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AbbVie v. Alembic: Alcaftadine Eye Drop Patent Dispute | PatSnap
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Case ID1:24-cv-00405
FiledMar 2024
ClosedMay 2024
Patent Litigation

AbbVie v. Alembic: LASTACAFT® Patent Dispute Ends in Consent Injunction

AbbVie, Allergan, and Johnson & Johnson Vision Care filed suit against Alembic Pharmaceuticals in the Delaware District Court, asserting two patents covering alcaftadine ophthalmic solution 0.25% (LASTACAFT®). Alembic admitted infringement and validity of both patents, consenting to a permanent injunction — all within a remarkable 45 days of filing.

Resolution time
45days
Resolved in 45 days — well under the typical 2–3 year ANDA patent litigation timeline
Patents asserted
2
US10617695B2 and US8664215B2 — LASTACAFT® alcaftadine ophthalmic solution 0.25%
Outcome
Dismissed without Prejudice
Remaining claims dismissed without prejudice per consent stipulation; core order is final
Cost ruling
No Cost Award
Parties mutually waived appeal rights; no cost or fee ruling recorded on public docket
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Consent Order in 45 Days: Alembic Admits Infringement of LASTACAFT® Patents

Filed on 29 March 2024 in the District of Delaware before Judge Stephanos Bibas, this Hatch-Waxman action was brought by AbbVie Inc., Allergan Inc., Allergan Sales LLC, and Johnson & Johnson Vision Care Inc. against Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals Inc. The plaintiffs asserted US Patent Nos. 8,664,215 and 10,617,695 in connection with Alembic’s ANDA 209290, which sought FDA approval for a generic version of alcaftadine ophthalmic solution 0.25% — the active ingredient in the branded antihistamine eye drop LASTACAFT®.

The case closed on 13 May 2024 — just 45 days after filing — when both sides entered a stipulated consent order. Alembic expressly admitted that both patents are valid, enforceable, and would be infringed by the commercial manufacture, use, or sale of its ANDA product. The court issued a permanent injunction barring Alembic from commercialising the generic product for the life of both patents, including any extensions and pediatric exclusivities. All remaining claims were dismissed without prejudice, and both parties waived all appeal rights.

A 45-day resolution is unusually rapid even by the standards of consent-heavy ANDA litigation, suggesting the parties likely had pre-suit communications that narrowed the dispute before filing. The without-prejudice dismissal of remaining claims preserves flexibility for both sides if Alembic pursues a different formulation or product scope beyond ANDA 209290. The public record does not disclose whether any licensing arrangement or commercial terms accompanied the injunction, nor what drove Alembic’s decision to admit infringement rather than mount a validity challenge.

Case at a glance
Case no.1:24-cv-00405
PlaintiffAbbVie, Inc.
DefendantAlembic
CourtDelaware
JudgeStephanos Bibas
FiledMarch 29, 2024
ClosedMay 13, 2024
Duration45 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 45 days

Resolved in 45 days — well under the typical 2–3 year ANDA patent litigation timeline

Case timeline: Complaint filed MAR 29 2024, APR–MAY — 45 days total Horizontal timeline showing the three key events in AbbVie, Inc. v Alembic from filing to resolution. Source: PACER, Delaware District Court. MAR 29 2024 Complaint filed Pre-trial proceedings MAY 13 2024 Dismissed without Prejudice 45 DAYS TOTAL
Dismissal terms

Consent injunction and without-prejudice dismissal: what the order means for both sides

Legal mechanism

Stipulated consent order: admission of infringement and validity

Under 35 U.S.C. § 271(e)(2)(A), the mere filing of an ANDA constitutes a technical act of infringement. Here, Alembic went further — expressly admitting that both the ‘215 and ‘695 patents are valid, enforceable, and would be infringed by commercialisation of ANDA 209290. This is a stronger concession than a typical without-prejudice dismissal and gives the plaintiffs an adjudicated record of infringement rather than a mere withdrawal.

Hatch-Waxman § 271(e)(2)(A) admission
Patent holder outcome

Permanent injunction secures LASTACAFT® market exclusivity

The consent order grants AbbVie and its co-plaintiffs a permanent injunction blocking Alembic from manufacturing, selling, or importing the generic alcaftadine product for the full life of both patents, including any extensions and pediatric exclusivities. The without-prejudice dismissal of remaining claims does not undermine this result — the core injunction is final and enforceable by the court, which retains jurisdiction.

Market exclusivity protected
Generic challenger outcome

Alembic’s ANDA 209290 pathway blocked; reformulation remains open

Alembic is permanently enjoined from commercialising the specific 0.25% alcaftadine product described in ANDA 209290 for the patent term. Both parties waived appeal rights, foreclosing any post-order challenge to the injunction. However, the without-prejudice dismissal of remaining claims and a carve-out for products other than ANDA 209290 suggest Alembic retains the ability to pursue a different formulation or a future challenge if the patent landscape shifts.

Appeal rights waived by both parties
Commercial implications

Rapid consent resolution reinforces branded ophthalmic IP enforcement

The 45-day resolution with a full infringement admission sends a strong deterrent signal to other generic filers targeting LASTACAFT®. For the ophthalmic pharmaceutical sector, this outcome illustrates that well-constructed patent portfolios covering both composition (the ‘215 patent) and therapeutic use (the ‘695 patent) can foreclose generic entry without costly multi-year litigation. Competitors should assess whether their ANDA strategies account for layered patent estates of this type.

Layered patent portfolio enforcement
Legal analysis based on PACER docket records for case 1:24-cv-00405 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffAbbVie, Inc.CompanyPharmaceutical and ophthalmic IP coalition — co-holders of US10617695B2 and US8664215B2Search in Eureka ↗
Co-PlaintiffJohnson & Johnson Vision Care, Inc.CompanySearch in Eureka ↗
Co-PlaintiffAllergan Sales, LLCCompanySearch in Eureka ↗
Co-PlaintiffAllergan, Inc.CompanySearch in Eureka ↗
DefendantAlembicIndividualAlembic Pharmaceuticals — Indian generic drug manufacturer seeking US ANDA approvalSearch in Eureka ↗
Co-DefendantAlembic Pharmaceuticals, Inc.CompanySearch in Eureka ↗
Plaintiff counselJack B. BlumenfeldAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff counselJeremy A. TiganAttorneyCounsel for AbbVie, Inc.Search in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting AbbVie, Inc.Search in Eureka ↗
Presiding judgeJudge Stephanos BibasJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“The Court, upon the consent and request of Plaintiffs AbbVie Inc., Allergan, Inc., Allergan Sales, LLC, and Johnson & Johnson Vision Care Inc., (collectively, “Plaintiffs”) and Defendants Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals, Inc. (collectively “Alembic” or “Defendants”), 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 Alembic for purposes of the Action. Venue is proper in this Court as to Plaintiffs and Alembic for the Action. 2. In the Action, Plaintiffs have asserted claims against Alembic for infringement of U.S. Patent Nos. 8,664,215 (the “’215 patent”) and 10,617,695 (the “’695 patent”) (collectively, the “Patents-in-Suit”) in connection with Alembic’s submission of Abbreviated New Drug Application (“ANDA”) 209290 directed to a generic alcaftadine ophthalmic solution 0.25% product to the U.S. Food and Drug Administration (“FDA”). Case 1:24-cv-00405-SB Document 14 Filed 05/13/24 Page 1 of 3 PageID #: 78 2 3. Alembic admits that the ’215 Patent and the ’695 Patent are enforceable, valid, and would be infringed by the commercial manufacture, use, and/or sale within the United States of the generic alcaftadine ophthalmic solution 0.25% product that are the subject of Alembic’s ANDA 209290. 4. Alembic admits that the submission of ANDA 209290 to the FDA for purposes of obtaining regulatory approval to engage in the commercial manufacture, use, and/or sale within the United States of the generic alcaftadine ophthalmic solution 0.25% product was an act of infringement of the ’215 Patent and the ’695 Patent under 35 U.S.C. § 271(e)(2)(A). 5. The parties agree that all other claims should be dismissed, without prejudice. ORDER Accordingly, pursuant to the above Stipulation, and upon the consent and request of Plaintiffs and Alembic, IT IS HEREBY ORDERED, ADJUDGED AND DECREED THAT: 1. The filing of ANDA 209290 was a technical act of infringement of the ’215 Patent, and the ’695 Patent under 35 U.S.C. § 271(e)(2)(A). 2. All other claims are hereby dismissed, without prejudice. 3. Alembic, 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 alcaftadine ophthalmic solution 0.25% product described by ANDA 209290 during the life of the ’215 Patent, and the ’695 Patent including any extensions and pediatric exclusivities thereof, absent a license agreement or other authorization by Plaintiffs. 4. Plaintiffs and Alembic each expressly waive any right to appeal or otherwise move for relief from this Stipulation And Order. Case 1:24-cv-00405-SB Document 14 Filed 05/13/24 Page 2 of 3 PageID #: 79 3 5. This Court retains jurisdiction over Plaintiffs and Alembic for purposes of enforcing this Stipulation And Order. 6. This Stipulation And Order shall finally resolve the Action between Plaintiffs and Alembic. 7. This Stipulation And Order is without prejudice to any claim, defense, or counterclaim in any possible future action between Alembic and any of the Plaintiffs regarding the ’215 Patent and the ’695 Patent and a product other than a generic alcaftadine ophthalmic solution 0.25% product described by ANDA 209290 . 8. The Clerk of the Court is directed to enter this Stipulation And Order forthwith in the Action.”
Source: PACER Docket, Case 1:24-cv-00405, Delaware District Court

The consent stipulation and order is unusually comprehensive for a 45-day case. Alembic’s express admission that both patents are valid, enforceable, and would be infringed goes beyond a typical ANDA settlement, creating an adjudicated record. The court’s retention of jurisdiction and the explicit waiver of appeal rights by both parties makes the injunction operationally final. The without-prejudice dismissal of remaining claims, however, is a deliberate carve-out — preserving future flexibility for both sides without disturbing the core injunctive relief.

PACER case 1:24-cv-00405 · Public docket record Explore in Eureka ↗
Patent at issue

US10617695B2 & US8664215B2 — Alcaftadine Ophthalmic Solution 0.25% (LASTACAFT®)

Publication No.US10617695B2
Application No.US15/267645
Patent details
ProductAlcaftadine ophthalmic solution methods of use for allergic conjunctivitis treatment
Cited in actionMarch 29, 2024

Publication No.US8664215B2
Application No.US11/690954
Patent details
ProductAlcaftadine ophthalmic solution 0.25% composition and formulation
Cited in actionMarch 29, 2024

US10617695B2 (application US15/267645) and US8664215B2 (application US11/690954) together protect the alcaftadine ophthalmic solution 0.25% formulation sold as LASTACAFT®, an H1-receptor antagonist indicated for the prevention of itching associated with allergic conjunctivitis. The ‘215 patent, with its earlier application date, covers foundational aspects of the alcaftadine composition, while the ‘695 patent — filed later — likely extends protection to specific formulation parameters or methods of therapeutic use, creating overlapping coverage across the product’s commercial life.

For the ophthalmic pharmaceutical sector, this dual-patent estate illustrates how layered IP coverage can make a single branded product highly defensible against generic entry. Any ANDA filer targeting alcaftadine 0.25% must design around or challenge both patents simultaneously. The explicit admission by Alembic that both patents are valid and enforceable — without any inter partes review or invalidity counterclaim — suggests the claims are written with sufficient breadth and specificity to deter straightforward invalidity challenges.

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

Should you run an FTO analysis against US10617695B2 and US8664215B2?

Any company developing, formulating, or seeking ANDA approval for alcaftadine ophthalmic products, or ophthalmic antihistamine eye drops with similar active concentrations, should treat both the ‘695 and ‘215 patents as live risks. Alembic’s uncontested admission of infringement — covering manufacture, use, offer for sale, and importation — confirms the claims have broad product-level reach. This is not a case where a narrow method claim left design-around room. R&D teams exploring ophthalmic antihistamine generics or biosimilar formulations should conduct FTO analysis before ANDA filing.

PatSnap Eureka’s FTO Search Agent can map the full claim scope of US10617695B2 and US8664215B2 against your candidate formulations, flag related continuation and divisional applications in the same family, and surface any post-grant proceedings or reexamination history. With pediatric exclusivity potentially extending the effective exclusivity window beyond patent expiry, understanding the precise expiry timeline for each patent in context is critical for accurate market entry modelling.

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Related litigation

Related ANDA patent cases: alcaftadine and ophthalmic antihistamine litigation

Browse other Hatch-Waxman ANDA infringement actions in the Delaware District Court involving ophthalmic pharmaceutical patents and branded eye drop formulations.

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AbbVie, Inc. patent enforcement history, Delaware case history, AbbVie, Inc.’s full IP portfolio, and comparable case analysis
Other alcaftadine ANDA casesOphthalmic ANDA § 271(e)(2) suitsAbbVie Delaware IP actionsAllergan patent enforcement history
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Strategic implications

What this case signals for the ophthalmic pharmaceutical IP landscape

A 45-day consent injunction with a full infringement admission is rare. Here is what it means for generic challengers and branded IP holders.

Dual-patent strategy effectively closed off alcaftadine generic entry

By asserting both a composition patent (US8664215B2) and a method-of-use/formulation patent (US10617695B2) simultaneously, the plaintiffs created a layered barrier that Alembic apparently assessed as insurmountable. R&D and IP teams building ophthalmic drug portfolios should consider how staggered patent filings can extend effective exclusivity beyond any single patent’s term.

Pre-suit alignment likely drove the unusually fast resolution

A 45-day case-to-consent-order timeline is consistent with parties having reached substantive agreement before the complaint was filed. In Hatch-Waxman practice, early engagement — including paragraph IV negotiation and pre-litigation licensing discussions — can convert a potential years-long battle into a swift consent order, reducing litigation cost for both sides while preserving enforceability.

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Frequently asked questions

AbbVie v Alembic — key questions answered

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Track ophthalmic ANDA patent risk before your next filing

PatSnap Eureka maps the full patent estate around branded ophthalmic products, flags active ANDA litigation, and surfaces pediatric exclusivity timelines. Run your FTO analysis on alcaftadine and adjacent antihistamine formulations before committing to an ANDA strategy.

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