The Generic Drug Was Approved. The Cartridges Were the Problem.

The short version

• A generic version of United Therapeutics’ drug Remodulin was approved, but one way of delivering it depended on a pump-and-cartridge system whose manufacturer had announced it was discontinuing production.
• United Therapeutics paid to keep that system in production. Later, it gained approval rights over cartridge sales and used them as leverage to get pharmacies to agree that the cartridges would be used only with Remodulin.
• Those pharmacies warned that shrinking supplies could leave them unable to serve patients who needed continuous infusions. The court described the risk as serious; it did not find that patients were actually injured.
• Sandoz launched its generic for intravenous use in March 2019. It didn’t begin selling the generic for under-the-skin delivery until May 2021, after an alternative cartridge was approved. Quite a few years after, in fact!
• The Third Circuit upheld dismissal of the antitrust claims, accepting United Therapeutics’ supply-related justifications and finding the plaintiffs had not shown a workable, substantially less restrictive alternative.
• But the court revived the contract dispute for trial and sent a separate interference claim back for analysis. The previous $61.6 million judgment was vacated (meaning it was undone).

The ruling is not a clean bill of health for every part of the dispute. It is also not a finding that United Therapeutics broke the law. Some claims are over; others are not. Please continue reading nya

About my source legal document

This account is based on the Third Circuit’s October 7, 2026 opinion, not outside reporting. It separates the court’s decisions from the parties’ allegations.

A generic drug can be approved and still hit a wall

Here’s the strange part: the dispute was not just about the drug. Negatory! But rather, it’s actually about the thing that helps get the drug into a patient.

Treprostinil treats pulmonary arterial hypertension, a serious disease involving high blood pressure in the arteries running from the heart to the lungs. United Therapeutics sells it under the brand name Remodulin. The medicine can be delivered into a vein or under the skin. For under-the-skin delivery, patients use a pump and disposable cartridges.

Those cartridges were made by Smiths Medical, which had announced in 2015 that it planned to discontinue the CADD-MS 3 pump. That created a supply problem before the generic launch even began. United Therapeutics stepped in to fund continued production: in 2016, it paid Smiths $2.5 million up front for 7,000 pumps and 1.6 million cartridges. It later committed additional funding tied to another 2.1 million cartridges.

I know that’s a lot of technical details thrown at you all at once, but please stay with me owo

That investment had a legitimate-sounding purpose: keep a dwindling medical-device supply alive for people who relied on Remodulin. But the same equipment was also needed for Sandoz’s generic version of treprostinil. A supply arrangement that helped protect one drug’s delivery system could also become a gate between a branded drug and its cheaper competitor.

The timing shows how long the two launch milestones were apart. It does not, by itself, prove that the cartridge restrictions caused every part of the delay or every commercial loss.

The consequence: the generic arrived in stages

On March 25, 2019, Sandoz launched generic treprostinil—but only for intravenous use. Its under-the-skin version had to wait. RareGen, Sandoz’s marketing partner, contracted with another device manufacturer in May 2019 to develop alternative cartridges. The FDA approved the alternative on March 26, 2021. Sandoz began selling the subcutaneous generic in May 2021.

That be more than two years between the first generic launch and the under-the-skin launch. For patients and pharmacies, the distinction was not academic: a treatment option is useful only when the required delivery system and supplies are available. The court record does not establish that patients went without medication, were forced to switch treatments, or suffered actual injury. It does establish that pharmacies warned they could be unable to serve patients—and that the court regarded the risk as serious.

The commercial stakes were substantial too. The opinion discusses more than $6 million in Sandoz product ultimately destroyed after sales fell short of forecasts. But that number is not proof that United Therapeutics caused the entire loss. Causation and liability are separate questions, and the appellate ruling did not resolve them in Sandoz’s favor.

Scorecard: where each claim stands

Claim or issue	What the Third Circuit did	What it means in plain English
Federal antitrust claims	Dismissal affirmed	The plaintiffs did not overcome the supply-related justifications or prove a workable, less restrictive alternative.
Breach of contract	Reversed and sent back	The settlement is ambiguous; a fact-finder must decide what it promised. Breach is not yet established.
Tortious interference	Dismissal reversed and remanded	The claim must be assessed separately under state law; no liability finding was made.
Unfair/deceptive trade practices	Dismissal affirmed	The court found the claim did not identify sufficiently distinct conduct to proceed.
Damages expert	Admission affirmed	The district court was allowed to admit the expert’s analysis, which compared 33 forecast models and other corroborating material.
$61.6 million judgment	Vacated	The award no longer stands because the contract ruling it depended on was reversed.

Primary source: Sandoz, Inc. v. United Therapeutics Corp., Nos. 24-3067, 24-3116, and 24-3146, U.S. Court of Appeals for the Third Circuit, opinion filed October 7, 2026. This article is based on the supplied opinion and does not incorporate outside reporting.