical for success.

FAQs

Q: What is PONVORY, and how is it used? A: PONVORY is a selective S1P1 receptor modulator approved for treating adults with relapsing forms of multiple sclerosis.

Q: How does PONVORY differentiate itself in the MS market? A: PONVORY clears out of the system within a week, making it a preferred option for patients planning to start families, and it has shown superiority over other MS drugs like Aubagio in clinical studies.

Q: Who acquired the rights to PONVORY, and when? A: Vanda Pharmaceuticals acquired the U.S. and Canadian rights to PONVORY from Janssen on December 7, 2023.

Q: What are the financial highlights for PONVORY in 2024? A: PONVORY net product sales were $8.6 million in the second quarter and $5.9 million in the third quarter of 2024, with total sales of $21.3 million for the first nine months.

Q: What are the main challenges facing PONVORY in the market? A: The main challenges include low detailing rates by sales reps, high operating expenses, and the need for effective differentiation in a crowded market.

Sources

1. FiercePharma: J&J's Ponvory may be late to the multiple sclerosis market, but docs still see potential: Study
2. PR Newswire: Vanda Pharmaceuticals Reports Second Quarter 2024 Financial Results
3. Citeline: Idorsia Cost-Reduction Effort Will End in 2023
4. PR Newswire: Vanda Pharmaceuticals Acquires U.S. and Canadian Rights to PONVORY
5. PR Newswire: Vanda Pharmaceuticals Reports Third Quarter 2024 Financial Results