velsipity Drug Patent Profile

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

Velsipity is a drug marketed by Pfizer and is included in one NDA. There are nine patents protecting this drug.

This drug has one hundred and twenty-nine patent family members in thirty countries.

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

DrugPatentWatch^® Generic Entry Outlook for Velsipity

Velsipity will be eligible for patent challenges on October 12, 2027. 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 October 12, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for velsipity

International Patents:	129
US Patents:	9
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Drug Prices:	Drug price information for velsipity
What excipients (inactive ingredients) are in velsipity?	velsipity excipients list
DailyMed Link:	velsipity at DailyMed

See drug prices for velsipity

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

216956

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.

Pharmacology for velsipity

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

US Patents and Regulatory Information for velsipity

velsipity is protected by nine US patents and one FDA Regulatory Exclusivity.

This potential generic entry date is based on NEW CHEMICAL ENTITY.

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
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes
Pfizer	VELSIPITY	etrasimod arginine	TABLET;ORAL	216956-001	Oct 12, 2023		RX	Yes	Yes			Y	Y

International Patents for velsipity

See the table below for patents covering velsipity around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	7219732
Mexico	2017016530	SAL CRISTALINA DE L-ARGININA DEL ACIDO (R)-2-(7-(4-CICLOPENTIL-3-( TRIFLUOROMETIL)BENCILOXI)-1,2,3,4-TETRAHIDROCICLOPENTA[B]INDOL-3- IL)ACETICO (COMPUESTO1) PARA SER UTILIZADA EN TRANSTORNOS ASOCIADOS CON EL RECEPTOR DE ESFINGOSINA-1-FOSFATO 1 (S1P1). (CRYSTALLINE L-ARGININE SALT OF (R)-2-(7-(4-CYCLOPENTYL-3-(TRIFLUO ROMETHYL)BENZYLOXY)-1,2,3,4-TETRAHYDROCYCLO-PENTA[B]INDOL-3-YL)A CETIC ACID(COMPOUND1) FOR USE IN SIPI RECEPTOR-ASSOCIATED DISORDERS.)
Morocco	42807
Canada	3102136	METHODES DE TRAITEMENT DE TROUBLES ASSOCIES AU RECEPTEUR S1P1<SB /> (METHODS OF TREATING CONDITIONS RELATED TO THE S1P1 RECEPTOR)

Supplementary Protection Certificates for velsipity

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2326621	2024C/532	Belgium		PRODUCT NAME: ETRASIMOD OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ETRASIMOD ARGININE; AUTHORISATION NUMBER AND DATE: EU/1/23/1790 20240219
2326621	202440027	Slovenia		PRODUCT NAME: ETRASIMOD OR ITS PHARMACEUTICALLY ACCEPTABLE SALT AS ETRASIMOD ARGININE; NATIONAL AUTHORISATION NUMBER: EU/1/23/1790; DATE OF NATIONAL AUTHORISATION: 20240216; AUTHORITY FOR NATIONAL AUTHORISATION: EU
2326621	301284	Netherlands		PRODUCT NAME: ETRASIMOD, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ETRASIMOD ARGININE; REGISTRATION NO/DATE: EU/1/23/1790 20240219
2326621	24C1031	France		PRODUCT NAME: ETRASIMOD, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, TEL QUE L'ETRASIMOD ARGININE; REGISTRATION NO/DATE: EU/1/23/1790 20240219

Market Dynamics and Financial Trajectory for VELSPITITY

Last updated: July 27, 2025

Introduction

VELSPITITY (Patisiran) has established a significant presence within the landscape of rare disease therapeutics. Approved by the U.S. Food and Drug Administration (FDA) in 2018 for hereditary transthyretin-mediated amyloidosis (hATTR amyloidosis), VELSPITITY is a pioneering RNA interference (RNAi) therapy that exemplifies the convergence of innovative molecular technology and personalized medicine. As a first-in-class RNAi drug, VELSPITITY’s market trajectory offers critical insights into the evolving pharmaceutical landscape, regulatory environment, competitive pressures, and commercial outlook for gene-silencing therapies.

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Market Overview and Indication Landscape

Hereditary Transthyretin-Mediated Amyloidosis (hATTR)

hATTR is a progressive, often fatal, multisystem disorder characterized by amyloid deposits derived from misfolded transthyretin (TTR) protein, affecting the nervous, cardiac, and gastrointestinal systems. Its rare disease designation classifies it as an orphan condition, with global prevalence estimated at approximately 50,000 cases[1].

Market Size and Unmet Needs

The global prevalence indicates a niche yet financially significant market, particularly in developed regions. Current estimates project the US hATTR therapeutics market to reach over $800 million by 2025, driven by enhanced diagnosis and expanded treatment options[2]. Despite its rarity, the high morbidity associated with hATTR creates a robust economic case for effective interventions like VELSPITITY, reinforced by premium pricing strategies aligned with orphan drug designations.

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Market Dynamics

Regulatory and Reimbursement Environment

The orphan drug designation afforded to VELSPITITY by FDA facilitates market exclusivity, tax credits, and priority review, expediting access. Reimbursement frameworks in the US and Europe demonstrate willingness to support high-cost therapies, especially when backed by compelling clinical efficacy and demonstrated improvements in survival and quality of life. Payers are increasingly adopting value-based agreements, tying reimbursement levels to real-world outcomes, thereby influencing the financial trajectory of VELSPITITY[3].

Competitive Landscape

VELSPITITY faces competition from other gene-based therapies. Notably, Tegsedi (inotersen), an antisense oligonucleotide (ASO), and Onpattro (patisiran) – the initial RNAi therapy – installed precedent but are associated with distinct safety profiles. Biotech giants and emerging biotech firms are developing next-generation gene-silencing agents, or alternative modalities such as small molecules (e.g., tafamidis), which, although less expensive, may offer varying efficacy or safety profiles.

Technological Innovation and Pipeline Development

The ongoing evolution of RNA interference technology enhances VELSPITITY’s potential market retention. Lipid nanoparticle delivery systems, enhanced tissue targeting, and combination therapies are under active investigation. As these developments mature, they shape the future competitive and financial landscape, potentially extending VELSPITITY’s market exclusivity and augmenting its efficacy profile.

Market Penetration and Adoption Drivers

Factors contributing to uptake include physician familiarity, early diagnosis of hATTR amyloidosis, and patient acceptance. The severity and progressive nature of the disease incentivize treatment initiation. In markets like the US and Europe, increased awareness campaigns, registries, and advocacy groups bolster early diagnosis and therapy acceptance, thus supporting VELSPITITY’s sales growth.

Pricing Considerations

VELSPITITY’s premium pricing, aligned with other orphan drugs (approximately $450,000 annually per patient), reflects the high-cost, high-value paradigm of rare disease therapies. Price negotiations with payers, access schemes, and the adoption of outcome-based agreements will influence revenue streams.

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Financial Trajectory Analysis

Initial Launch and Revenue Trends

Since its launch, VELSPITITY has experienced steady revenue growth. Biogen, its primary marketer, reported U.S. net product revenues nearing $372 million in 2021, indicating strong adoption among specialists treating hATTR[4]. Growth rates are expected to accelerate with increased diagnosis, expanded indications, and geographic expansion.

Market Expansion and Label Extensions

Recent clinical trials investigate VELSPITITY's efficacy in treating transthyretin amyloid cardiomyopathy (ATTR-CM), an indication with broader patient populations. A positive outcome could diversify revenue streams significantly, possibly expanding the addressable market by hundreds of thousands of patients globally[5].

Globally, reimbursement negotiations and regulatory approvals in Europe, Japan, and other territories remain pivotal. Given the drug’s orphan classification, localized price negotiations and health authority decisions significantly impact global revenue.

Pipeline Synergy and Long-term Outlook

Next-generation delivery platforms, combination regimens, and potential biomarkers for response prediction could enhance patient outcomes, driving long-term sustainment of revenue streams. Conversely, competitive entry or biosimilar development might exert downward pressure, emphasizing the importance of patent protection and innovation.

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Risks and Opportunities

• Regulatory Risks: Delays in approval of expanded indications or new formulations could temper growth.
• Pricing and Reimbursement Risks: Increasing pressures on drug pricing amid broader healthcare cost containment initiatives could constrain revenue.
• Technological Risks: Competitors developing superior therapies or disruption via gene-editing could erode market share.
• Opportunities: Broadening indications, expanding to emerging markets, and integrating real-world evidence into value propositions promise substantial upside.

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Conclusion and Future Outlook

The financial trajectory of VELSPITITY is marked by robust initial growth driven by the high unmet need in hATTR amyloidosis, complemented by favorable regulatory and reimbursement frameworks. Its potential expansion into broader amyloidosis indications and continued technological advancements suggest sustained revenue growth, contingent on successful regulatory navigation, competitive positioning, and cost management.

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Key Takeaways

• Market Position: VELSPITITY pioneers RNAi therapies in rare neurological and cardiac indications, positioning itself uniquely within the orphan drug market.
• Revenue Drivers: Increasing diagnosis rates, expanded indications (e.g., ATTR-CM), and global regulatory approvals will underpin future sales.
• Competitive Environment: The presence of similar agents, emerging therapies, and next-gen technologies necessitate continuous innovation and strategic planning.
• Pricing Strategies: Premium pricing models aligned with orphan drug policies sustain revenue but require careful engagement with payers.
• Long-Term Outlook: The integration of real-world evidence, pipeline advancements, and market expansion initiatives are critical for maintaining a positive financial trajectory.

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FAQs

1. What is the primary therapeutic function of VELSPITITY?
   VELSPITITY (patisiran) utilizes RNA interference to silence transthyretin (TTR) gene expression, reducing amyloid deposit formation in hereditary transthyretin-mediated amyloidosis.

2. How does VELSPITITY compare to other treatments like tafamidis?
   While tafamidis stabilizes the TTR protein to prevent amyloid formation, VELSPITITY decreases TTR production altogether via gene silencing. Clinical outcomes demonstrate VELSPITITY’s superior effects on neurological symptoms, though differences in safety and cost impact treatment choice.

3. What are the key challenges impacting VELSPITITY’s financial growth?
   Regulatory delays for expanded indications, reimbursement pressures, emerging competitors, and potential biosimilar entries pose challenges to revenue sustainability.

4. What future indications are being explored for VELSPITITY?
   The primary focus is on transthyretin amyloid cardiomyopathy (ATTR-CM). Clinical trials are underway to assess efficacy in this broader amyloidosis subtype, potentially boosting its market.

5. What strategies could enhance VELSPITITY’s market share?
   Expanding global access, advocating for early diagnosis, demonstrating long-term cost-effectiveness, and innovating in delivery and combination therapies are key strategies.

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Sources

[1] Adams, D., et al. (2018). Hereditary Transthyretin Amyloidosis. Nature Reviews Disease Primers.
[2] MarketsandMarkets. (2022). Rare Disease Treatment Market Forecast.
[3] IQVIA. (2021). Rare Disease Drug Pricing and Reimbursement Report.
[4] Biogen Annual Report. (2021).
[5] TTR Amyloidosis: Clinical Development Pipeline. (2023).

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This article offers a detailed, authoritative analysis tailored to business professionals seeking strategic insights into VELSPITITY’s market prospects and financial trajectory.