Allergan v. Sun Pharma: Viberzi Eluxadoline Patent Resolved in 34 Days
Allergan Holdings, AbbVie, and Eden Biodesign filed suit in Delaware against Sun Pharmaceutical over ANDA No. 213447 for generic eluxadoline 75 mg tablets, asserting US12097187B2. The parties reached a stipulated consent order within 34 days, enjoining Sun from commercialising the generic product for the life of the patent.
Rapid ANDA consent order locks Sun Pharma out of eluxadoline market
On 23 October 2024, Allergan Holdings Unlimited Co., AbbVie US LLC, AbbVie Inc., and Eden Biodesign LLC filed an infringement action in the District of Delaware against Sun Pharmaceutical Industries, Inc. The complaint alleged that the filing of ANDA No. 213447 — seeking approval to market generic eluxadoline oral tablets at the 75 mg strength — constituted an act of infringement of US12097187B2 under 35 U.S.C. § 271(e)(2)(A), the Hatch-Waxman provision that treats an ANDA filing as a constructive act of infringement.
The case closed on 26 November 2024 — just 34 days after filing — via a stipulated consent order signed by Judge Richard G. Andrews. The order formally adjudges that ANDA No. 213447 infringed the ‘187 Patent, issues a permanent injunction barring Sun and its agents from manufacturing, using, selling, offering for sale, or importing the specified generic product for the life of the patent including any extensions and paediatric exclusivities, and dismisses all remaining claims, counterclaims, and defences without prejudice. Sun expressly waived any right to appeal.
A 34-day resolution is notably swift even by consent-order standards in Hatch-Waxman litigation, suggesting the parties entered settlement discussions promptly or had reached an agreement before or shortly after filing. The public record does not disclose any licence or commercial terms between the parties. The order preserves Allergan and AbbVie’s ability to pursue future actions against Sun regarding the ‘187 Patent in connection with products other than the ANDA 213447 eluxadoline 75 mg tablets, indicating the scope of the resolution was deliberately narrow.
Filing to Dismissed without Prejudice in 34 days
34 days — resolved well below the typical ANDA Hatch-Waxman litigation timeline
Consent order and injunction: what the stipulated resolution means for both parties
ANDA filing deemed infringement under § 271(e)(2)(A)
Under the Hatch-Waxman Act, the submission of an ANDA with a Paragraph IV certification is itself a statutory act of patent infringement — even before any generic product is sold. Here, the stipulated order formally adjudges that Sun’s filing of ANDA No. 213447 infringed US12097187B2. This is a consent-based adjudication: Sun agreed to the finding rather than contest it, allowing the parties to resolve the dispute without a full trial or merits ruling on validity.
§ 271(e)(2)(A) constructive infringementPermanent injunction secures Viberzi® market exclusivity for patent life
Allergan and AbbVie secured a permanent injunction blocking Sun from commercialising generic eluxadoline 75 mg under ANDA 213447 for the full remaining life of US12097187B2, including any extensions and paediatric exclusivities. Remaining claims were dismissed without prejudice — preserving plaintiffs’ ability to re-assert rights if Sun seeks approval for a different eluxadoline product or if future circumstances warrant. No licence terms were disclosed in the public record.
Permanent injunction grantedSun enjoined for patent life; appeal rights expressly waived
Sun Pharmaceutical cannot manufacture, sell, offer to sell, or import generic eluxadoline 75 mg tablets described in ANDA No. 213447 within the United States for the life of the ‘187 Patent, absent a licence from plaintiffs. Critically, Sun expressly waived any right to appeal or seek relief from the order. The without-prejudice dismissal of counterclaims means Sun retains theoretical validity and non-infringement positions for a different eluxadoline product, but its commercial path for this specific ANDA is closed.
Appeal waived; ANDA blockedEluxadoline generic entry delayed; IBS-M market remains branded
Viberzi® (eluxadoline) treats irritable bowel syndrome with mixed bowel habits, a condition affecting millions of patients. The consent injunction effectively delays generic entry for this 75 mg formulation until US12097187B2 expires or is licensed. Other ANDA filers pursuing eluxadoline generics face a strengthened IP posture from AbbVie and Allergan. The narrow scope of the order — limited to ANDA 213447 and the 75 mg strength — suggests the broader patent landscape for eluxadoline remains actively managed.
Generic entry blocked for patent termFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Allergan Holdings Unlimited Co. | Company | Pharma IP holding group (AbbVie/Allergan) — holder of US12097187B2 covering Viberzi® eluxadolineSearch in Eureka ↗ |
| Co-Plaintiff | AbbVie US LLC | Company | Search in Eureka ↗ |
| Co-Plaintiff | Eden Biodesign, LLC | Company | Search in Eureka ↗ |
| Co-Plaintiff | AbbVie, Inc. | Company | Search in Eureka ↗ |
| Defendant | Sun Pharmaceutical Industries, Inc. | Company | Sun Pharmaceutical Industries, Inc. — generic drug manufacturer, ANDA No. 213447 filerSearch in Eureka ↗ |
| Plaintiff counsel | Brian P. Egan | Attorney | Counsel for Allergan Holdings Unlimited Co.Search in Eureka ↗ |
| Plaintiff counsel | Jeremy A. Tigan | Attorney | Counsel for Allergan Holdings Unlimited Co.Search in Eureka ↗ |
| Plaintiff law firm | Morris, Nichols, Arsht & Tunnell LLP | Law Firm | Representing Allergan Holdings Unlimited Co.Search in Eureka ↗ |
| Defendant counsel | Dominick T. Gattuso | Attorney | Counsel for Sun Pharmaceutical Industries, Inc.Search in Eureka ↗ |
| Defendant law firm | Heyman Enerio Gattuso & Hirzel, LLP | Law Firm | Representing Sun Pharmaceutical Industries, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Richard G. Andrews | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated order is structured as a hybrid adjudication and injunction: it contains a formal finding of infringement under § 271(e)(2)(A) — giving it res judicata weight on that specific issue — while dismissing all remaining disputes without prejudice. The appeal waiver in paragraph 4 is particularly significant: it forecloses any post-order challenge by Sun to the infringement finding or injunction scope, making the consent order functionally final as to ANDA 213447. The court’s retained jurisdiction in paragraph 5 provides a streamlined enforcement mechanism if Sun violates the injunction.
US12097187B2 — Eluxadoline oral tablet formulation (Viberzi® 75 mg)
US12097187B2, filed under application number US18/324449, covers the eluxadoline oral tablet formulation commercialised as Viberzi®. Eluxadoline is a mixed opioid receptor agonist-antagonist approved for the treatment of irritable bowel syndrome with mixed bowel habits (IBS-M) in adults. The patent’s protection of a specific oral tablet formulation at the 75 mg strength is the basis for the Hatch-Waxman infringement allegation against Sun’s ANDA. Patent term extensions and paediatric exclusivities referenced in the consent order suggest a protected exclusivity window extending beyond the base patent term.
US12097187B2 sits within AbbVie’s post-acquisition Allergan portfolio, a collection that has been systematically enforced against generic challengers. The involvement of Eden Biodesign as a co-patentee suggests a multi-party ownership or licensing arrangement that complicates potential invalidity challenges — any IPR petition would need to name all patent owners. For generic manufacturers and biosimilar developers working in GI therapeutics, this patent represents a significant freedom-to-operate consideration. The without-prejudice scope of the order signals that AbbVie intends to enforce the patent against any future eluxadoline ANDA filer.
Should your team run an FTO analysis against US12097187B2?
Any company developing, formulating, or seeking regulatory approval for a generic or branded eluxadoline oral tablet product — particularly at the 75 mg or 100 mg strengths — should treat US12097187B2 as a primary FTO concern. The patent is actively enforced: AbbVie secured a consent injunction against Sun Pharma within 34 days of filing suit. Paediatric exclusivities referenced in the order may extend market protection beyond the base patent term, and related continuations or divisionals may cover alternative formulations or dosing regimens.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of US12097187B2 against your product specification, identify the expiry date accounting for patent term extensions, surface related family members and continuations filed by AbbVie or Eden Biodesign, and flag prior art that could support an IPR petition. For in-house IP and R&D teams in GI therapeutics, running this analysis before ANDA filing can save years of litigation and licensing costs. Start with a targeted Eureka landscape search on eluxadoline formulation patents.
Run a freedom-to-operate analysis on US12097187B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA eluxadoline and GI therapeutics patent cases in Delaware
Cases involving Hatch-Waxman ANDA infringement actions over GI drug formulation patents litigated in the District of Delaware.
What this case signals for the ANDA pharma IP enforcement landscape
A 34-day consent order with appeal waiver is a textbook Hatch-Waxman enforcement playbook — and sets a marker for future eluxadoline challengers.
Rapid consent orders signal pre-litigation commercial alignment
A 34-day resolution in Hatch-Waxman litigation typically suggests the branded company and ANDA filer had substantive negotiations before or immediately after suit was filed. Companies monitoring AbbVie’s enforcement strategy should treat the speed of this resolution as consistent with a disciplined IP licensing or settlement programme rather than adversarial litigation.
Without-prejudice dismissal preserves plaintiff optionality on future ANDAs
The order is deliberately scoped to ANDA 213447 and the 75 mg strength. By dismissing all other claims without prejudice, AbbVie and Allergan retain the ability to sue Sun — or any other party — if a new ANDA, different strength, or reformulated eluxadoline product emerges. Patent counsel advising generic entrants should treat US12097187B2 as an actively enforced barrier across the eluxadoline product family.
Allergan v Sun — key questions answered
The court entered a stipulated consent order on 26 November 2024 finding that Sun’s filing of ANDA No. 213447 infringed US12097187B2 under 35 U.S.C. § 271(e)(2)(A). The order permanently enjoins Sun from making, using, selling, or importing generic eluxadoline 75 mg tablets for the life of the patent, and dismisses all remaining claims without prejudice. Sun waived its right to appeal.
US12097187B2, filed under application US18/324449, covers the eluxadoline oral tablet formulation marketed as Viberzi® (75 mg). It is held jointly by Allergan, AbbVie entities, and Eden Biodesign. The patent is actively enforced under Hatch-Waxman: any ANDA filer seeking to market generic eluxadoline must design around this patent, license it, or successfully challenge its validity through IPR before commercial launch.
The 34-day resolution is consistent with a pre-negotiated or rapidly settled Hatch-Waxman dispute. In such cases, parties often reach substantive agreement before or shortly after the complaint is filed, using litigation as the vehicle to formalise the consent order and obtain a court-enforceable injunction. The public record does not disclose any licence or financial terms agreed between the parties.
The without-prejudice dismissal of remaining claims, counterclaims, and defences means those issues were not adjudicated on the merits. The parties retain the right to raise them in future proceedings. Notably, the order explicitly preserves plaintiffs’ ability to sue Sun regarding the ‘187 Patent in connection with any eluxadoline product other than the specific generic described in ANDA 213447.
The plaintiffs are Allergan Holdings Unlimited Co., AbbVie US LLC, AbbVie Inc., and Eden Biodesign LLC. The multi-entity structure is consistent with a layered IP ownership arrangement. For any party considering an IPR petition against US12097187B2, all co-owners must typically be accounted for. The presence of Eden Biodesign alongside the AbbVie/Allergan entities suggests the patent’s chain of title warrants careful mapping before any challenge is filed.
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