Azurity Pharmaceuticals v. MSN Pharmaceuticals: FLEQSUVY® Patent Action Dismissed
Azurity Pharmaceuticals filed suit against MSN Pharmaceuticals in the District of New Jersey asserting two patents covering its FLEQSUVY® baclofen oral suspension. The case closed after 111 days when Azurity voluntarily dismissed without prejudice under Rule 41(a)(1)(A)(i), preserving its right to refile.
FLEQSUVY® formulation patents exit New Jersey court without merits ruling
On 25 July 2025, Azurity Pharmaceuticals, Inc. filed a patent infringement action against MSN Pharmaceuticals Inc. in the United States District Court for the District of New Jersey, Case No. 2:25-cv-13775. The complaint asserted two patents — US11324696B2 and US11446246B2 — directed to formulations underlying Azurity’s branded baclofen oral suspension product, FLEQSUVY®. The suit is consistent with Hatch-Waxman ANDA litigation patterns, in which branded pharmaceutical companies assert listed patents against generic applicants seeking FDA approval to market competing versions of a reference listed drug.
The case was voluntarily dismissed on 13 November 2025, 111 days after filing. Azurity invoked Federal Rule of Civil Procedure 41(a)(1)(A)(i), which allows a plaintiff to dismiss an action without a court order before the defendant serves an answer or a motion for summary judgment. The dismissal was expressly stated to be without prejudice, meaning Azurity retains the legal ability to refile the same claims against MSN Pharmaceuticals Inc. and MSN Laboratories Pvt. Ltd. at a future date. No costs or adverse judgment were imposed.
A voluntary dismissal without prejudice at this early stage typically signals one of several scenarios: a negotiated resolution between the parties, a strategic decision to refile in a different forum, or a reassessment of the litigation posture. The 111-day duration — ending before any answer on record — suggests the case resolved or was withdrawn before substantive engagement. The public docket does not disclose whether a licensing agreement, covenant not to sue, or other commercial arrangement accompanied the dismissal, and no settlement terms are publicly available.
Filing to Voluntary dismissal in 111 days
111 days — resolved before any substantive court ruling
Voluntarily dismissed: what the Rule 41 exit means for both parties
Rule 41(a)(1)(A)(i): plaintiff’s unilateral right to exit
Under FRCP 41(a)(1)(A)(i), a plaintiff may dismiss an action without court approval before the defendant files an answer or motion for summary judgment. No defendant agent appears on the docket, suggesting MSN had not yet answered. This procedural exit leaves no judicial ruling on the merits — the patents were neither validated nor invalidated by this proceeding.
No merits adjudicationWithout prejudice: the distinction that matters
A dismissal ‘with prejudice’ permanently bars the plaintiff from refiling the same claim — effectively a final judgment. A dismissal ‘without prejudice’ imposes no such bar: Azurity expressly preserved its right to bring the same patent claims against MSN in a future action. The public record does not disclose whether any side agreement — such as a covenant not to sue or settlement — accompanies this dismissal. That distinction is material for MSN’s ongoing FDA approval timeline.
Right to refile preservedMSN faces residual uncertainty despite dismissal
The without-prejudice dismissal means MSN Pharmaceuticals and MSN Laboratories Pvt. Ltd. cannot treat this case as a cleared obstacle. Unless a formal covenant not to sue exists — which is not publicly disclosed — Azurity may reassert US11324696B2 or US11446246B2 if MSN proceeds toward FDA approval of its ANDA product. MSN’s commercial launch plans for a baclofen oral suspension product may remain constrained by this patent overhang.
Patent risk not extinguishedFLEQSUVY® market exclusivity: the clock keeps running
In Hatch-Waxman litigation, a voluntary dismissal without prejudice can reflect a negotiated delay rather than a genuine exit. Azurity’s FLEQSUVY® patents remain in force and are not challenged by this outcome. Generic competitors — including MSN and potential follow-on ANDA filers — should treat these patents as active enforcement risks. The baclofen oral suspension space warrants continued FTO monitoring against both asserted patents.
Enforcement risk remains activeFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Azurity Pharmaceuticals, Inc. | Company | Specialty pharmaceutical company — holder of US11324696B2 and US11446246B2 (FLEQSUVY®)Search in Eureka ↗ |
| Defendant | MSN PHARMACEUTICALS INC, | Company | Generic pharmaceutical manufacturer and ANDA applicant, U.S. subsidiary of MSN Laboratories Pvt. Ltd.Search in Eureka ↗ |
| Plaintiff counsel | KRISTINA HANSON | Attorney | Counsel for Azurity Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | SEAN M. ANDERSON | Attorney | Counsel for Azurity Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | WENDI OPPER UZAR | Attorney | Counsel for Azurity Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff counsel | WENDY DEVINE | Attorney | Counsel for Azurity Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | RIKER DANZIG LLP | Law Firm | Representing Azurity Pharmaceuticals, Inc.Search in Eureka ↗ |
| Plaintiff law firm | WILSON, SONSINI, GOODRICH & ROSATI | Law Firm | Representing Azurity Pharmaceuticals, Inc.Search in Eureka ↗ |
| Presiding judge | Judge N/A | Judge | New Jersey District CourtSearch in Eureka ↗ |
Official order — verbatim text
The dismissal notice invokes Rule 41(a)(1)(A)(i) and expressly names both MSN Pharmaceuticals Inc. and MSN Laboratories Pvt. Ltd. as dismissed parties — suggesting both entities had been named or were anticipated defendants. The explicit ‘without prejudice’ language is legally operative: it forecloses any res judicata defense by MSN. No merits ruling was issued, no claim construction occurred, and the validity or infringement of US11324696B2 or US11446246B2 was not adjudicated by this court.
US11324696B2 & US11446246B2 — FLEQSUVY® baclofen oral suspension formulations
US11324696B2 (application US17/133415) and US11446246B2 (application US17/725923) are U.S. utility patents covering pharmaceutical formulation technology underlying FLEQSUVY®, Azurity’s baclofen oral suspension indicated for spasticity. Both patents are listed in the FDA Orange Book for FLEQSUVY®, which is the mechanism that triggers Hatch-Waxman patent certification obligations for any ANDA filer. The sequential application numbers suggest these patents represent a continuation or related family, with the later application (US17/725923) likely narrowing or extending claims from the earlier filing.
For a branded pharmaceutical company like Azurity, Orange Book-listed formulation patents are the primary commercial moat protecting a product from generic competition. By asserting these two patents in an ANDA context, Azurity signals it views the claims as covering any commercially viable baclofen oral suspension product that a generic filer would seek to market. The outcome of this case — and any future enforcement action — will materially affect the timing of generic entry into the baclofen oral suspension market, making claim scope and prosecution history critical inputs for competitor strategy.
Should you run an FTO against US11324696B2 and US11446246B2?
Any company developing, manufacturing, or seeking FDA approval for a baclofen oral suspension product should treat these two Orange Book-listed patents as active freedom-to-operate risks. The without-prejudice dismissal in this case does not extinguish Azurity’s enforcement rights. ANDA filers, 505(b)(2) applicants, and API suppliers in the baclofen supply chain should each assess whether their product formulations, excipient choices, or manufacturing processes fall within the independent claims of either patent.
PatSnap Eureka’s FTO Search Agent can rapidly map the claim landscape of US11324696B2 and US11446246B2, identify prior art that may limit claim scope, and surface related family members or continuation applications that could extend enforcement exposure. For product teams and regulatory affairs groups working on baclofen oral suspension generics, Eureka’s prosecution history analysis can reveal file-wrapper estoppel constraints that narrow the patents’ enforceable scope — a critical input before any Paragraph IV certification.
Run a freedom-to-operate analysis on US11324696B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent infringement cases: baclofen and oral suspension formulations
Cases in the District of New Jersey involving Hatch-Waxman assertions over oral suspension pharmaceutical formulation patents, including baclofen and related specialty drug products.
What this case signals for the pharmaceutical patent enforcement landscape
Early voluntary dismissals in ANDA litigation are rarely random — they typically signal negotiation, forum strategy, or commercial resolution.
Without-prejudice dismissals are not safe harbors for generic filers
MSN’s ANDA pathway for a baclofen oral suspension product is not cleared by this dismissal. Unless Azurity has provided a written covenant not to sue — which the docket does not reflect — the two asserted patents remain a live enforcement risk. Generic entrants and follow-on ANDA applicants should not treat this exit as a market green light.
Rule 41 exits before answer are a known tactic in Hatch-Waxman strategy
Filing and then voluntarily dismissing before an answer allows a branded company to reset litigation timelines, explore settlement, or test ANDA filing dates without triggering a 30-month stay expiration. IP teams tracking FLEQSUVY® competitive dynamics should monitor for a refiled action or supplemental Orange Book patent listings that could extend exclusivity.
Azurity v MSN — key questions answered
Azurity Pharmaceuticals asserted two patents: US11324696B2 (application US17/133415) and US11446246B2 (application US17/725923). Both patents are Orange Book-listed for FLEQSUVY®, Azurity’s baclofen oral suspension product, and cover pharmaceutical formulation technology relevant to that product.
The public docket does not disclose the reason. A Rule 41(a)(1)(A)(i) voluntary dismissal without prejudice before the defendant answers typically suggests a negotiated resolution, a strategic forum decision, or a commercial arrangement between the parties. No settlement terms or covenant not to sue are publicly available from this case record.
Not necessarily. A dismissal without prejudice does not extinguish the asserted patents or Azurity’s right to refile. Unless MSN holds a written covenant not to sue from Azurity — which the public record does not confirm — US11324696B2 and US11446246B2 remain active enforcement risks. MSN’s FDA approval timeline and any 30-month stay implications would need separate analysis.
FLEQSUVY® is Azurity Pharmaceuticals’ branded baclofen oral suspension, indicated for spasticity. As an FDA-approved drug with Orange Book-listed patents, any generic ANDA applicant must certify against those patents. A Paragraph IV certification — asserting the patents are invalid or not infringed — triggers the branded company’s right to file a 30-month stay lawsuit, which is the standard mechanism for this type of litigation.
The case was filed in the United States District Court for the District of New Jersey, Case No. 2:25-cv-13775. New Jersey is a common venue for Hatch-Waxman ANDA litigation, as many pharmaceutical companies have their principal place of business or registered agents in the state. The case was closed after 111 days without any merits ruling.
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