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Actelion & Nippon Shinyaku v. Alembic — Selexipag Patent Consent Judgment | PatSnap
Patent Litigation

Actelion & Nippon Shinyaku v. Alembic: Consent Judgment & Permanent Injunction on Selexipag Patent

Actelion Pharmaceuticals and Nippon Shinyaku filed suit against Alembic in Delaware District Court over US7205302B2, covering selexipag tablets marketed as Uptravi. The case resolved in 92 days with a court-entered consent judgment and permanent injunction barring Alembic's generic ANDA products until at least October 31, 2026.

Resolution time
92days
Case resolved in 92 days — well under the median ANDA patent litigation timeline
Patents asserted
1
US7205302B2 — selexipag (Uptravi) tablets, heterocyclic compound derivative for pulmonary arterial hypertension
Outcome
Injunction Granted
Agreed by the parties, entered by the court — binding judgment with permanent injunction through Oct 31, 2026
Cost ruling
No Costs Awarded
Consent judgment expressly provides no costs, disbursements, or attorney fees to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

Permanent injunction locks out Alembic's generic selexipag until 2026

On April 4, 2023, Actelion Pharmaceuticals US, Inc., Actelion Pharmaceuticals Ltd., and Nippon Shinyaku Co., Ltd. filed an infringement action in the District of Delaware against Alembic Pharmaceuticals Limited and Alembic Pharmaceuticals, Inc., asserting U.S. Patent No. 7,205,302 (the "'302 Patent"). The patent covers heterocyclic compound derivatives, specifically selexipag — the active ingredient in Uptravi tablets used in the treatment of pulmonary arterial hypertension. The suit was triggered by Alembic's Abbreviated New Drug Application (ANDA No. 214414) seeking approval for generic selexipag tablets in six dosage strengths ranging from 0.2 mg to 1.6 mg.

The case closed on July 5, 2023, just 92 days after filing, via a consent judgment and order of permanent injunction entered by Judge Gregory B. Williams. Under the consent judgment, Alembic acknowledged the '302 Patent as valid and enforceable, and agreed to be permanently enjoined from making, using, selling, offering to sell, or importing its ANDA products in the United States until after the later of October 31, 2026, or the last day of any pediatric exclusivity period that may attach to the '302 Patent. The complaint and all remaining claims and counterclaims were dismissed without prejudice and without costs to any party. The recorded basis of termination is Injunction Granted; the docket order is styled as a consent judgment with a stipulated dismissal without prejudice of residual claims.

The 92-day resolution suggests the parties reached agreement shortly after service, which is consistent with the negotiated posture common in Hatch-Waxman ANDA litigation where generic entry timelines are often managed commercially rather than adjudicated. The consent judgment preserves the court's jurisdiction to enforce the injunction. The specific commercial terms underlying the parties' agreement — beyond those stated in the public court order — are not disclosed in the available record.

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Case at a glance
DefendantAlembic
CourtDelaware District Court
JudgeGregory B. Williams
FiledApril 4, 2023
ClosedJuly 5, 2023
Duration92 days
OutcomeInjunction Granted
Verdict causeInfringement Action
BasisInjunction Granted
Prior Art Intelligence
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Case timeline

Filing to Injunction Granted in 92 days

Case resolved in 92 days — well under the median ANDA patent litigation timeline

Case timeline: Complaint filed APR 4 2023 — 92 days total Horizontal timeline showing the three key events in Actelion Pharmaceuticals US, Inc. v Alembic from filing to resolution. Source: PACER, Delaware District Court. APR 4 2023 Complaint filed Pre-trial proceedings JUL 5 2023 Injunction Granted 92 DAYS TOTAL
Patent at issue

US7205302B2 — Selexipag heterocyclic compound derivative (Uptravi)

Publication No.US7205302B2
Application No.US10/476196
Patent details
ProductSelexipag tablets — heterocyclic compound derivative for pulmonary arterial hypertension (Uptravi)
Cited in actionApril 4, 2023
Technical brief · sourced from PatSnap patent database
Representative claim (1 of 7 independent)
1. A pharmaceutical composition comprising a heterocyclic compound represented by the following general formula (1) or a salt thereof as an active ingredient: wherein R 1 and R 2 are the same or different and each represents an optionally substituted aryl, and the substituents are the same or different and 1 to 3 substituents are selected from the group consisting of halogen, alkyl, haloalkyl, arylalkyl, alkoxy, alkylthio, alkoxyalkyl, alkylsulfonyl, hydroxy, amino, monoalkylamino, dialkylamino, carboxy, cyano and nitro, Y represents N or N→O, Z represents CR 6 ; and R 6 represents hydrogen, alkyl, or halogen, A…
Technical background
TECHNICAL FIELD The present invention relates to a novel heterocyclic derivative which is useful as a medicine, or a salt thereof, and a PGI 2 receptor agonist containing the same as an active ingredient. BACKGROUND ART Prostaglandin I 2 (PGI 2 ) is produced from arachidonic acid via prostaglandin H 2 (PGH 2 ) in the living body and has various potent pharmacological effects such as inhibition of platelet aggregation, vasodilation, inhibition of lipid deposition, and inhibition of leucocyte activation. It is theref…
Patent family
35 family members across 21 jurisdictions (BR, CA, NL, PT, MX, DK, AU, IT, CN, BE, RU, ES)
PatSnap Eureka · FTO Search Agent
Should you run an FTO against US7205302B2?

Any generic pharmaceutical manufacturer, API supplier, or specialty pharma company active in the pulmonary arterial hypertension space who is considering selexipag formulations, structurally related heterocyclic compound derivatives, or competing ANDA submissions should conduct a freedom-to-operate analysis against US7205302B2. The patent has been actively enforced and a defendant has acknowledged its validity in a binding court order — the commercial risk profile is materially higher than for an unenforced or contested compound patent.

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Official verdict

Official order — verbatim text

Plaintiffs Actelion Pharmaceuticals US, Inc. ("Actelion Inc.") and Actelion Pharmaceuticals Ltd ("Actelion Ltd") (together, "Actelion") and Nippon Shinyaku Co., Ltd. ("Nippon Shinyaku") ( collectively, "Plaintiffs") and Defendants Alembic Pharmaceuticals Limited ("Alembic Ltd.") and Alembic Pharmaceuticals, Inc. ("Alembic Inc.") ( collectively, "Defendants" or "Alembic") ( collectively, the "Parties"), by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and injunction in this action as follows: IT IS, this ~ day o;:::f',Yb , 2023 HEREBY ORDERED, ADJUDGED AND DECREED that: 1. For purposes of this action only, this Court has jurisdiction over the subject matter of the above action and has personal jurisdiction over the Parties. 2. As used in this Consent Judgment and Order of Permanent Injunction, (i) the term "the ' 302 Patent" means U.S. Patent No. 7,205,302, which Alembic agrees is valid and enforceable, (ii) the term "Alembic's ANDA Products" means the products described in Abbreviated New Drug Application ("ANDA") No. 214414 ("Alembic's ANDA"), namely 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.4 mg, and 1.6 mg selexipag tablets as a generic version ofUptravi tablets as existing on the date of entry of this Consent Judgment, and as amended or supplemented from time to time in the ordinary course of business, (iii) the term "Affiliate" shall mean any entity controlling, controlled by, or under common control with a Party, but only as long as such control continues, where "control" means: (1) the ownership of at least fifty percent (50%) of the equity or beneficial interest of such entity, or the right to vote for or appoint a majority of the board of directors or other governing body of such entity; or (2) the power to directly, or indirectly direct or cause the direction of the management and policies of such entity by any means whatsoever. 3. Unless otherwise authorized by Plaintiffs, Alembic, including any of its successors and assigns, is enjoined from making, using, selling or offering to sell in, or importing into, the United States Alembic's ANDA Products, on its own part or through any Affiliate, officer, agent, servant, employee or attorney, or through any person in concert or coordination with Alembic or its Affiliates, through and until after the later of (a) October 31 , 2026, or (b) the last day of any period of pediatric exclusivity that is or may become associated with the ' 302 Patent. 4. The Parties agree that jurisdiction and venue for an action to enforce performance under this Consent Judgment and Order of Permanent Injunction, including for a preliminary injunction against the breaching conduct, exists in this District Court, and the Parties hereby waive any and all defenses based on personal jurisdiction and venue. 5. This Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and Order of Permanent Injunction. 6. The Complaint and all remaining claims, counterclaims, or affirmative defenses in the above action are dismissed without prejudice and without costs, disbursements, or attorney fees to any party.
Source: PACER Docket, Case 1:23-cv-00383, Delaware District Court

The consent judgment order records Alembic's express acknowledgment that US7205302B2 is valid and enforceable, and imposes a permanent injunction through at least October 31, 2026, with a pediatric exclusivity extension clause. Residual claims are dismissed without prejudice. The recorded basis of termination is Injunction Granted; the order itself is styled as a consent judgment, with a stipulated without-prejudice dismissal of remaining claims. The specific terms negotiated between the parties beyond the four corners of the public order are not disclosed in the available record.

PACER case 1:23-cv-00383 · Public docket record Explore in Eureka ↗
Judgment terms

Consent judgment: what the agreed resolution means for both parties

Legal mechanism

A court-entered judgment binding on all parties

A consent judgment is a binding, court-entered judgment on terms agreed by the parties — it carries the full force of a judicial order, not merely a private settlement. Here, Judge Williams entered both a judgment and a permanent injunction. The court expressly retained jurisdiction to enforce or supervise performance, meaning any breach by Alembic can be addressed as a contempt or enforcement proceeding in the same court without re-filing.

Permanent injunction entered
Patent holder outcome

Uptravi exclusivity protected through at least October 2026

Actelion and Nippon Shinyaku secured court-entered protection for Uptravi without going to trial. Alembic expressly acknowledged the '302 Patent as valid and enforceable, which strengthens the patent's litigation posture against other ANDA filers. The injunction extends through the later of October 31, 2026, or the end of any applicable pediatric exclusivity period, providing a defined exclusivity runway for the branded product.

Validity acknowledged by defendant
Defendant outcome

Alembic enjoined from U.S. market entry until at least Oct 2026

Alembic is barred from commercialising its ANDA products in the U.S. for all six dosage strengths until the injunction period expires. Residual claims and counterclaims were dismissed without prejudice, which preserves certain legal positions for the future. No costs or attorney fees were awarded against Alembic. The specific commercial terms, if any, underlying the parties' agreement to the consent judgment are not disclosed in the available record.

Market entry delayed to 2026+
Commercial implications

ANDA challengers face a validated, court-acknowledged compound patent

Alembic's acknowledgment of validity and enforceability of the '302 Patent in a court-entered judgment is a commercially significant data point for other generic manufacturers tracking the selexipag ANDA landscape. It raises the risk profile for any competing ANDA filer targeting the same compound patent before the injunction period expires. Companies monitoring the Uptravi generic entry window should track both the October 2026 date and any pediatric exclusivity extension that may apply.

Heightened risk for competing ANDA filers
Legal analysis based on PACER docket records for case 1:23-cv-00383 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffActelion Pharmaceuticals US, Inc.Company/Search in Eureka ↗
Co-PlaintiffNippon Shinyaku Co., Ltd.CompanySearch in Eureka ↗
Co-PlaintiffActelion Pharmaceuticals, Ltd.CompanySearch in Eureka ↗
DefendantAlembicIndividual/Search in Eureka ↗
Co-DefendantAlembic Pharmaceuticals, Inc.CompanySearch in Eureka ↗
Plaintiff counselAndrew Colin MayoAttorneyCounsel for Actelion Pharmaceuticals US, Inc.Search in Eureka ↗
Plaintiff counselSteven J. BalickAttorneyCounsel for Actelion Pharmaceuticals US, Inc.Search in Eureka ↗
Plaintiff law firmAshby & Geddes PCLaw FirmRepresenting Actelion Pharmaceuticals US, Inc.Search in Eureka ↗
Defendant counselAnne Shea GazaAttorneyCounsel for AlembicSearch in Eureka ↗
Defendant law firmYoung Conaway Stargatt & Taylor, LLPLaw FirmRepresenting AlembicSearch in Eureka ↗
Presiding judgeJudge Gregory B. WilliamsJudgeDelaware District CourtSearch in Eureka ↗
R&D signals

R&D signals in the selexipag and PAH compound patent space

Forward-looking patent and R&D intelligence for teams tracking Actelion, Nippon Shinyaku, and the selexipag/PAH therapeutic landscape.

Patent portfolio

Actelion & Nippon Shinyaku's selexipag patent filing activity

Beyond the '302 compound patent, Actelion and Nippon Shinyaku are likely to hold continuation, formulation, and method-of-use patents around selexipag. Mapping their full portfolio in the heterocyclic compound and prostacyclin receptor agonist space can reveal the depth of the IP thicket protecting Uptravi and identify where generic or next-generation compound development may find freedom.

Selexipag patent family depth
Technology landscape

Filing trends in prostacyclin receptor agonists for PAH

Pulmonary arterial hypertension is a competitive therapeutic area with active patent filings across prostacyclin pathway agonists. Tracking filing trends around IP2 receptor agonists and selexipag-adjacent heterocyclic compounds can reveal which companies are building competing compound positions and where the next wave of ANDA or NDA challenges to incumbent PAH therapies may emerge.

PAH filing trends 2020–2025
Competitor IP posture

Alembic's generic pharmaceutical patent landscape

Alembic Pharmaceuticals has an active ANDA filing programme across multiple therapeutic areas. Analysing their patent filings and ANDA history in cardiovascular and respiratory drug spaces can signal where they are building generic entry positions next — and which branded compound patents may face ANDA challenges in upcoming litigation cycles.

Alembic ANDA pipeline signals
White space

Adjacent PAH compound derivatives beyond selexipag's claim scope

The '302 Patent's compound-level coverage of selexipag creates a defined exclusion zone, but the broader heterocyclic compound derivative space may contain structurally distinct PAH-active compounds outside current claim scope. R&D teams exploring next-generation IP2 receptor agonists or alternative PAH mechanisms should map claim boundaries against candidate structures to identify credible white space for novel compound filings.

PAH compound white space
Related litigation

Similar ANDA patent infringement cases involving selexipag and PAH drugs

Explore comparable Hatch-Waxman ANDA infringement cases in Delaware District Court involving compound patents in the pulmonary arterial hypertension and cardiovascular pharmaceutical space.

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Access 40+ similar cases in PatSnap Eureka
Actelion Pharmaceuticals US, Inc. patent enforcement history, Delaware District Court case history, Actelion Pharmaceuticals US, Inc.'s full IP portfolio, and comparable case analysis
Other Uptravi ANDA casesNippon Shinyaku enforcementPAH compound patent suitsActelion Delaware filings
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Strategic implications

What this case signals for the selexipag and PAH drug patent landscape

A rapid 92-day consent judgment with a defendant's validity acknowledgment sends a clear signal to the generic selexipag field.

Defendant's validity concession raises the bar for all ANDA challengers

When a generic filer concedes validity and enforceability in a court-entered consent judgment, it creates a reference point that other ANDA applicants and their counsel must account for. Any competitor targeting US7205302B2 before October 2026 should expect a well-fortified patent position backed by this precedent of rapid, successful enforcement.

Pediatric exclusivity tail is a live variable for generic entry timing

The injunction runs until the later of October 31, 2026, or the last day of any pediatric exclusivity tied to the '302 Patent. Companies modelling generic entry timelines for selexipag must track FDA's pediatric exclusivity determinations — the consent judgment does not cap Alembic's exclusion at 2026 if exclusivity extends further.

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Full strategic analysis in PatSnap Eureka
Unlock full strategic analysis of the selexipag ANDA patent landscape and consent judgment implications at district court level.
Portfolio enforcement mapCompeting ANDA filer riskExclusivity expiry scenarios
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Frequently asked questions

Actelion v Alembic — key questions answered

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PatSnap Eureka

Monitor selexipag patent enforcement and ANDA entry risk

Track new ANDA filings and litigation against US7205302B2 before the October 2026 injunction window opens. PatSnap Eureka surfaces enforcement activity, patent family depth, and competitor ANDA pipeline signals in real time.

Disclaimer

This page is compiled from public court dockets and third-party patent and litigation data via PatSnap Eureka, and is provided for general informational purposes only. The information shown — including party names, patent and application numbers, dates, case status, outcomes, and any analysis — may be incomplete, may not reflect the most recent filings or legal status, and may contain errors or omissions. Verify all details against official court records (for example, PACER) and the relevant patent office before relying on them.

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