Bausch & Lomb v. Sandoz: Loteprednol Gel Patents Dismissed Without Prejudice
Bausch & Lomb sued Sandoz in the District of New Jersey over two patents covering a loteprednol etabonate ophthalmic gel 0.38% formulation, targeting Sandoz's proposed generic product. The parties stipulated to dismissal without prejudice under Rules 41(a)(1) and 41(c) after 400 days, with the court retaining jurisdiction to enforce any underlying agreement.
ANDA patent dispute over generic loteprednol gel ends in stipulated dismissal
On February 11, 2025, Bausch & Lomb, Inc. filed suit against Sandoz, Inc. in the U.S. District Court for the District of New Jersey, asserting infringement of two patents — US11534395B2 and US10596107B2 — directed to loteprednol etabonate ophthalmic gel formulations. The accused product is Sandoz's proposed generic loteprednol etabonate gel, 0.38%, consistent with the framework of an ANDA-related pharmaceutical patent dispute.
The recorded basis of termination is dismissal without prejudice. The docket order states that the parties stipulated under Federal Rules of Civil Procedure 41(a)(1) and 41(c) to dismiss all claims, counterclaims, and affirmative defenses without prejudice and without costs, disbursements, or attorneys' fees to either party. The stipulation further provides that the District of New Jersey retains jurisdiction to enforce and resolve disputes arising under a referenced Agreement, though the specific terms of that Agreement are not disclosed in the available record.
The case closed approximately 400 days after filing, suggesting resolution before any substantive merits rulings such as claim construction or summary judgment. The court's retained jurisdiction clause indicates the parties entered into some form of collateral arrangement, but its content is not public. What drove the parties to this resolution — and whether the underlying patents remain enforceable against Sandoz's product — cannot be determined from the available record.
See Complete Case & Patent Analysis →Filing to Dismissed without Prejudice in 400 days
400 days from filing to dismissal in D.N.J. — consistent with early resolution before claim construction
US11534395B2 & US10596107B2 — Loteprednol Etabonate Ophthalmic Gel
Any company developing or seeking regulatory approval for a loteprednol etabonate ophthalmic gel formulation — particularly at or near the 0.38% concentration — should treat these two patents as active enforcement risk. Neither was found invalid or not infringed in this proceeding. The without-prejudice dismissal means Bausch & Lomb retains full ability to assert them in future actions, and the broader continuation family may include additional claims not yet asserted.
Official order — verbatim text
The stipulated dismissal order expressly preserves both parties' positions — no claims are adjudicated on the merits, no costs are assigned, and all counterclaims and affirmative defenses are equally extinguished without prejudice. The court's retained jurisdiction to enforce 'the Agreement' is the operative signal: it suggests the dismissal is not a clean walk-away but is tied to a binding arrangement whose terms are not disclosed in the available record.
Dismissed without prejudice: what the stipulated resolution means for both parties
Dismissal without prejudice under Rule 41 — door stays open
A dismissal without prejudice does not adjudicate the merits of infringement or validity. Either party may theoretically re-litigate the same claims in a future action. The stipulation was entered under Rules 41(a)(1) and 41(c), covering both claims and counterclaims. The court's retained jurisdiction to enforce a referenced underlying Agreement suggests the dismissal is tied to a collateral arrangement, though its terms are not in the public record.
No merits adjudicationBausch & Lomb preserves the right to refile on both patents
Because the dismissal is without prejudice, Bausch & Lomb retains the ability to reassert US11534395B2 and US10596107B2 against Sandoz in future proceedings if circumstances warrant — for example, if Sandoz were to launch a generic product. The patents are not adjudicated invalid or not infringed. The specific terms of any agreement between the parties are not disclosed in the available record.
Patents remain liveSandoz avoids adverse judgment but faces ongoing patent risk
Sandoz secured dismissal without a finding of infringement, and no costs or fees were assessed against it. However, because the dismissal is without prejudice, Sandoz's proposed generic loteprednol etabonate gel 0.38% could face renewed patent challenge if it proceeds toward commercial launch. The retained-jurisdiction clause suggests a broader arrangement may govern the parties' near-term rights, but those terms are not publicly available.
No infringement findingGeneric loteprednol entry timeline remains uncertain
The without-prejudice dismissal leaves the competitive landscape for loteprednol etabonate gel 0.38% unresolved on the merits. Other generic applicants targeting this formulation should monitor whether Bausch & Lomb refiles or whether Sandoz proceeds to market. The retained-jurisdiction clause is typically consistent with an underlying commercial or licensing arrangement, but the specific terms are not disclosed in the available record.
Market entry unresolvedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bausch & Lomb, Inc. | Company | /Search in Eureka ↗ |
| Defendant | Sandoz, Inc. | Company | /Search in Eureka ↗ |
| Plaintiff counsel | J. BRUGH LOWER | Attorney | Counsel for Bausch & Lomb, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Stephen R. Donat | Attorney | Counsel for Bausch & Lomb, Inc.Search in Eureka ↗ |
| Plaintiff counsel | William P. Deni , Jr. | Attorney | Counsel for Bausch & Lomb, Inc.Search in Eureka ↗ |
| Plaintiff law firm | FBT GIBBONS LLP | Law Firm | Representing Bausch & Lomb, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Gibbons PC | Law Firm | Representing Bausch & Lomb, Inc.Search in Eureka ↗ |
| Defendant counsel | Eric I. Abraham | Attorney | Counsel for Sandoz, Inc.Search in Eureka ↗ |
| Defendant counsel | Kristine L. Butler | 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 ↗ |
R&D signals in the ophthalmic formulation patent space
Forward-looking patent and innovation intelligence derived from Bausch & Lomb's and Sandoz's positions in the loteprednol etabonate and ophthalmic gel formulation landscape.
Bausch & Lomb's ophthalmic formulation filing activity
US11534395B2 and US10596107B2 sit within a broader Bausch & Lomb ophthalmic formulation portfolio. Tracking continuation filings and related application families around these patents can reveal where the company is extending its IP perimeter — particularly in gel-based corticosteroid delivery systems that could affect competitive freedom to operate in the ophthalmic space.
Portfolio mappingFiling trends in ophthalmic corticosteroid gel formulations
Loteprednol etabonate gel technology sits at the intersection of ophthalmic drug delivery and corticosteroid formulation chemistry. Tracking recent PCT and US applications in this space — covering excipient systems, viscosity enhancers, and preservative-free gel platforms — can identify where innovation is concentrating and which incumbents are building defensive positions around 0.38% and adjacent concentrations.
Filing trend analysisSandoz's patent activity in ophthalmic generics
As a major generic pharmaceutical manufacturer, Sandoz's own patent filings in ophthalmic drug delivery and formulation may signal where it is building IP to support future ANDA-independent product launches or differentiated generics. Monitoring Sandoz's application activity in the ophthalmic gel space can provide early signals of their R&D pipeline priorities beyond the loteprednol etabonate challenge.
Generic competitor signalsAdjacent claim space around loteprednol etabonate delivery
Beyond the specific gel formulation covered by the asserted patents, adjacent technologies — including preservative-free loteprednol systems, alternative polymer matrices, nanoemulsion platforms, and combination ophthalmic products — may represent white-space for R&D investment. A freedom-to-operate and landscape analysis can identify gaps where neither Bausch & Lomb nor current competitors hold blocking positions.
Innovation white spaceSimilar ANDA patent cases involving ophthalmic formulations in D.N.J.
Explore related patent infringement actions involving ophthalmic pharmaceutical formulations and ANDA challenges litigated in the District of New Jersey.
What this case signals for the ophthalmic generic drug IP landscape
Early without-prejudice dismissals in ANDA patent cases often reflect commercial resolution rather than technical defeat — but leave enforcement risk intact.
Retained court jurisdiction signals a collateral agreement between the parties
When a stipulated dismissal explicitly preserves court jurisdiction to enforce 'the Agreement,' it consistently signals that a binding commercial or licensing arrangement was reached alongside the dismissal. Patent counsel and generic entrants monitoring this space should treat the loteprednol etabonate gel market as subject to private constraints not visible in the public docket.
Both asserted patents remain in force — Bausch & Lomb can refile
US11534395B2 and US10596107B2 were not found invalid or not infringed. Any company pursuing a competing loteprednol etabonate ophthalmic gel formulation should conduct a fresh FTO analysis against both patents before advancing development or seeking regulatory approval, as neither patent has been adjudicated away.
Bausch v Sandoz — key questions answered
Bausch & Lomb asserted two patents: US11534395B2 (App. No. 16/826,366) and US10596107B2 (App. No. 15/006,525), both directed to loteprednol etabonate ophthalmic gel formulations. The accused product was Sandoz's proposed generic loteprednol etabonate gel, 0.38%.
The case was dismissed without prejudice by stipulation under Federal Rules of Civil Procedure 41(a)(1) and 41(c). All claims, counterclaims, and affirmative defenses were dismissed without costs or fees to either party. The court retained jurisdiction to enforce any disputes arising under a referenced Agreement. The case closed approximately 400 days after filing.
The dismissal without prejudice means no court ruled on infringement or validity. It does not confer any right for Sandoz to market its product, nor does it extinguish Bausch & Lomb's ability to refile. The commercial status of Sandoz's proposed generic product depends on FDA approval and the terms of any underlying agreement between the parties, which are not disclosed in the public record.
The stipulation states that the District of New Jersey retains jurisdiction to enforce and resolve disputes arising under 'the Agreement.' This clause is consistent with the parties having entered a collateral commercial or licensing arrangement. The specific terms of that arrangement are not disclosed in the available record. Retained jurisdiction allows either party to return to the same court to enforce the deal without filing a new action.
Yes. A dismissal without prejudice does not affect the validity or enforceability of the asserted patents. Neither US11534395B2 nor US10596107B2 was found invalid or not infringed. Both remain active issued patents and could be asserted in future proceedings against Sandoz or any other party, subject to applicable statutory limitations.
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