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Allergan v. Mankind Pharma — Bimatoprost Patent Litigation | PatSnap
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Case ID1:23-cv-00272
FiledMar 2023
ClosedOct 2024
Patent Litigation

Allergan v. Mankind Pharma: Bimatoprost Patent Consent Injunction After 596 Days

Allergan and AbbVie filed a Hatch-Waxman infringement action against Mankind Pharma in Delaware over US7851504, protecting LUMIGAN® 0.01% bimatoprost ophthalmic solution. Mankind ultimately admitted the patent was valid, enforceable, and infringed, resulting in a consent injunction blocking generic entry for the life of the patent — a decisive outcome for the brand holder.

Resolution time
596days
596 days to resolution — typical Hatch-Waxman ANDA cases in Delaware average 2–4 years; this resolved within roughly two years via stipulation
Patents asserted
1
US7851504B2 — LUMIGAN® 0.01% bimatoprost ophthalmic solution, prostaglandin analogue glaucoma treatment
Outcome
Dismissed without Prejudice
Remaining claims dismissed without prejudice; infringement admitted by consent and permanent injunction entered by court order
Cost ruling
Costs Not Specified
Stipulation and Order silent on attorneys’ fees and costs; each party likely bears its own expenses
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Consent Injunction Locks Mankind Out of US Bimatoprost Market

On 13 March 2023, Allergan, Inc. and AbbVie Inc. filed a patent infringement action in the District of Delaware against Mankind Pharma Ltd., an Indian generics manufacturer. The suit arose from Mankind’s submission of Abbreviated New Drug Application (ANDA) 218196 to the FDA, which carried a Paragraph IV certification challenging US7851504B2 — the patent underpinning LUMIGAN® 0.01%, Allergan’s prostaglandin analogue eye-drop therapy indicated for intraocular pressure reduction in glaucoma and ocular hypertension.

The case closed on 29 October 2024 via a court-entered Stipulation and Order. Mankind admitted that the ‘504 patent is valid, enforceable, and that one or more claims would be infringed by commercial manufacture, use, or sale of its proposed generic product. The court formally decreed that ANDA 218196’s filing constituted a technical act of infringement under 35 U.S.C. § 271(e)(2)(A), and issued a permanent injunction barring Mankind from commercialising the generic product in the United States for the full life of the patent, including extensions and paediatric exclusivities.

Resolution after 596 days — without a full trial — suggests the parties likely concluded that the patent’s validity and infringement positions were difficult to contest, consistent with a strategic decision by Mankind to avoid costly litigation. The dismissal without prejudice of remaining claims preserves Mankind’s ability to re-litigate in future actions involving different products, but the injunction itself is binding and enforceable. The public record does not disclose whether any licensing discussions occurred in parallel or whether commercial supply terms were negotiated privately.

Case at a glance
Case no.1:23-cv-00272
PlaintiffAllergan
CourtDelaware
JudgeJohn F. Murphy
FiledMarch 13, 2023
ClosedOctober 29, 2024
Duration596 days
OutcomeDismissed without Prejudice
Verdict causeInfringement Action
BasisDismissed without Prejudice
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Dismissed without Prejudice in 596 days

596 days to resolution — typical Hatch-Waxman ANDA cases in Delaware average 2–4 years; this resolved within roughly two years via stipulation

Case timeline: Complaint filed MAR 13 2023, JAN–FEB — 596 days total Horizontal timeline showing the three key events in Allergan v Mankind Pharma, Ltd. from filing to resolution. Source: PACER, Delaware District Court. MAR 13 2023 Complaint filed Pre-trial proceedings OCT 29 2024 Dismissed without Prejudice 596 DAYS TOTAL
Dismissal terms

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

Legal mechanism

Stipulated infringement admission and consent injunction

Rather than proceeding to trial, the parties entered a court-endorsed Stipulation and Order. Mankind formally admitted patent validity, enforceability, and that commercial launch would infringe. The court then entered a permanent injunction under the same order. This mechanism is common in Hatch-Waxman litigation when a generic filer concludes that its invalidity and non-infringement defences are unlikely to succeed — it avoids trial costs while producing a binding, court-enforceable outcome.

Hatch-Waxman consent order
Patent holder outcome

Allergan secures injunction for full patent life including extensions

The consent order delivers Allergan and AbbVie the strongest available remedy short of a trial win: a permanent injunction blocking Mankind from manufacturing, selling, or importing its generic bimatoprost 0.01% product in the United States for the entire remaining life of US7851504, including any patent term extensions and paediatric exclusivities. Mankind’s admission of validity also strengthens the patent’s standing against future ANDA challengers, though it is expressly limited to this specific product and ANDA.

Permanent injunction secured
Challenger outcome

Mankind blocked from US generic launch; Paragraph IV cert may be retained

Mankind is enjoined from commercialising its bimatoprost 0.01% ANDA product in the United States for the life of the ‘504 patent. Notably, the order expressly permits Mankind to maintain its Paragraph IV certification in ANDA 218196 for purposes of receiving or maintaining final FDA approval — meaning the ANDA itself is not abandoned. Both parties waived appeal rights, foreclosing further challenge. The dismissal without prejudice of other claims preserves Mankind’s theoretical ability to litigate different products in future.

Enjoined; appeal waived
Commercial implications

Bimatoprost 0.01% generic entry delayed; market exclusivity reinforced

The consent injunction reinforces Allergan’s commercial exclusivity over the LUMIGAN® 0.01% formulation in the US market for the remaining patent term. Other ANDA filers targeting the same product will now face a judicial record in which one challenger has admitted validity and infringement — a development that may influence settlement posture or litigation strategy in any parallel ANDA proceedings. Companies developing ophthalmic prostaglandin generics should closely monitor the ‘504 patent’s expiry date and any term extension filings.

Generic entry blocked
Legal analysis based on PACER docket records for case 1:23-cv-00272 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAllerganIndividualOphthalmic pharmaceuticals company — holder of US7851504B2 covering LUMIGAN® 0.01%Search in Eureka ↗
DefendantMankind Pharma, Ltd.CompanyIndian generics manufacturer seeking US market entry via ANDA 218196 for bimatoprost 0.01%Search in Eureka ↗
Plaintiff counselAlex M. GrabowskiAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselAngela WhitesellAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselBrian A. BiggsAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselBrianne BharkhdaAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselCatherine HuangAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselChristopher N. SipesAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselDavid P. FrazierAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselDouglas A. BehrensAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselEllen A. ScordinoAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselErica N. AndersenAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselFerlillia V. RobersonAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselHenry R. FildesAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselJack B. BlumenfeldAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselJeremy A. TiganAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselJia Hui JiangAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselMichael A. MorinAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselMichael A. SitzmanAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselMichael N. KennedyAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselRebecca L. RabensteinAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselStephanie M. PiperAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselSusan KrumplitschAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff counselYi SunAttorneyCounsel for AllerganSearch in Eureka ↗
Plaintiff law firmDLA Piper LLPLaw FirmRepresenting AllerganSearch in Eureka ↗
Plaintiff law firmDLA Piper LLP (US)Law FirmRepresenting AllerganSearch in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting AllerganSearch in Eureka ↗
Defendant counselAlan H. PollackAttorneyCounsel for Mankind Pharma, Ltd.Search in Eureka ↗
Defendant counselAndrew J. MillerAttorneyCounsel for Mankind Pharma, Ltd.Search in Eureka ↗
Defendant counselDaniel TaylorAttorneyCounsel for Mankind Pharma, Ltd.Search in Eureka ↗
Defendant counselJason A. LiefAttorneyCounsel for Mankind Pharma, Ltd.Search in Eureka ↗
Defendant counselJoanna G. GoldsteinAttorneyCounsel for Mankind Pharma, Ltd.Search in Eureka ↗
Defendant counselKiersten A. FowlerAttorneyCounsel for Mankind Pharma, Ltd.Search in Eureka ↗
Defendant counselNeal C. BelgamAttorneyCounsel for Mankind Pharma, Ltd.Search in Eureka ↗
Defendant law firmSmith, Katzenstein & Jenkins LLPLaw FirmRepresenting Mankind Pharma, Ltd.Search in Eureka ↗
Presiding judgeJudge John F. MurphyJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“The Court, upon the consent and request of Plaintiffs Allergan, Inc. and AbbVie Inc. (collectively, “Plaintiffs”) and Defendant Mankind Pharma Ltd. (“Mankind”), hereby acknowledges the following Stipulation and issues the following Order in the above-captioned action. STIPULATION 1. This Court has subject matter jurisdiction over this patent infringement action (the “Action”) and personal jurisdiction over Plaintiffs and Mankind for purposes of the Action. 2. Venue is proper in this Court as to Plaintiffs and Mankind for the Action. 3. Plaintiffs have asserted claims against Mankind for infringement of U.S. Patent No. 7,581,504 (the “’504 Patent”) in connection with Mankind’s submission of Abbreviated New Drug Application (“ANDA”) 218196 directed to generic bimatoprost ophthalmic solution (0.01%) product to the U.S. Food and Drug Administration (“FDA”). 4. Mankind admits in this Action that the ’504 Patent is enforceable, valid, and one or more claims thereof would be infringed by the commercial manufacture, use, and/or sale Case 1:23-cv-00272-JFM Document 135 Filed 10/29/24 Page 1 of 4 PageID #: 1852 2 within the United States of the generic bimatoprost ophthalmic solution (0.01%) product that is the subject of Mankind’s ANDA 218196. 5. Mankind admits that the submission of ANDA 218196 to the FDA containing a Paragraph IV certification for purposes of obtaining regulatory approval to engage in the commercial manufacture, use, and/or sale within the United States of generic bimatoprost ophthalmic solution (0.01%) was a technical act of infringement of the ’504 Patent under 35 U.S.C. § 271(e)(2)(A). 6. The parties agree that all other claims, counterclaims, and defenses asserted against each other in Plaintiffs’ and Mankind’s pleadings in the Action, including the allegations and averments contained therein, should be dismissed, without prejudice. 7. Nothing herein prohibits Mankind from maintaining a Paragraph IV certification to the ’504 Patent in Mankind’s ANDA 218196 for the purposes of receiving or maintaining final approval of Mankind’s ANDA 218196. ORDER Accordingly, pursuant to the above Stipulation, and upon the consent and request of Plaintiffs and Mankind, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT: 1. The filing of ANDA 218196 was a technical 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 Mankind’s pleadings in the Action, including the allegations and averments contained therein are hereby dismissed, without prejudice. 3. Mankind, 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 Case 1:23-cv-00272-JFM Document 135 Filed 10/29/24 Page 2 of 4 PageID #: 1853 3 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 218196 during the life of the ’504 Patent, including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by Plaintiffs. 4. Plaintiffs and Mankind 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 Mankind 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 Mankind and any of the Plaintiffs regarding the ’504 Patent and a product other than generic bimatoprost ophthalmic solution (0.01%) product described by ANDA 218196. 8. The Clerk of the Court is directed to enter this Stipulation And Order forthwith in the Action.”
Source: PACER Docket, Case 1:23-cv-00272, Delaware District Court

The Stipulation and Order is unusually explicit for a consent resolution: Mankind’s admission of validity, enforceability, and infringement is on the public record, not merely implied by settlement. The court’s decree under 35 U.S.C. § 271(e)(2)(A) confirms the Hatch-Waxman technical infringement trigger, while the permanent injunction language — covering manufacture, use, offer to sell, sale, and importation — mirrors the full scope of § 271(a) relief. The without-prejudice dismissal of remaining claims limits res judicata to the specific product and ANDA at issue.

PACER case 1:23-cv-00272 · Public docket record Explore in Eureka ↗
Patent at issue

US7851504B2 — Bimatoprost Ophthalmic Solution 0.01% (LUMIGAN®)

Publication No.US7851504B2
Application No.US11/083261
Patent details
ProductBimatoprost ophthalmic solution 0.01% formulation for glaucoma and ocular hypertension treatment
Cited in actionMarch 13, 2023

US7851504B2 protects a formulation of bimatoprost ophthalmic solution at a 0.01% concentration — the active ingredient in Allergan’s LUMIGAN® product used to reduce elevated intraocular pressure in patients with glaucoma or ocular hypertension. The patent covers the specific composition enabling once-daily dosing at this concentration, distinguishing it from earlier 0.03% formulations. It is listed in the FDA Orange Book against LUMIGAN® 0.01% and has been the subject of multiple ANDA-triggered Hatch-Waxman litigations.

Bimatoprost 0.01% represents a commercially significant ophthalmic franchise for Allergan and AbbVie. The ability to maintain patent exclusivity at this concentration — rather than solely at the legacy 0.03% dose — is strategically valuable because the lower-concentration formulation offers a differentiated tolerability profile that has driven prescriber and patient adoption. Any generic manufacturer targeting this specific concentration must contend with US7851504 as the primary Orange Book barrier, making FTO clearance for bimatoprost 0.01% products non-negotiable for market entry planning.

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 for bimatoprost 0.01% products?

Any company developing, manufacturing, or seeking to commercialise a generic or branded bimatoprost ophthalmic solution at 0.01% concentration in the United States should treat US7851504B2 as a mandatory FTO target. The Mankind consent order confirms that at least one claim reads on a 0.01% bimatoprost ANDA product. Companies already holding ANDAs, or in pre-ANDA development, should assess both independent and dependent claims to identify whether any formulation design-around is available before submission.

PatSnap Eureka’s FTO Search Agent can rapidly map the claim scope of US7851504B2 against your proposed formulation parameters, identify prosecution history file wrapper estoppels, and surface any continuation or divisional patents in the same family that may extend the effective exclusivity period. Eureka also monitors the Orange Book listing and USPTO Patent Term Extension filings in real time — giving your regulatory and IP teams the accurate expiry dates needed for launch-readiness planning.

PatSnap Eureka FTO Search

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Related litigation

Similar Hatch-Waxman Bimatoprost & Ophthalmic ANDA Cases

Cases below involve Hatch-Waxman ANDA patent disputes over ophthalmic formulations litigated in Delaware District Court, directly comparable to this bimatoprost action.

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Strategic implications

What this case signals for the ophthalmic pharma IP landscape

This consent order illustrates how Hatch-Waxman patent disputes over established ophthalmic brands can resolve swiftly when challenger defences are commercially unviable.

Infringement admissions in consent orders raise the bar for parallel ANDA challengers

Mankind’s public admission that US7851504 is valid and infringed by bimatoprost 0.01% generics creates a persuasive record. Other ANDA filers targeting LUMIGAN® 0.01% will need to articulate why their own invalidity or design-around arguments are stronger — or face comparable settlement pressure. Brand holders typically cite consent judgements in parallel litigations during claim construction and settlement negotiations.

Paragraph IV certification retention means Mankind preserves a strategic option

The order permits Mankind to retain its Paragraph IV certification for ANDA 218196. While this does not allow commercial sale during the patent term, it preserves Mankind’s position to launch immediately upon patent expiry without re-filing. Companies tracking competitive generic entry timelines for bimatoprost 0.01% should factor this into launch-readiness planning — Mankind is positioned to move quickly once the ‘504 patent lapses.

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Frequently asked questions

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