Drybench Patent.

TREPROSTINIL DIOLAMINE, NDA 203496

The patents and exclusivities FDA's Orange Book lists for NDA 203496 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured: 14 October 2026
Paragraph IV list captured: 17 October 2026
Last checked: 30 October 2026
Data-branch commit: dadcab56563716abea6c5e31a5e1970080c778ef

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

Open in the app TREPROSTINIL DIOLAMINE in the molecule app

Listed protection

Listed dates run from 27 Apr 2026 to 11 Aug 2031, each by its own rule; no one date stands for this product.

Earliest listed date: 27 Apr 2026US 9,393,203, product and use patentRule R1 · Products 001, 002, 003, 004, 005 · patent.txt lines 3,952, 3,962, 3,971, 3,980, 3,988
Latest listed date: 11 Aug 2031US 8,747,897, product and use patentRule R1 · Products 001, 002, 003, 004, 005 · patent.txt lines 3,951, 3,961, 3,970, 3,979, 3,987
Latest substance patent: 15 Dec 2028US 9,604,901, substance patentRule R1 · Products 001, 005 · patent.txt lines 3,954, 3,990
Latest listed patent: 11 Aug 2031US 8,747,897, product and use patentRule R1 · Products 001, 002, 003, 004, 005 · patent.txt lines 3,951, 3,961, 3,970, 3,979, 3,987
Latest exclusivity: 18 Oct 2026ODE-272 exclusivityRule R3 · Products 001, 002, 003, 004, 005 · exclusivity.txt lines 331–335

5 patents with a delist request, kept in the table · 15 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 203496, as listed. The sections below name products by these numbers.

Product 001 · ORENITRAM
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
EQ 0.125MG BASE
Approval date as listed
20 Dec 2013
Type as listed
RX
Applicant as listed
UNITED THERAPEUTICS CORP
Product 002 · ORENITRAM
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
EQ 0.25MG BASE
Approval date as listed
20 Dec 2013
Type as listed
RX
Applicant as listed
UNITED THERAPEUTICS CORP
Product 003 · ORENITRAM
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
EQ 1MG BASE
Approval date as listed
20 Dec 2013
Type as listed
RX
Applicant as listed
UNITED THERAPEUTICS CORP
Product 004 · ORENITRAM
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
EQ 2.5MG BASE
Approval date as listed
20 Dec 2013
Type as listed
RX
Applicant as listed
UNITED THERAPEUTICS CORP
Product 005 · ORENITRAM
Dosage form; route
TABLET, EXTENDED RELEASE;ORAL
Strength
EQ 5MG BASE
Approval date as listed
7 Oct 2016
Type as listed
RX
Applicant as listed
UNITED THERAPEUTICS CORP

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

10 entries from 45 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

US 9,393,203, product and use patent
patent.txt lines 3,952, 3,962, 3,971, 3,980, 3,988
Expiry as listed
27 Apr 2026
Rule
R1
Flags
product · use code U-1877
Product numbers
001, 002, 003, 004, 005
US 7,417,070, substance patent
patent.txt lines 3,947, 3,956, 3,965, 3,974, 3,983
Expiry as listed
30 Jul 2026
Rule
R1
Flags
substance
Product numbers
001, 002, 003, 004, 005
US 11,723,887, substance patent
patent.txt lines 3,946, 3,955, 3,964, 3,973, 3,982
Expiry as listed
15 Dec 2028
Rule
R1
Flags
substance
Product numbers
001, 002, 003, 004, 005
US 8,497,393, substance patent
patent.txt lines 3,959, 3,968, 3,977
Expiry as listed
15 Dec 2028
Rule
R1
Flags
substance · delist requested
Product numbers
002, 003, 004
US 9,593,066, substance patent
patent.txt lines 3,953, 3,963, 3,972, 3,981, 3,989
Expiry as listed
15 Dec 2028
Rule
R1
Flags
substance
Product numbers
001, 002, 003, 004, 005
US 9,604,901, substance patent
patent.txt lines 3,954, 3,990
Expiry as listed
15 Dec 2028
Rule
R1
Flags
substance · delist requested
Product numbers
001, 005
US 8,410,169, product patent
patent.txt lines 3,949, 3,958, 3,967, 3,976, 3,985
Expiry as listed
13 Feb 2030
Rule
R1
Flags
product
Product numbers
001, 002, 003, 004, 005
US 8,349,892, product patent
patent.txt lines 3,948, 3,957, 3,966, 3,975, 3,984
Expiry as listed
22 Jan 2031
Rule
R1
Flags
product
Product numbers
001, 002, 003, 004, 005
US 8,747,897, product and use patent
patent.txt lines 3,950, 3,960, 3,969, 3,978, 3,986
Expiry as listed
11 Aug 2031
Rule
R1
Flags
product · use code U-2724
Product numbers
001, 002, 003, 004, 005
US 8,747,897, product and use patent
patent.txt lines 3,951, 3,961, 3,970, 3,979, 3,987
Expiry as listed
11 Aug 2031
Rule
R1
Flags
product · use code U-2725
Product numbers
001, 002, 003, 004, 005

Listed exclusivities

Each exclusivity FDA lists for NDA 203496, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

ODE-272 exclusivity
exclusivity.txt lines 331–335
Date
18 Oct 2026
Rule
R3
Definition
Orphan drug exclusivity (to be checked against FDA's list)
Product numbers
001, 002, 003, 004, 005

Paragraph IV list rows giving NDA 203496

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 203496, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 203496

Treprostinil · Extended-release Tablets · 0.125 mg and 5 mg
RLD/NDA as listed: Orenitram 203496
First PIV submission
28 Dec 2020
ANDAs
1
180-day status
blank
Decision posted
blank
First applicant approval
blank
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
11 Aug 2031
Treprostinil · Extended-release Tablets · 0.25 mg and 1 mg
RLD/NDA as listed: Orenitram 203496
First PIV submission
19 May 2016
ANDAs
1
180-day status
blank
Decision posted
blank
First applicant approval
blank
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
22 Jan 2031
Treprostinil · Extended-release Tablets · 2.5 mg
RLD/NDA as listed: Orenitram 203496
First PIV submission
24 Dec 2015
ANDAs
1
180-day status
blank
Decision posted
blank
First applicant approval
blank
First marketing
blank
Last qualifying patent expiry (as listed by FDA)
22 Jan 2031

Notes from the trace

R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivity How to read the Orange Book data files Paragraph IV certification What changed, by week