Aurinia Pharmaceuticals v. Sandoz: LUPKYNIS® Patent Suit Consolidated in New Jersey
Aurinia Pharmaceuticals filed suit against generic manufacturer Sandoz in the District of New Jersey, asserting patents US11622991B2 and US10286036B2 covering its LUPKYNIS® (voclosporin) drug product. After 209 days, the case was consolidated with related actions under Lead Case No. 25-2580 for unified pre-trial proceedings.
Voclosporin ANDA litigation consolidated before New Jersey District Court
On May 8, 2025, Aurinia Pharmaceuticals, Inc. filed Case No. 2:25-cv-03986 against Sandoz, Inc. in the United States District Court for the District of New Jersey, alleging infringement of two patents — US11622991B2 and US10286036B2 — covering the formulation and use of voclosporin, marketed as LUPKYNIS®, a calcineurin inhibitor approved for the treatment of lupus nephritis. This action is consistent with the ANDA litigation framework under the Hatch-Waxman Act, whereby a branded pharmaceutical company asserts listed patents in response to a generic manufacturer’s Abbreviated New Drug Application.
On December 3, 2025, the Court entered an order consolidating Case No. 2:25-cv-03986 with related actions under Lead Case No. 25-2580 for all pre-trial purposes, including discovery and case management. The consolidation was granted pursuant to Federal Rule of Civil Procedure 42(a) and Local Civil Rule 42.1, with the Court finding common questions of law and fact across the consolidated actions and no opposition from any party. All future filings in the consolidated action are to be made solely in the lead case docket.
The 209-day timeline from filing to consolidation reflects a relatively efficient early case management phase, suggesting the related actions were filed in close proximity and the parties moved promptly toward consolidated proceedings. Consolidation does not resolve the underlying merits — infringement and validity of the asserted voclosporin patents remain to be adjudicated. The public record does not disclose the total number of related actions consolidated, the specific Sandoz ANDA filing details, or any scheduling order for the lead case.
Filing to Case Consolidated in 209 days
209 days from filing to consolidation order — typical for early-stage ANDA pharmaceutical consolidations
Cases merged under Lead Case 25-2580: what consolidation means for both parties
Rule 42(a) consolidation merges related actions into one
Federal Rule of Civil Procedure 42(a) permits a court to consolidate actions that share common questions of law or fact. Here, the Court found that Case No. 2:25-cv-03986 and the related actions involve overlapping legal and factual issues — almost certainly the same LUPKYNIS® patents and the same Sandoz ANDA. Consolidation streamlines discovery and case management but does not adjudicate any substantive claim. The lead case, No. 25-2580, will govern all further pre-trial proceedings.
Procedural — merits unresolvedAurinia benefits from coordinated, resource-efficient enforcement
Consolidation is typically neutral-to-favorable for a plaintiff managing parallel ANDA suits against multiple generic filers. Aurinia can coordinate its infringement and validity positions across all related defendants in a single pre-trial framework, reducing duplicative discovery and the risk of inconsistent rulings. The 30-month stay triggered by Hatch-Waxman may still be operative, meaning LUPKYNIS® market exclusivity continues while litigation proceeds under the lead docket.
Coordinated enforcement preservedSandoz faces unified litigation timeline with co-defendants
For Sandoz, consolidation means its case will be managed alongside other generic challengers in a single pre-trial schedule. This can create efficiencies — shared invalidity discovery and claim construction briefing — but also means Sandoz’s litigation strategy will be conducted in a more visible, multi-party setting. No merits determination has been made; Sandoz retains the ability to contest validity and non-infringement of both asserted patents in the lead case proceedings.
Merits defence fully intactVoclosporin patent exclusivity remains contested but intact for now
LUPKYNIS® is the first FDA-approved calcineurin inhibitor for lupus nephritis, a niche but commercially significant indication. The consolidation order signals that multiple generic manufacturers may be pursuing ANDA approvals simultaneously, suggesting commercial pressure on Aurinia’s exclusivity position is intensifying. Until validity and infringement are resolved in the lead case, generic entry remains blocked pending the Hatch-Waxman litigation stay, and the scope of the two asserted patents will be a critical determinant of market timing.
Generic entry timeline uncertainFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Aurinia Pharmaceuticals, Inc. | Company | Biopharmaceutical company — holder of US11622991B2 and US10286036B2 covering LUPKYNIS® (voclosporin)Search in Eureka ↗ |
| Defendant | Sandoz, Inc. | Company | Sandoz, Inc. — global generic and biosimilar pharmaceutical manufacturerSearch in Eureka ↗ |
| Plaintiff counsel | C. COLLETTE CORSER | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | DANIELLE A. DUSZCZYSZYN | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | EMILY R. GABRANSKI | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | EMMA CAPITANELLI | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | J. BRUGH LOWER | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | JUSTIN SILVERBERG | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | MARK FELDSTEIN | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | RYAN V. MCDONNELL | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | William P. Deni , Jr. | Attorney | Counsel for Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Gibbons PC | Law Firm | Representing Aurinia Pharmaceuticals, Inc.Search in Eureka ↗ |
| Defendant counsel | Eric I. Abraham | Attorney | Counsel for Sandoz, Inc.Search in Eureka ↗ |
| Defendant counsel | JOVIAL WONG | Attorney | Counsel for Sandoz, Inc.Search in Eureka ↗ |
| Defendant counsel | Kristine L. Butler | Attorney | Counsel for Sandoz, Inc.Search in Eureka ↗ |
| Defendant counsel | MAUREEN RURKA | Attorney | Counsel for Sandoz, Inc.Search in Eureka ↗ |
| Defendant law firm | Hill Wallack LLP | Law Firm | Representing Sandoz, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The consolidation order is a procedural instrument under Rule 42(a) and carries no substantive finding on infringement or validity. The Court’s recitation that ‘no parties opposed’ the order suggests the consolidation was uncontested — consistent with standard ANDA practice where related cases share the same patents and product. The designation of Lead Case No. 25-2580 means that docket will govern discovery, scheduling, and ultimately trial. Parties and observers should monitor Lead Case No. 25-2580 exclusively for substantive developments.
US11622991B2 & US10286036B2 — LUPKYNIS® Voclosporin Formulations
US11622991B2 (application No. US17/713140) and US10286036B2 (application No. US15/835219) both cover aspects of voclosporin, a novel calcineurin inhibitor developed for the treatment of active lupus nephritis. Voclosporin is a cyclosporine analogue with a modified side chain that confers a more predictable pharmacokinetic profile than earlier calcineurin inhibitors. The patents likely cover formulation, dosing methodology, or therapeutic use claims, though the precise claim scope is determinative of the infringement exposure Sandoz faces and would need to be assessed against the ANDA specification.
LUPKYNIS® received FDA approval in January 2021 and represents a commercially significant asset for Aurinia in the orphan-disease adjacent lupus nephritis space. Two separately prosecuted patents asserted in this suit — filed years apart based on their application numbers — suggest a layered patent portfolio strategy designed to extend exclusivity across different claim categories. For competitors or licensees in the calcineurin inhibitor or nephrology drug space, the breadth of these patents and any inter partes review history warrants close scrutiny before advancing any competing formulation or ANDA.
Should your team run an FTO against US11622991B2 and US10286036B2?
Any company developing a generic, biosimilar-adjacent, or reformulated voclosporin product — or any calcineurin inhibitor targeting lupus nephritis — should treat both asserted patents as live FTO risks. The fact that Aurinia has already initiated consolidated ANDA litigation against at least two defendants signals an active enforcement posture. R&D and regulatory teams working on nephrology or immunosuppressive drug pipelines should assess both patents’ claim scope before committing to an ANDA filing or formulation strategy.
PatSnap Eureka’s FTO Search Agent can map the claim landscape of US11622991B2 and US10286036B2 against your proposed formulation or dosing regimen, identify relevant prior art that may support an invalidity argument, and surface any related family members or continuation applications that could extend the exclusivity window. With consolidated litigation already underway in New Jersey, early FTO analysis is essential to informing both ANDA strategy and potential IPR petition timing.
Run a freedom-to-operate analysis on US11622991B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent cases: calcineurin inhibitors and lupus nephritis litigation
Explore related Hatch-Waxman patent infringement cases involving calcineurin inhibitors and immunosuppressive drug formulations filed in the District of New Jersey.
What this case signals for the pharmaceutical patent enforcement landscape
Multi-defendant ANDA consolidations are accelerating in New Jersey — the preferred venue for Hatch-Waxman patent suits.
New Jersey remains the dominant venue for ANDA patent disputes
The District of New Jersey’s experience with pharmaceutical patent litigation and its Local Civil Rules — including Local Rule 42.1 — make it the venue of choice for Hatch-Waxman suits. Branded companies filing here benefit from a court familiar with complex multi-defendant ANDA consolidations, which can accelerate case management timelines and reduce the risk of inconsistent rulings across related actions.
Multiple ANDA filers signal heightened competitive pressure on LUPKYNIS®
The existence of related actions consolidated under a single lead case suggests more than one generic manufacturer has filed an ANDA referencing LUPKYNIS®. This pattern typically indicates the branded product has reached a commercial scale that justifies generic entry litigation risk, and that Aurinia’s patent portfolio will face sustained validity challenges. Monitoring the lead case docket for IPR petitions is advisable.
Aurinia v Sandoz — key questions answered
Consolidation under Federal Rule of Civil Procedure 42(a) merges Case No. 2:25-cv-03986 with related actions into a single pre-trial framework governed by Lead Case No. 25-2580. All discovery, case management orders, and pre-trial rulings will issue from that docket. The underlying infringement and validity disputes remain fully unresolved and will proceed in the lead case.
Aurinia asserts US11622991B2 (application No. US17/713140) and US10286036B2 (application No. US15/835219), both covering aspects of voclosporin — the active ingredient in LUPKYNIS® — a calcineurin inhibitor approved for active lupus nephritis treatment.
The case characteristics — a branded pharmaceutical company asserting drug product patents against a generic manufacturer in New Jersey District Court — are consistent with Hatch-Waxman ANDA litigation. The public record does not confirm the ANDA number or filing date, but the litigation structure, venue, and parties are typical of paragraph IV certification disputes.
Consolidation is a procedural case management tool and does not independently alter the Hatch-Waxman 30-month stay triggered by the original infringement suit. The stay’s operative period depends on the date the NDA holder received notice of the paragraph IV certification and when the original complaint was filed — details not fully disclosed in the public consolidation order.
Yes, filing an IPR petition at the USPTO is a separate proceeding and is not precluded by district court consolidation. However, the one-year bar under 35 U.S.C. § 315(b) — which prevents an IPR petition if filed more than one year after the petitioner was served with a complaint alleging infringement — means Sandoz must assess the timing carefully relative to when it was originally served in any related action.
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