Veloxis Pharmaceuticals, Inc. v. Sun Pharmaceutical Industries, Inc. et al.
Infringement action filed 19 Jun 2024 in the United States District Court for the District of Delaware and closed 6 Apr 2026, with 8 patents asserted. Recorded basis of termination: consent judgment.
Case record
- Patents involved
- US10864199B2US11419823B2US9549918B2US12083103B2US11123331B2US10166190B2US11110081B2US8685998B2
- Case no.
- 1:24-cv-00726
- Verdict cause
- Infringement action
- Court
- D. Del.
- Court level
- District Court
- Case region
- Delaware
- Chief judge
- Maryellen Noreika
- Trial level
- First instance
- Filed – Closed
- 19 Jun 2024 – 6 Apr 2026
- Duration
- 656 days
- Basis of termination
- Consent Judgment
- Products & marks
- ENVARSUS XR® (tacrolimus)
Check this patent against your own product
Prior art, claim scope, infringement exposure and design-around routes. Every answer cites the records behind it.
Get an FTO claim chart- 01Ranked prior artEvery hit source-linked
- 02Claim-level comparisonAgainst your own product
- 03Legal statusAcross 174 jurisdictions
Tacrolimus for improved treatment of transplant patients
An extended release oral dosage form comprising as active substance tacrolimus or a pharmaceutically active analogue thereof for a once daily immunosuppressive treatment of a patient in need thereof, preferable a kidney or liver transplant patient. The dosage form releases the active substance over an extended period of time. It also provides improved pharmacokinetic parameters due to an extended and constant in vivo release including substantial decreased peak concentrations, despite increased bioavailability, substantial extended times for maximal concentration, and higher minimal concentrations when compared with conventional immediate release dosage forms and a recent modified release tacrolimus dosage form.
- Legal status
- Active
- Granted
- 15 Dec 2020
- Earliest priority
- 30 May 2007
- Est. expiry
- 30 May 2028
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- GORDON, ROBERT D. · HOLM, PER · LADEMANN, ANNE-MARIE · NORLING, TOMAS
- Classification
- A61K31/436A61K9/48A61K9/00A61K47/10A61K9/20A61K9/28A61K9/16
- Prosecution counsel
- Blank Rome LLP
- Examiner
- BAEK, BONG-SOOK
Stabilized tacrolimus composition
The invention relates to a stable pharmaceutical composition comprising comprising a solid dispersion of tacrolimus in a vehicle further comprising a stabilizing agent capable of providing a pH below 7 in the composition, as measured after re-dispersion in water, and preventing or reducing the formation upon storage of major degradation products of tacrolimus, in particular the 8-epitacrolimus.
- Legal status
- Active
- Granted
- 23 Aug 2022
- Earliest priority
- 17 Feb 2010
- Est. expiry
- 30 May 2028
- Validity challenges
- None recorded
- Licences recorded
- None recorded
- Inventors
- SKAK, NIKOLAJ · HOLM, PER
- Classification
- A61K9/20A61K9/14A61K31/436
- Prosecution counsel
- Blank Rome LLP
- Examiner
- STEVENS, MARK V
Also asserted in this case
6 moreThe docket lists 8 asserted patents. Full bibliographic detail, drawings and prosecution history for the remaining 6 asserted patents are one query away in Eureka.
- US9549918B2Stabilized tacrolimus composition
- US12083103B2Tacrolimus for improved treatment of transplant patients
- US11123331B2Tacrolimus for improved treatment of transplant patients
- US10166190B2Stabilized tacrolimus composition
- US11110081B2Tacrolimus for improved treatment of transplant patients
- US8685998B2Tacrolimus for improved treatment of transplant patients
Parties of record
Veloxis Pharmaceuticals, Inc.
- Core tech
- A61K31/436A61K9/48A61K9/00A61K47/10
- Counsel
- Brooke Kootman Dodson · Catherine T. Mattes · Iyah Chen · Jack B. Blumenfeld · James E. Baker · Jeremy A. Tigan · John Galanek · John Yang · Laura L. Fairneny
- Firm
- Morris, Nichols, Arsht & Tunnell LLP
Sun Pharmaceutical Industries, Inc.
- Core tech
- Not recorded
- Counsel
- Brian Sodikoff · Christopher B. Ferenc · Danielle I. Bell · George J. Barry III · Jillian M. Schurr-Hendrix · John Thallemer · Kelly E. Farnan · Michael P. Hogan · R. Touhey Myer · Sara M. Pistilli · Timothy H. Kratz
- Firm
- Kratz & Barry LLP, Richards, Layton & Finger, PA
- Also named
- Sun Pharmaceutical Industries, Inc.
Counsel of record
Basis of termination
From the record · verbatim“Plaintiff Veloxis Pharmaceuticals, Inc. (“Plaintiff”) and Defendant Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, “Defendants”), the parties in the above-captioned action, hereby stipulate and consent to entry of judgment and an injunction in this action as follows: IT IS this 6th day of April 2026: ORDERED, ADJUDGED, AND DECREED as follows: 1. This Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties for purposes of this action only, including as set forth below in Paragraph 6 of this Consent Judgment. 2. As used in this Consent Judgment, the term “Sun ANDA Product” shall mean the tacrolimus drug products manufactured, sold, offered for sale, marketed, or distributed pursuant to Abbreviated New Drug Application No. 215836. 3. As used in this Consent Judgment, the term “Patents-in-Suit” shall mean U.S. Patent Nos. 10,166,190; 11,123,331; and 11,419,823. Case 1:24-cv-00726-MN Document 150 Filed 04/06/26 Page 1 of 3 PageID #: 7066 2 4. Until expiration of the Patents-in-Suit, Defendants, including any of their successors and assigns, are enjoined from infringing the Patents-in-Suit, on their own part or through any third party on their behalf, by making, having made, using, selling, offering to sell, importing, or distributing of the Sun ANDA Product, unless and to the extent otherwise specifically authorized by Veloxis, and are further enjoined from assisting or cooperating with any third parties in connection with any infringement of the Patents-in-Suit by any such third parties, unless and to the extent otherwise specifically authorized by Veloxis. 5. Compliance with this Consent Judgment may be enforced by Veloxis and its respective successors in interest or assigns. 6. All remaining claims, counterclaims, affirmative defenses and demands in this action are hereby dismissed with prejudice and without costs, disbursements or attorneys’ fees to any party. For the avoidance of doubt, this dismissal does not foreclose Sun from raising invalidity or non-infringement defenses in another action relating to the Patents-in-Suit relating to a product other than the Sun ANDA Product. 7. Nothing herein prohibits or is intended to prohibit Defendant from maintaining a “Paragraph IV Certification” pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12) with respect to the Patents-in-Suit. 8. Nothing herein restricts or is intended to restrict the U.S. Food and Drug Administration from approving the Sun ANDA No. 215836 at any time.”
Case 1:24-cv-00726 · D. Del. · closed 6 April 2026
Related cases
Three questions this record usually leads to. Each one runs against the full litigation and patent corpus, and cites what it finds.
Frequently asked questions
What is case 1:24-cv-00726?
1:24-cv-00726 is a patent infringement action brought by Veloxis Pharmaceuticals, Inc. against Sun Pharmaceutical Industries, Inc., filed on 19 Jun 2024 in the United States District Court for the District of Delaware. The case closed on 6 April 2026.
Which patents were asserted in 1:24-cv-00726?
US10864199B2 (“Tacrolimus for improved treatment of transplant patients”), assigned to VELOXIS PHARMACEUTICALS INC., currently active; US11419823B2 (“Stabilized tacrolimus composition”), assigned to VELOXIS PHARMACEUTICALS INC., currently active; US9549918B2 (“Stabilized tacrolimus composition”), assigned to VELOXIS PHARMACEUTICALS INC.; US12083103B2 (“Tacrolimus for improved treatment of transplant patients”), assigned to VELOXIS PHARMACEUTICALS INC.; US11123331B2 (“Tacrolimus for improved treatment of transplant patients”), assigned to VELOXIS PHARMACEUTICALS INC.; US10166190B2 (“Stabilized tacrolimus composition”), assigned to VELOXIS PHARMACEUTICALS INC.; US11110081B2 (“Tacrolimus for improved treatment of transplant patients”), assigned to VELOXIS PHARMACEUTICALS INC.; US8685998B2 (“Tacrolimus for improved treatment of transplant patients”), assigned to VELOXIS PHARMACEUTICALS INC.. The record also lists ENVARSUS XR® (tacrolimus).
How was case 1:24-cv-00726 terminated?
The recorded basis of termination is consent judgment. The termination text reads: “Plaintiff Veloxis Pharmaceuticals, Inc. (“Plaintiff”) and Defendant Sun Pharmaceutical Industries Ltd. and Sun Pharmaceutical Industries, Inc. (collectively, “Defendants”), the parties in the above-captioned action, hereby stipulate and consent to entry of judgment and an injunction in this action as follows: IT IS this 6th day of April 2026: ORDERED, ADJUDGED, AND DECREED as follows: 1. This Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the parties for purposes of this action only, including as set forth below in Paragraph 6 of this Con
What does dismissal with prejudice mean?
A dismissal with prejudice permanently ends the claims that were filed, so the same claims cannot be brought again against that defendant. It is the usual form when the parties have settled.
How long did case 1:24-cv-00726 take?
656 calendar days, from filing on 19 Jun 2024 to closure on 6 April 2026.
Who were the attorneys and the judge in 1:24-cv-00726?
Chief Judge Maryellen Noreika presided. Brooke Kootman Dodson, Catherine T. Mattes, Iyah Chen, Jack B. Blumenfeld, James E. Baker, Jeremy A. Tigan, John Galanek, John Yang and Laura L. Fairneny are recorded as counsel for plaintiff Veloxis Pharmaceuticals. Brian Sodikoff, Christopher B. Ferenc, Danielle I. Bell, George J. Barry III, Jillian M. Schurr-Hendrix, John Thallemer, Kelly E. Farnan, Michael P. Hogan, R. Touhey Myer, Sara M. Pistilli and Timothy H. Kratz appear for defendant Sun Pharmaceutical Industries.
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