Untitled case

This patent infringement litigation, case number 1:25-cv-00458, is currently pending in the Delaware District Court before Judge Maryellen Noreika. The plaintiff is Veloxis Pharmaceuticals, Inc., a Delaware corporation and the holder of NDA No. 206406 for ENVARSUS XR®, which are tacrolimus extended-release tablets. Veloxis is an operating company in the pharmaceutical industry, focusing on organ transplant therapies. The defendant is Glenmark Pharmaceuticals Inc., USA, also a Delaware corporation, which filed ANDA No. 217905 seeking approval from the FDA to market and sell generic 0.75 mg, 1 mg, and 4 mg extended-release tablets of tacrolimus. This constitutes the accused product in this Hatch-Waxman litigation.

The core dispute revolves around Glenmark's Paragraph IV Certification that its ANDA products do not infringe, or that the asserted patents are invalid or unenforceable. The patents-in-suit include U.S. Patent No. 10,166,190 (the '190 patent), among others. The '190 patent is directed to stabilized pharmaceutical compositions comprising tacrolimus, or an analogue, dissolved or dispersed in a vehicle and a stabilizing agent. Specifically, it aims to prevent or reduce the formation of degradation products of tacrolimus, particularly 8-epitacrolimus, by maintaining a pH below 7 in the composition, often through the use of an organic acid like tartaric acid. The choice of the District of Delaware is common for ANDA cases due to its established patent law expertise and the fact that both parties are Delaware corporations.

This case is part of broader ANDA litigation initiated by Veloxis Pharmaceuticals to protect its tacrolimus extended-release product, ENVARSUS XR®. Veloxis has been involved in similar litigation against other generic manufacturers, such as Sun Pharmaceutical Industries Ltd. and Alkem Laboratories Ltd., also in the District of Delaware. A Markman hearing in this case with Glenmark was held on October 20, 2025, before Judge Noreika, indicating the case is progressing through the claim construction phase. A stay was previously in effect, and the parties provided a status update regarding the litigation in May 2026. The prevalence of such ANDA suits highlights the significant market value of tacrolimus extended-release formulations and the ongoing efforts by brand-name pharmaceutical companies to defend their intellectual property against generic competition. No direct linkage to PTAB IPRs specifically for the '190 patent in this case was readily found in the search results.

This summary details the key legal developments and current posture of the patent infringement litigation Veloxis Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc., USA, Case No. 1:25-cv-00458-MN, in the District of Delaware.

Key Legal Developments and Outcome:

1. Filing & Initial Pleadings:

• Complaint: Veloxis Pharmaceuticals, Inc. filed the complaint on April 14, 2025. The complaint alleges infringement of U.S. Patent Nos. 8,664,239, 8,685,998, 9,549,918, 10,166,190, 10,864,199, 11,110,081, 11,123,331, 11,419,823, and 12,083,103, relating to Glenmark's ANDA No. 217905 for extended-release tacrolimus tablets.
• Answer & Counterclaims: Glenmark Pharmaceuticals Inc., USA filed its answer, affirmative defenses, and counterclaims on June 5, 2025. Glenmark denied the allegations of infringement and challenged the validity of Veloxis's patents.

2. Pre-trial Motions of Substance:

• Motion to Stay: The case was stayed. On February 2, 2026, Veloxis and Glenmark filed a stipulation and order regarding a stay of the litigation. This stay was in effect as of May 2026, with the parties having agreed to an extension. The stipulation allows either party to request that the court lift the stay at any time.

3. Claim Construction (Markman) Outcomes:

• A Claim Construction Hearing is scheduled for July 1, 2026.

4. Discovery Milestones with Strategic Significance:

• No specific strategically significant discovery milestones were identified in the available information beyond the general progression of a Hatch-Waxman case that includes the filing of initial disclosures and responses to interrogatories and requests for production by Glenmark's counsel.

5. Trial Events, Verdict, and Post-trial Motions:

• A bench trial is currently scheduled for February 8, 2027.

6. Settlement, Dismissal, Judgment, or Appeal:

• The case is currently in a stayed status. No settlement, dismissal, or judgment has been reached.

7. Parallel PTAB IPR/PGR Proceedings:

• No parallel PTAB IPR/PGR proceedings on the asserted patents for this specific case (1:25-cv-00458-MN) were found in the available information. However, Veloxis Pharmaceuticals Inc. has been involved in other patent litigation cases, including some that have settled.

In Veloxis Pharmaceuticals, Inc. v. Glenmark Pharmaceuticals Inc., USA, Case No. 1:25-cv-00458 in the District of Delaware, the plaintiff, Veloxis Pharmaceuticals, Inc., is represented by attorneys from Morris, Nichols, Arsht & Tunnell LLP and Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.

Here's a breakdown of the identified counsel:

Morris, Nichols, Arsht & Tunnell LLP (Delaware Local Counsel)

• Jeremy A. Tigan
  • Role: Likely local counsel and a key member of the litigation team. He has filed several documents on behalf of Veloxis, including proposed orders, answers to counterclaims, and status reports.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Note: Morris Nichols is a prominent Delaware law firm known for its intellectual property litigation, particularly in the pharmaceutical and biotechnology sectors. Mr. Tigan is an associate with the Intellectual Property Litigation group and focuses on patent litigation in pharmaceuticals, biotechnology, and medical devices. He has represented Veloxis in other related cases.
• Jack B. Blumenfeld
  • Role: Likely local counsel. He has signed court documents on behalf of Veloxis in related cases.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Note: Mr. Blumenfeld is a well-known attorney at Morris Nichols, a firm recognized for handling high-stakes, complex matters in intellectual property litigation.
• Travis J. Murray
  • Role: Associate with the Intellectual Property Litigation group.
  • Firm & Office Location: Morris, Nichols, Arsht & Tunnell LLP, Wilmington, DE.
  • Note: Mr. Murray's practice focuses on patent litigation encompassing pharmaceuticals, biotechnology, and medical devices. He is also a registered pharmacist.

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (Lead Counsel)

• Andrew M. Berdon
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP (office location not specified in direct search results for this case, but Finnegan has multiple offices, including Washington, D.C., and New York).
  • Note: Finnegan is a leading full-service intellectual property firm with extensive experience in pharmaceutical patent litigation, including Hatch-Waxman cases.
• James E. Baker
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
  • Note: Finnegan attorneys are known for their expertise in managing patent portfolios and handling complex patent infringement and Hatch-Waxman litigation in the life sciences sector.
• Laura Fairneny
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
  • Note: Finnegan frequently represents pharmaceutical clients in all aspects of patent law.
• Iyah Chen
  • Role: Lead Counsel (appeared pro hac vice).
  • Firm & Office Location: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP.
  • Note: Finnegan has a team of IP specialists regularly engaged in patent portfolio management and litigation for pharmaceutical and biotechnology companies.

I'll research the defendant's counsel of record for this case.

Let me get the detailed counsel listing and docket entries.

Let me verify the specific attorneys and their firms.

Defendant's Counsel of Record — Glenmark Pharmaceuticals Inc., USA

Bottom line: Glenmark's counsel in this case is a two-tier structure: a Delaware firm serving as local/lead counsel of record on the docket, plus a national patent-litigation team appearing pro hac vice. The pro hac vice roster has changed materially during the case — the original national team (Winston & Strawn LLP) withdrew in June 2025, and a different team appears by 2026. Details below, with sourcing and explicit flags where my verification was incomplete.

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1. Delaware counsel of record (lead attorney on the docket)

Docket support: Notice of Appearance, D.I. 8 (May 1, 2025); Rule 7.1 Disclosure Statement, D.I. 9 (May 1, 2025); Stipulation to Extend Time, D.I. 10 (May 1, 2025); Answer, Defenses and Counterclaims, D.I. 11 (June 5, 2025) (signed/filed by Gattuso); PHV motions, D.I. 12 (June 6, 2025) and D.I. 14 in the related case (see §3). CourtListener's parties page for this docket lists him under "LEAD ATTORNEY" for Glenmark.

Note on the corporate parent: Glenmark's D.I. 9 disclosure identifies Glenmark Pharmaceuticals Limited as its corporate parent, but the parent is not a named defendant here (unlike some other Glenmark ANDA matters, e.g., D. Del. C.A. No. 18-1043-LPS, where both Glenmark entities were defendants and were represented by Young Conaway + Knobbe Martens). No separate parent-entity counsel appears on this docket.

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2. Pro hac vice counsel for Glenmark

⚠️ Verification flag: My searching was cut short before I could confirm the firm affiliations for Ward, Summers, Weeks, and Weinstein from firm biographies or the PHV motion papers themselves. What is documented is (a) they are listed as Glenmark's counsel of record, and (b) Ward, Summers and Seth moved for pro hac vice admission together in the related case. Because Neal Seth is definitively Wiley Rein, the most likely reading is that Ward/Summers/Treece are the Wiley Rein team that replaced Winston & Strawn — but I am treating that as an inference, not a confirmed fact. These affiliations should be verified against the actual PHV motion and the Wiley Rein attorney directory before being relied on.

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3. Former counsel — Winston & Strawn LLP (withdrawn)

Docket support: D.I. 12 (motion, June 6, 2025) → SO ORDERED by Judge Noreika June 6, 2025 → PHV fee paid, D.I. 13 → D.I. 14, "NOTICE of Withdrawal of Maureen Rurka, Samantha Lerner, Sharon Lin McIntosh and Anna Sonju of Winston & Strawn LLP as counsel for Defendant" (June 20, 2025). This is a notable strategic data point: Glenmark's original national Hatch-Waxman team appeared for roughly two weeks and then withdrew, with a replacement national team in place by 2026.

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4. Parallel/related case — same defendant, overlapping defense team

A second Veloxis v. Glenmark action, No. 1:26-cv-00305-MN (D. Del., filed March 20, 2026) — on U.S. Patent No. 12,403,095 ("Stabilized Tacrolimus Composition," issued Sept. 2, 2025), same ANDA No. 217905 — shows the same defense lineup:

• D.I. 13 (June 12, 2026) — Answer and counterclaims filed by Gattuso.
• D.I. 14 (June 24, 2026) — MOTION for Pro Hac Vice Appearance of Neal Seth, Teresa Summers, Joshua R. Treece, and Christine S. Ward, filed by Gattuso, granted June 24, 2026 (PHV fee receipt ADEDC-5000067).
• D.I. 12 (May 11, 2026) — notice requesting Clerk remove Wesley E. Weeks and Corey Weinstein as co-counsel.
• Per the UniCourt docket mirror, that case was dismissed without prejudice (D.I. 17 stipulation of dismissal; D.I. 18 SO ORDERED terminating the case, Aug. 27, 2026; D.I. 19 patent report).

Joshua R. Treece appears only in the '305 PHV motion; I did not confirm his appearance in 1:25-cv-00458 or his firm. Firm affiliation unconfirmed.

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5. Discrepancies and open items I want to flag

1. Possible resolution of this case (conflicts with the earlier case sections). The CourtListener docket feed for 1:25-cv-00458 shows entries dated August 27, 2026 — "Stipulation of Dismissal" (D.I. 68) and "Patent/Trademark Report to Commissioner of Patents" (D.I. 69), with further notices of service (D.I. 70–71, Aug. 28, 2026). If those entries belong to this docket, this case was resolved in late August 2026, which would be inconsistent with the previously generated sections stating the case "remains stayed" with a bench trial set for February 8, 2027. Because the related '305 case has parallel dismissal entries (#17–19) on the exact same date, I could not conclusively separate the two dockets from the search snippets. This should be confirmed on PACER before the case posture is described as "stayed/litigating."
2. The "Markman hearing on October 20, 2025" in the prior summary appears to be a misread. The actual October 20, 2025 event on this docket (D.I. 34) is a STIPULATION TO EXTEND TIME for Plaintiff to serve its Initial Infringement Contentions to October 23, 2025, SO ORDERED by Judge Noreika — not a claim construction hearing. Claim construction activity on the docket instead shows Plaintiff's Preliminary Proposed Terms served January 5, 2026.
3. No in-house Glenmark counsel appears of record on this docket in any of the sources I reviewed.
4. No sealed counselor filings were identified; the sources do not indicate any sealed attorney appearances.

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Source basis / caveats

Grounded in: the CourtListener docket Parties page for 1:25-cv-00458 (docket 69892763); the Justia and DocketBird docket mirrors for 1:25-cv-00458 (D.I. 8–14, and the Sept. 2025–Aug. 2026 discovery/status entries); the UniCourt docket mirror for 1:26-cv-00305 (D.I. 12–19); and the Eleventh Circuit appellee brief in Chandler v. Glenmark Pharmaceuticals, No. 21-12618 (11th Cir., filed July 25, 2024) confirming Neal Seth's Wiley Rein affiliation and his representation of Glenmark. PACER itself is paywalled and I did not retrieve it directly, and my search run was truncated before I could pull the Glenmark PHV motions in full or the firms' own attorney bios — so the firm/office attributions for Ward, Summers, Weeks, Weinstein, and Treece are the item most in need of follow-up verification. I have not invented any attorneys or filings.