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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.

This drug has one hundred and ninety-three patent family members in thirty-nine 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 will be eligible for patent challenges on January 22, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

Summary for LUPKYNIS

International Patents:	193
US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	30
Clinical Trials:	1
Patent Applications:	585
Drug Prices:	Drug price information 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

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

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/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 LUPKYNIS

See the table below for patents covering LUPKYNIS around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	20042028
Ecuador	SP045059	SINTESIS DE ANALOGOS DE CICLOSPORINA
Japan	2005516893

LUPKYNIS Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for LUPKYNIS

Introduction

LUPKYNIS, developed by Aurinia Pharmaceuticals, is a groundbreaking treatment for adults with active lupus nephritis, a severe and potentially life-threatening complication of systemic lupus erythematosus (SLE). This article delves into the market dynamics and financial trajectory of LUPKYNIS, highlighting key milestones, revenue growth, and the company's strategic initiatives.

Market Penetration and Patient Growth

Aurinia has seen significant growth in the number of patients on LUPKYNIS therapy. As of September 30, 2022, there were approximately 1,354 patients on therapy, increasing to 1,731 by March 31, 2023, and further to 2,178 by March 31, 2024[1][4][5].

Patient Start Forms (PSFs) and Conversion Rates

The company has consistently reported strong PSF numbers and high conversion rates. In the third quarter of 2022, Aurinia added 374 PSFs, with conversion rates, adherence rates, and confirmed patient access remaining at peak levels since the drug's launch. By the first quarter of 2024, the company added 448 PSFs, with approximately 85% of these forms converted to patients on therapy[1][4].

Persistency Rates

Persistency rates, which measure how long patients remain on treatment, have been reasonable and consistent. As of March 31, 2024, the 12-month persistency rate increased to 56% from approximately 51% in the previous year[4].

Financial Performance

Aurinia's financial performance has been robust, driven primarily by the increasing sales of LUPKYNIS.

Revenue Growth

In 2022, total net revenue from LUPKYNIS sales was $105.6 million for the nine months ended September 30, compared to $22.2 million for the same period in 2021. This increase was partly due to a $30 million regulatory milestone from Otsuka following the European Commission's marketing authorization for LUPKYNIS[1].

For the nine months ended September 30, 2023, total net revenue increased to $130.4 million, a 24% increase over the prior year. Net product revenue for the same period was $116.2 million, a 55% year-over-year increase[2][3].

Quarterly Financial Highlights

• In the third quarter of 2023, net product revenue was $40.8 million, a 60% year-over-year increase.
• For the first quarter of 2024, total net revenue was $50.3 million, with net product revenue of $48.1 million, representing year-over-year growth of approximately 46% and 40%, respectively[3][5].

Regulatory Milestones and Global Expansion

Aurinia has made significant strides in regulatory approvals and global expansion.

European Market Authorization

In September 2022, the European Commission granted marketing authorization for LUPKYNIS, valid in all EU member states, Iceland, Liechtenstein, Norway, and Northern Ireland. This authorization was a critical milestone, leading to increased revenue and market penetration in Europe[1].

Additional Regulatory Approvals

Aurinia received a $10 million milestone payment from Otsuka in 2023 for securing pricing and reimbursement approvals in three of the five major European markets. This further solidifies LUPKYNIS's presence in the European market[2][3].

Strategic Initiatives and Marketing Efforts

Aurinia has been proactive in its marketing and educational efforts to drive growth.

FDA Label Update

In 2024, the FDA approved a label update for LUPKYNIS, incorporating long-term efficacy data from the AURORA Clinical Program. This update enhances the drug's profile and reinforces its efficacy and safety over the long term[4][5].

Marketing Campaigns

The company launched an innovative marketing campaign to educate rheumatologists about the seriousness of lupus nephritis and the urgent need for appropriate treatment. This campaign is part of Aurinia's commitment to solid execution and driving growth[4][5].

Financial Outlook and Guidance

Aurinia has provided positive financial guidance, reflecting its confidence in the market dynamics and sales trajectory of LUPKYNIS.

2024 Guidance

For the fiscal year 2024, the company narrowed its net product revenue guidance to a range of $200 to $220 million. This guidance is based on assumptions regarding PSF run rates, consistent conversion rates, time to convert, persistency, and pricing[5].

Cash Flow and Financial Resources

Aurinia believes it has sufficient financial resources to fund its operations for at least the next few years. As of September 30, 2023, the company had $338.5 million in cash, cash equivalents, and restricted cash and investments. The company expects to be cash flow positive, excluding share repurchases, in the second quarter of 2024, with estimated annual cost savings of $50 to $55 million[2][5].

Clinical Efficacy and Safety

The clinical efficacy and safety of LUPKYNIS have been reinforced through various studies.

AURORA 2 Study

Full results from the AURORA 2 study, a long-term extension of the Phase 3 AURORA trial, were published in Arthritis & Rheumatology. The study demonstrated kidney preservation over a 3-year period, as measured by eGFR, along with additional efficacy, safety, and tolerability of LUPKYNIS[2].

Key Takeaways

• Patient Growth: Significant increase in patients on LUPKYNIS therapy, with over 2,178 patients as of March 31, 2024.
• Revenue Growth: Total net revenue and net product revenue have consistently increased, with a 24% increase in the first nine months of 2023 compared to the prior year.
• Regulatory Milestones: European Commission marketing authorization and additional approvals in major European markets.
• Strategic Initiatives: FDA label update and innovative marketing campaigns to educate rheumatologists.
• Financial Outlook: Positive guidance for 2024 with expected net product revenue of $200 to $220 million.

FAQs

Q: What is LUPKYNIS used for?

LUPKYNIS is used for the treatment of adults with active lupus nephritis, a complication of systemic lupus erythematosus (SLE).

Q: How has the patient base for LUPKYNIS grown?

The patient base has grown significantly, from approximately 1,354 patients as of September 30, 2022, to over 2,178 patients as of March 31, 2024.

Q: What were the key financial highlights for Aurinia in 2023?

Aurinia reported total net revenue of $130.4 million for the nine months ended September 30, 2023, a 24% increase over the prior year. Net product revenue for the same period was $116.2 million, a 55% year-over-year increase.

Q: What regulatory milestones has LUPKYNIS achieved?

LUPKYNIS received European Commission marketing authorization in September 2022 and additional pricing and reimbursement approvals in major European markets in 2023.

Q: What is the financial outlook for Aurinia in 2024?

Aurinia expects net product revenue to be in the range of $200 to $220 million for 2024 and anticipates being cash flow positive, excluding share repurchases, in the second quarter of 2024.

Sources

1. Aurinia Reports Third Quarter and Nine Months 2022 Financial and Operational Results. Business Wire.
2. Aurinia Pharmaceuticals Reports Third Quarter and Nine Months 2023 Financial and Operational Results. Business Wire.
3. Earnings call: Aurinia Pharmaceuticals reports robust Q3 2023 results, explores strategic options. Investing.com.
4. Aurinia Pharmaceuticals Reports First Quarter 2024 Financial and Operational Results. BioSpace.
5. Aurinia Pharmaceuticals Reports First Quarter 2024 Financial and Operational Results. Aurinia Pharmaceuticals.