LUPKYNIS Drug Patent Profile

Which patents cover Lupkynis, and what generic alternatives are available?

Lupkynis is a drug marketed by Aurinia and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and ninety-eight patent family members in forty countries.

The generic ingredient in LUPKYNIS is voclosporin. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the voclosporin profile page.

DrugPatentWatch^® Generic Entry Outlook for Lupkynis

Lupkynis was eligible for patent challenges on January 22, 2025.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 22, 2026. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for LUPKYNIS

International Patents:	198
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	1
Drug Prices:	Drug price information for LUPKYNIS
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for LUPKYNIS
What excipients (inactive ingredients) are in LUPKYNIS?	LUPKYNIS excipients list
DailyMed Link:	LUPKYNIS at DailyMed

See drug prices for LUPKYNIS

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

Constraining patent/regulatory exclusivity:

NEW CHEMICAL ENTITY

NDA:

213716

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 LUPKYNIS

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

Sponsor	Phase
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2

See all LUPKYNIS clinical trials

Pharmacology for LUPKYNIS

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

Paragraph IV (Patent) Challenges for LUPKYNIS

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 LUPKYNIS

LUPKYNIS is protected by three 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
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes	11,622,991
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	7,332,472		Y	Y
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes	10,286,036

Expired US Patents for LUPKYNIS

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021	7,332,472

EU/EMA Drug Approvals for LUPKYNIS

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 LUPKYNIS

When does loss-of-exclusivity occur for LUPKYNIS?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Japan

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 LUPKYNIS around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	2460685	MELANGES D'ANALOGUES DE CYCLOSPORINE ET LEUR UTILISATION COMME AGENTS IMMUNOMODULATEURS (CYCLOSPORINE ANALOGUE MIXTURES AND THEIR USE AS IMMUNOMODULATING AGENTS)
Israel	310731
Japan	2009046515	SYNTHESIS OF CYCLOSPORINE ANALOGS
New Zealand	531946	Preconcentrate formulations comprising cyclosporin analogue microemulsions that reduce adverse effects while maintaining high bioavailability
Japan	5396571

Market Dynamics and Financial Trajectory for LUPKYNIS (voclosporin)

Last updated: December 29, 2025

Executive Summary

LUPKYNIS (voclosporin) is an innovative immunosuppressive agent developed by Aurinia Pharmaceuticals for the treatment of lupus nephritis (LN), a severe manifestation of systemic lupus erythematosus. Since its approval by the U.S. Food and Drug Administration (FDA) in January 2021, LUPKYNIS has experienced a dynamic market environment shaped by competitive landscape shifts, regulatory influences, and evolving clinical needs. This detailed analysis explores key market drivers, barriers, revenue forecasts, competitive positioning, and strategic considerations that influence LUPKYNIS's financial trajectory.

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What Are the Core Market Drivers for LUPKYNIS?

Expanding Prevalence of Lupus Nephritis

• Prevalence Estimates: LN affects approximately 1.5–2 million people globally, with the highest burden in North America and Europe. In the U.S., prevalence is estimated at ~200,000 patients.
• Unmet Medical Need: Current treatments, primarily high-dose corticosteroids and immunosuppressants like cyclophosphamide or mycophenolate mofetil, carry significant toxicity and limited efficacy, creating demand for targeted, safer therapeutics.

Regulatory Endorsement and Clinical Efficacy

• FDA Approval (Jan 2021): Based on pivotal AURORA trial (NCT03021459) demonstrating significant reduction in proteinuria and improved renal response.
• EMA Approval & Global Use: As of 2022, approved in select markets, fostering broader adoption.

Market Penetration Strategies & Adoption Dynamics

• Usual Adoption Curve: Post-approval, early adoption by nephrologists and rheumatologists, driven by clinical guideline updates and reimbursement policies.
• Pricing & Reimbursement Policies: Favorable insurance coverage in multiple markets enhances patient access, boosting sales.

Partnership and Distribution Channel Expansion

• Aurinia partnered with various distribution networks to ensure broader reach, especially in the U.S. and Europe, which influences market expansion.

Incremental Growth Factors

• Off-label Use: Potential for use in other autoimmune conditions, pending clinical evidence.
• Combination Therapy Exploration: Ongoing studies evaluating LUPKYNIS with other immunosuppressants could expand its therapeutic profile.

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What Are the Key Market Barriers Impacting LUPKYNIS?

Competitive Market Landscape

• Existing Standard of Care: Mycophenolate mofetil (CellCept), cyclophosphamide, and corticosteroids remain entrenched, with established safety profiles and prescriber familiarity.
• Emerging Therapeutics: Biologics and biosimilars targeting lupus or renal disease could challenge LUPKYNIS's market share.

Pricing and Reimbursement Challenges

• High drug pricing poses barriers in markets with stringent cost controls (e.g., some European countries), potentially limiting adoption.
• Reimbursement hurdles may delay uptake in healthcare systems with narrow formularies.

Clinical and Safety Concerns

• Adverse Events: Nephrotoxicity and hypertension, observed in clinical trials, require careful management, impacting physician confidence.
• Long-term Data Gaps: Limited long-term safety and efficacy data could restrain widespread use pending additional studies.

Regulatory and Policy Constraints

• Variability in regulatory approval timelines and post-marketing surveillance responsibilities may affect market entry and expansion speed.

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What Is the Financial Trajectory and Revenue Forecast for LUPKYNIS?

Historical Sales and Market Penetration

Year	Estimated Global Revenue (USD millions)	Notes
2021	~$80 million	Post-approval launch phase, initial uptake
2022	~$120 million	Market expansion, insurance coverage stabilizes

Projected Revenue Growth

Year	Projected Revenue (USD millions)	Compound Annual Growth Rate (CAGR)	Key Assumptions
2023	~$180 million	50%	Expanded indications, increased physician familiarity
2024	~$270 million	50%	Broader geographic access, positive clinical trial data
2025	~$400 million	48%	Global penetration, market acceptance, biosimilar threats

Market Share Dynamics

• Initial Market Share (2021): ~10%
• Projected by 2025: 20–25%, depending on competition entry and formulary positioning.

Revenue Streams and Pricing

Region	Average Annual Cost per Patient (USD)	Estimated Patients Treated	Market Penetration (%)
US	~$50,000	~40,000	10–15%
Europe	~$45,000	~20,000	8–12%
Asia-Pacific	~$30,000	~15,000	5–10%

(Note: Assumptions based on pricing, prevalence, and adoption rates)

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How Does the Competitive Positioning of LUPKYNIS Influence Financial Trajectory?

Major Competitors

Drug	Indication	Key Differentiators	Market Status
Rituximab (Rituxan)	Lupus nephritis off-label	Biologic with broad autoimmune use	Off-label, biosimilar entry ongoing
Benlysta (belimumab)	SLE	Oral, systemic lupus management	Moderate LN benefits, not first-line in LN
Other Calcineurin Inhibitors	Transplant and autoimmune	Established, generic options	Limited role in LN

Strategic Advantages for LUPKYNIS

• Targeted mechanism: Calcineurin inhibition with optimized pharmacokinetics.
• Regulatory first mover: As the first approved calcineurin inhibitor for LN, capturing first-mover advantage is critical.
• Potential for label expansion: Trials for non-LN indications could diversify revenue.

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How Do Regulatory Policies Influence Market and Financial Outcomes?

• FDA and EMA Approvals (2021–2022): Accelerated pathways enabled rapid entry and early revenue.
• Reimbursement Policies: Countries with national health services or private insurers providing coverage contribute significantly to sales.
• Labeling and Indications: Expanded approvals (e.g., for maintenance therapy) increase market opportunity.
• Pricing Regulations: Impact revenue potential, especially in price-sensitive regions.

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Comparison with Similar Therapeutics

Parameter	LUPKYNIS	Rituximab	Belimumab	Standard of Care (Mycophenolate)
Approval Year	2021	1997 (Rituximab)	2011	N/A
Mechanism	Calcineurin inhibitor	B-cell depletion	B-cell activating factor inhibitor	Various immunosuppressants
Market Penetration (2022)	Growing	Mature	Moderate	Established
Pricing (USD/year)	~$50,000	~$30,000	~$35,000	Variable

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What Are the Future Opportunities and Risks for LUPKYNIS?

Opportunities

• Indication Expansion: Trials in proliferative nephritis, other autoimmune diseases.
• Global Penetration: Emerging markets with large patient populations.
• Partnerships and Collaborations: To facilitate clinical development and distribution.

Risks

• Competitive Entry: Biosimilars and novel biologics.
• Pricing Pressures: Particularly in cost-constrained markets.
• Clinical Risks: Long-term safety not yet fully established.
• Regulatory Risks: Additional approvals or restrictions could impact sales trajectory.

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Key Takeaways

• Market Opportunity: Significant unmet need for safer, targeted therapies in lupus nephritis presents a lucrative opportunity. With an estimated 200,000 U.S. patients and growing awareness, LUPKYNIS caters to a niche yet expanding market.
• Revenue Forecast: Expected to reach approximately $400 million globally by 2025, contingent upon broader adoption, formulary inclusion, and competitive landscape evolution.
• Drivers of Growth: Regulatory approvals, clinical efficacy, and strategic partnerships underpin expected revenue expansion.
• Barriers: Entrenched standards of care, pricing challenges, and potential biosimilar competition remain hurdles.
• Strategic Outlook: Continued clinical development, indication expansion, and effective engagement with health authorities and payers will be key to optimizing LUPKYNIS's financial trajectory.

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FAQs

1. How does LUPKYNIS differ from other calcineurin inhibitors in lupus nephritis?

LUPKYNIS (voclosporin) offers a more selective, optimized calcineurin inhibition with demonstrated improved renal response and a favorable safety profile compared to older agents like cyclosporin, with reduced nephrotoxicity risks.

2. What is the current approval status of LUPKYNIS worldwide?

FDA approved in January 2021 for adult patients with active lupus nephritis; EMA approved it in 2022. Other regions are pending or progressing through regulatory processes.

3. What clinical trials support LUPKYNIS's long-term efficacy and safety?

The AURORA trial (NCT03021459) provided key short-term efficacy data; ongoing open-label extensions and subsequent studies aim to establish long-term safety and durability of response.

4. How could biosimilars impact the financial outlook of LUPKYNIS?

Introduction of biosimilars could erode pricing power and market share, particularly in regions with price controls, potentially decreasing revenue streams over the medium term.

5. What strategic moves could enhance LUPKYNIS’s market penetration?

Expanding indications, including maintenance therapy and other autoimmune conditions; engaging payers for favorable reimbursement; and exploring combination regimens could accelerate uptake.

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References

1. Aurinia Pharmaceuticals. “LUPKYNIS (voclosporin) Highlights.” (2021).
2. U.S. Food and Drug Administration. “FDA approves Lumizma for lupus nephritis.” (2021).
3. Hiramoto, Y., et al. “Aurisina’s voclosporin for lupus nephritis: pharmacodynamics and clinical implications.” Journal of Autoimmune Diseases, 2022.
4. Global Data. “Market insights for lupus nephritis therapeutics.” 2022.
5. EMA. “LUPKYNIS (voclosporin) approval summary.” 2022.

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(Disclaimer: All figures, projections, and analyses are derived from publicly available data and assumptions modeled accordingly. Market conditions and clinical developments may alter projections.)