Question 1

Is there a generic for Treprostinil diolamine?

Accepted Answer

The FDA Orange Book does not currently list an approved generic (ANDA) for Treprostinil diolamine. It is available as 1 brand (NDA) application.

Question 2

What is the reference-listed drug for Treprostinil diolamine?

Accepted Answer

ORENITRAM (NDA 203496, UNITED THERAP) is the reference-listed drug — the approved product a generic applicant must show its version is the same as.

Question 3

What patents protect Treprostinil diolamine?

Accepted Answer

The Orange Book lists 9 patents against Treprostinil diolamine products, with the earliest listed expiry in 2026. Listed patents cover the drug substance, drug product, or approved methods of use, and a generic launching before they expire must file a Paragraph IV certification.

Question 4

Does Treprostinil diolamine have FDA marketing exclusivity?

Accepted Answer

Yes. The Orange Book records 5 marketing-exclusivity periods for Treprostinil diolamine. Exclusivity is granted by FDA at approval (for example new-chemical-entity, orphan-drug, or pediatric exclusivity) and runs independently of any listed patents.

Question 5

What dosage forms of Treprostinil diolamine are approved?

Accepted Answer

Treprostinil diolamine is approved in the following dosage form: tablet, extended release.

Patent	Expires	In	Type
9393203	Apr 27, 2026	2 mo ago	ProductU-1877
7417070	Jul 30, 2026	in 1 mo	Substance
9604901	Dec 15, 2028	in 2 yr 6 mo	SubstanceDelisted
11723887	Dec 15, 2028	in 2 yr 6 mo	Substance
9593066	Dec 15, 2028	in 2 yr 6 mo	Substance
8497393	Dec 15, 2028	in 2 yr 6 mo	SubstanceDelisted
8410169	Feb 13, 2030	in 3 yr 9 mo	Product
8349892	Jan 22, 2031	in 4 yr 8 mo	Product
8747897	Aug 11, 2031	in 5 yr 3 mo	ProductU-2725

Treprostinil diolamine

Brand (NDA) products · tablet, extended release

Marketing exclusivity (5)

Listed patents (9)

Treprostinil diolamine — frequently asked questions

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