Veloxis Pharmaceuticals, Inc. v. Glenmark Pharms. Inc.

This is an ongoing Abbreviated New Drug Application (ANDA) patent infringement case initiated by Veloxis Pharmaceuticals, Inc. against Glenmark Pharms. Inc. in the District Court, Delaware. Veloxis Pharmaceuticals, Inc., an Asahi Kasei company, is a specialty pharmaceutical company dedicated to transplant medicine, focusing on the development and commercialization of medications for transplant patients, making it an operating company. Glenmark Pharms. Inc. is the U.S. subsidiary of Glenmark Pharmaceuticals Ltd., a global, research-led pharmaceutical company that operates in generics, specialty, and over-the-counter (OTC) businesses, positioning it as an operating company with a significant generics arm.

The core of the dispute centers on Glenmark's submission of an ANDA to the FDA, seeking approval to manufacture and market generic extended-release tacrolimus tablets. This generic product is alleged to infringe Veloxis's branded immunosuppressant, ENVARSUS XR®. ENVARSUS XR® contains the active ingredient tacrolimus, a calcineurin-inhibitor immunosuppressant critical for preventing organ rejection in kidney transplant patients. The primary patent asserted in this litigation is U.S. Patent No. 8,685,998, titled "Tacrolimus for Improved Treatment of Transplant Patients." This patent generally describes stable pharmaceutical compositions of tacrolimus, particularly extended-release oral dosage forms designed to enhance bioavailability and provide an improved pharmacokinetic profile for transplant patients, often through the inclusion of a stabilizing agent to prevent drug degradation.

The case, filed on April 14, 2025, is proceeding in the District Court, Delaware, under case number 1:25-cv-00458. The specific judge assigned to this case is not identified in public search results, though the District of Delaware is a prominent venue for patent litigation. This venue is particularly significant because a substantial majority of major U.S. technology and pharmaceutical companies are incorporated in Delaware, which establishes mandatory venue in the state. The district is recognized for its experienced patent-specialist judges, who offer predictability, clear procedural scheduling, and expertise in complex patent issues, including claim construction and early resolution of Section 101 invalidity challenges. This litigation is notable as a standard ANDA challenge in the pharmaceutical industry, where the outcome directly impacts the market exclusivity of ENVARSUS XR® and the potential for generic competition, thereby affecting access and pricing for a crucial transplant medication. While no specific IPRs linked to this particular case were found, such challenges are common in ANDA disputes.

Key Legal Developments and Outcome in Veloxis Pharmaceuticals, Inc. v. Glenmark Pharms. Inc.

Case Caption: Veloxis Pharmaceuticals, Inc. v. Glenmark Pharms. Inc.
Case Number: 1:25-cv-00458
Court: District Court, Delaware
Filed: 2025-04-14
Status: Ongoing
Patents at Issue: 8685998

This is an ongoing ANDA patent infringement case filed by Veloxis Pharmaceuticals, Inc. against Glenmark Pharms. Inc. in the District Court, Delaware. The case is actively moving through pre-trial phases, including claim construction and discovery.

Here's a chronological overview of the key legal developments:

• Filing of Complaint: Veloxis Pharmaceuticals, Inc. filed its patent infringement complaint against Glenmark Pharms. Inc. on April 14, 2025, in the U.S. District Court for the District of Delaware. Specific docket entry details for the complaint itself were not found in the public search results.
• Initial Pleadings (Answer & Counterclaims): Information regarding the specific filing dates or content of Glenmark's answer and any counterclaims were not readily available in the public search results.
• Claim Construction (Markman) Hearing: A Markman hearing was held on October 20, 2025, before Judge Maryellen Noreika. While the hearing date is confirmed, the specific outcome of the Markman hearing, such as the issuance of a claim construction order or opinion, was not identified in the public search results, nor was its date of entry.
• Pre-trial Motions of Substance: No explicit details regarding substantive pre-trial motions to dismiss, transfer, or stay (e.g., pending IPR) specifically for this case (1:25-cv-00458) were found in the public search results.
• Discovery Milestones: The court has issued and extended deadlines for discovery. On October 28, 2025, an order was signed setting or resetting deadlines, including opening expert reports due 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. Further extensions were ordered on January 13, 2026, revising these deadlines to: rebuttal expert reports due by January 20, 2026, reply expert reports by February 5, 2026, and expert discovery by February 27, 2026. These extensions indicate active and ongoing expert discovery.
• Trial Events, Verdict, and Post-trial Motions: As of June 1, 2026, the case is ongoing, and there have been no reported trial events, verdicts, or post-trial motions.
• Settlement, Dismissal, Judgment, or Appeal: The case is currently active and ongoing. No settlement, dismissal, or judgment has been reported for this specific case. It is important to note that a "CONSENT JUDGMENT" terminating related cases (1:24-cv-00784 and 1:24-cv-00726) was signed on January 13, 2026, but this does not apply to the Veloxis Pharmaceuticals, Inc. v. Glenmark Pharms. Inc. 1:25-cv-00458 case, which remains active.
• Parallel PTAB IPR/PGR Proceedings: There are no Post-Grant Review (PGR) or Inter Partes Review (IPR) proceedings on file at the USPTO Patent Trial and Appeal Board (PTAB) challenging patent 8685998. Therefore, these proceedings have not had an effect on the litigation.

The case continues to proceed through its pre-trial schedule, with discovery expected to be completed by late February 2026, as per the last reported scheduling order.

Veloxis Pharmaceuticals, Inc. is represented by attorneys from Morris, Nichols, Arsht & Tunnell LLP in this patent infringement case. This firm frequently serves as local counsel in complex patent and Abbreviated New Drug Application (ANDA) litigation in the District of Delaware.

Based on available information for case 1:25-cv-00458, the following attorneys are associated with the plaintiff:

• Jeremy A. Tigan
  • Role: Local Counsel (Partner)
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE
  • Note: An IP litigation partner with experience in patent infringement and trade secret disputes, often acting as lead or Delaware counsel, particularly in pharmaceutical technologies and ANDA litigation.

While not explicitly confirmed as having entered appearances in this specific case 1:25-cv-00458 through the direct docket snippets, other prominent Morris, Nichols, Arsht & Tunnell LLP attorneys frequently involved in similar Veloxis ANDA litigation and are likely to be part of the legal team include:

• Jack B. Blumenfeld

  • Role: Local Counsel (Senior Partner)
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE
  • Note: Recognized as a "dean of the Delaware IP bar" with extensive experience in pharmaceutical, medical product, and biotechnology patent litigation, frequently serving as lead, Delaware, or co-counsel in ANDA cases.

• Brian P. Egan

  • Role: Local Counsel (Partner)
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE
  • Note: Focuses on IP and patent litigation involving pharmaceuticals, medical devices, and other technologies, drawing on his prior experience as a patent examiner.

• Anthony D. Raucci

  • Role: Local Counsel (Special Counsel)
  • Firm: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE
  • Note: Concentrates on IP litigation, including patent and trade secret cases, and has experience as both lead and Delaware counsel in pharmaceutical and other technology areas.

As of the current date, direct search results from public dockets and legal news for case 1:25-cv-00458 primarily indicate the involvement of Morris, Nichols, Arsht & Tunnell LLP. No specific lead counsel from a national IP litigation firm for Veloxis Pharmaceuticals, Inc. in this particular case has been explicitly identified through the conducted web searches.

Glenmark Pharmaceuticals Inc. USA is represented by attorneys from several firms in this patent infringement case (1:25-cv-00458).

Counsel of Record for Glenmark Pharms. Inc.:

• Dominick Gattuso

  • Role: Counsel
  • Firm: Mannion Tahan & Gattuso, P.A. (Delaware office, likely local counsel given the firm's location and common practice in Delaware for ANDA cases).
  • Note: Dominick Gattuso has appeared in filings related to service of discovery documents for Glenmark in this case.

• Jeremy Tigan

  • Role: Counsel
  • Firm: Not specified in direct relation to this case, but likely associated with one of Glenmark's primary litigation firms.
  • Note: Jeremy Tigan filed a notice requesting the removal of Brooke Kootman Dodson as co-counsel, indicating active involvement in the case.

While specific lead counsel roles aren't definitively assigned in the available docket snippets, firms that frequently represent generic pharmaceutical companies in ANDA litigation and have represented Glenmark in past cases include:

• Winston & Strawn LLP: This firm has a substantial patent litigation practice and is noted for representing generic pharmaceutical companies in over 100 ANDA cases since 2018.
• Quinn Emanuel Urquhart & Sullivan, LLP: The firm has a strong life sciences and pharmaceutical patent litigation practice, having litigated over 300 ANDA cases.
• Robins Kaplan LLP: This firm has represented Glenmark in other patent infringement suits, such as GlaxoSmithKline LLC v. Glenmark Pharms. Inc., USA.
• Finnegan, Henderson, Farabow, Garrett & Dunner, LLP: Finnegan is a leading IP law firm with experience in Hatch-Waxman litigation.

It's common in ANDA litigation for larger national firms to serve as lead counsel, with local Delaware counsel, such as Mannion Tahan & Gattuso, handling filings and appearances specific to the District of Delaware. Past cases show Glenmark has been involved in numerous patent infringement lawsuits concerning generic drug approvals, often in the District of Delaware, including disputes over carvedilol (Coreg®), bendamustine hydrochloride (Treanda®), and azelaic acid (Finacea® Gel).