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.
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.
See Complete Case & Patent Analysis →Filing to Consent Judgment in 113 days
Days from filing to consent judgment — resolved in under four months
US11596600B2, US9259425B2, US11833245B2 & US8293742B2 — Lumify® brimonidine tartrate ophthalmic solution


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.
Official order — verbatim text
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.
Consent judgment: what the agreed resolution means for both parties
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 injunctionBausch & 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 expirationGranules 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 preservedLumify® 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 deferredFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bausch & Lomb, Inc. | Company | /Search in Eureka ↗ |
| Defendant | Granules India, Ltd. | Company | /Search in Eureka ↗ |
| Plaintiff counsel | J. BRUGH LOWER | 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 | Dmitry V. Shelhoff | Attorney | Counsel for Granules India, Ltd.Search in Eureka ↗ |
| Defendant counsel | KENNETH CANFIELD | Attorney | Counsel for Granules India, Ltd.Search in Eureka ↗ |
| Defendant law firm | SHELHOFF CANFIELD & CHIN LLC | Law Firm | Representing Granules India, Ltd.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
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.
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 watchPatent 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 IPGranules 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 pipelineAdjacent 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 innovationSimilar 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.
Related patent case — similar technology
Comparable case in the same technology domain. Patent holder and defendant reached resolution after proceedings.
SettledRelated infringement action — same court
Comparable Lumify® Brimonidine tartrate 0.025% ophthalmic solution-adjacent infringement action. Patent enforcement dynamics analysed in depth.
Active · District CourtRelated invalidity challenge — appellate outcome
Combined invalidity and infringement action in the same technology space. Decided after substantive proceedings.
DecidedBausch & Lomb, Inc.'s broader IP enforcement history
Bausch & Lomb, Inc.'s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat 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.
NDA 208144 patent wall: expiration timeline shapes generic entry window
Understanding the expiration dates of US8,293,742, US9,259,425, US11,596,600, and US11,833,245 is critical for timing a viable generic entry strategy. The newest patent (US11,833,245) filed under application US18/103404 likely sets the outer boundary. Any ANDA strategy must account for potential patent term extensions and pediatric exclusivity on NDA 208144.
Bausch & Lomb's ophthalmic portfolio signals continued enforcement appetite
This case is consistent with an active Hatch-Waxman enforcement posture across Bausch & Lomb's ophthalmic franchise. R&D teams and IP counsel benchmarking the redness-relief eye drop space should monitor Bausch & Lomb's continuation filings and any new patent listings in the FDA Orange Book for NDA 208144 as potential future barriers.
Bausch v Granules — key questions answered
Bausch & Lomb asserted four patents: US8,293,742, US9,259,425, US11,596,600, and US11,833,245, collectively referred to in the consent judgment as the 'Patents-in-Suit.' All four cover Lumify® brimonidine tartrate 0.025% ophthalmic solution referenced under NDA 208144.
The case was resolved by a court-entered consent judgment on April 1, 2026, 113 days after filing. Granules India is enjoined from infringing the four patents-in-suit until expiration. All claims were dismissed without prejudice and without costs. The specific commercial terms underlying the agreement are not disclosed in the available record.
Under the consent judgment, Granules India is enjoined from commercial activity with its ANDA product (ANDA No. 220937) until the patents-in-suit expire. However, the judgment expressly preserves Granules' Paragraph IV certification and its right to conduct activities under 35 U.S.C. § 271(e)(1), and does not restrict FDA from approving the ANDA.
A dismissal without prejudice means no merits findings were made on infringement or validity — neither party received a judicial ruling on the substantive issues. The injunction arises from the court-entered consent judgment itself, not from a finding of infringement. The without-prejudice dismissal of claims is consistent with Granules preserving its Paragraph IV rights.
The 113-day resolution is notably swift for a four-patent Hatch-Waxman action. The public record does not disclose the commercial terms or negotiations that led to the consent judgment. The speed is consistent with parties reaching a negotiated position early — before substantive motion practice or claim construction — but the specific factors driving rapid resolution are not disclosed in the available record.
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.
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