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Orenitram

treprostinil · Tablet, Extended Release

Prescription NDA RLD
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Orenitram
Generic name
treprostinil
Dosage form
Tablet, Extended Release
Route
Oral
Marketing category
NDA · NDA
Labeler
United Therapeutics Corporation
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
5
NDC product codes
5
Packages
10
Data completeness
60% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Treprostinil .125 mg/1 349407 View
Treprostinil .25 mg/1 349407 View
Treprostinil 1 mg/1 349407 View
Treprostinil 2.5 mg/1 349407 View
Treprostinil 5 mg/1 349407 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Extended Release
Route of administration
Oral
Presentations
15

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Prostacycline Vasodilator [EPC] EPC 8 members — no class page
Prostaglandins I [CS] CS 8 members — no class page
Vasodilation [PE] PE All 31 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
203496
Application type
NDA · New Drug Application
Approval date
December 20, 2013
Sponsor
UNITED THERAP
Products on application
5
Submissions recorded
8
Products approved under application 203496.
Product Trade name Form Strength Ingredient Status TE Flags
203496-001 ORENITRAM TABLET, EXTENDED RELEASE TREPROSTINIL DIOLAMINE Prescription — RLD
203496-002 ORENITRAM TABLET, EXTENDED RELEASE TREPROSTINIL DIOLAMINE Prescription — RLD
203496-003 ORENITRAM TABLET, EXTENDED RELEASE TREPROSTINIL DIOLAMINE Prescription — RLD RS
203496-004 ORENITRAM TABLET, EXTENDED RELEASE TREPROSTINIL DIOLAMINE Prescription — RLD
203496-005 ORENITRAM TABLET, EXTENDED RELEASE TREPROSTINIL DIOLAMINE Prescription — RLD

Therapeutic equivalence

Source: Orange Book
TE code
—
Reference Listed Drug
Yes
Reference Standard
Yes

Codes beginning with “A” indicate products the FDA considers therapeutically equivalent. Codes beginning with “B” indicate bioequivalence has not been established. See methodology.

Patents and exclusivity

Source: Orange Book
Patent listings submitted under 21 U.S.C. 355(b)(1) and (c)(2).
Patent Expires Product Substance Use code Submitted
9393203 April 27, 2026 001 No U-1877 July 22, 2016
9393203 April 27, 2026 002 No U-1877 July 22, 2016
9393203 April 27, 2026 003 No U-1877 July 22, 2016
9393203 April 27, 2026 004 No U-1877 July 22, 2016
9393203 April 27, 2026 005 No U-1877 February 9, 2017
7417070 July 30, 2026 001 Yes January 9, 2014
7417070 July 30, 2026 002 Yes January 9, 2014
7417070 July 30, 2026 003 Yes January 9, 2014
7417070 July 30, 2026 004 Yes January 9, 2014
7417070 July 30, 2026 005 Yes February 9, 2017
9604901 December 15, 2028 001 Yes March 28, 2017
11723887 December 15, 2028 001 Yes August 15, 2023
9593066 December 15, 2028 001 Yes March 14, 2017
9593066 December 15, 2028 002 Yes March 14, 2017
8497393 December 15, 2028 002 Yes January 9, 2014
11723887 December 15, 2028 002 Yes August 15, 2023
11723887 December 15, 2028 003 Yes August 15, 2023
9593066 December 15, 2028 003 Yes March 14, 2017
8497393 December 15, 2028 003 Yes January 9, 2014
11723887 December 15, 2028 004 Yes August 15, 2023
8497393 December 15, 2028 004 Yes January 9, 2014
9593066 December 15, 2028 004 Yes March 14, 2017
9593066 December 15, 2028 005 Yes March 14, 2017
9604901 December 15, 2028 005 Yes March 28, 2017
11723887 December 15, 2028 005 Yes August 15, 2023
8410169 February 13, 2030 001 No January 9, 2014
8410169 February 13, 2030 002 No January 9, 2014
8410169 February 13, 2030 003 No January 9, 2014
8410169 February 13, 2030 004 No January 9, 2014
8410169 February 13, 2030 005 No February 9, 2017
8349892 January 22, 2031 001 No January 9, 2014
8349892 January 22, 2031 002 No January 9, 2014
8349892 January 22, 2031 003 No January 9, 2014
8349892 January 22, 2031 004 No January 9, 2014
8349892 January 22, 2031 005 No February 9, 2017
8747897 August 11, 2031 001 No U-2725 June 13, 2014
8747897 August 11, 2031 001 No U-2724 June 13, 2014
8747897 August 11, 2031 002 No U-2725 June 13, 2014
8747897 August 11, 2031 002 No U-2724 June 13, 2014
8747897 August 11, 2031 003 No U-2724 June 13, 2014
8747897 August 11, 2031 003 No U-2725 June 13, 2014
8747897 August 11, 2031 004 No U-2725 June 13, 2014
8747897 August 11, 2031 004 No U-2724 June 13, 2014
8747897 August 11, 2031 005 No U-2725 February 9, 2017
8747897 August 11, 2031 005 No U-2724 February 9, 2017
Regulatory exclusivity periods.
Code Expires Product
ODE-272 October 18, 2026 001
ODE-272 October 18, 2026 002
ODE-272 October 18, 2026 003
ODE-272 October 18, 2026 004
ODE-272 October 18, 2026 005

Approval history

Source: Drugs@FDA
Most recent submissions on application 203496.
Type No. Action Status Date Review
Supplement 17 Manufacturing (CMC) Approved August 4, 2026 Standard
Supplement 13 Manufacturing (CMC) Approved November 3, 2020 Standard
Supplement 11 Efficacy Approved October 18, 2019 Standard
Supplement 7 Labeling Approved June 7, 2017 Standard
Supplement 6 Labeling Approved January 24, 2017 Standard
Supplement 2 Efficacy Approved January 28, 2016 Standard
Supplement 1 Manufacturing (CMC) Approved October 6, 2014 Standard
Original application 1 Type 3 - New Dosage Form Approved December 20, 2013 Standard

Review documents

  • 0 · Supplement · August 4, 2026
  • 0 · Supplement · December 12, 2025
  • 0 · Supplement · December 9, 2025
  • 0 · Supplement · October 22, 2019
  • 0 · Supplement · October 21, 2019
  • 0 · Supplement · June 16, 2017
  • 0 · Supplement · June 14, 2017
  • 0 · Supplement · January 27, 2017
  • 0 · Supplement · January 24, 2017
  • 0 · Supplement · February 11, 2016
  • 0 · Supplement · January 28, 2016
  • 0 · Original application · December 9, 2014
  • 0 · Original application · December 9, 2014
  • 0 · Supplement · October 9, 2014
  • 0 · Supplement · October 8, 2014
  • 0 · Original application · December 24, 2013
  • 0 · Original application · December 23, 2013

Adverse event reports

Source: openFDA FAERS
124,759
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: TREPROSTINIL. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
66302-300-01 66302-300 United Therapeutics Corporation 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-300-01) December 20, 2013
66302-300-02 66302-300 United Therapeutics Corporation 1 BLISTER PACK in 1 CARTON (66302-300-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 30, 2021
66302-302-01 66302-302 United Therapeutics Corporation 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-302-01) December 20, 2013
66302-302-02 66302-302 United Therapeutics Corporation 1 BLISTER PACK in 1 CARTON (66302-302-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 30, 2021
66302-310-01 66302-310 United Therapeutics Corporation 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-310-01) December 20, 2013
66302-310-02 66302-310 United Therapeutics Corporation 1 BLISTER PACK in 1 CARTON (66302-310-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 30, 2021
66302-325-01 66302-325 United Therapeutics Corporation 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-325-01) December 20, 2013
66302-325-02 66302-325 United Therapeutics Corporation 1 BLISTER PACK in 1 CARTON (66302-325-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 30, 2021
66302-350-01 66302-350 United Therapeutics Corporation 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (66302-350-01) December 20, 2013
66302-350-02 66302-350 United Therapeutics Corporation 1 BLISTER PACK in 1 CARTON (66302-350-02) / 10 TABLET, EXTENDED RELEASE in 1 BLISTER PACK June 30, 2021
66302-300 66302-300 United Therapeutics Corporation — December 20, 2013
66302-302 66302-302 United Therapeutics Corporation — December 20, 2013
66302-310 66302-310 United Therapeutics Corporation — December 20, 2013
66302-325 66302-325 United Therapeutics Corporation — December 20, 2013
66302-350 66302-350 United Therapeutics Corporation — December 20, 2013

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Orange Book FDA Therapeutic equivalence codes, reference drug flags, patents, exclusivity
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 12 sections on this page.