Voclosporin - Generic Drug Details

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

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-three patent family members in thirty-nine countries.

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

Summary for voclosporin

International Patents:	193
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:	19
Patent Applications:	1,426
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
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 2
Labcorp Drug Development, Inc.	Phase 3
Leiden University Medical Center	Phase 2

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

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

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/005256 Lupkynis 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
Norway	20042028
Ecuador	SP045059	SINTESIS DE ANALOGOS DE CICLOSPORINA
Japan	2005516893
Taiwan	I274393
China	100344648

Voclosporin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Voclosporin

Introduction

Voclosporin, marketed as LUPKYNIS by Aurinia Pharmaceuticals, is a second-generation calcineurin inhibitor approved for the treatment of active lupus nephritis (LN) in combination with background immunosuppression. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting key milestones, revenue growth, and operational efficiencies.

Market Penetration and Patient Base

Growing Patient Base

The patient base for LUPKYNIS has been steadily increasing. As of March 31, 2024, there were 2,178 patients on therapy, up from 1,731 patients in the same period in 2023. This growth is attributed to 448 additional patient start forms and 148 new patients who either restarted LUPKYNIS or received it through a hospital pharmacy during the first quarter of 2024[1].

Market Expansion

Aurinia's marketing and selling efforts have been successful in expanding the drug's presence in both nephrology and rheumatology. The company has seen significant growth in patient start forms, patients on therapy, and wallets shipped, all of which have contributed to the drug's market penetration[4].

Revenue Growth

Quarterly and Annual Revenue

For the first quarter of 2024, Aurinia reported $50.3 million in total net revenue and $48.1 million in net product revenue, representing year-over-year growth of approximately 46% and 40%, respectively. This consistent growth trend is evident in the full-year 2023 results as well, where net product revenue was $158.5 million, a 53% increase from $103.5 million in 2022[1][5].

Revenue Projections

The company has reaffirmed its 2024 net product revenue guidance of $200 to $220 million, indicating continued confidence in the drug's market performance. This guidance is based on assumptions regarding patient start form run rates, conversion rates, persistency, and pricing[1][5].

Financial Efficiency and Cost Management

Cost of Sales and Operating Expenses

The cost of sales for LUPKYNIS increased due to higher sales volumes and the amortization of the monoplant finance right of use asset. However, the gross margin remained strong, at approximately 85% for the first quarter of 2024, although slightly lower than the 99% in the same period in 2023[1].

Restructuring and Cost Savings

Aurinia has completed a restructuring process aimed at enhancing operational efficiency. The company expects to achieve annual cost savings of $50 to $55 million, which will contribute to its goal of being cash flow positive, excluding share repurchases, in the second quarter of 2024[1][5].

Collaboration and Licensing Revenue

Partnership with Otsuka

Aurinia's collaboration with Otsuka Pharmaceutical Co. Ltd. has generated additional revenue streams. The company received a $10 million payment from Otsuka following the achievement of European pricing and reimbursement milestones. Moreover, manufacturing services revenue from Otsuka has contributed to the increase in license, collaboration, and royalty revenue[2].

Clinical and Economic Validation

Clinical Efficacy

The AURORA 1 and AURORA 2 studies have demonstrated the long-term efficacy and safety of voclosporin in preserving kidney function in patients with LN. These studies, published in Arthritis & Rheumatology, highlight the drug's ability to reduce proteinuria and maintain kidney function over a 3-year period[2][3].

Cost-Effectiveness

From a US healthcare perspective, voclosporin has been shown to be cost-effective. An analysis by the Institute for Clinical and Economic Review (ICER) indicated that voclosporin is cost-effective at $149,260 per quality-adjusted life-year (QALY) and $131,528 per equal value of life-years gained (evLYG). Updated data further reinforced its cost-effectiveness, with incremental costs per QALY and evLYG substantially below the ICER willingness-to-pay threshold[3].

Marketing and Educational Initiatives

Educational Campaigns

Aurinia has launched innovative marketing campaigns to educate rheumatologists about the seriousness of lupus nephritis and the need for appropriate treatment. These initiatives have contributed to the increased adoption of LUPKYNIS among healthcare providers[1].

Cash Position and Strategic Flexibility

Cash Reserves

As of December 31, 2023, Aurinia had $350.7 million in cash, cash equivalents, restricted cash, and investments. This strong cash position, combined with expected cost savings, provides the company with significant strategic flexibility[5].

Key Takeaways

• Revenue Growth: Voclosporin has seen consistent revenue growth, with a 46% year-over-year increase in the first quarter of 2024.
• Market Penetration: The patient base for LUPKYNIS has expanded, with a notable increase in patients on therapy.
• Financial Efficiency: Aurinia has achieved significant cost savings through restructuring and expects to be cash flow positive in the second quarter of 2024.
• Clinical Validation: Voclosporin has demonstrated long-term efficacy and safety in clinical studies.
• Cost-Effectiveness: The drug is cost-effective from a US healthcare perspective, with incremental costs below the ICER willingness-to-pay threshold.
• Strategic Flexibility: A strong cash position and expected cost savings provide Aurinia with strategic flexibility.

FAQs

Q: What is the current market performance of LUPKYNIS?

A: LUPKYNIS has shown significant market performance with a 46% year-over-year increase in net product revenue in the first quarter of 2024.

Q: How has the patient base for LUPKYNIS evolved?

A: The patient base has increased, with 2,178 patients on therapy as of March 31, 2024, up from 1,731 patients in the same period in 2023.

Q: What are the key factors driving the revenue growth of LUPKYNIS?

A: The revenue growth is driven by increased sales to specialty pharmacies, higher patient start forms, and the expansion into rheumatology.

Q: Is voclosporin cost-effective for the treatment of lupus nephritis?

A: Yes, voclosporin has been shown to be cost-effective, with incremental costs per QALY and evLYG substantially below the ICER willingness-to-pay threshold.

Q: What are the financial projections for Aurinia Pharmaceuticals in 2024?

A: Aurinia has reaffirmed its 2024 net product revenue guidance of $200 to $220 million and expects to be cash flow positive, excluding share repurchases, in the second quarter of 2024.

Sources

1. Aurinia Pharmaceuticals Reports First Quarter 2024 Financial and Operational Results. Aurinia Pharmaceuticals.
2. Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results. BioSpace.
3. Evaluating the cost-effectiveness of voclosporin for the treatment of lupus nephritis. PubMed.
4. Aurinia Pharmaceuticals Reports Second Quarter and Six Months 2023 Financial and Operational Results. BioSpace.
5. Aurinia Discloses 2023 Year-End Financial and Operational Results, Announces Corporate Actions Focused on Enhancing Shareholder Value. Financial Post.