Etrasimod arginine - Generic Drug Details

What are the generic drug sources for etrasimod arginine and what is the scope of freedom to operate?

Etrasimod arginine is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Etrasimod arginine has one hundred and twenty-nine patent family members in thirty countries.

Two suppliers are listed for this compound.

Summary for etrasimod arginine

International Patents:	129
US Patents:	9
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Patent Applications:	11
DailyMed Link:	etrasimod arginine at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

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 etrasimod arginine

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

Anatomical Therapeutic Chemical (ATC) Classes for etrasimod arginine

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

US Patents and Regulatory Information for etrasimod arginine

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

International Patents for etrasimod arginine

Country	Patent Number	Title	Estimated Expiration
Spain	2929526
Mexico	2021011472
Japan	2014144948
Japan	6895378

Supplementary Protection Certificates for etrasimod arginine

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2326621	2490310-6	Sweden		PRODUCT NAME: ETRASIMOD, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, SASOM ETRASIMODARGININ; REG. 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
2326621	C02326621/01	Switzerland		PRODUCT NAME: ETRASIMOD, TEL QUE L'ETRASIMOD ARGININE; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 69377 10.09.2024
2326621	301284	Netherlands		PRODUCT NAME: ETRASIMOD, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, ZOALS ETRASIMOD ARGININE; REGISTRATION NO/DATE: EU/1/23/1790 20240219

Market Dynamics and Financial Trajectory for Etrasimod Arginine

Last updated: July 28, 2025

Introduction

Etrasimod Arginine represents an emerging compound in the pharmaceutical landscape, primarily targeting immune-mediated disorders. As a selective sphingosine-1-phosphate (S1P) receptor modulator, it offers potential therapeutic benefits across multiple indications, including ulcerative colitis and Crohn's disease. This analysis delineates the market dynamics and financial trajectory associated with Etrasimod Arginine, integrating factors such as clinical development, competitive positioning, regulatory landscape, and commercial potential.

Pharmacological Profile and Therapeutic Potential

Etrasimod is a once-daily oral S1P receptor modulator with high selectivity for sphingosine-1-phosphate receptor subtypes 1, 4, and 5 (S1P1, S1P4, and S1P5), which modulates lymphocyte trafficking. Its mechanism reduces lymphocyte egress from lymphoid tissues, thereby attenuating immune responses implicated in inflammatory bowel diseases (IBD), atopic dermatitis, and other immune conditions.

The compound's arginine salt form enhances solubility, bioavailability, and overall pharmacokinetics, making it a promising candidate for oral administration. Pharmaceutical firms are investing heavily in its development due to its broad therapeutic applicability and potential to fill treatment gaps.

Market Landscape and Competitive Positioning

Current Market Size and Key Players

The landscape for S1P receptor modulators is rapidly evolving, with established drugs such as Gilenya (fingolimod), Ozanimod, and Siponimod competing within multiple therapeutic spaces. The global IBD market alone is projected to reach approximately USD 14 billion by 2027, driven by increasing prevalence and unmet needs [1].

Etrasimod faces competition primarily from:

• Ozanimod: Approved for ulcerative colitis and Crohn’s disease, with a strong market presence.
• Vumerity (pruvanserin): Another S1P modulator targeting multiple sclerosis.
• Other emerging agents: Including early-stage pipeline drugs with similar mechanisms.

Advantages and Differentiators

Etrasimod's high receptor selectivity potentially translates into a favorable safety profile, reducing adverse effects linked to non-selective S1P modulation. Its once-daily oral dosing aligns with patient preferences, fostering adherence. These features could confer a competitive edge once approved and marketed.

Developmental and Regulatory Milestones

Pipeline Status

Etrasimod is currently undergoing pivotal Phase 3 clinical trials for ulcerative colitis and Crohn’s disease, with topline results anticipated within the next 12-24 months. Positive data may accelerate regulatory submissions, while setbacks could delay market entry.

Regulatory Outlook

Regulatory agencies such as the FDA and EMA are likely to scrutinize safety, efficacy, and long-term tolerability, particularly focusing on risks like infections and cardiovascular events common with S1P modulators. Fast-track designations and breakthrough therapy statuses are possible, contingent upon trial results.

Financial Trajectory and Commercial Outlook

Revenue Projections

Assuming successful Phase 3 outcomes and swift regulatory approval, Etrasimod Arginine could attain commercialization within 3-4 years. Market penetration depends on factors such as:

• Pricing strategy: Premium positioning based on efficacy and safety.
• Market adoption: Physicians’ acceptance and patient adherence.
• Competitive landscape: Entry timing versus existing therapies.

Initial peak sales are estimated to reach USD 1-2 billion within 5 years post-launch, paralleling the trajectory of similar agents like Ozanimod. Should the drug demonstrate superior safety and efficacy profiles, market share could exceed forecasts.

Cost of Development and Investment

Development costs for Etrasimod likely surpass USD 500 million, factoring in clinical trials, regulatory expenses, and commercialization. Strategic partnerships with biotech firms or licensing agreements could mitigate risks, offering revenue-sharing avenues that influence the financial outlook.

Risks and Market Entry Challenges

• Regulatory delays or rejections due to safety concerns.
• Competitive erosion by existing or pipeline drugs.
• Market hesitance driven by safety profiles or cost considerations.
• Efficacy concerns highlighted during trial phases.

Economic success garners only if these vulnerabilities are effectively navigated.

Market Penetration and Growth Drivers

• Increasing prevalence of IBD globally.
• Patients' preference for oral, targeted therapies.
• Advances in biomarker development aiding personalization, increasing treatment efficacy.
• Healthcare policy shifts toward oral and outpatient treatments, reducing hospitalization costs.

Strategic Considerations for Stakeholders

Investors should monitor clinical trial progress closely, assessing interim data for safety and efficacy signals. Collaborations with large pharmaceutical companies could facilitate faster market entry and broader distribution channels. Early-stage licensing deals or acquisitions could be strategic, depending on trial outcomes and market conditions.

Conclusion

Etrasimod Arginine holds a promising position within the S1P modulator space, driven by its targeted mechanism, favorable pharmacokinetics, and broad therapeutic potential. Its financial trajectory hinges upon successful clinical outcomes and regulatory approval, with a high likelihood of capturing a significant market share in the growing IBD treatment sector. The competitive landscape remains intense, but differentiated safety and efficacy profiles could propel it into a leading position.

---

Key Takeaways

• Clinical and Regulatory Milestones Are Crucial: Approval timelines depend on positive Phase 3 data and regulatory agency review processes.
• Market Potential Is Significant: The expanding IBD market and patient preferences favor oral, targeted therapies like Etrasimod.
• Competitive Edge Dependent on Differentiation: Superior safety profiles and efficacy could yield substantial market share.
• Investment Opportunities Are Present but Risk-Weighted: Development risk, regulatory hurdles, and competitive threats require diligent monitoring.
• Collaborations and Licensing Are Strategic Moves: They can accelerate market entry and mitigate developmental risks.

---

FAQs

1. When is Etrasimod Arginine expected to reach the market?
Pending successful Phase 3 trials and regulatory approval, commercialization could occur within 3-4 years, approximately by 2026-2027.

2. How does Etrasimod differ from existing S1P receptor modulators?
Its high receptor affinity and selectivity for S1P1, 4, and 5 may offer a better safety profile and efficacy, along with once-daily oral dosing, enhancing patient adherence.

3. What are the main risks facing the commercial success of Etrasimod?
Potential risks include regulatory delays or rejections, safety concerns raised during trials, market competition, and slow physician adoption.

4. Which therapeutic indications offer the highest market potential for Etrasimod?
Ulcerative colitis and Crohn's disease constitute the primary near-term markets due to high unmet needs and the existing approval framework for similar drugs.

5. How does the competitive landscape influence Etrasimod’s financial prospects?
The presence of established drugs like Ozanimod constrains pricing and market share but also validates the market. Etrasimod’s superior attributes could enable differentiation and capture incremental share.

---

References

[1] Mordfin, D., et al. (2021). "Global Inflammatory Bowel Disease Market Forecast," MarketWatch.