Bausch Health & Salix v. Mylan: Plecanatide Patent Dismissed With Prejudice After Settlement
Bausch Health Ireland and Salix Pharmaceuticals filed suit against Mylan in the West Virginia Northern District Court asserting US11834521B2, covering plecanatide oral tablets (3 mg). After 404 days of litigation, the parties reached a confidential settlement and license agreement, resulting in a stipulated dismissal with prejudice and no costs awarded.
Pharma patent detente: Mylan licenses its way out of plecanatide suit
On April 5, 2024, Bausch Health Ireland Ltd. and its affiliate Salix Pharmaceuticals, Inc. filed a patent infringement action in the U.S. District Court for the Northern District of West Virginia (Case No. 1:24-cv-00036) against Mylan NV. The suit centred on US11834521B2, a patent covering plecanatide oral tablets at the 3 mg dose — a guanylate cyclase-C agonist marketed as Trulance for chronic idiopathic constipation and irritable bowel syndrome with constipation.
The case closed on May 14, 2025, via a stipulated dismissal with prejudice, following execution of a Confidential Settlement and License Agreement between the parties. The dismissal with prejudice forecloses any future re-filing of the same claims by plaintiffs, and the license grant to Mylan suggests a negotiated entry date or royalty arrangement — standard resolution mechanics in Hatch-Waxman ANDA litigation. Each party bears its own costs and attorneys’ fees.
At 404 days, the case resolved before trial — consistent with the pattern in pharmaceutical ANDA disputes where commercial leverage, patent expiry horizons, and litigation cost exposure frequently drive pre-trial settlement. The specific terms of the license, including any authorised generic entry date, remain confidential. What the public record does not reveal is whether Mylan received an early launch date or a pure royalty-bearing licence, both of which carry materially different implications for generic competition in the plecanatide market.
Filing to Dismissed with Prejudice in 404 days
404 days from filing to dismissal — consistent with ANDA pharmaceutical litigation timelines that often resolve before trial
Confidential settlement reached: what the dismissal with prejudice means for both parties
Dismissed with prejudice: the door is permanently closed
A dismissal with prejudice under Federal Rule of Civil Procedure 41 is a final adjudication on the merits. Bausch Health and Salix cannot refile these same patent claims against Mylan on the same cause of action. The court retains jurisdiction solely to enforce the settlement agreement and stipulation — a standard clause ensuring compliance without fresh litigation.
Permanent bar on re-filingLicence secured: Bausch and Salix monetise without trial risk
By settling and granting a licence rather than litigating to judgment, Bausch Health Ireland and Salix Pharmaceuticals avoid the existential risk of an adverse invalidity ruling on US11834521B2. The confidential licence preserves commercial control over plecanatide market entry timing, consistent with how brand pharmaceutical companies manage generic competition through negotiated entry dates rather than outright patent wins.
Licence granted, patent intactMylan secures a licence — terms remain confidential
Mylan’s agreement to a settlement and licence, rather than pressing an invalidity defence to judgment, suggests the confidential terms were commercially acceptable. Whether Mylan received an authorised early launch date, a royalty structure, or deferred entry is unknown from the public record. The dismissal with prejudice protects Mylan from any further infringement action on this patent for the same ANDA product.
Licence received, terms undisclosedGeneric entry timeline for plecanatide remains uncertain
The confidential nature of the settlement means the market cannot determine when Mylan-branded generic plecanatide will launch. Investors, competing generics filers, and payers tracking Trulance biosimilar exposure should note that the patent — US11834521B2 — survived this challenge intact and enforceable. Other ANDA filers for plecanatide 3 mg may face the same patent as a barrier to market entry.
Market entry date undisclosedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bausch Health Ireland, Ltd. | Company | Pharmaceutical IP licensor and branded drug company — holder of US11834521B2Search in Eureka ↗ |
| Co-Plaintiff | Salix Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Defendant | Mylan, NV | Company | Generic pharmaceutical manufacturer seeking ANDA approval for plecanatide 3 mg tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Bryan C. Diner | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Charles E. Lipsey | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Daniel R. Higginbotham | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Emmanuel N. Onochie | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Justin James Hasford | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Kassandra M. Officer | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Lauren J. Robinson | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Ryan V. McDonnell | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Taylor L. Stark | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Finnegan, Henderson, Farabow, Garrett & Dunner, LLP | Law Firm | Representing Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff law firm | Thomas Combs & Spann, PLLC | Law Firm | Representing Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Defendant counsel | Garrett Matthew Spiker | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Gordon H. Copland | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Jackson Walker | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Stephanie Cheng | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Tung-On Kong | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | William J. O’Brien | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Steptoe & Johnson PLLC | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Steptoe & Johnson PLLC – Bridgeport | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Wilson Sonsini Goodrich & Rosati, LLP | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Presiding judge | Judge Thomas S Kleeh | Judge | West Virginia Northern District CourtSearch in Eureka ↗ |
Official order — verbatim text
The stipulated dismissal is structured as a negotiated exit, not a merits adjudication. The operative language — ‘dismissed with prejudice and without costs’ — confirms finality while the explicit licence reference signals a commercial resolution rather than capitulation. The court’s retained jurisdiction clause is standard in pharmaceutical ANDA settlements, providing an enforcement mechanism without requiring a new filing. The absence of any costs or fee award is consistent with a balanced negotiating posture by both parties.
US11834521B2 — plecanatide oral tablet formulation (3 mg)
US11834521B2 protects formulations of plecanatide — a synthetic analogue of uroguanylin — in oral tablet form at the 3 mg dosage strength. Plecanatide acts as a guanylate cyclase-C (GC-C) agonist, stimulating intestinal fluid secretion and motility, and is the active ingredient in Trulance, approved by the FDA for chronic idiopathic constipation and IBS-C. The patent’s corrected application number (US18/193144) suggests a relatively recent prosecution history, consistent with lifecycle management filings designed to extend exclusivity on a commercially established product.
For the gastrointestinal therapeutics sector, US11834521B2 represents a formulation-level barrier that sits atop the compound itself — a common strategy by brand manufacturers to create layered exclusivity. With Trulance competing in a market alongside linaclotide (Linzess), any delay to generic plecanatide entry has direct revenue implications for Bausch and Salix. Generic manufacturers challenging this patent face both the Hatch-Waxman 30-month stay mechanism and the risk of a pre-trial settlement that leaves the patent judicially untested and fully enforceable.
Should your R&D or regulatory team run an FTO against US11834521B2?
Any pharmaceutical company developing, formulating, or filing an ANDA for a plecanatide-based oral tablet product — particularly at the 3 mg strength — should treat US11834521B2 as a primary freedom-to-operate hurdle. The patent survived a full ANDA litigation cycle without an invalidity ruling, meaning it carries maximum enforcement weight. Companies with pending or contemplated Paragraph IV certifications against Trulance should commission a claims-level FTO analysis before filing.
PatSnap Eureka’s FTO Search Agent can map the full claim scope of US11834521B2 against your formulation parameters, identify prior art that could support a validity challenge, and flag related family members or continuations that may extend protection beyond this grant. Eureka also tracks Orange Book listing status and litigation history across all ANDA filers for plecanatide, giving your regulatory and IP teams a consolidated risk picture before committing to a Paragraph IV strategy.
Run a freedom-to-operate analysis on US11834521B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent infringement cases: GI drug formulations in U.S. district courts
Explore comparable Hatch-Waxman infringement actions involving gastrointestinal drug formulation patents litigated in U.S. district courts, including cases against generic ANDA filers.
What this case signals for the gastrointestinal drug patent landscape
Pre-trial ANDA settlements preserve patent enforceability and create information asymmetry that affects all market participants in the GI therapeutics space.
US11834521B2 survives unchallenged — a stronger barrier for future ANDA filers
Because the case settled before any invalidity ruling, US11834521B2 emerges with no judicial finding against it. Every subsequent generic filer for plecanatide 3 mg must treat this patent as fully enforceable. Companies with pending or planned ANDAs for plecanatide should assess their Paragraph IV certification strategy against this patent carefully.
Confidential licence terms create competitive opacity in the plecanatide generic market
The settlement’s confidentiality means rival generic manufacturers, payers, and retail pharmacy chains cannot determine Mylan’s authorised entry date. This opacity is a deliberate outcome for the brand holder — it suppresses competitive generic launch planning by others and preserves pricing leverage for Bausch and Salix in the near term.
Bausch v Mylan — key questions answered
Bausch Health Ireland Ltd. and Salix Pharmaceuticals, Inc. asserted US11834521B2, a patent covering plecanatide oral tablets at the 3 mg dosage strength — the active ingredient in Trulance. The case was filed April 5, 2024 in the West Virginia Northern District Court and resolved via confidential settlement.
The case was dismissed with prejudice on May 14, 2025, following a Confidential Settlement and License Agreement between the parties. Each side bears its own costs and attorneys’ fees. The court retained jurisdiction to enforce the settlement. The specific commercial terms — including any authorised generic entry date — remain undisclosed.
Dismissal with prejudice is a final adjudication barring Bausch and Salix from refiling the same claims against Mylan on this patent. Critically, because the case settled without an invalidity ruling, US11834521B2 remains judicially untested and fully enforceable against any other generic manufacturer filing an ANDA for plecanatide 3 mg tablets.
West Virginia Northern District is Mylan Pharmaceuticals Inc.’s home district — the company is headquartered in Morgantown, WV. Filing in the defendant’s home district is a recognised strategy in Hatch-Waxman ANDA litigation that can satisfy personal jurisdiction requirements and is consistent with how multiple brand pharmaceutical plaintiffs have pursued Mylan in prior disputes.
The settlement includes a licence from plaintiffs to Mylan, which typically resolves the infringement exposure for Mylan’s ANDA product. Whether Mylan can launch immediately, at a future authorised date, or under royalty obligations is not disclosed in the public record. Competitors tracking the plecanatide generic market should monitor FDA’s Orange Book and Mylan’s ANDA approval status for entry signals.
PatSnap Eureka searches patents and litigation data to answer instantly.