VOCLOSPORIN - Generic Drug Details

What are the generic sources for voclosporin and what is the scope of patent protection?

Voclosporin is the generic ingredient in one branded drug marketed by Aurinia and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Voclosporin has one hundred and ninety-seven patent family members in forty countries.

There is one drug master file entry for voclosporin. One supplier is listed for this compound.

Summary for VOCLOSPORIN

International Patents:	197
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	22
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VOCLOSPORIN
What excipients (inactive ingredients) are in VOCLOSPORIN?	VOCLOSPORIN excipients list
DailyMed Link:	VOCLOSPORIN at DailyMed

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

Dosage:

CAPSULE;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 VOCLOSPORIN

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

Sponsor	Phase
Chinese PLA General Hospital	EARLY_PHASE1
NephroNet, Inc.	PHASE4
Aurinia Pharmaceuticals Inc.	PHASE3

See all VOCLOSPORIN clinical trials

Pharmacology for VOCLOSPORIN

Drug Class	Calcineurin Inhibitor Immunosuppressant
Mechanism of Action	Calcineurin Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors P-Glycoprotein Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for VOCLOSPORIN

L04AD	Calcineurin inhibitors
L04A	IMMUNOSUPPRESSANTS
L04	IMMUNOSUPPRESSANTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for VOCLOSPORIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
LUPKYNIS	Capsules	voclosporin	7.9 mg	213716	8	2025-01-22

US Patents and Regulatory Information for VOCLOSPORIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes			Y	Y
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes

Expired US Patents for VOCLOSPORIN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021

EU/EMA Drug Approvals for VOCLOSPORIN

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Otsuka Pharmaceutical Netherlands B.V.	Lupkynis	voclosporin	EMEA/H/C/005256Lupkynis is indicated in combination with mycophenolate mofetil for the treatment of adult patients with active class III, IV or V (including mixed class III/V and IV/V) lupus nephritis (LN).	Authorised	no	no	no	2022-09-15

International Patents for VOCLOSPORIN

Country	Patent Number	Title	Estimated Expiration
Croatia	P20231469
European Patent Office	1816138
China	1571657
China	100344648

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: Voclosporin

Last updated: July 28, 2025

Introduction

Voclosporin represents a promising advancement in immunosuppressive therapy, primarily approved for the treatment of lupus nephritis (LN). Developed by Aurinia Pharmaceuticals, it is a calcineurin inhibitor designed to offer improved efficacy and safety profiles over existing therapies. As the lupus nephritis market evolves, understanding the drug’s market dynamics and financial trajectory becomes crucial for stakeholders, including pharmaceutical companies, investors, and healthcare providers.

Market Overview

Lupus Nephritis: Unmet Medical Need

Lupus nephritis is a severe manifestation of systemic lupus erythematosus (SLE), affecting approximately 50% of SLE patients and contributing significantly to morbidity and mortality [1]. The current standard of care involves corticosteroids and immunosuppressants such as mycophenolate mofetil (MMF) and cyclophosphamide. However, these treatments carry limitations, including adverse effects and suboptimal remission rates, underscoring the necessity for targeted, efficacious therapies like voclosporin.

Regulatory Milestones and Adoption

In January 2021, the U.S. Food and Drug Administration (FDA) approved voclosporin (brand name Lupkynis) for moderate to severe lupus nephritis, marking an important milestone for Aurinia. This approval expanded the therapeutic landscape, positioning voclosporin as a potential first-in-class oral calcineurin inhibitor specifically indicated for LN. Subsequent approval in the European Union further broadened its geographic reach [2].

Market Penetration: Early adoption has varied across regions, influenced by factors such as prescriber familiarity, cost, and healthcare infrastructure. The drug’s targeting of refractory and high-risk patient populations highlights its potential for rapid uptake in specialized healthcare settings.

Market Dynamics Influencing Voclosporin

Competitive Landscape

The lupus nephritis market is characterized by limited approved treatments. Currently, only a few drugs like mycophenolate mofetil, cyclophosphamide, and novel biologics such as obinutuzumab are used off-label or in clinical trials. Voclosporin's unique oral administration route and targeted mechanism provide a competitive advantage.

Emerging Therapies: Biologics and novel immunomodulators are in development, potentially impacting voclosporin’s market share. However, the established efficacy and safety profile of voclosporin, coupled with regulatory approval, position it favorably relative to experimental agents.

Pricing and Reimbursement Factors

Pricing strategies significantly influence market adoption. Aurinia launched Lupkynis at a wholesale acquisition cost (WAC) of approximately $31,000 per year [3]. Insurance coverage and reimbursement policies are critical; high drug costs pose barriers, especially in markets with limited healthcare coverage. Cost-effectiveness analyses demonstrating long-term benefits could enhance market acceptance.

Stakeholder Perspectives

Physicians weigh factors such as efficacy, safety, convenience, and cost. The favorable safety profile of voclosporin, especially reduced nephrotoxicity compared to other calcineurin inhibitors, appeals to clinicians managing complex LN cases. Patient adherence may improve with oral administration, further supporting market growth.

Market Challenges

• Adoption hesitancy: Physicians cautious of new drugs, especially in complex conditions.
• Pricing pressures: Payers demand cost-effective solutions.
• Competitive threats: Emerging therapeutics may challenge voclosporin’s position.
• Regulatory hurdles: Off-label use restrictions and regional approvals could impact market expansion.

Financial Trajectory and Revenue Projections

Revenue Drivers

• Market Penetration: Key indicators include the number of prescriptions, patient population size, and market share growth.
• Pricing Strategies: Adjustments based on competitive landscape and reimbursement negotiations.
• Geographic Expansion: Entry into Europe, Asia, and other markets could significantly augment revenues.
• Clinical Adoption: Adoption driven by published trial data, clinical guidelines, and physician experience.

Short-term Revenue Outlook (2023–2025)

Aurinia’s initial revenue figures for Lupkynis indicate gradual adoption. In 2021, the company reported approximately $36 million in global sales [4], driven mainly by the North American market. Targeted uptake is expected to accelerate as awareness grows and prescriber familiarity increases.

Mid-to-long term Projections (2026–2030)

Analysts project revenues to approach $200–$300 million annually within five years, contingent upon:

• Expanded approvals in additional regions.
• Inclusion in clinical guidelines for LN management.
• Demonstration of superior efficacy or safety signals.
• Competitive landscape stability.

Revenue Risks and Opportunities

• Risks: Pricing pressures, biosimilar competition, slower-than-expected adoption, or regulatory setbacks.
• Opportunities: Combination therapies, expanding indications (e.g., other autoimmune diseases), and entry into emerging markets.

Strategic Factors Impacting Financial Trajectory

R&D Investment and Pipeline

Ongoing clinical trials exploring voclosporin’s utility in other autoimmune conditions (e.g., dry eye disease, transplant rejection) could diversify revenue streams. Strategic collaborations with biotech firms and academic institutions will bolster the drug’s profile.

Partnerships and Licensing

Strengthening alliances with healthcare providers, payers, and global distributors will facilitate wider access and greater revenue flow.

Cost Management

Optimizing manufacturing and reducing drug costs could improve margins and enable more competitive pricing, fostering higher adoption.

Market Outlook Summary

The pharmacoeconomic and clinical landscape suggests lukewarm but steady growth for voclosporin, driven by regulatory momentum and competitive advantages. The net financial trajectory hinges heavily on market penetration, pricing strategies, and clinical acceptance. As Lupkynis establishes itself within treatment algorithms, its revenues are expected to grow consistently, particularly in regions with advanced healthcare infrastructure.

---

Key Takeaways

• Market Opportunity: Voclosporin addresses an unmet need in lupus nephritis, with significant growth potential given limited current options.

• Competitive Edge: Its oral administration, safety profile, and regulatory approval distinguish it from off-label treatments and experimental therapies.

• Revenue Growth: Initial sales demonstrate early traction; long-term projections are optimistic, contingent upon expanded approvals, clinical data, and reimbursement frameworks.

• Challenges & Risks: Pricing pressures, competition, and adoption barriers could impede growth; proactive strategies are essential.

• Strategic Outlook: Diversification through pipeline development, geographic expansion, and strategic partnerships will be pivotal for maximizing financial returns.

---

FAQs

1. What is the primary indication for voclosporin?
   Voclosporin is primarily approved for the treatment of adult patients with active, moderate to severe lupus nephritis in combination with standard therapies.

2. How does voclosporin differ from other calcineurin inhibitors?
   It is designed with structural modifications leading to enhanced potency and a better safety profile, notably reduced nephrotoxicity, compared to traditional calcineurin inhibitors like cyclosporine.

3. What are the main barriers to voclosporin’s market expansion?
   High pricing, reimbursement challenges, physician adoption hesitancy, and competition from emerging therapies pose significant barriers.

4. What is the projected revenue for voclosporin in the next five years?
   Industry estimates suggest revenues could approach $200–$300 million annually by 2028, subject to market penetration and regional approvals.

5. Are there upcoming clinical trials for voclosporin?
   Yes, ongoing studies are exploring its use in other autoimmune conditions such as dry eye disease and transplant rejection, potentially expanding its indications.

---

References

1. Dash, S., et al. (2019). Lupus nephritis: Pathogenesis and prospects for targeted therapy. International Journal of Molecular Sciences, 20(9), 2268.
2. European Medicines Agency. (2021). Lupkynis: Summary of opinion for approval.
3. Aurinia Pharmaceuticals. (2022). Lupkynis pricing and reimbursement updates.
4. Aurinia Pharmaceuticals. (2022). Financial results and revenue report for Q1 2022.