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Actelion v. Lannett: Uptravi® Selexipag Patent Consent Judgment | PatSnap
Explore in Eureka
Case ID1:24-cv-01162
FiledOct 2024
ClosedJan 2025
Patent Litigation

Actelion & Nippon Shinyaku v. Lannett: Uptravi® Selexipag Consent Judgment

Actelion Pharmaceuticals and Nippon Shinyaku secured a consent judgment and permanent injunction against Lannett Company blocking its generic selexipag ANDA products across all eight dosage strengths of Uptravi®. Lannett acknowledged both patents valid and enforceable — the case resolved in just 98 days.

Resolution time
98days
98 days — resolved well under the typical 30-month ANDA litigation stay window
Patents asserted
2
US9284280B2 and US8791122B2 — selexipag (Uptravi®) pharmaceutical composition patents
Outcome
Consent Judgment
Lannett stipulated both patents valid and enforceable; permanent injunction entered
Cost ruling
No Costs
Parties agreed no costs, disbursements, or attorney fees awarded to any party
Published by PatSnap Insights Team · Verified by PatSnap Eureka Data
Case overview

ANDA infringement action ends in permanent injunction with Lannett’s concession

Filed on 17 October 2024 in the District of Delaware before Judge Gregory B. Williams, this action was brought by Actelion Pharmaceuticals US, Inc., Actelion Pharmaceuticals Ltd., and Nippon Shinyaku Co., Ltd. against Lannett Company, Inc. The plaintiffs asserted US Patent Nos. 9,284,280 and 8,791,122 — both covering selexipag, the active ingredient in Uptravi® — against Lannett’s ANDA No. 219117 seeking approval for generic selexipag tablets across eight dosage strengths from 200 mcg to 1600 mcg.

The case terminated on 23 January 2025 via a consent judgment and order of permanent injunction, stipulated by all parties. Lannett agreed both patents-in-suit are valid and enforceable, and is enjoined from making, using, selling, offering to sell, or importing its ANDA products in the United States until expiration of both patents, including any patent term extensions or adjustments. The complaint and all remaining claims were dismissed without prejudice and without costs to any party.

Resolution in 98 days is notably swift even by ANDA litigation standards, suggesting Lannett assessed its infringement exposure as strong after reviewing the patents’ scope. The concession of validity and enforceability — rather than a mere dismissal — strengthens Actelion’s and Nippon Shinyaku’s position against any future generic challengers. What remains unknown from the public record is whether any confidential licensing or market entry date agreement was negotiated alongside the consent judgment.

Case at a glance
Case no.1:24-cv-01162
CourtDelaware
JudgeGregory B. Williams
FiledOctober 17, 2024
ClosedJanuary 23, 2025
Duration98 days
OutcomeConsent Judgment
Verdict causeInfringement Action
BasisConsent Judgment
Prior Art Intelligence
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Case data sourced from PACER / Delaware District Court via PatSnap Eureka Litigation Intelligence Explore similar cases ↗
Case timeline

Filing to Consent Judgment in 98 days

98 days — resolved well under the typical 30-month ANDA litigation stay window

Case timeline: Complaint filed OCT 17 2024, DEC–JAN — 98 days total Horizontal timeline showing the three key events in Actelion Pharmaceuticals US, Inc. v Lannett Company, Inc. from filing to resolution. Source: PACER, Delaware District Court. OCT 17 2024 Complaint filed Pre-trial proceedings JAN 23 2025 Consent Judgment 98 DAYS TOTAL
Dismissal terms

Consent judgment and permanent injunction: what the order means for both sides

Legal mechanism

Consent judgment blocks Lannett until patent expiry

A consent judgment is a court-entered order reflecting the parties’ own agreement, carrying full legal force. Here, the court ordered a permanent injunction prohibiting Lannett from commercialising its ANDA products — in any form, through any affiliate or agent — until both US9284280 and US8791122 expire, including any patent term extensions. Lannett also waived all appellate rights, making the injunction final.

Permanent injunction entered
Patent holder outcome

Validity concession fortifies Uptravi® exclusivity

Actelion and Nippon Shinyaku obtained more than a dismissal — Lannett expressly stipulated that both patents are valid and enforceable. While this stipulation is ‘for purposes of this action only,’ it signals Lannett found no credible invalidity argument to mount. Combined with the waiver of appeal, brand-holders retain a strong exclusivity position against this particular generic entrant across all eight Uptravi® dosage strengths.

Both patents upheld
Generic challenger outcome

Lannett’s ANDA products blocked; no market entry path preserved

Lannett is enjoined from any commercial activity relating to its selexipag ANDA until patent expiry, and has waived all rights to appeal or seek relief from this judgment. The absence of any licensed market entry date in the public record suggests no authorised-generic or settlement licence was agreed. Lannett’s ANDA No. 219117 effectively remains on hold for the life of both patents.

ANDA commercialisation blocked
Commercial implications

Uptravi® faces no near-term generic erosion from this ANDA filer

The consent judgment removes Lannett as a generic competitor for selexipag tablets in the US market for the patent term. For payers, prescribers, and competing ANDA filers, this signals that the Uptravi® patent estate is actively enforced and that at least one challenger found it untenable to contest validity. Other pending ANDA applications for selexipag may face heightened scrutiny of their paragraph IV certification strategy in light of this outcome.

Brand exclusivity preserved
Legal analysis based on PACER docket records for case 1:24-cv-01162 and PatSnap Eureka litigation intelligence Search PatSnap Eureka ↗
Parties and representation

Full party and counsel information

RoleNameTypeDetail
PlaintiffActelion Pharmaceuticals US, Inc.CompanyPharmaceutical IP holders — Uptravi® brand; holders of US9284280 and US8791122Search in Eureka ↗
Co-PlaintiffShinyaku Co., Ltd.CompanySearch in Eureka ↗
Co-PlaintiffActelion Pharmaceuticals, Ltd.CompanySearch in Eureka ↗
DefendantLannett Company, Inc.CompanyLannett Company, Inc. — generic pharmaceutical manufacturer; ANDA filer for selexipag tabletsSearch 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 ↗
Presiding judgeJudge Gregory B. WilliamsJudgeDelaware District CourtSearch in Eureka ↗
Official verdict

Official order — verbatim text

“Plaintiffs Actelion Pharmaceuticals US, Inc. and Actelion Pharmaceuticals Ltd (together, "Actelion") and Nippon Shinyaku Co., Ltd. ("Nippon Shinyaku") (collectively, "Plaintiffs") and Defendant Lannett Company, Inc. ("Defendant" or "Lannett") (collectively, the "Parties"), by their respective undersigned attorneys, hereby stipulate and consent to entry of judgment and injunetion in this action as follows: day of Jawvary HEREBY ORDERED, ADJUDGED AND DECREED that: 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. As used in this Consent Judgment and Order of Permanent Injunction, (i) the term "Patents-in-Suit" means U.S. Patent Nos. 8,791,122 and 9,284,280 respectively, which Lannett agrees are both valid and enforceable, (ii) the term "Lannett’s ANDA Produets" means the 3. 4. products described in Abbreviated New Drug Application ("ANDA") No. 219117 ("Lannett’s ANDA"), namely selexipag tablets (200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, and 1600 mcg) as generic versions of Uptravi® as existing on the date of entry of this Consent Judgment, and as amended or supplemented, (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. Unless otherwise authorized by Plaintiffs, Lannett, including any of its successors and assigns, is enjoined from making, using, selling or offering to sell in, or importing into, the United States Lannett’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 Lannett or its Affiliates, until after the expiration of the Patents-in-Suit, including any patent term extensions and/or patent term adjustments and during the period of any associated exclusivity. 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. The Parties waive all right to appeal or otherwise move for relief from this Judgment and Order. 6. 7. 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. This Court retains jurisdiction to enforce or supervise performance under this Consent Judgment and Order of Permanent Injunction.”
Source: PACER Docket, Case 1:24-cv-01162, Delaware District Court

The consent judgment is notable for two reasons beyond the injunction itself. First, Lannett expressly agreed that both patents-in-suit are ‘valid and enforceable’ — a concession that, while limited to this action, goes further than a simple non-contest dismissal. Second, all parties waived the right to appeal or seek relief from the judgment, rendering the permanent injunction immediately final. The court retains jurisdiction to enforce compliance, and the dismissal of remaining claims without prejudice preserves theoretical future claims while practically closing this dispute.

PACER case 1:24-cv-01162 · Public docket record Explore in Eureka ↗
Patent at issue

US9284280B2 & US8791122B2 — selexipag pharmaceutical compositions (Uptravi®)

Publication No.US9284280B2
Application No.US14/160641
Patent details
Productselexipag pharmaceutical compositions and methods of use — Uptravi®
Cited in actionOctober 17, 2024

Publication No.US8791122B2
Application No.US13/379531
Patent details
Productselexipag pharmaceutical compositions and formulations — Uptravi®
Cited in actionOctober 17, 2024

US9284280B2 (application no. US14/160641) and US8791122B2 (application no. US13/379531) both cover pharmaceutical compositions and related aspects of selexipag, the active ingredient in Uptravi® — a prostacyclin receptor agonist approved for the treatment of pulmonary arterial hypertension (PAH). Uptravi® is available in eight dosage strengths (200 mcg–1600 mcg), all of which were encompassed by Lannett’s ANDA and therefore within the scope of the asserted patents.

Selexipag occupies a commercially critical position in the PAH market, and the patent estate around it is actively enforced — as this case demonstrates. For generic manufacturers, the breadth of dosage strengths covered and the explicit validity concession in the Lannett consent judgment signal that formulation-around strategies will face significant scrutiny. For competitors and licensees in the prostacyclin pathway space, both patents warrant close monitoring for patent term extension applications that could push exclusivity further than current expiry dates suggest.

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

Should your selexipag product programme run an FTO against US9284280 and US8791122?

Any company developing, manufacturing, or filing an ANDA for selexipag tablets — or any prostacyclin receptor agonist formulation that could be read onto these claims — should treat US9284280B2 and US8791122B2 as priority FTO targets. The Lannett case demonstrates that Actelion and Nippon Shinyaku will pursue litigation swiftly and that the patents have now withstood at least one adversarial validity challenge without contest. R&D teams working on PAH pipeline assets or next-generation selexipag formulations face non-trivial freedom-to-operate risk.

PatSnap Eureka’s FTO Search Agent can map your product’s technical features against the claim scope of US9284280B2 and US8791122B2, identify prior art that may limit claim breadth, and surface any continuation or divisional applications in the same family. Running a structured FTO now — before ANDA filing or product launch — is materially cheaper than defending consent judgment terms later. Eureka also tracks patent term extension filings and regulatory exclusivity periods, so your timeline modelling reflects the full statutory exclusivity picture.

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Related litigation

Similar ANDA patent infringement cases: selexipag & PAH pharmaceutical disputes

Explore comparable ANDA-triggered patent infringement actions in the PAH and specialty pharmaceutical space litigated in Delaware District Court.

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Actelion Pharmaceuticals US, Inc. patent enforcement history, Delaware case history, Actelion Pharmaceuticals US, Inc.’s full IP portfolio, and comparable case analysis
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Strategic implications

What this case signals for the selexipag and pulmonary arterial hypertension IP landscape

A swift consent judgment with a validity concession tells competitors and counsel more than a simple dismissal would.

Validity concession raises the bar for future selexipag paragraph IV challenges

Lannett’s stipulation that US9284280 and US8791122 are both valid and enforceable — though limited to this action — suggests the patents withstood pre-litigation scrutiny. Any subsequent ANDA filer contemplating a paragraph IV certification on these patents must now frame a clearly differentiated invalidity or non-infringement argument to avoid similar outcomes.

98-day resolution suggests aggressive early enforcement strategy by Actelion

Actelion and Nippon Shinyaku moved quickly from filing to judgment, consistent with a strategy of applying maximum early pressure on generic challengers. Companies holding branded pharmaceutical IP should note that swift litigation combined with robust patent estates can deter ANDA filers before costly discovery and trial phases are reached.

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Frequently asked questions

Actelion v Lannett — key questions answered

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Monitor selexipag patent enforcement and ANDA activity with PatSnap

The Lannett consent judgment signals active enforcement of the Uptravi® patent estate. Run an FTO against US9284280B2 and US8791122B2, track new ANDA filings for selexipag, and model patent expiry with Eureka’s pharmaceutical intelligence tools.

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