Orenitram Generic: When Will Generic Treprostinil Diolamine Be Available?

Orenitram’s Road to a Generic

Orenitram has had the market to itself since the FDA approved it in December 2013 (United Therapeutics Corp). Its FDA protection (orphan drug) runs to October 2026. Its 9 listed patents run to August 2031 (2 already expired). Generic companies have challenged its patents with the FDA since December 2015.

The first generic of Orenitram is expected in June 2027.

Why that month: the brand company and a generic maker settled their patent fight and agreed on when a generic can launch. That is about 4 years before the last listed patent runs out, in August 2031.

Each bar runs from the brand’s approval to the day that protection ends. The green band is our projection for the first generic: a month, never a day, because legal dates move and a generic reaches shelves days to weeks after it is allowed. Sources: FDA Orange Book; the expected month from court records and company announcements.

Orenitram Patents and FDA Protections

Every patent and exclusivity the FDA Orange Book lists for Orenitram’s own applications. A protection running past the expected month does not mean the date is wrong: a settlement or a court ruling can let a generic in before a patent ends, and a patent on one formulation or use does not block every generic.

Source: FDA Orange Book, application 203496. Patent numbers open the patent on Google Patents.

Patent Challenges to Orenitram

The first patent challenge to Orenitram reached the FDA in December 2015, from one company on that first day. The FDA’s list has 3 entries for Orenitram, by form and strength.

Source: the FDA’s Paragraph IV Patent Certifications list, as of September 2026. The FDA began posting the 180-day decisions and the first challenger’s approval and first sale in June 2019: an older entry it has not updated since reads “Not posted”, and “Not yet” means the list records no such event. “Companies that day” is the FDA’s count of challenges that arrived on the first day.

Who Is Lined Up to Make Generic Treprostinil Diolamine

Three steps stand between a brand and a generic you can buy: a company applies to the FDA, the FDA approves it, and the company starts selling it.

Sources: how many companies have applied, from court records and company announcements; approved generics from the FDA Orange Book; tentative approvals from Drugs@FDA; what is for sale from the FDA NDC Directory. The FDA does not disclose an application before it approves it (21 CFR 314.430).

Orenitram Price: What Pharmacies Pay and What Generics Usually Do

What Medicare and Medicaid Spend on Orenitram

Big public spending is part of why generic makers line up for a medicine, and why its first generic matters beyond the pharmacy counter. Figures are before manufacturer rebates, which are confidential.

Orenitram Strengths and Forms

Source: FDA Orange Book, United Therapeutics Corp. Listed for sale today by United Therapeutics Corporation (FDA NDC Directory).

Orenitram NDC Codes and Packages

Each Orenitram package sold today has its own NDC, the product number printed on the box and on the pharmacy label. Open one to see that package’s details, what pharmacies pay for it and its patent timeline.

Source: the FDA NDC Directory, current listings only. Only packages sold under Orenitram’s own FDA approval (NDA 203496) are listed, never a generic. Some codes belong to companies that repackage Orenitram: it is the same medicine in a different package.

Changes to This Projection

• October 2026First generic expected June 2027 on this month’s schedule. A line is added here whenever a monthly update moves the month, the reason or how sure it is.

Every change to the expected month is logged here with the month we saw it.