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Bausch & Lomb v. Granules India — Lumify® Patent Consent Judgment | PatSnap
Patent Litigation

Bausch & Lomb v. Granules India: Consent Judgment in Lumify® ANDA Patent Dispute

Bausch & Lomb filed suit against Granules India in the District of New Jersey, asserting four patents covering Lumify® brimonidine tartrate 0.025% ophthalmic solution against Granules' ANDA No. 220937. The case resolved by court-entered consent judgment in just 113 days, enjoining Granules from infringing the patents-in-suit until their expiration.

Resolution time
113days
Days from filing to consent judgment — resolved in under four months
Patents asserted
4
US11596600B2, US9259425B2, US11833245B2, and US8293742B2 — Lumify® brimonidine tartrate 0.025% ophthalmic solution
Outcome
Consent Judgment
Agreed by parties, entered by the court, binding and final — injunction in force until patent expiration
Cost ruling
No Costs
Dismissed without costs, disbursements, or attorneys' fees to any party per the consent judgment
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Bausch & Lomb secures injunction against Lumify® generic via consent judgment

Bausch & Lomb, Inc. filed this Hatch-Waxman patent infringement action on December 9, 2025 in the United States District Court for the District of New Jersey, targeting Granules India, Ltd.'s Abbreviated New Drug Application No. 220937, which sought FDA approval for a generic version of Lumify® — brimonidine tartrate 0.025% ophthalmic solution. Bausch & Lomb asserted four patents: US8,293,742; US9,259,425; US11,596,600; and US11,833,245, each directed to the Lumify® product referencing NDA 208144.

The recorded basis of termination is Consent Judgment; the docket order is styled as an 'ORDERED, ADJUDGED, AND DECREED' consent judgment that enjoins Granules India from infringing the four patents-in-suit until their expiration and simultaneously dismisses all claims, counterclaims, and affirmative defenses without prejudice and without costs. The court retained jurisdiction to enforce the consent judgment. The specific commercial terms underlying the parties' agreement are not disclosed in the available record.

Resolution in 113 days is notably swift for a multi-patent Hatch-Waxman action, suggesting the parties reached alignment well before any substantive motion practice or claim construction proceedings. The consent judgment preserves Granules' ability to maintain its Paragraph IV certification and to engage in activities permitted under 35 U.S.C. § 271(e)(1), and does not restrict FDA from approving ANDA No. 220937 — factors that may be commercially significant but whose practical implications are not elaborated in the public record.

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Case at a glance
CourtNew Jersey District Court
JudgeN/A
FiledDecember 9, 2025
ClosedApril 1, 2026
Duration113 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
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Case timeline

Filing to Consent Judgment in 113 days

Days from filing to consent judgment — resolved in under four months

Case timeline: Complaint filed DEC 9 2025 — 113 days total Horizontal timeline showing the three key events in Bausch & Lomb, Inc. v Granules India, Ltd. from filing to resolution. Source: PACER, New Jersey District Court. DEC 9 2025 Complaint filed Pre-trial proceedings APR 1 2026 Consent Judgment 113 DAYS TOTAL
Patent at issue

US11596600B2, US9259425B2, US11833245B2 & US8293742B2 — Lumify® brimonidine tartrate ophthalmic solution

Publication No.US11596600B2
Application No.US17/585395
Patent details
Productbrimonidine tartrate 0.025% ophthalmic solution formulation
Cited in actionDecember 9, 2025

Publication No.US9259425B2
Application No.US14/044929
Patent details
Productbrimonidine tartrate ophthalmic solution compositions and methods
Cited in actionDecember 9, 2025

Publication No.US11833245B2
Application No.US18/103404
Patent details
Productbrimonidine tartrate 0.025% ophthalmic solution — continuation formulation claims
Cited in actionDecember 9, 2025

Publication No.US8293742B2
Application No.US12/460941
Patent details
Productbrimonidine tartrate ophthalmic solution — foundational composition claims
Cited in actionDecember 9, 2025
Technical brief · sourced from PatSnap patent database
Patent figurePatent figure
Representative claim (1 of 1 independent)
1. A method for reducing eye redness in a human subject having ocular hyperemia, comprising topically administering to an eye of said human in need of said reduction of eye redness an ocular drop comprising about 0.025% weight by volume brimonidine as the sole active ingredient, wherein the ocular drop has a pH between 5.5 to 6.5.
Technical background
CROSS REFERENCE TO RELATED APPLICATIONS This application is a continuation of U.S. patent application Ser. No. 17/476,104, filed Sep. 15, 2021, which is a continuation of U.S. patent application Ser. No. 16/179,261 filed Nov. 2, 2018, which is a continuation of U.S. patent application Ser. No. 12/460,967 filed Jul. 27, 2009, which claims priority to U.S. Provisional Application Ser. No. 61/137,714, filed Aug. 1, 2008; 61/192,777 filed Sep. 22, 2008; 61/203,120 filed Dec. 18, 2008, and 61/207,481 filed Feb. 12, 2009…
Patent family
47 family members across 21 jurisdictions (US, IT, SI, EP, CA, JP, CY, WO, NO, DK, ES, AT)
PatSnap Eureka · FTO Search Agent
Should you run an FTO against US11596600B2 and the Lumify® patent family?

Any company developing, filing an ANDA for, or commercialising a brimonidine tartrate ophthalmic solution product — particularly at 0.025% concentration — referencing NDA 208144 should conduct a thorough freedom-to-operate analysis against all four patents. The consent judgment confirms Bausch & Lomb's willingness to enforce these patents swiftly. Generic manufacturers, contract development organisations, and ophthalmic product developers in this space face concrete injunction risk.

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Official verdict

Official order — verbatim text

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 fmth below in Paragraph 6 of this Consent Judgment. 2. As used in this Consent Judgment, the term "Defendant ANDA Product" shall mean a drug product manufactured, impmted, sold, offered for sale, marketed, or disti'ibuted pursuant to Abbreviated New Drug Application No. 220937 in or for the United States of America, including its territories, possessions, and the Commonwealth of Puerto Rico.As used in this Consent Judgment, the term "Patents-in-Suit" shall mean U.S. Patent Nos. 8,293,742, 9,259,425, 11,596,600, and 11,833,245. 4. Until expiration of the Patents-in-Suit, Defendant, including any of its successors and assigns, is enjoined from infringing the Patents-in-Suit, on its own part or through any third party on its behalf, by making, having made, using, selling, offering to sell, impo1iing, or distributing of the Defendant ANDA Product in or for the United States of America, unless and to the extent othe1wise specifically authorized by Plaintiffs, and is further enjoined from assisting or cooperating with any third parties in connection with any infringement of the Patents-in-Suit by any such third patiies in connection with making, having made, using, selling, offering to sell, importing, or distributing of any brimonidine tartrate 0.025% ophthalmic solution that references NDA208144 in or for the United States of America, unless and to the extent otherwise specifically authorized by Plaintiffs. 5. Compliance with this Consent Judgment may be enforced by Plaintiffs and their respective successors in interest or assigns. 6. This Court retains jurisdiction to enforce the terms of this Consent Judgment and to enforce and resolve any disputes related thereto. 7. All claims, counterclaims, affirmative defenses, motions and petitions asserted in this Action are hereby dismissed without prejudice and without costs, disbursements or attorneys' fees to any patiy. 8. Nothing herein prohibits or is intended to prohibit Defendant from maintaining any "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.Nothing herein prohibits or is intended to prohibit Defendant from engaging in any activity permitted under 35 U.S.C. § 271(e)(l). 10. Nothing herein restricts or is intended to restrict the U.S. Food and Dmg Administration from approving Abbreviated New Drug Application No. 220937 or the ANDA Product.
Source: PACER Docket, Case 3:25-cv-18325, New Jersey District Court

The consent judgment is a court-entered order with full injunctive force, not merely a private settlement. It enjoins Granules India from any commercial activity with its ANDA product until all four patents expire, while simultaneously preserving Granules' Paragraph IV certification and § 271(e)(1) safe harbor rights. The dismissal of all claims without prejudice means no merits findings were made on infringement or validity; the specific terms that induced the consent are not disclosed in the available record.

PACER case 3:25-cv-18325 · Public docket record Explore in Eureka ↗
Judgment terms

Consent judgment: what the agreed resolution means for both parties

Legal mechanism

What a consent judgment means in a Hatch-Waxman case

A consent judgment is a binding, court-entered judgment that reflects terms agreed upon by the parties, ending the litigation with the full force of a judicial order. Unlike a settlement agreement that merely dismisses claims, a consent judgment is enforceable by the court itself. Here, the court explicitly retained jurisdiction to enforce the terms. All claims were dismissed without prejudice and without costs.

Court-entered, binding injunction
Patent holder outcome

Bausch & Lomb obtains injunction protecting all four Lumify® patents

Under the consent judgment, Granules India is enjoined from infringing US8,293,742, US9,259,425, US11,596,600, and US11,833,245 until those patents expire. This bars Granules from making, selling, offering to sell, importing, or distributing its ANDA product in the United States, effectively protecting Lumify®'s market position. Enforcement rights extend to Bausch & Lomb's successors and assigns.

Injunction until patent expiration
Defendant outcome

Granules India retains Paragraph IV rights and § 271(e)(1) carve-out

While enjoined from commercial launch, the consent judgment expressly preserves Granules India's ability to maintain its Paragraph IV certification against the patents-in-suit and to engage in activities permitted under 35 U.S.C. § 271(e)(1) (the safe harbor for pre-approval activities). FDA approval of ANDA No. 220937 is also explicitly not restricted. The specific commercial terms underlying these carve-outs are not disclosed in the available record.

Para. IV & safe harbor preserved
Commercial implications

Lumify® brand protection reinforced across full patent term

The consent judgment signals that the Lumify® patent estate — four issued U.S. patents covering brimonidine tartrate 0.025% ophthalmic solution — presented a sufficiently robust barrier to deter early generic entry by Granules India. Other ANDA filers referencing NDA 208144 will likely face the same four asserted patents. The speed of resolution (113 days) is consistent with parties reaching a negotiated position without extensive validity or infringement litigation.

Generic entry deferred
Legal analysis based on PACER docket records for case 3:25-cv-18325 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBausch & Lomb, Inc.Company/Search in Eureka ↗
DefendantGranules India, Ltd.Company/Search in Eureka ↗
Plaintiff counselJ. BRUGH LOWERAttorneyCounsel for Bausch & Lomb, Inc.Search in Eureka ↗
Plaintiff counselWilliam P. Deni , Jr.AttorneyCounsel for Bausch & Lomb, Inc.Search in Eureka ↗
Plaintiff law firmFBT GIBBONS LLPLaw FirmRepresenting Bausch & Lomb, Inc.Search in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting Bausch & Lomb, Inc.Search in Eureka ↗
Defendant counselDmitry V. ShelhoffAttorneyCounsel for Granules India, Ltd.Search in Eureka ↗
Defendant counselKENNETH CANFIELDAttorneyCounsel for Granules India, Ltd.Search in Eureka ↗
Defendant law firmSHELHOFF CANFIELD & CHIN LLCLaw FirmRepresenting Granules India, Ltd.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew Jersey District CourtSearch in Eureka ↗
R&D signals

R&D signals in the ophthalmic redness-relief patent space

Forward-looking patent and R&D intelligence on Bausch & Lomb's Lumify® portfolio and the broader brimonidine tartrate ophthalmic solution landscape.

Patent portfolio

Bausch & Lomb's continuation filing activity around Lumify®

The four asserted patents span applications from US12/460941 to US18/103404, consistent with an active continuation strategy. Monitoring Bausch & Lomb's pending applications in this family can signal when additional patent barriers may emerge for ANDA filers and highlight the breadth of claim scope being pursued around brimonidine tartrate 0.025% formulations.

Continuation family watch
Technology landscape

Patent filing trends in low-concentration alpha-agonist ophthalmic drops

Brimonidine tartrate at sub-0.1% concentrations for redness relief represents a distinct formulation niche. Tracking patent filings in this space — including excipient combinations, preservative systems, and pH optimisation — can reveal competitor innovation trajectories and potential white space for next-generation ophthalmic redness-relief formulations.

Alpha-agonist ophthalmic IP
Competitor IP posture

Granules India's ophthalmic IP development and ANDA pipeline

Granules India's filing of ANDA No. 220937 signals a strategic interest in the ophthalmic OTC market. Reviewing Granules India's broader patent portfolio and any R&D filings in ophthalmic formulations can indicate whether they are developing proprietary alternatives or pursuing additional ANDA strategies in adjacent ophthalmic product categories.

Generic ophthalmic pipeline
White space

Adjacent R&D opportunities in OTC ophthalmic redness relief

The strong patent estate around brimonidine tartrate 0.025% may push innovation toward alternative active ingredients, novel delivery systems (e.g. sustained-release drops, gels), or combination formulations for redness relief. Patent landscape analysis around alpha-adrenergic agonists, vasoconstrictor alternatives, and preservative-free ophthalmic technologies could surface design-around or first-mover opportunities.

OTC ophthalmic innovation
Related litigation

Similar Hatch-Waxman ophthalmic patent cases in the District of New Jersey

Explore comparable ANDA patent infringement actions involving ophthalmic pharmaceutical products litigated in the District of New Jersey, including other Bausch & Lomb enforcement actions.

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Bausch & Lomb, Inc. patent enforcement history, New Jersey District Court case history, Bausch & Lomb, Inc.'s full IP portfolio, and comparable case analysis
Bausch & Lomb ANDA casesNJ ophthalmic patent suitsBrimonidine patent litigationHatch-Waxman consent judgments
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Strategic implications

What this case signals for the ophthalmic pharmaceutical IP landscape

A swift consent judgment against a Lumify® ANDA filer reinforces the depth of Bausch & Lomb's patent estate and the enforcement posture it is willing to take.

Four-patent assertion strategy raises the bar for Lumify® ANDA challengers

Asserting all four patents simultaneously in a single Hatch-Waxman suit — and reaching a consent judgment in under four months — suggests Bausch & Lomb's patent portfolio around brimonidine tartrate 0.025% is sufficiently layered to discourage protracted ANDA litigation. Companies with pending or planned ANDAs referencing NDA 208144 should map their exposure across all four patents before filing.

Paragraph IV carve-out leaves the door open for future generic challenge

The consent judgment expressly preserves Granules India's Paragraph IV certification. This means the current injunction does not foreclose a future challenge to the patents' validity or non-infringement if circumstances change. Competitors and Bausch & Lomb alike should track any inter partes review filings or subsequent ANDA activity referencing these four patents.

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Patent expiration timelineOrange Book listing riskIPR vulnerability map
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Frequently asked questions

Bausch v Granules — key questions answered

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PatSnap Eureka

Track Lumify® patent enforcement and ANDA activity in real time

Monitor new ANDA filings against NDA 208144, continuation patent grants in the Lumify® family, and competitor ophthalmic formulation IP with PatSnap Eureka. Run an FTO before committing to any brimonidine tartrate 0.025% development programme.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

Nothing on this page constitutes legal advice or a legal opinion on the validity, infringement, enforceability, or scope of any patent or case, and no attorney‑client relationship is created by its use. Any description of an outcome (such as a dismissal, settlement, or consent judgment) is a general summary, not a legal determination. All patents, trademarks, and company or law‑firm names are the property of their respective owners. PatSnap makes no warranty as to the accuracy or completeness of this content and disclaims, to the fullest extent permitted by law, all liability for reliance on it. For advice on a specific matter, consult qualified legal counsel.

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