LUPKYNIS Drug Patent Profile

Which patents cover Lupkynis, and when can generic versions of Lupkynis launch?

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-seven 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:	197
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
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 LUPKYNIS

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 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
Ecuador	SP045061	MEZCLAS ANALOGAS DE CICLOSPORINA Y SU USO COMO AGENTES INMUNOMODULADORES
Austria	332917
China	100430526
Poland	3634463

Market Dynamics and Financial Trajectory for LUPKYNIS (voclosporin)

Last updated: September 2, 2025

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Introduction

LUPKYNIS (voclosporin) represents a significant advancement in the immunosuppressive therapy landscape, specifically targeting autoimmune nephropathy in patients with lupus nephritis (LN). Developed by Aurinia Pharmaceuticals, LUPKYNIS gained FDA approval in January 2021, marking a strategic milestone in addressing a high unmet medical need. Its unique mechanism, market positioning, and evolving lifecycle shape a compelling narrative for investors and stakeholders aiming to evaluate its market dynamics and financial prospects.

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Market Overview and Unmet Medical Need

Lupus nephritis afflicts approximately 60,000 to 100,000 Americans, representing a severe manifestation of systemic lupus erythematosus (SLE). Current standard treatments include corticosteroids, immunosuppressants such as mycophenolate mofetil (MMF), cyclophosphamide, and rituximab, yet clinical challenges persist—relapse rates, adverse effects, and limited long-term efficacy.

LUPKYNIS addresses a critical gap by offering a targeted, oral calcineurin inhibitor with improved safety, efficacy, and tolerability profiles. Its approval fills a substantial unmet need, making LN management more effective and patient-centric.

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Market Dynamics

Competitive Landscape

LUPKYNIS faces competition from established therapies, notably MMF, cyclophosphamide, and biologics like rituximab. However, its differentiated profile—specifically targeting calcineurin pathways—positions it uniquely in the treatment paradigm.

The primary comparator for LUPKYNIS remains MMF, which commands dominant market share but presents limitations in tolerability and long-term safety. Biologics like rituximab, although used off-label, are not FDA-approved specifically for LN — positioning LUPKYNIS as a potentially preferred oral agent with device-like familiarity.

In the broader autoimmune sphere, biologics and targeted therapies are expanding, but their high costs and administration complexities limit widespread affordability, positioning oral small molecules like LUPKYNIS favourably.

Market Penetration Strategies

Aurinia’s integration into nephrology clinics hinges on key factors:

• Physician education: Emphasizing the clinical benefits over traditional therapies.
• Reimbursement landscape: Ensuring access through favorable insurance coverage.
• Clinical trials: Demonstrating long-term safety and efficacy.
• Key opinion leader (KOL) endorsement: Building trust among nephrologists.

Initial launches in the U.S. have targeted high-volume lupus nephritis centers, with optimistic projections for broader adoption.

Regulatory and Reimbursement Environment

Since LUPKYNIS is a first-in-class medication for LN, securing favorable formulary placement and reimbursement pathways is pivotal. The FDA’s approval coupled with positive reimbursement strategies will influence adoption rates.

Market Growth Drivers

• Increase in diagnosed LN cases: Rising awareness and early diagnosis expand the potential patient pool.
• Treatment paradigm shift: Toward targeted immunomodulation.
• Enhanced safety profile: Supporting long-term compliance.
• Expansion potential: To other autoimmune or transplant indications.

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Financial Trajectory Perspective

Revenue Forecasts

Based on Aurinia’s publicly available guidance and market analysts:

• Initial Year (2021-2022): Launch revenues are projected in the low hundreds of millions USD, contingent on market acceptance.
• Mid-term (2023-2025): Expected growth at a compounded annual growth rate (CAGR) of approximately 20-30%, as adoption widens.
• Long-term (2026 onward): Potential peak sales could reach between $1 billion and $2 billion globally, driven by expanded indications and geographic expansion.

Pricing and Reimbursement

Pricing strategies position LUPKYNIS at a premium but competitive pricing relative to biologics, with initial U.S. list prices around $85,000 per year. Reimbursement success depends on negotiations with payers and demonstrated cost-effectiveness compared to existing standards of care.

Market Share Outlook

• In the immediate launch phase, capturing 10-15% of the LN market is a realistic target.
• Over 3-5 years, equipping with additional formulary coverage, expanding geographic markets, and demonstrating real-world efficacy may elevate market share to 25-30%.

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Challenges and Opportunities

Challenges

• Market penetration resistance: Entrenched use of MMF and other immunosuppressants.
• Pricing pressures: Payer negotiations may seek discounts or value-based contracts.
• Long-term safety profile: Requires robust post-marketing data to sustain confidence.

Opportunities

• Indication expansion: Beyond LN, including other autoimmune disorders or transplant indications.
• Combination therapies: Potential to explore synergistic regimens.
• Geographic expansion: Europe, Asia, and emerging markets.

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Regulatory Outlook and Lifecycle Milestones

Aurinia’s ongoing phase 3 trials for non-LN indications, strategic label expansions, and post-market studies will define the future revenue trajectory. As long as safety and efficacy are maintained, LUPKYNIS's lifecycle promises a steady revenue stream, with potential peaks aligned with new indications and market expansion.

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Key Takeaways

• LUPKYNIS capitalizes on an unmet need in lupus nephritis, offering a targeted oral therapy with promising safety and efficacy.
• Market adoption depends on physician acceptance, reimbursement success, and real-world evidence.
• Projected revenues indicate significant growth potential, potentially surpassing $1 billion annually within a decade, contingent on expansion and clinical validation.
• Competitive advantage relies on differentiating through safety profile, convenience, and clinical outcomes.
• Strategic lifecycle management—including indication expansion and international entry—will be critical to realizing full financial potential.

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FAQs

1. What distinguishes LUPKYNIS from existing lupus nephritis treatments?
   Its targeted mechanism as a calcineurin inhibitor offers a more selective immunosuppressive effect with a potentially improved safety profile, and it is administered orally, enhancing convenience over injectable biologics.

2. What are the primary factors influencing LUPKYNIS’s market adoption?
   Physician education, reimbursement pathways, demonstrated long-term safety and efficacy, and patient acceptance are vital for uptake.

3. How does the pricing of LUPKYNIS compare to its direct competitors?
   While aggressive compared to traditional generics, LUPKYNIS is priced below biologics like rituximab, balancing cost with convenience and safety benefits.

4. What are the main risks impacting LUPKYNIS’s future revenue?
   Competition from established therapies, payer resistance, safety concerns post-market, and slower-than-anticipated market penetration pose significant risks.

5. Are there plans for expanding LUPKYNIS’s indications?
   Yes, ongoing trials in other autoimmune conditions and transplant settings aim to broaden its therapeutic scope, bolstering long-term growth.

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References

1. [FDA approval announcement]
2. [Aurinia Pharmaceuticals investor presentations]
3. [Market research reports on lupus nephritis]
4. [Peer-reviewed clinical trial data on voclosporin]
5. [Pricing and reimbursement analyses in renal autoimmune therapy]