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.
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.
Filing to Dismissed with Prejudice in 1162 days
1,162 days — well above the ~730-day median for Hatch-Waxman district court cases
Confidential license secured: what the Mylan settlement means for both parties
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-litigationBausch/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 concededMylan 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 securedGeneric 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 uncertainFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bausch Health Ireland, Ltd. | Company | Specialty pharma IP holder — originator of Trulance® (plecanatide) GC-C agonist franchiseSearch in Eureka ↗ |
| Co-Plaintiff | Salix Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Defendant | Mylan, NV | Company | Generic pharmaceutical manufacturer (Mylan/Viatris group) seeking ANDA approval for plecanatideSearch in Eureka ↗ |
| Co-Defendant | Mylan Pharmaceuticals, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Mylan, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Viatris, Inc. | Company | Search in Eureka ↗ |
| Co-Defendant | Mylan API US, LLC | Company | Search in Eureka ↗ |
| Co-Defendant | Agila Specialties Inc. | Company | Search in Eureka ↗ |
| Plaintiff counsel | Ashley Nichole Deem | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Bryan C. Diner | Attorney | Counsel for Bausch Health Ireland, Ltd.Search in Eureka ↗ |
| Plaintiff counsel | Caitlin E. O’Connell | 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 | J. BRUGH LOWER | 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 | Kyu Yun Kim | 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 | M. David Griffith , Jr. | 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 | SCOTT JOEL ETISH | 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 counsel | William P. Deni , Jr. | 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 | Gibbons PC | 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 | Arnold B. Calmann | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Catherine Magdy Soliman | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Gordon H. Copland | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | Jakob Benjamin Halpern | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant counsel | William J. O’Brien | Attorney | Counsel for Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Saiber, LLC | Law Firm | Representing Mylan, NVSearch in Eureka ↗ |
| Defendant law firm | Steptoe & Johnson PLLC – Bridgeport | 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 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.
US8637451B2 and 7 further patents — plecanatide GC-C agonist oral tablet franchise
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.
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.
Run a freedom-to-operate analysis on US8637451B2 to assess your product’s exposure
Run FTO in Eureka →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.
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
Comparable Trulance® Plecanatide oral tablets, 3 mg-adjacent infringement action. Patent enforcement dynamics analysed in depth.
Active · District CourtRelated invalidity challenge — appellate outcome
Combined invalidity and infringement action in the same technology space. Decided after substantive proceedings.
DecidedBausch Health Ireland, Ltd.’s broader IP enforcement history
Bausch Health Ireland, Ltd.’s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat 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.
The confidential launch date in ANDA No. 215686 is the key commercial variable
All commercial forecasting for plecanatide market share hinges on the undisclosed Mylan launch date. PatSnap Eureka can surface comparable Hatch-Waxman settlement timelines in the GI therapeutics space to triangulate the likely exclusivity window granted to Bausch/Salix under this agreement.
Paragraph IV certification survival signals residual challenge risk for remaining patents
Mylan’s preserved Paragraph IV certifications to patents not originally asserted in litigation — including US11142549, US11319346, US11834521, and US12146003 — suggest these newer patents were added to the estate post-filing. Future ANDA challengers should assess whether these continuations are independently vulnerable to IPR or obviousness-type double-patenting attacks.
Bausch v Mylan — key questions answered
The parties settled via a Confidential Settlement and License Agreement, dismissing all claims with prejudice and without costs. The settlement preserved Mylan’s Paragraph IV certifications to ten plecanatide patents and confirmed Mylan’s right to pursue FDA approval for ANDA No. 215686 before patent expiry. The specific licensed launch date was not disclosed in the public filing.
Eight patents were asserted in the complaint: US8637451B2, US9610321B2, US7041786B2, US7799897B2, US9925231B2, US10011637B2, US9919024B2, and US9616097B2. The final settlement referenced ten patents in total, including US11142549, US11319346, US11834521, and US12146003 — suggesting additional patents were added during the litigation period.
Yes. The stipulation of dismissal explicitly states that nothing prevents the FDA from granting final approval to Mylan’s ANDA No. 215686, and plaintiffs acknowledged Mylan’s right to pursue approval before patent expiry. The exact launch date is governed by the Confidential Settlement and License Agreement and is not publicly disclosed.
A Paragraph IV certification challenges the validity or non-infringement of listed patents. By preserving these certifications under 21 C.F.R. § 314.94(a)(12)(v), the settlement allows Mylan’s ANDA to remain pending and eventually receive FDA approval without requiring the certifications to be withdrawn to Paragraph III. This is the standard structure for a Hatch-Waxman licensed entry agreement.
Under 21 U.S.C. § 355(j)(5)(B)(iii), a Hatch-Waxman lawsuit filed within 45 days of notice of a Paragraph IV certification triggers an automatic 30-month stay of FDA approval. The stipulation confirms this stay had expired by settlement, meaning FDA could have approved Mylan’s ANDA at any time regardless of litigation outcome — significantly reducing plaintiffs’ leverage and likely accelerating settlement.
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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