Veloxis Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries Ltd. et al.

Veloxis Pharmaceuticals, Inc., a specialty pharmaceutical company focused on medications for transplant patients and an Asahi Kasei company, has initiated a patent infringement lawsuit against Sun Pharmaceutical Industries Ltd. and its subsidiary, Sun Pharmaceutical Industries, Inc.. Sun Pharmaceutical, an Indian multinational pharmaceutical company, is a leading global specialty generic company that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients in over 100 countries.. The core of the dispute centers around Sun Pharmaceutical's alleged infringement through its Abbreviated New Drug Application (ANDA) seeking to market a generic version of Veloxis's ENVARSUS XR (tacrolimus extended-release tablets), a once-daily immunosuppressant used to prevent organ rejection in kidney transplant patients..

The litigation specifically asserts US Patent 11,110,081, among others not detailed in the provided information, which generally pertains to an extended-release oral dosage form containing tacrolimus or a pharmaceutically active analog for once-daily immunosuppressive treatment, particularly for kidney or liver transplant patients, with the dosage form designed to release the active substance over an extended period.. This case is being heard in the United States District Court for the District of Delaware, with Judge Maryellen Noreika presiding.. The District of Delaware is a prominent venue for patent litigation, particularly for Hatch-Waxman (ANDA) cases, with a significant percentage of such cases nationwide filed in this court due to its experienced judiciary..

This case is notable as it is an ANDA litigation, a common type of pharmaceutical patent dispute where a generic manufacturer challenges the patents of a brand-name drug to bring a generic version to market. The thirty-month stay deadline, set for November 9, 2026, is a critical aspect of this case, as it marks a period during which the FDA is typically prevented from approving the generic drug, allowing time for the patent litigation to proceed.. Such cases have significant market implications for both the brand-name drug's exclusivity and the introduction of more affordable generic alternatives..

Veloxis Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries Ltd. et al., Case 1:24-cv-00726, filed in the District of Delaware on June 19, 2024, involved allegations of infringement concerning U.S. Patent 11,110,081, among others. The case ultimately concluded with a consent judgment in April 2026.

Here's a chronological summary of the key legal developments and outcome:

Filing & Initial Pleadings:

• Complaint Filed: Veloxis Pharmaceuticals, Inc. initiated the patent infringement action on June 19, 2024. [cite: 1 in original search, 2 in original search, 7 in original search]
• Amended Complaint: An amended complaint was filed on May 16, 2025. [cite: 3 in original search]
• Answer & Counterclaims: Defendants Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. filed an answer, including counterclaims, at an unspecified date following the complaint. Their role as "Counter Claimant" is indicated in docket records.

Pre-Trial Motions of Substance:

• Motion to Strike: Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. filed a redacted motion to strike the supplemental expert report of Vivian Gray. Veloxis Pharmaceuticals, Inc. subsequently filed a redacted answering brief in opposition. The specific outcome of this motion is not explicitly detailed in public records, but it was likely resolved or rendered moot by the case's final disposition.
• Procedural Motions: A motion for exemption of persons from a District of Delaware standing order on personal devices was granted on April 1, 2026. [cite: 2 in original search] No substantive motions to dismiss, transfer, or stay pending IPR were identified in the available records for this specific case.

Claim Construction (Markman) Outcomes:

• An official transcript of a Markman hearing held on October 20, 2025, before Judge Maryellen Noreika, is noted in a related case (1:24-cv-00784, Veloxis Pharma Inc v. Alkem Laboratories Ltd). While not explicitly in the docket for 1:24-cv-00726, it is common in multi-defendant ANDA litigation for claim construction in one related case to apply or inform others, or for such events to be coordinated.

Discovery Milestones with Strategic Significance:

• Expert Report Deadlines: The court issued several stipulations and orders to extend deadlines related to expert discovery.
  • An order signed on October 28, 2025, set deadlines for opening expert reports by December 5, 2025, rebuttal expert reports by January 14, 2026, reply expert reports by January 30, 2026, and expert discovery by February 24, 2026.
  • These deadlines were further extended by an order signed on January 13, 2026, with rebuttal expert reports due by January 20, 2026, reply expert reports by February 5, 2026, and expert discovery by February 27, 2026.

Trial Events, Verdict, and Post-Trial Motions:

• Bench Trial Scheduled: A bench trial was scheduled for April 6, 2026. [cite: 1 in original search] However, the case was terminated on this same date by consent judgment.

Settlement, Dismissal, Judgment, or Appeal – Final Disposition:

• Consent Judgment and Termination: The case was terminated on April 6, 2026, when a Consent Judgment was signed by Judge Maryellen Noreika. This consent judgment resulted in the termination of the civil case. Public records indicate the case was "settled".

Parallel PTAB IPR/PGR Proceedings on the Asserted Patents:

• Searches for Inter Partes Review (IPR) or Post-Grant Review (PGR) proceedings specifically against US Patent 11,110,081 by Sun Pharmaceutical or any other entity did not yield public records indicating such filings at the USPTO's Patent Trial and Appeal Board (PTAB). Therefore, there is no publicly available information about parallel PTAB proceedings affecting this litigation.

The counsel of record identified for Veloxis Pharmaceuticals, Inc. in Veloxis Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries Ltd. et al., Case No. 1:24-cv-00726, is:

• Jeremy A. Tigan
  • Role: Partner, acting as both lead and Delaware counsel. He previously served as the head of his firm's Intellectual Property Litigation practice group from 2020-2024.
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, located in Wilmington, Delaware.
  • Relevant Patent Litigation Experience: Mr. Tigan's practice concentrates on patent infringement and trade secret disputes, primarily before the U.S. District Court for the District of Delaware. He has experience across a range of technologies, including pharmaceuticals, semiconductors, software, and consumer products. His litigation background includes both bench and jury trials in the District of Delaware, as well as appeals to the Third and Federal Circuits. He is consistently recognized as a leading Delaware patent litigator by various legal publications.

While the initial filing for the plaintiff indicated "Attorney(s) for Plaintiffs," implying potentially multiple attorneys, Jeremy A. Tigan is the specific attorney identified in the publicly available portion of that document. No other specific counsel of record for Veloxis Pharmaceuticals, Inc. in this particular case could be definitively identified from the provided search results.

In patent infringement cases filed in the District of Delaware, defendants typically retain both lead counsel and local counsel due to the court's specific rules and practices. While a comprehensive list of counsel for Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. in Veloxis Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries Ltd. et al. (1:24-cv-00726) is not publicly available without direct PACER access, general information about typical defense counsel in similar Delaware patent cases and Sun Pharma's past litigation can provide insight.

Sun Pharmaceutical has been involved in numerous patent litigation cases, often as an alleged infringer in ANDA litigation, demonstrating their regular engagement with intellectual property defense.

Based on general practices in the District of Delaware and the nature of ANDA litigation, the defendant's legal team is likely to include:

Lead Counsel: These attorneys would be primarily responsible for the overall litigation strategy, substantive arguments, and courtroom appearances. Given Sun Pharma's extensive history in patent disputes, they likely engage firms with strong national patent litigation practices, particularly those experienced in pharmaceutical and Hatch-Waxman cases.

Local Counsel: Delaware District Court rules typically require out-of-state attorneys to associate with local counsel. Firms like Connolly Gallagher LLP, Potter Anderson & Corroon LLP, Richards, Layton & Finger, and Smith, Katzenstein & Jenkins LLP are frequently engaged as local counsel in Delaware patent litigation due to their expertise in local rules and court practices.

• Connolly Gallagher LLP: Their intellectual property litigation attorneys often act as Delaware counsel for patent, trademark, and copyright infringement cases, working closely with lead counsel on local rules and practices. Attorneys like Arthur G. Connolly III and Alan R. Silverstein are noted in this practice area.
• Potter Anderson & Corroon LLP: This firm frequently serves as lead or Delaware counsel in patent and trademark infringement matters, including ANDA litigation. They represent both plaintiffs and defendants in a wide range of technologies, including pharmaceuticals.
• Richards, Layton & Finger: This firm has a highly active intellectual property litigation practice in Delaware, often serving as lead or Delaware counsel in large-scale patent and trademark infringement matters.
• Smith, Katzenstein & Jenkins LLP: Lawyers from this firm have served as Delaware counsel for over 20 years to leading IP practices, representing both plaintiffs and defendants in patent cases, including ANDA matters.

Without access to the specific docket entries for case 1:24-cv-00726, identifying the exact individuals and their roles for Sun Pharmaceutical is not possible at this time. Filings are typically public unless sealed, so once appearances are entered on the docket, specific counsel can be identified.