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.
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.
Filing to Dismissed without Prejudice in 45 days
Resolved in 45 days — well under the typical 2–3 year ANDA patent litigation timeline
Consent injunction and without-prejudice dismissal: what the order means for both sides
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) admissionPermanent 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 protectedAlembic’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 partiesRapid 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 enforcementFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | AbbVie, Inc. | Company | Pharmaceutical and ophthalmic IP coalition — co-holders of US10617695B2 and US8664215B2Search in Eureka ↗ |
| Co-Plaintiff | Johnson & Johnson Vision Care, Inc. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Allergan Sales, LLC | Company | Search in Eureka ↗ |
| Co-Plaintiff | Allergan, Inc. | Company | Search in Eureka ↗ |
| Defendant | Alembic | Individual | Alembic Pharmaceuticals — Indian generic drug manufacturer seeking US ANDA approvalSearch in Eureka ↗ |
| Co-Defendant | Alembic Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Jack B. Blumenfeld | Attorney | Counsel for AbbVie, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Jeremy A. Tigan | Attorney | Counsel for AbbVie, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing AbbVie, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Stephanos Bibas | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
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.
US10617695B2 & US8664215B2 — Alcaftadine Ophthalmic Solution 0.25% (LASTACAFT®)
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.
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.
Run a freedom-to-operate analysis on US10617695B2 to assess your product’s exposure
Run FTO in Eureka →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.
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
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Active · District CourtRelated invalidity challenge — appellate outcome
Combined invalidity and infringement action in the same technology space. Decided after substantive proceedings.
DecidedAbbVie, Inc.’s broader IP enforcement history
AbbVie, 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 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.
Without-prejudice carve-out creates a live future risk for plaintiffs
The stipulation explicitly preserves Alembic’s right to challenge the ‘215 and ‘695 patents in a future action involving a different product. If Alembic or a related entity files a new ANDA for a modified formulation or concentration, the current admission does not bind them. Patent holders should monitor Alembic’s FDA filings pipeline for new alcaftadine-related applications.
Pediatric exclusivity extension language in the order has downstream implications
The injunction explicitly covers any pediatric exclusivities attached to the ‘215 and ‘695 patents. This language signals that plaintiffs may be pursuing or holding pediatric study protections under BPCA, which could add six months beyond patent expiry. Generic filers targeting post-expiry entry windows must account for this additional exclusivity layer in their market entry modelling.
AbbVie v Alembic — key questions answered
Alembic expressly admitted that US Patent Nos. 8,664,215 and 10,617,695 are valid, enforceable, and would be infringed by the commercial manufacture, use, or sale of the generic alcaftadine ophthalmic solution 0.25% product described in ANDA 209290. It also admitted that the ANDA filing itself constituted a technical act of infringement under 35 U.S.C. § 271(e)(2)(A).
The Delaware District Court issued a permanent injunction prohibiting Alembic, its officers, agents, and employees from manufacturing, using, offering to sell, selling, or importing the generic alcaftadine 0.25% product of ANDA 209290 in the United States for the life of both the ‘215 and ‘695 patents, including any extensions and pediatric exclusivities, absent a licence from the plaintiffs.
The 45-day resolution is consistent with pre-suit commercial alignment between the parties. In Hatch-Waxman litigation, it is common for branded and generic companies to negotiate informally before — or immediately after — a complaint is filed. The speed of the consent order here suggests Alembic assessed the validity and infringement positions as unfavourable and agreed to terms, converting the action into a streamlined consent proceeding rather than contested litigation.
The stipulation expressly states it is without prejudice to any claim, defence, or counterclaim in any possible future action between Alembic and the plaintiffs regarding the ‘215 and ‘695 patents — provided that action involves a product other than the generic alcaftadine 0.25% product of ANDA 209290. Alembic’s admission of validity in this action, however, may create practical evidentiary challenges in any future invalidity proceeding.
Based on this litigation, US Patent No. 8,664,215 (application US11/690954) and US Patent No. 10,617,695 (application US15/267645) were asserted as covering LASTACAFT® alcaftadine ophthalmic solution 0.25%. Both were held by the plaintiff group comprising AbbVie Inc., Allergan Inc., Allergan Sales LLC, and Johnson & Johnson Vision Care Inc. The injunction covers the full patent life including any extensions and pediatric exclusivities.
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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