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.
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.
Filing to Consent Judgment in 98 days
98 days — resolved well under the typical 30-month ANDA litigation stay window
Consent judgment and permanent injunction: what the order means for both sides
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 enteredValidity 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 upheldLannett’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 blockedUptravi® 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 preservedFull party and counsel information
| Role | Name | Type | Detail |
|---|---|---|---|
| Plaintiff | Actelion Pharmaceuticals US, Inc. | Company | Pharmaceutical IP holders — Uptravi® brand; holders of US9284280 and US8791122Search in Eureka ↗ |
| Co-Plaintiff | Shinyaku Co., Ltd. | Company | Search in Eureka ↗ |
| Co-Plaintiff | Actelion Pharmaceuticals, Ltd. | Company | Search in Eureka ↗ |
| Defendant | Lannett Company, Inc. | Company | Lannett Company, Inc. — generic pharmaceutical manufacturer; ANDA filer for selexipag tabletsSearch in Eureka ↗ |
| Plaintiff counsel | Andrew Colin Mayo | Attorney | Counsel for Actelion Pharmaceuticals US, Inc.Search in Eureka ↗ |
| Plaintiff counsel | Steven J. Balick | Attorney | Counsel for Actelion Pharmaceuticals US, Inc.Search in Eureka ↗ |
| Plaintiff law firm | Ashby & Geddes PC | Law Firm | Representing Actelion Pharmaceuticals US, Inc.Search in Eureka ↗ |
| Presiding judge | Judge Gregory B. Williams | Judge | Delaware District CourtSearch in Eureka ↗ |
Official order — verbatim text
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.
US9284280B2 & US8791122B2 — selexipag pharmaceutical compositions (Uptravi®)
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.
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.
Run a freedom-to-operate analysis on US9284280B2 to assess your product’s exposure
Run FTO in Eureka →Similar ANDA patent infringement cases: selexipag & PAH pharmaceutical disputes
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SettledRelated infringement action — same court
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DecidedActelion Pharmaceuticals US, Inc.’s broader IP enforcement history
Actelion Pharmaceuticals US, Inc.’s full litigation history covering prior enforcement, licensing activity, and inter partes review proceedings.
Portfolio viewWhat 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.
Patent term extension strategy may extend Uptravi® exclusivity window further
The consent judgment explicitly preserves the injunction through any patent term extensions and adjustments — a deliberate drafting choice. Stakeholders should model the maximum potential exclusivity period for US9284280 and US8791122, including Hatch-Waxman PTE eligibility, to accurately forecast the earliest possible generic entry date for selexipag in the US.
Other pending selexipag ANDA filers face a weakened invalidity posture after this concession
While the Lannett stipulation is action-specific, the public signal to the FDA ANDA pipeline and to competing generic manufacturers is material. Counsel advising other ANDA applicants on selexipag should reassess paragraph IV certification strength in light of this outcome and consider whether paragraph III or authorised-generic negotiations offer a lower-risk path to market.
Actelion v Lannett — key questions answered
Lannett stipulated that US Patent Nos. 9,284,280 and 8,791,122 are both valid and enforceable, for purposes of this action. Lannett also waived all rights to appeal or seek relief from the consent judgment and permanent injunction, which blocks commercialisation of its selexipag ANDA products until both patents expire.
The injunction covers all products described in Lannett’s ANDA No. 219117 — selexipag tablets in dosage strengths of 200 mcg, 400 mcg, 600 mcg, 800 mcg, 1000 mcg, 1200 mcg, 1400 mcg, and 1600 mcg, as generic versions of Uptravi®. Lannett, its successors, assigns, and affiliates are all bound.
Plaintiffs asserted US Patent No. 9,284,280 (application US14/160641) and US Patent No. 8,791,122 (application US13/379531), both covering pharmaceutical compositions of selexipag, the active ingredient in Uptravi®, a treatment for pulmonary arterial hypertension.
The complaint and all remaining claims, counterclaims, and affirmative defenses were dismissed without prejudice and without costs to any party. However, the central outcome was not the dismissal but the court-entered consent judgment and permanent injunction, which carries full legal force and is not subject to appeal under the terms of the stipulation.
The case resolved in 98 days from filing on 17 October 2024 to the consent judgment entered on 23 January 2025. This is notably swift within the typical 30-month Hatch-Waxman stay window and suggests Lannett assessed its invalidity and non-infringement arguments as unlikely to succeed after reviewing the patents’ scope, leading to a rapid negotiated resolution.
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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