Bausch Health v. Mylan: Trulance® Plecanatide ANDA Patent Settlement
Bausch Health Ireland and Salix Pharmaceuticals sued Mylan over a 10-patent portfolio protecting Trulance® (plecanatide) 3 mg oral tablets, alleging infringement triggered by Mylan’s ANDA filing. The case resolved in just 121 days via a confidential settlement and license agreement — with Mylan retaining its Paragraph IV certifications and a clear path to FDA approval before patent expiry.
ANDA patent standoff over Trulance® ends in negotiated licence
On January 13, 2025, Bausch Health Ireland Limited and Salix Pharmaceuticals, Inc. filed a patent infringement action in the U.S. District Court for the Northern District of West Virginia against Mylan Pharmaceuticals Inc., case no. 1:25-cv-00003, before Judge Thomas S. Kleeh. The suit was triggered by Mylan’s ANDA No. 215686 seeking approval for a generic version of Trulance® (plecanatide) 3 mg oral tablets, with Mylan having filed Paragraph IV certifications against ten Bausch/Salix patents, including the lead asserted patent US12,146,003 B2.
The action was dismissed with prejudice on May 14, 2025, pursuant to a Confidential Settlement and License Agreement. Critically, the stipulation expressly preserves Mylan’s Paragraph IV certifications against all ten patents and acknowledges that the 30-month stay on Mylan’s ANDA has expired. The parties further agreed that the FDA is not prevented from granting final approval to Mylan’s ANDA at any time, and Bausch/Salix acknowledged Mylan’s right to obtain approval and launch its product before all asserted patents expire.
Resolution within 121 days — well before discovery or claim construction proceedings would ordinarily commence — is consistent with settlements driven by a negotiated market entry date rather than litigation risk alone. The confidential nature of the licence terms means the precise launch date, royalty structure, and any exclusivity window granted to Mylan remain unknown from the public record. The express preservation of Paragraph IV rights and acknowledgment of ANDA approval rights strongly suggests Bausch secured a delayed but controlled generic entry rather than a litigation win.
Filing to Dismissed with Prejudice in 121 days
121 days — resolved well under the typical ANDA 30-month stay window
Dismissed with prejudice: what the Bausch–Mylan settlement means
Dismissal with prejudice via stipulated settlement
A dismissal with prejudice terminates all claims and counterclaims permanently — Bausch cannot re-file the same infringement claims against Mylan for this ANDA. The dismissal was entered by stipulation, meaning both parties consented, and the court retains jurisdiction solely to enforce the settlement agreement and related licence terms. No merits ruling was issued on any of the ten asserted patents.
Permanent bar on re-litigationBausch secures licence control but yields Paragraph IV standing
Bausch Health and Salix retain their patent portfolio and the confidential licence likely dictates when and how Mylan may enter the market. However, by expressly acknowledging Mylan’s right to maintain Paragraph IV certifications and pursue FDA approval before patent expiry, Bausch conceded that generic entry will occur prior to natural patent term exhaustion. The settlement converts litigation risk into a structured commercial arrangement, details of which are not publicly disclosed.
Controlled generic entry negotiatedMylan preserves Paragraph IV rights and ANDA approval path
The stipulation is notably favourable in its express terms for Mylan. The Paragraph IV certifications against all ten patents are preserved, the 30-month stay is confirmed expired, and Bausch acknowledges FDA may approve Mylan’s ANDA at any time. Mylan’s commercial launch timing will be governed by the confidential licence agreement — likely including a negotiated entry date — rather than patent expiry, typically a better commercial outcome than waiting out full patent term.
ANDA pathway and Para IV intactStructured generic entry signals managed Trulance® lifecycle
The settlement structure — with 30-month stay expired and ANDA approval unblocked — suggests Bausch prioritised a negotiated entry window over sustained exclusivity. For the GI pharmaceutical sector, this is consistent with brand-holder strategies that use patent litigation defensively to extract licence value rather than permanently exclude generics. Other ANDA filers targeting the plecanatide portfolio should monitor FDA approval timelines for Mylan’s ANDA No. 215686 as a market entry signal.
GI pharma lifecycle managementFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Bausch Health Ireland, Ltd. | Company | Pharmaceutical IP holding company — holder of US12146003B2 and Trulance® patent portfolioSearch in Eureka ↗ |
| Defendant | Mylan, NV | Company | Generic pharmaceutical manufacturer pursuing ANDA No. 215686 for plecanatide 3 mg tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Bryan C. Diner | 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 | Justin James Hasford | 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 | William J. O`Brien. | Attorney | Counsel for 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 records beyond mere case closure. By naming all ten asserted patent numbers, confirming the 30-month stay has expired, and acknowledging Mylan’s right to FDA approval before patent expiry, the parties created a public record that substantively defines the competitive landscape for plecanatide generics — even though the commercial licence terms remain confidential. The court’s retained jurisdiction to enforce the settlement agreement means any breach of licence terms could result in further proceedings before Judge Kleeh in the Northern District of West Virginia.
US12146003B2 — plecanatide formulation and treatment patent
US12,146,003 B2 (application no. US18/511852) is the lead asserted patent in a ten-patent portfolio covering Trulance® (plecanatide) 3 mg oral tablets, indicated for chronic idiopathic constipation and irritable bowel syndrome with constipation. The portfolio spans composition of matter, formulation, and method-of-use claims, representing a layered lifecycle protection strategy by Bausch Health and Salix Pharmaceuticals across multiple patent families. The breadth of the Paragraph IV certifications filed by Mylan — covering all ten patents — confirms Mylan considered each patent a meaningful barrier to generic entry.
Plecanatide is a synthetic guanylate cyclase-C agonist, and the patent estate reflects incremental innovation around formulation stability, dosing, and therapeutic application — a common lifecycle management architecture in branded GI therapeutics. For competitors active in the guanylate cyclase-C agonist space or adjacent GI constipation treatments, this portfolio’s survival through settlement without invalidity findings means all ten patents remain enforceable and available for assertion against future ANDA filers. The absence of any IPR petitions in the public record further suggests the portfolio has not been stress-tested at the PTAB.
Should you run an FTO against US12146003B2 and the Trulance® portfolio?
Any company developing a generic or biosimilar plecanatide product, a next-generation GC-C agonist, or a competing oral tablet formulation for chronic constipation or IBS-C should treat this ten-patent portfolio as an active enforcement risk. The Bausch–Mylan settlement confirms the patents remain intact and licensable — not invalidated — and the brand holder has demonstrated willingness to litigate ANDA challenges promptly. Formulation, composition, and method-of-use claims all require independent FTO analysis.
PatSnap Eureka’s FTO Search Agent can map your candidate formulation or compound against the full Bausch/Salix plecanatide patent family, identify claim-by-claim overlap, flag continuation and divisional applications that may extend coverage, and surface non-obviousness risks before you commit to ANDA preparation costs. Given the ten-patent breadth confirmed in this case, a comprehensive landscape search rather than a single-patent FTO is strongly advisable for any GC-C agonist product development programme.
Run a freedom-to-operate analysis on US12146003B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent litigation: GI pharmaceutical cases in U.S. district courts
Cases matching the Bausch–Mylan pattern: ANDA-triggered infringement suits over GI pharmaceutical patents resolved in U.S. district courts via confidential settlement and licence.
What this case signals for the GI pharmaceutical patent landscape
The Bausch–Mylan settlement is a textbook ANDA lifecycle management play — with implications for every company in the plecanatide competitive set.
30-month stay expiry shifts negotiating leverage to generic filers
Once the 30-month stay on an ANDA lapses, the brand holder loses its automatic exclusivity shield. Bausch’s explicit acknowledgment that Mylan can now pursue FDA approval at any time confirms that stay expiry materially altered the litigation economics, pushing both parties toward a negotiated licence rather than continued litigation.
Ten-patent portfolio did not prevent early settlement — breadth alone is not deterrence
Despite asserting ten patents including composition, formulation, and method-of-use claims across Trulance®, Bausch settled within 121 days. A large asserted patent count signals thorough lifecycle management but does not guarantee litigation durability — particularly when the generic challenger has preserved Paragraph IV certifications across the full portfolio.
Bausch v Mylan — key questions answered
Bausch Health Ireland and Salix Pharmaceuticals asserted ten patents covering Trulance® (plecanatide) 3 mg oral tablets: US7,041,786; US9,610,321; US9,616,097; US9,919,024; US9,925,231; US10,011,637; US11,142,549; US11,319,346; US11,834,521; and US12,146,003. The lead docketed patent was US12,146,003 B2 (application no. US18/511852). All ten patents were subject to Paragraph IV certifications by Mylan in its ANDA No. 215686.
The case was dismissed with prejudice on May 14, 2025, pursuant to a Confidential Settlement and License Agreement. The dismissal covered all complaints, claims, counterclaims, and affirmative defenses. No costs, disbursements, or attorney fees were awarded to either party. The court retained jurisdiction to enforce the settlement and related agreements.
Preserving Paragraph IV certifications means Mylan’s formal position that the Bausch/Salix patents are invalid or will not be infringed by its generic product remains intact in the FDA record under 21 C.F.R. § 314.94(a)(12)(v). This is significant because it means Mylan did not concede patent validity or infringement as part of the settlement, and the certifications support Mylan’s ongoing ANDA approval process.
Yes. The stipulation of dismissal in case 1:25-cv-00003 expressly states that the 30-month stay with respect to approval of Mylan’s ANDA under 21 U.S.C. § 355(j)(5)(B)(iii) has expired. Bausch Health and Salix further acknowledged in the stipulation that FDA is not prevented from granting final approval to Mylan’s ANDA No. 215686 at any time.
Plecanatide (brand name Trulance®) is a synthetic guanylate cyclase-C agonist indicated for chronic idiopathic constipation and irritable bowel syndrome with constipation in adults. It is marketed by Salix Pharmaceuticals. Its commercial significance in patent litigation stems from its status as a branded GI therapeutic with substantial market revenues, making it a prime target for ANDA generic challenges and necessitating a multi-patent lifecycle protection strategy by its holders.
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