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Allergan & AbbVie v. Amneal Pharmaceuticals — LUMIGAN® Bimatoprost Patent | PatSnap
Explore in Eureka
Case ID2:23-cv-06208
FiledAug 2023
ClosedSep 2025
Patent Litigation

Allergan & AbbVie v. Amneal: LUMIGAN® 0.01% Patent Battle Ends in Consent Injunction

Allergan and AbbVie filed suit in the Eastern District of New York against Amneal Pharmaceuticals asserting 12 patents covering bimatoprost ophthalmic solution 0.01% (LUMIGAN®) in response to Amneal’s ANDA 217289. After 759 days, the case closed via a stipulated consent order — blocking Amneal from the U.S. market for the life of the ‘504 Patent.

Resolution time
759days
759 days — above the median ANDA litigation duration before resolution
Patents asserted
12
US7851504B2 and 11 further patents asserted covering bimatoprost ophthalmic formulations
Outcome
Dismissed without Prejudice
Stipulated injunction — ANDA filing deemed infringing; remaining claims dismissed w/o prejudice
Cost ruling
Each Side Bears Own
No costs awarded; parties resolved by mutual stipulation and consent order
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

12-Patent ANDA Battle Over LUMIGAN® Ends in Permanent Market Block

Allergan and AbbVie, Inc. filed suit on August 17, 2023 in the U.S. District Court for the Eastern District of New York against Amneal Pharmaceuticals, Inc., Amneal Pharmaceuticals Private Limited, and Amneal EU, Limited. The complaint asserted 12 U.S. patents covering bimatoprost ophthalmic solution 0.01% — marketed as LUMIGAN® — in direct response to Amneal’s filing of ANDA 217289 seeking FDA approval to market a generic version of the product before patent expiry.

The case resolved on September 11, 2025 via a stipulated consent order entered by the court three days before the formal closure date. The order established that Amneal’s ANDA filing constituted an act of infringement of the ‘504 Patent (US7851504B2) under 35 U.S.C. § 271(e)(2)(A). Amneal is permanently enjoined from manufacturing, using, selling, or importing the ANDA 217289 product in the United States for the life of the ‘504 Patent, including any extensions and pediatric exclusivities — absent a license from Allergan or AbbVie.

At 759 days, the case ran longer than many ANDA matters that settle early, suggesting substantive litigation activity before the parties reached agreement. The stipulation preserves Amneal’s right to challenge the ‘504 Patent in future actions involving different products, and all remaining claims and counterclaims were dismissed without prejudice — leaving the door open to future disputes. The financial terms of any underlying commercial arrangement are not disclosed in the public record.

Case at a glance
Case no.2:23-cv-06208
PlaintiffAllergan
CourtNew York Eastern
JudgeN/A
FiledAugust 17, 2023
ClosedSeptember 14, 2025
Duration759 days
OutcomeDismissed without Prejudice
Verdict causeInfringement Action
BasisDismissed without Prejudice
Prior Art Intelligence
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Case data sourced from PACER / New York Eastern District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Dismissed without Prejudice in 759 days

759 days — above the median ANDA litigation duration before resolution

Case timeline: Complaint filed AUG 17 2023, AUG–SEP — 759 days total Horizontal timeline showing the three key events in Allergan v Amneal Pharmaceuticals, Inc. from filing to resolution. Source: PACER, New York Eastern District Court. AUG 17 2023 Complaint filed Pre-trial proceedings SEP 14 2025 Dismissed without Prejudice 759 DAYS TOTAL
Dismissal terms

Consent injunction entered: what the stipulated order means for both parties

Legal mechanism

ANDA filing deemed infringement under § 271(e)(2)(A)

Under 35 U.S.C. § 271(e)(2)(A), the mere act of filing an ANDA seeking approval to market a patented drug before patent expiry constitutes a defined act of infringement. Here, the stipulated order explicitly adjudicates that Amneal’s filing of ANDA 217289 infringed the ‘504 Patent. This is a negotiated concession — Amneal accepted infringement liability on that patent in exchange for resolution of all remaining claims without prejudice.

§ 271(e)(2)(A) ANDA infringement
Patent holder outcome

Allergan and AbbVie secure market exclusivity for LUMIGAN® 0.01%

Allergan and AbbVie secured a permanent injunction blocking Amneal’s ANDA 217289 product from the U.S. market for the full life of the ‘504 Patent, including extensions and pediatric exclusivities. This effectively preserves LUMIGAN® 0.01% market exclusivity against this particular generic entry. The without-prejudice dismissal of other claims means plaintiffs retain the right to assert remaining patents if Amneal pursues a different generic product or modified ANDA.

Permanent injunction granted
Generic challenger outcome

Amneal blocked from ANDA 217289 product — but future challenges preserved

Amneal is enjoined from commercializing its ANDA 217289 bimatoprost 0.01% product in the United States for the patent term. However, the stipulation was carefully structured: all other claims and defenses are dismissed without prejudice, and the order explicitly preserves Amneal’s right to challenge the ‘504 Patent in future actions involving different products. Amneal and both plaintiffs expressly waived any right to appeal this order.

Market entry blocked; appeal waived
Commercial implications

12-patent fortress signals durable protection for branded ophthalmic drugs

The layering of 12 patents across a single ophthalmic formulation — spanning composition, method, and formulation claims — illustrates the depth of IP protection major pharma companies build around blockbuster ophthalmology products. Generic entrants face compounding litigation risk when each ANDA triggers potential infringement across multiple patent families. The consent injunction outcome, without any disclosed royalty or settlement payment, suggests Amneal calculated the litigation risk as not worth pursuing to trial.

Ophthalmic patent fortress strategy
Legal analysis based on PACER docket records for case 2:23-cv-06208 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAllerganIndividualPharmaceutical patent holder — holder of US7851504B2 and 11 further bimatoprost patentsSearch in Eureka ↗
Co-PlaintiffAbbVie, Inc.CompanySearch in Eureka ↗
DefendantAmneal Pharmaceuticals, Inc.CompanyGeneric pharmaceutical manufacturer that filed ANDA 217289 for bimatoprost ophthalmic solution 0.01%Search in Eureka ↗
Co-DefendantAmneal Pharmaceuticals Private LimitedIndividualSearch in Eureka ↗
Co-DefendantAmneal EU, LimitedIndividualSearch in Eureka ↗
Plaintiff counselAlan Mark VinegradAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselBrianne Bharkhda SullivanAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselChristopher N. SipesAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselDouglas BehrensAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselErica Nicole AndersenAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselJia Hui JiangAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselJustin Warren BurnamAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselKevin Patrick MulryAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselMichael N. KennedyAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselTobias MaAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff law firmCovington & Burling LLPLaw FirmRepresenting AllerganSearch in Eureka ↗
Plaintiff law firmCovington & Burling LLP, Washington DCLaw FirmRepresenting AllerganSearch in Eureka ↗
Defendant counselBen WitteAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselGiancarlo ScacciaAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselJonathan Richard WiseAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselJulie P. BookbinderAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselKathryn AlbaneseAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselMark LeskoAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselRichard PettusAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant counselScott Joseph BornsteinAttorneyCounsel for Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant law firmGreenberg Traurig PALaw FirmRepresenting Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Defendant law firmLaPinta LeskoLaw FirmRepresenting Amneal Pharmaceuticals, Inc.Search in Eureka ↗
Presiding judgeJudge N/AJudgeNew York Eastern District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Accordingly, pursuant to the above Stipulation, and upon the consent and request of Plaintiffs and Amneal, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT: 1. The filing of ANDA 217289 was an act of infringement of the ’504 Patent under 35 U.S.C. § 271(e)(2)(A). 2. All other claims, counterclaims, and defenses asserted by the parties against each other in Plaintiffs’ and Amneal’s pleadings in the Action, including the allegations and averments contained therein are hereby dismissed, without prejudice. 3. Amneal, its officers, agents, servants, employees, and attorneys, and all other persons in active concert or participation with any of them who receive actual notice of this Order by personal service or otherwise, are hereby enjoined from manufacturing, using, offering to sell, or selling within the United States, or importing into the United States, the generic bimatoprost ophthalmic solution (0.01%) product described by ANDA 217289 during the life of Case 2:23-cv-06208-NJC-ST Document 133 Filed 09/11/25 Page 2 of 4 PageID #: 14740 the ’504 Patent including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by Plaintiffs. 4. Plaintiffs and Amneal each expressly waive any right to appeal or otherwise move for relief from this Stipulation And Order. 5. This Court retains jurisdiction over Plaintiffs and Amneal for purposes of enforcing this Stipulation And Order. 6. This Stipulation And Order shall finally resolve the Action between the Parties. 7. This Stipulation And Order is without prejudice to any claim, defense, or counterclaim in any possible future action between Amneal and any of the Plaintiffs regarding the ’504 Patent and a product other than generic bimatoprost ophthalmic solution (0.01%) product described by ANDA 217289.”
Source: PACER Docket, Case 2:23-cv-06208, New York Eastern District Court

The stipulated order is notable for its precision: it adjudicates infringement of the ‘504 Patent (US7851504B2) only, while dismissing all remaining claims without prejudice. This structure protects both parties — Allergan and AbbVie secure an enforceable injunction, while Amneal avoids a broader merits judgment on the other 11 patents. The explicit waiver of appeal rights by both sides signals a fully negotiated resolution with no remaining litigation exposure under the current ANDA. The court retains jurisdiction solely for enforcement purposes.

PACER case 2:23-cv-06208 · Public docket record Explore in Eureka ↗
Patent at issue

US7851504B2 — Bimatoprost ophthalmic solution, the ‘504 Patent anchor

Publication No.US8299118B2
Application No.US13/370529
Patent details
ProductBimatoprost ophthalmic solution formulation
Cited in actionAugust 17, 2023

Publication No.US8772338B2
Application No.US13/827774
Patent details
ProductBimatoprost ophthalmic formulation and composition
Cited in actionAugust 17, 2023

Publication No.US9155716B2
Application No.US13/826047
Patent details
ProductBimatoprost ophthalmic solution methods of use
Cited in actionAugust 17, 2023

Publication No.US8933127B2
Application No.US13/551362
Patent details
ProductBimatoprost ophthalmic solution composition
Cited in actionAugust 17, 2023

Publication No.US8278353B2
Application No.US13/370574
Patent details
ProductBimatoprost low-concentration ophthalmic formulation
Cited in actionAugust 17, 2023

Publication No.US8524777B2
Application No.US13/551379
Patent details
ProductBimatoprost ophthalmic solution preservation system
Cited in actionAugust 17, 2023

Publication No.US8586630B2
Application No.US13/715332
Patent details
ProductBimatoprost ophthalmic formulation variant
Cited in actionAugust 17, 2023

Publication No.US8933120B2
Application No.US14/100914
Patent details
ProductBimatoprost ophthalmic composition and excipients
Cited in actionAugust 17, 2023

Publication No.US9241918B2
Application No.US13/254543
Patent details
ProductBimatoprost ophthalmic prostaglandin analogue formulation
Cited in actionAugust 17, 2023

Publication No.US8309605B2
Application No.US12/965514
Patent details
ProductBimatoprost ophthalmic solution packaging and delivery
Cited in actionAugust 17, 2023

Publication No.US7851504B2
Application No.US11/083261
Patent details
ProductBimatoprost prostaglandin analogue core composition — ‘504 Patent
Cited in actionAugust 17, 2023

Publication No.US8338479B2
Application No.US12/351383
Patent details
ProductBimatoprost ophthalmic formulation method claims
Cited in actionAugust 17, 2023

US7851504B2 — the ‘504 Patent — covers bimatoprost, a prostaglandin analogue used in LUMIGAN® 0.01% ophthalmic solution for reduction of intraocular pressure in glaucoma and ocular hypertension. The patent, filed via application US11/083261, is the anchor of a 12-patent portfolio that collectively protects formulation, composition, and method-of-use aspects of the product. The breadth of the portfolio — spanning application filings from the early 2010s — reflects a layered exclusivity strategy designed to extend effective market protection well beyond any single patent’s expiry.

LUMIGAN® 0.01% is a commercially significant ophthalmology product for Allergan and AbbVie, competing in the crowded but high-value glaucoma treatment segment. The 12-patent portfolio surrounding this single drug product is consistent with innovator pharma strategy of building overlapping IP coverage across formulation variants, concentrations, and delivery methods. Generic challengers must navigate all layers simultaneously, and the adjudicated infringement of the ‘504 Patent — the foundational composition patent — in this consent order signals the central importance of that patent to the portfolio’s defensive value.

Patent data sourced from USPTO via PatSnap Eureka patent database Search patent records in Eureka ↗
Freedom to operate

Should you run an FTO against US7851504B2 and the LUMIGAN® patent portfolio?

Any company developing a bimatoprost ophthalmic solution, prostaglandin analogue eye drop, or formulation targeting intraocular pressure reduction should treat this 12-patent portfolio as a primary FTO priority. The consent order confirms that ANDA 217289 — a product aimed directly at LUMIGAN® 0.01% — was found to infringe the ‘504 Patent. Formulation scientists and regulatory teams should assess not just the ‘504 Patent but all 12 asserted patents before committing to ANDA filing or product development timelines.

PatSnap Eureka’s FTO Search Agent allows R&D and IP teams to map claim scope across all 12 asserted patents simultaneously, identify design-around opportunities, and flag pediatric exclusivity extensions that affect market entry windows. With the ‘504 Patent injunction extending through all extensions and exclusivities, understanding the precise expiry landscape is commercially critical for any generic or biosimilar entrant targeting this product segment.

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Related litigation

Similar ANDA Patent Cases: Ophthalmic Drug Formulation Disputes

Explore comparable ANDA infringement actions in ophthalmic pharmaceutical formulations litigated in U.S. district courts, including multi-patent consent orders and injunctions.

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Allergan patent enforcement history, New York Eastern case history, Allergan’s full IP portfolio, and comparable case analysis
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Strategic implications

What this case signals for the ophthalmic pharmaceutical IP landscape

This consent injunction reinforces how multi-patent portfolios deter generic market entry in high-value ophthalmology drug segments.

Multi-patent ANDA stacking creates compounding litigation risk for generics

Asserting 12 patents against a single ANDA forces generic challengers to invalidate or design around every family simultaneously. Even if a challenger is confident on some patents, the cost and risk of full litigation across a 12-patent portfolio often tips the commercial calculus toward settlement — as this case suggests.

Without-prejudice dismissal preserves future enforcement optionality for plaintiffs

By dismissing all non-‘504 claims without prejudice, Allergan and AbbVie retained the ability to assert the remaining 11 patents if Amneal modifies its formulation or files a new ANDA. This is a standard strategic preservation move in ANDA litigation — innovators avoid giving up IP coverage they may need later.

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Full strategic analysis in PatSnap Eureka
Unlock gated analysis on ophthalmic pharma patent strategy and ANDA litigation trends in E.D.N.Y. district court.
Pediatric exclusivity riskE.D.N.Y. ANDA trendsRemaining 11-patent exposure
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Frequently asked questions

Allergan v Amneal — key questions answered

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PatSnap Eureka

Track bimatoprost patent risk before your next ANDA filing

The 12-patent LUMIGAN® portfolio remains a live enforcement threat for any generic entrant. Use PatSnap Eureka to run FTO searches, monitor patent expiries including pediatric exclusivity windows, and track new ANDA-related litigation in this drug class.

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