Book a demo

Cut patent&paper research from weeks to hours with PatSnap Eureka AI!

Try now
Actelion v. Gland Pharma — Epoprostenol ANDA Patent Dispute | PatSnap
Explore in Eureka
Case ID1:24-cv-00434
FiledApr 2024
ClosedOct 2025
Patent Litigation

Actelion v. Gland Pharma: VELETRI® Patent Consent Judgment — 564 Days

Actelion Pharmaceuticals filed suit in Delaware against generic challenger Gland Pharma over US8598227, protecting epoprostenol sodium for injection sold as VELETRI®. The case resolved in 564 days via a consent judgment that validated the patent and enjoined Gland’s generic from the US market until patent expiry.

Resolution time
564days
564 days — below the median ANDA Hatch-Waxman trial timeline of ~730 days
Patents asserted
1
US8598227 — epoprostenol sodium for injection (VELETRI®), pulmonary arterial hypertension
Outcome
Consent Judgment
Patent valid and enforceable; Gland enjoined from US market until ‘227 patent expires
Cost ruling
Own Costs
Each party bears its own attorneys’ fees and litigation costs
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Hatch-Waxman ANDA consent judgment shields VELETRI® until expiry

Actelion Pharmaceuticals Ltd filed this action on 5 April 2024 in the United States District Court for the District of Delaware, asserting infringement of US8598227 — a patent covering formulations of epoprostenol sodium for injection commercialised as VELETRI®. The trigger was Gland Pharma’s ANDA No. 219237 containing a Paragraph IV certification, a statutory act of infringement under 35 U.S.C. §271(e)(2)(A) that required Actelion to respond to protect its NDA No. 022260 franchise.

The action closed on 21 October 2025 through a consent judgment agreed by both parties. The court found subject matter jurisdiction, personal jurisdiction, and venue all proper. Critically, Gland’s ANDA filing was adjudicated a technical act of infringement and the asserted claims of the ‘227 patent were declared valid and enforceable. An injunction was entered barring Gland from manufacturing, selling, or importing its generic product in the United States until the ‘227 patent expires, including any term extensions. Both parties agreed to bear their own fees and waived any right of appeal.

Resolution in 564 days — before reaching any Markman hearing or trial — suggests the parties identified an acceptable commercial arrangement relatively early in the litigation lifecycle. The consent judgment preserves Gland’s ANDA and allows FDA to grant final approval; Gland retains the right to enter the market under a written authorisation from Actelion, consistent with a potential future licensing arrangement the public record does not disclose. Whether royalties or milestone payments underpin the settlement is not reflected in publicly available filings.

Case at a glance
Case no.1:24-cv-00434
CourtDelaware
JudgeN/A
FiledApril 5, 2024
ClosedOctober 21, 2025
Duration564 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
See what prior art exists on this patent.
Eureka scans millions of patents and papers to surface prior art that may have invalidated these claims before costly litigation begins.
Check Prior Art
Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 564 days

564 days — below the median ANDA Hatch-Waxman trial timeline of ~730 days

Case timeline: Complaint filed APR 5 2024, JAN–FEB — 564 days total Horizontal timeline showing the three key events in Actelion Pharmaceuticals, Ltd. v Gland Pharma, Ltd. from filing to resolution. Source: PACER, Delaware District Court. APR 5 2024 Complaint filed Pre-trial proceedings OCT 21 2025 Consent Judgment 564 DAYS TOTAL
Dismissal terms

Consent judgment: what the agreed order means for both parties

Legal mechanism

Consent judgment is a court-enforceable agreed order

A consent judgment is not a unilateral dismissal — it is a binding court order entered on the parties’ agreement. Here it simultaneously adjudicates infringement and validity in Actelion’s favour and imposes an injunction. Because the parties expressly waived appeal, the order is final. All remaining claims, defences, and counterclaims were dismissed without prejudice, preserving theoretical future issues not addressed by the order.

Binding — appeal waived
Plaintiff outcome

Actelion secures patent validation and market exclusivity

The consent judgment delivers Actelion the core relief sought in any ANDA case: a court declaration that ‘227 patent claims are valid and enforceable and a market-blocking injunction against Gland’s generic. VELETRI® retains protected US market access until patent expiry. The order also allows Actelion to selectively authorise Gland’s entry in writing — preserving optionality for a future authorised generic arrangement without reopening litigation.

Injunction secured — market protected
Defendant outcome

Gland enjoined but ANDA preserved for future authorised entry

Gland cannot launch its generic epoprostenol sodium in the US without Actelion’s written consent until the ‘227 patent expires. However, the ANDA itself remains intact — FDA is not restricted from granting final approval, and Gland retains the right to file or maintain a Paragraph IV certification. This structure is consistent with an authorised generic or licence arrangement taking effect at or before patent expiry, though no such terms are publicly disclosed.

Enjoined — ANDA intact
Commercial implications

Reinforced exclusivity pattern for branded PAH therapies

The outcome is consistent with a wider industry pattern in which branded pulmonary arterial hypertension (PAH) drug holders secure consent judgments that delay generic entry to patent expiry while leaving a licensed entry pathway open. Other generic manufacturers with ANDA filings on epoprostenol formulations should assess the ‘227 patent’s remaining term and any pending term extensions before committing to litigation-only strategies, as consent-based resolutions raise the cost baseline for holdout challengers.

PAH exclusivity extended
Legal analysis based on PACER docket records for case 1:24-cv-00434 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffActelion Pharmaceuticals, Ltd.CompanyPharmaceutical innovator — holder of US8598227 covering VELETRI® epoprostenol sodium injectionSearch in Eureka ↗
DefendantGland Pharma, Ltd.CompanyGland Pharma Ltd — Indian generic pharmaceutical manufacturer, ANDA filer for generic epoprostenol sodiumSearch in Eureka ↗
Plaintiff counselJack B. BlumenfeldAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselJeremy A. TiganAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff counselLisa GlasserAttorneyCounsel for Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Plaintiff law firmMorris, Nichols, Arsht & Tunnell LLPLaw FirmRepresenting Actelion Pharmaceuticals, Ltd.Search in Eureka ↗
Defendant counselCharles K. ShihAttorneyCounsel for Gland Pharma, Ltd.Search in Eureka ↗
Defendant counselDominick T. GattusoAttorneyCounsel for Gland Pharma, Ltd.Search in Eureka ↗
Defendant counselEmer SimicAttorneyCounsel for Gland Pharma, Ltd.Search in Eureka ↗
Defendant counselJeffrey S. WardAttorneyCounsel for Gland Pharma, Ltd.Search in Eureka ↗
Defendant law firmHeyman Enerio Gattuso & Hirzel, LLPLaw FirmRepresenting Gland Pharma, Ltd.Search in Eureka ↗
Presiding judgeJudge N/AJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“WHEREAS, this action for patent infringement ("Action") was brought by Plaintiff Actelion Pharmaceuticals Ltd ("Actelion") against Defendant Gland Pharma Limited ("Gland," together with Actelion, "the Parties") for infringement of United States Patent No. 8,598,227 (the ‘227 patent); WHEREAS, Actelion currently markets in the United States, pursuant to New Drug Application No. 022260, epoprostenol sodium for injection, eq. 1.5 mg base/vial and eq. 0.5 mg base/vial, under the trade name VELETRI® (the "Veletri Product"); WHEREAS, Actelion’s commencement of the Action was based on its receipt of notice from Gland that it had filed with the United States Food and Drug Administration ("FDA") Abbreviated New Drug Application ("ANDA") No. 219237 (the "Gland ANDA") containing a "Paragraph IV certification" and seeking approval to engage in the commercial manufacture, use, offer for sale, and/or sale within the United States, and/or importation into the United States of generic versions of epoprostenol sodium for injection, eq. 1.5 mg base/vial and eq. 0.5 mg base/vial (the "Gland Product"), prior to the expiration of the ‘227 patent;WHEREAS, the Parties desire to avoid substantial litigation costs that would otherwise be incurred and conserve the parties’ and the Court’s resources by resolving the Action, and have agreed to resolve the Action for good and valuable consideration recognized by the parties; WHEREAS, the Parties have agreed to terminate the pending litigation by the entry of this Judgment and Order; and WHEREAS, Actelion and Gland now consent to this Judgment and Order. The Court, upon the consent and request of Actelion and Gland, and upon due consideration and for good cause shown, issues the following Consent Judgment and Dismissal Order. IT IS HEREBY ORDERED, ADJUDGED, AND DECREED THAT: Subject matter jurisdiction, personal jurisdiction, and venue are all proper in this 1. Court. The submission of the Gland ANDA to the FDA for the purpose of obtaining regulatory approval to engage in the commercial manufacture, use, sale, offer for sale, and/or importation of the Gland Product within the United States prior to the expiration of the ‘227 Patent was a technical act of patent infringement with respect to one or more claims of the ‘227 Patent under 35 U.S.C. §271(e)(2)(A). The Asserted Claims are valid and enforceable for purposes of this litigation with respect to the manufacture, use, sale, offer for sale, and/or importation of the Gland Product within the United States. Except to the extent authorized in writing by Actelion, Gland and its affiliates are hereby enjoined from manufacturing, using, offering for sale, selling in the United States, or importing into the United States, the Gland Product until the expiration of the ‘227 Patent, including any patent term extensions and/or patent term adjustments, other than as recognized by the parties.Nothing in this Judgment and Order shall be construed as prohibiting Gland from maintaining and/or (e.g., in the case of a recertification pursuant to 21 C.F.R. § 314.96(d)) filing a "Paragraph IV Certification" pursuant to 21 U.S.C. § 355(j)(2)(A)(vii)(IV) or pursuant to 21 C.F.R. § 314.94(a)(12) with respect to the Gland ANDA and the ‘227 Patent. Nothing in this Judgment and Order shall be construed as restricting the FDA from granting final approval of the Gland ANDA. Nothing in this Judgment and Order shall be construed as restricting Gland’s ability to commercially manufacture, use, offer for sale, have offered for sale, sell, have sold and/or import, have imported into the United States the Gland Product before the expiration of the ‘227 Patent as authorized by Actelion. All claims, affirmative defenses, and counterclaims in this action are hereby dismissed without prejudice. Each party shall bear its own fees and costs in connection with this Action, including attorneys’ fees. The Parties agree that there will be no appeal from this Judgment and Order. 11. This Court shall retain jurisdiction of this action and over the Parties for purposes of enforcement of the provisions of this Judgment and Order.”
Source: PACER Docket, Case 1:24-cv-00434, Delaware District Court

The consent judgment is notable for its dual function: it simultaneously resolves the litigation and creates a durable commercial framework. By adjudicating Gland’s ANDA filing as a technical act of infringement and declaring the ‘227 patent valid and enforceable, the order forecloses any estoppel-free re-litigation of those issues between these parties. The injunction’s explicit reference to patent term extensions and adjustments signals that Actelion sought — and obtained — protection against extended-term scenarios. The mutual appeal waiver and own-costs provision suggest a balanced negotiated resolution rather than a one-sided capitulation.

PACER case 1:24-cv-00434 · Public docket record Explore in Eureka ↗
Patent at issue

US8598227 — Epoprostenol sodium for injection formulation (VELETRI®)

Publication No.US8598227B2
Application No.US13/621489
Patent details
ProductStable epoprostenol sodium formulations for intravenous injection in pulmonary arterial hypertension
Cited in actionApril 5, 2024

US8598227 (application no. US13/621,489) covers formulations of epoprostenol sodium for injection — the active pharmaceutical ingredient in VELETRI®, Actelion’s commercially approved prostacyclin analogue for pulmonary arterial hypertension (PAH). VELETRI® is distinguished from earlier epoprostenol products by its thermostability, allowing storage at room temperature without the glycine buffer required by earlier products. The patent’s formulation claims are the commercial core of the NDA 022260 franchise.

From a competitive standpoint, US8598227 represents a significant barrier to generic entry in the US PAH injectable market. Epoprostenol sodium is the first-line intravenous therapy for severe PAH, commanding substantial pricing power and clinical entrenchment. The consent judgment’s validation of the patent’s claims strengthens Actelion’s enforcement posture against any remaining or future ANDA filers targeting the VELETRI® formulation. Companies developing thermostable prostacyclin formulations or alternative delivery systems should conduct a thorough FTO analysis against this patent and its family before IND filing.

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

Should you run an FTO analysis against US8598227?

Any company developing, manufacturing, or seeking to commercialise epoprostenol sodium injection products in the United States — including reformulations, biosimilar-adjacent generics, or combination device products — should treat US8598227 as a priority FTO target. The consent judgment’s validity finding, while not technically binding on third parties, signals that the patent survived adversarial scrutiny by a well-resourced generic challenger and their litigation counsel.

PatSnap Eureka’s FTO Search Agent can map the full claim scope of US8598227 against your product’s formulation parameters, identify design-around opportunities in the epoprostenol sodium formulation space, and surface related family members or continuation risks. For R&D teams at PAH-focused generics or specialty pharma companies, proactive FTO analysis now is materially cheaper than reactive ANDA litigation later.

PatSnap Eureka FTO Search

Run a freedom-to-operate analysis on US8598227B2 to assess your product’s exposure

Run FTO in Eureka →
Related litigation

Similar ANDA patent infringement cases in pharmaceutical formulation

Cases involving Paragraph IV ANDA challenges to pharmaceutical injection formulation patents in Delaware District Court, resolved by consent judgment or settlement.

🔍
Access 40+ similar cases in PatSnap Eureka
Actelion Pharmaceuticals, Ltd. patent enforcement history, Delaware case history, Actelion Pharmaceuticals, Ltd.’s full IP portfolio, and comparable case analysis
Other VELETRI® ANDA actionsPAH drug patent disputesDelaware consent judgment casesEpoprostenol formulation IP
Unlock similar cases in Eureka →
Strategic implications

What this case signals for the ANDA pharmaceutical IP landscape

Consent judgments that validate patents and enjoin generics while preserving ANDA approval rights are a structurally important settlement form in Hatch-Waxman litigation.

Early consent judgments shift leverage back to the innovator quickly

By settling before Markman or trial, Actelion converted a Paragraph IV challenge into a court-validated injunction in under two years. Generic challengers should factor in the reputational and financial cost of contesting well-defended ANDA cases — especially where branded products have established PAH market positions and clinical differentiation.

ANDA preserved with FDA approval pathway — watch for authorised generic deals

The consent judgment’s explicit preservation of Gland’s ANDA and FDA approval pathway is a structural tell: it leaves room for an authorised generic agreement to take effect at or around patent expiry. Competitors and payers monitoring the epoprostenol sodium market should track any FDA tentative approval notices for ANDA 219237 as a proxy for deal timing.

🔒
Full strategic analysis in PatSnap Eureka
Unlock deeper strategic analysis on US8598227 exclusivity, PAH ANDA filing trends, and Delaware District Court consent judgment patterns.
Patent term extension riskIPR vulnerability analysisAuthorised generic timing signals
Unlock full analysis →
Analysis powered by PatSnap Eureka Litigation Intelligence Explore in Eureka ↗
Frequently asked questions

Actelion v Gland — key questions answered

Still have questions? PatSnap Eureka can answer them instantly from patent and litigation data. Ask Eureka ↗
PatSnap Eureka

Monitor epoprostenol patent risk before your next ANDA filing

US8598227 has been court-validated in a consent judgment. PatSnap Eureka helps generic and specialty pharma teams run FTO searches, track patent expiry and extension filings, and monitor new enforcement actions before committing to ANDA strategy.

Ask anything about this case.
PatSnap Eureka searches patents and litigation data to answer instantly.
Powered by PatSnap Eureka
Link copied to clipboard

Related Litigation Cases

Help us improve this page

Found incorrect or outdated information? Let us know and we'll get it fixed.