Details for Patent: 10,286,036

Which drugs does patent 10,286,036 protect, and when does it expire?

Patent 10,286,036 protects LUPKYNIS and is included in one NDA.

This patent has thirty patent family members in twenty-three countries.

Summary for Patent: 10,286,036

Title:	Protocol for treatment of lupus nephritis
Abstract:	By employing a pharmacodynamic dosing regimen, the effectiveness of a protocol for treatment of lupus nephritis with voclosporin can be maximized while minimizing undesirable side effects.
Inventor(s):	Solomons; Neil (Victoria, CA), Huizinga; Robert B. (North Saanich, CA)
Assignee:	AURINIA PHARMACEUTICALS INC. (Victoria, CA)
Application Number:	15/835,219
Patent Claim Types: see list of patent claims	Use;

Detailed Analysis of the Scope and Claims of United States Patent 10,286,036

Introduction

United States Patent 10,286,036, assigned to Aurinia Pharmaceuticals Inc., is a crucial patent that protects the protocol for the treatment of lupus nephritis using voclosporin. This patent is significant in the pharmaceutical industry, particularly in the treatment of autoimmune diseases.

Patent Overview

• Patent Number: US 10,286,036
• Issued: May 14, 2019
• Inventors: Neil Solomons and Robert B. Huizinga
• Assignee: Aurinia Pharmaceuticals Inc.[2][3][4].

Claims and Scope

The patent primarily focuses on a protocol for treating lupus nephritis, a severe form of kidney inflammation caused by systemic lupus erythematosus (SLE). Here are the key aspects of the patent:

Pharmacodynamic Dosing Regimen

The patent describes a pharmacodynamic dosing regimen for voclosporin, which is designed to maximize the effectiveness of the treatment while minimizing undesirable side effects. This regimen involves adjusting the dose based on the patient's estimated glomerular filtration rate (eGFR), a measure of kidney function[2][4].

Use of Voclosporin

Voclosporin is an immunomodulating agent that belongs to the class of cyclosporine analogues. The patent outlines the specific use of voclosporin in treating lupus nephritis, highlighting its efficacy and safety profile when administered according to the patented protocol[4].

Patent Expiration and Protection

• Expiration Date: December 7, 2037
• Protection Status: The patent is currently active and will remain so until its expiration date. This provides Aurinia Pharmaceuticals Inc. with exclusive rights to market and sell voclosporin for the treatment of lupus nephritis under the brand name LUPKYNIS[2][3].

Related Patents and Exclusivities

In addition to the '036 patent, LUPKYNIS is protected by other patents and exclusivities:

Other Patents

• US 7,332,472: This patent covers cyclosporine analogue mixtures and is set to expire on October 17, 2025.
• US 11,622,991: This patent also relates to the treatment protocol for lupus nephritis and expires on December 7, 2037, similar to the '036 patent[3].

FDA Exclusivities

• New Chemical Entity (NCE) Exclusivity: LUPKYNIS has been granted NCE exclusivity by the FDA, which will expire on January 22, 2026. This exclusivity prevents other companies from marketing a generic or bioequivalent version of LUPKYNIS until this date[3].

Litigation and Settlements

The '036 patent has been involved in legal proceedings, notably a challenge by Sun Pharmaceutical Industries Ltd.

Challenge by Sun Pharmaceuticals

In February 2022, Sun Pharmaceuticals initiated an Inter Partes Review (IPR) against the '036 patent. However, this challenge was settled on January 25, 2023, as part of a broader settlement agreement. Under this agreement, Sun Pharmaceuticals dropped the IPR challenge and ceased further litigation against Aurinia Pharmaceuticals Inc.[1][3][5].

Impact on Generic Launch

The combination of patent protection and FDA exclusivities significantly delays the potential launch of generic versions of LUPKYNIS. The earliest generic launch date is estimated to be December 7, 2037, coinciding with the expiration of the '036 and '991 patents[3].

Global Patent Landscape

While the focus here is on U.S. patents, it is crucial to note that LUPKYNIS is protected by patents in multiple countries. Understanding the global patent landscape is essential for strategizing market entry and identifying potential generic entry points in regions with weaker patent protection[3].

Key Takeaways

• Patent Protection: The '036 patent provides exclusive rights to Aurinia Pharmaceuticals Inc. for the treatment of lupus nephritis with voclosporin until December 7, 2037.
• Dosing Regimen: The patent involves a pharmacodynamic dosing regimen based on eGFR, enhancing the treatment's efficacy and safety.
• Litigation and Settlements: The patent challenge by Sun Pharmaceuticals was settled, ensuring continued protection for LUPKYNIS.
• Generic Launch: The earliest estimated generic launch date is December 7, 2037, due to the combination of patent and exclusivity protections.

FAQs

1. What is the primary focus of United States Patent 10,286,036?

   • The primary focus is on a protocol for treating lupus nephritis using voclosporin, with a pharmacodynamic dosing regimen based on eGFR.

2. Who is the assignee of the '036 patent?

   • The assignee is Aurinia Pharmaceuticals Inc.

3. When does the '036 patent expire?

   • The patent expires on December 7, 2037.

4. What is the status of the IPR challenge by Sun Pharmaceuticals against the '036 patent?

   • The challenge was settled on January 25, 2023, as part of a broader settlement agreement.

5. What is the estimated earliest generic launch date for LUPKYNIS?

   • The estimated earliest generic launch date is December 7, 2037.

Sources:

1. AUPH Settles Patent Disputes with Sun - BPIQ
2. Generic Lupkynis Availability - Drugs.com
3. Lupkynis patent expiration - Pharsight
4. US10286036B2 - Protocol for treatment of lupus nephritis - Google Patents
5. Aurinia Announces LUPKYNIS® (voclosporin) Patent Challenge Settlement Reached with Sun Pharmaceuticals - Biospace

Drugs Protected by US Patent 10,286,036

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Aurinia	LUPKYNIS	voclosporin	CAPSULE;ORAL	213716-001	Jan 22, 2021		RX	Yes	Yes	10,286,036					TREATMENT OF PATIENTS WITH ACTIVE LUPUS NEPHRITIS

International Family Members for US Patent 10,286,036

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2018266850
Australia	2024202977
Brazil	112019023766
Canada	3063040