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Bausch Health v. Mylan: Trulance Plecanatide Patent Litigation | PatSnap
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Case ID1:22-cv-00020
FiledMar 2022
ClosedMay 2025
Patent Litigation

Bausch Health & Salix v. Mylan: Trulance® Plecanatide Patent Settlement After 1,162 Days

Bausch Health Ireland and Salix Pharmaceuticals filed suit against Mylan and five affiliated entities in March 2022, asserting eight patents covering Trulance® (plecanatide) 3 mg oral tablets and GC-C agonist formulations for chronic constipation and IBS-C. The case resolved in May 2025 via a confidential settlement and license agreement — notably preserving Mylan’s Paragraph IV certifications and its right to pursue FDA approval of ANDA No. 215686.

Resolution time
1162days
1,162 days — well above the ~730-day median for Hatch-Waxman district court cases
Patents asserted
8
US8637451B2 and 7 further patents asserted — plecanatide GC-C agonist oral tablet formulations
Outcome
Dismissed with Prejudice
Dismissed with prejudice under confidential license agreement; Mylan retains ANDA pathway
Cost ruling
No Costs
Parties stipulated dismissal without costs, disbursements, or attorney fees to either side
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

A Hatch-Waxman battle over Trulance® ends in licensed settlement

Filed on 9 March 2022 in the West Virginia Northern District Court before Judge Thomas S. Kleeh, this Hatch-Waxman infringement action pitted Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc. against Mylan NV, Mylan Pharmaceuticals Inc., Mylan Inc., Viatris Inc., Mylan API US LLC, and Agila Specialties Inc. The plaintiffs asserted eight U.S. patents — spanning application numbers filed as early as US10/107814 — protecting plecanatide (Trulance®) 3 mg oral tablets and methods of treating chronic idiopathic constipation and IBS-C via guanylate cyclase-C agonism.

The case closed on 14 May 2025 when the parties filed a stipulation of dismissal with prejudice, reflecting the terms of a Confidential Settlement and License Agreement. All complaints, counterclaims, and affirmative defenses were dismissed without costs. Critically, the settlement explicitly acknowledges Mylan’s right to maintain its Paragraph IV certifications to all ten listed patents and to pursue and obtain FDA approval for ANDA No. 215686 prior to patent expiry — a concession that strongly suggests a licensed entry date was agreed upon.

At 1,162 days, the case ran significantly longer than the Hatch-Waxman median, suggesting substantive litigation through claim construction or expert discovery before settlement pressure intensified. The 30-month stay under 21 U.S.C. § 355(j)(5)(B)(iii) had already expired by the time the stipulation was filed, removing a key procedural lever for the plaintiffs. The specific launch date granted to Mylan under the confidential license remains undisclosed, which is typical of negotiated Hatch-Waxman resolutions but leaves market entry timing uncertain for commercial stakeholders.

Case at a glance
Case no.1:22-cv-00020
DefendantMylan, NV
CourtWest Virginia Northern
JudgeThomas S Kleeh
FiledMarch 9, 2022
ClosedMay 14, 2025
Duration1162 days
OutcomeDismissed with Prejudice
Verdict causeInfringement Action
BasisDismissed with Prejudice
Prior Art Intelligence
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Case data sourced from PACER / West Virginia Northern District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Dismissed with Prejudice in 1162 days

1,162 days — well above the ~730-day median for Hatch-Waxman district court cases

Case timeline: Complaint filed MAR 9 2022, OCT–NOV — 1162 days total Horizontal timeline showing the three key events in Bausch Health Ireland, Ltd. v Mylan, NV from filing to resolution. Source: PACER, West Virginia Northern District Court. MAR 9 2022 Complaint filed Pre-trial proceedings MAY 14 2025 Dismissed with Prejudice 1162 DAYS TOTAL
Settlement terms

Confidential license secured: what the Mylan settlement means for both parties

Legal mechanism

Dismissed with prejudice under a confidential license agreement

A dismissal with prejudice under Fed. R. Civ. P. 41(a)(1)(A)(ii) extinguishes all asserted claims permanently — neither party may relitigate the same infringement allegations. Here the dismissal is paired with a Confidential Settlement and License Agreement, which typically grants the generic a contractual right to launch on a negotiated date. The court retains jurisdiction to enforce the settlement’s terms.

Permanent bar on re-litigation
Patent holder outcome

Bausch/Salix secure structured protection — but concede ANDA pathway

By agreeing that Mylan may pursue FDA approval before patent expiry and retain Paragraph IV certifications, Bausch Health and Salix have effectively acknowledged that full patent exclusivity through expiry was not achievable via litigation alone. The confidential license likely provides a defined exclusivity window and potentially royalty income, which is a commercially rational outcome when the 30-month stay has already lapsed.

Licensed entry conceded
Challenger outcome

Mylan preserves ANDA rights and a clear FDA approval pathway

The stipulation expressly preserves Mylan’s Paragraph IV certifications to all ten listed patents and confirms FDA may grant final approval to ANDA No. 215686 at any time. This is a commercially significant win for the Mylan/Viatris group: it eliminates litigation risk, avoids any court-ordered injunction, and secures a contractual launch date — likely before the last patent expires — without requiring a court ruling on validity or infringement.

ANDA pathway secured
Commercial implications

Generic plecanatide entry now a matter of when, not whether

The settlement signals that the plecanatide patent estate, while broad at ten listed patents, was insufficient to block Mylan entirely. Payers, pharmacy benefit managers, and competing generic filers should treat the undisclosed license date as a material uncertainty. Any subsequent ANDA filer for plecanatide must independently negotiate or litigate around the same patent estate — and this settlement sets a precedent that licensed entry is achievable.

Generic entry timeline uncertain
Legal analysis based on PACER docket records for case 1:22-cv-00020 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffBausch Health Ireland, Ltd.CompanySpecialty pharma IP holder — originator of Trulance® (plecanatide) GC-C agonist franchiseSearch in Eureka ↗
Co-PlaintiffSalix Pharmaceuticals, Inc.CompanySearch in Eureka ↗
DefendantMylan, NVCompanyGeneric pharmaceutical manufacturer (Mylan/Viatris group) seeking ANDA approval for plecanatideSearch in Eureka ↗
Co-DefendantMylan Pharmaceuticals, Inc.CompanySearch in Eureka ↗
Co-DefendantMylan, Inc.CompanySearch in Eureka ↗
Co-DefendantViatris, Inc.CompanySearch in Eureka ↗
Co-DefendantMylan API US, LLCCompanySearch in Eureka ↗
Co-DefendantAgila Specialties Inc.CompanySearch in Eureka ↗
Plaintiff counselAshley Nichole DeemAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselBryan C. DinerAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselCaitlin E. O’ConnellAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselCharles E. LipseyAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselDaniel R. HigginbothamAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselEmmanuel N. OnochieAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselJ. BRUGH LOWERAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselJustin James HasfordAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselKassandra M. OfficerAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselKyu Yun KimAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselLauren J. RobinsonAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselM. David Griffith , Jr.AttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselRyan V. McDonnellAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselSCOTT JOEL ETISHAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselTaylor L. StarkAttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff counselWilliam P. Deni , Jr.AttorneyCounsel for Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff law firmFinnegan, Henderson, Farabow, Garrett & Dunner, LLPLaw FirmRepresenting Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff law firmGibbons PCLaw FirmRepresenting Bausch Health Ireland, Ltd.Search in Eureka ↗
Plaintiff law firmThomas Combs & Spann, PLLCLaw FirmRepresenting Bausch Health Ireland, Ltd.Search in Eureka ↗
Defendant counselArnold B. CalmannAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselCatherine Magdy SolimanAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselGordon H. CoplandAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselJakob Benjamin HalpernAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant counselWilliam J. O’BrienAttorneyCounsel for Mylan, NVSearch in Eureka ↗
Defendant law firmSaiber, LLCLaw FirmRepresenting Mylan, NVSearch in Eureka ↗
Defendant law firmSteptoe & Johnson PLLC – BridgeportLaw FirmRepresenting Mylan, NVSearch in Eureka ↗
Presiding judgeJudge Thomas S KleehJudgeWest Virginia Northern District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“WHEREAS, Plaintiffs Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc., (collectively, “Plaintiffs”), and Defendant Mylan Pharmaceuticals Inc., have agreed to the terms and conditions representing a negotiated settlement of this action and have set forth those terms and conditions in a Confidential Settlement and License Agreement (the “Settlement Agreement”), IT IS HEREBY STIPULATED AND AGREED, by and between Plaintiffs and Defendant, through their undersigned counsel of record, that: 1. The Complaints and all remaining claims, counterclaims, or affirmative defenses in the above action are dismissed with prejudice and without costs, disbursements, or attorney fees. 2. This Court will retain jurisdiction to enforce this Stipulation of Dismissal and the parties’ related agreements resolving this matter. 3. Plaintiffs acknowledge that Defendant is entitled to maintain its Case 1:22-cv-00020-TSK Document 296 Filed 05/14/25 Page 1 of 3 PageID #: 9098 2 Paragraph IV certification to U.S. Patent Nos. 7,041,786, 9,610,321, 9,616,097, 9,919,024, 9,925,231, 10,011,637, 11,142,549, 11,319,346, 11,834,521, and 12,146,003 pursuant to 21 C.F.R. § 314.94(a)(12)(v). 4. Each Party acknowledges and agrees that the 30-month stay with respect to the approval of the Mylan ANDA under 21 U.S.C. § 355(j)(5)(B)(iii) is expired. 5. Nothing herein shall prevent FDA from granting final approval to Mylan’s ANDA No. 215686 at any time, and Plaintiffs acknowledge that Mylan is entitled to pursue and obtain FDA approval for Mylan’s Abbreviated New Drug Application and the Mylan Product (as defined in the Parties’ Settlement Agreement) prior to expiration of U.S. Patent Nos. 7,041,786, 9,610,321, 9,616,097, 9,919,024, 9,925,231, 10,011,637, 11,142,549, 11,319,346, 11,834,521, and 12,146,003. 6. The Clerk of Court is directed to enter this Stipulation of Dismissal”
Source: PACER Docket, Case 1:22-cv-00020, West Virginia Northern District Court

The stipulation of dismissal is notable for what it explicitly preserves rather than what it resolves. The retention of Mylan’s Paragraph IV certifications to ten patents — including four not originally asserted in the case — confirms the settlement operates as a forward-looking license, not merely a litigation exit. The court’s retained jurisdiction clause is standard in Hatch-Waxman settlements and allows either party to enforce the confidential agreement without refiling. The absence of any cost award reflects a mutual concession consistent with a negotiated commercial resolution rather than a capitulation by either side.

PACER case 1:22-cv-00020 · Public docket record Explore in Eureka ↗
Patent at issue

US8637451B2 and 7 further patents — plecanatide GC-C agonist oral tablet franchise

Publication No.US8637451B2
Application No.US13/339785
Patent details
Productplecanatide GC-C agonist peptide formulations and oral dosage forms
Cited in actionMarch 9, 2022

Publication No.US9610321B2
Application No.US14/845644
Patent details
Productplecanatide oral tablet compositions and chronic constipation treatment methods
Cited in actionMarch 9, 2022

Publication No.US7041786B2
Application No.US10/107814
Patent details
Productguanylate cyclase-C agonist peptide and methods of treating gastrointestinal disorders
Cited in actionMarch 9, 2022

Publication No.US7799897B2
Application No.US11/347115
Patent details
Productplecanatide peptide pharmaceutical compositions
Cited in actionMarch 9, 2022

Publication No.US9925231B2
Application No.US15/467631
Patent details
Productmethods of treating constipation and IBS-C using GC-C agonist peptides
Cited in actionMarch 9, 2022

Publication No.US10011637B2
Application No.US14/896019
Patent details
Productoral GC-C agonist peptide formulations for gastrointestinal treatment
Cited in actionMarch 9, 2022

Publication No.US9919024B2
Application No.US15/467648
Patent details
Productmethods of treating chronic idiopathic constipation with guanylate cyclase-C agonists
Cited in actionMarch 9, 2022

Publication No.US9616097B2
Application No.US13/421769
Patent details
Productplecanatide oral dosage formulations and gastrointestinal treatment methods
Cited in actionMarch 9, 2022

The eight asserted patents span a multi-generational estate built around plecanatide, a synthetic 16-amino-acid guanylate cyclase-C (GC-C) agonist peptide that mimics uroguanylin to stimulate intestinal fluid secretion. The earliest patent in the estate (US7041786B2, application US10/107814) covers the foundational GC-C agonist peptide compositions. Later patents extend protection to specific oral tablet formulations, dosing regimens, and methods of treating chronic idiopathic constipation and IBS-C. The breadth of the estate — spanning composition-of-matter, formulation, and method-of-treatment claims — reflects a deliberate evergreening strategy around the Trulance® franchise.

For the gastrointestinal therapeutics sector, this patent estate matters because plecanatide competes directly with linaclotide (Linzess®), which faces its own generic entry dynamics. A robust multi-patent barrier around plecanatide was intended to preserve Bausch Health’s GI revenue post-acquisition of the Salix portfolio. The settlement outcome — conceding pre-expiry generic entry — suggests that while the estate successfully delayed Mylan, it could not achieve full exclusivity through expiry. Competitors developing next-generation GC-C agonists or formulation improvements should monitor continuation applications filing from the same priority chains.

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

Should your GI drug program run an FTO against US8637451B2 and the plecanatide estate?

Any company developing oral GC-C agonist peptides, chronic constipation therapies, or IBS-C treatments — including formulation scientists, biosimilar developers, and NDA/ANDA filers — should treat the Bausch/Salix plecanatide estate as a live clearance risk. The ten patents named in the final settlement extend across composition, formulation, and method-of-treatment claim types. Even with Mylan’s licensed entry confirmed, independent ANDA filers will face the same patent landscape without the benefit of a pre-negotiated license.

PatSnap Eureka’s FTO Search Agent can rapidly map all active claims across US8637451B2, US7041786B2, US9610321B2, and the remaining six asserted patents against your specific compound, formulation parameters, and proposed dosing regimen. Eureka’s citation analysis also surfaces continuation applications and prosecution history estoppel arguments that may narrow claim scope — critical intelligence before committing to an ANDA Paragraph IV strategy targeting the plecanatide indication.

PatSnap Eureka FTO Search

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Related litigation

Similar Hatch-Waxman GC-C agonist and GI peptide patent cases

Comparable Hatch-Waxman infringement actions involving GC-C agonist and gastrointestinal peptide patents litigated in U.S. district courts, including the West Virginia Northern District.

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Bausch Health Ireland, Ltd. patent enforcement history, West Virginia Northern case history, Bausch Health Ireland, Ltd.’s full IP portfolio, and comparable case analysis
Linzess® linaclotide ANDA casesSalix GI patent disputesMylan ANDA settlement patternsGC-C agonist IPR proceedings
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Strategic implications

What this case signals for the Hatch-Waxman GC-C agonist IP landscape

A 1,162-day fight ending in a licensed settlement reframes how the plecanatide patent estate should be evaluated by generic entrants and investors.

30-month stay expiry accelerates settlement pressure on originators

Once the 30-month stay expired, Bausch/Salix lost their most powerful procedural delay tool. Generic filers targeting constipation and IBS-C treatments should time ANDA submissions to maximise stay expiry as a settlement leverage point — the public record here suggests it was decisive.

Ten-patent estates do not guarantee extended exclusivity in ANDA disputes

Despite asserting eight patents in litigation (with ten listed in the final settlement), Bausch and Salix could not prevent a licensed pre-expiry entry. Larger patent estates raise litigation costs for generics but do not proportionally increase the likelihood of full-term exclusivity — a calibration point for both originators building evergreening strategies and generics assessing clearance costs.

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Unlock deeper analysis of Hatch-Waxman settlement dynamics and GC-C agonist patent exposure at the West Virginia Northern District Court level.
Mylan launch date signalsIPR vulnerability analysisComparable GI settlement terms
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Frequently asked questions

Bausch v Mylan — key questions answered

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Track every plecanatide and GC-C agonist patent move in real time

The Mylan settlement leaves the plecanatide patent estate intact and a confidential launch date undisclosed. PatSnap Eureka monitors new filings, continuation applications, and ANDA-related litigation across the full Bausch/Salix GI portfolio so you never miss a clearance risk.

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