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UPTRAVI

Selexipag · Tablet, Film Coated

Prescription NDA TE AB 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
UPTRAVI
Generic name
Selexipag
Dosage form
Tablet, Film Coated
Route
Oral
Marketing category
NDA · NDA
Labeler
Actelion Pharmaceuticals US, Inc.
Product type
Human Prescription Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
2
Packages
2
Data completeness
54% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Selexipag 100 ug/1 1729007 View
Selexipag 150 ug/1 1729007 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Tablet, Film Coated
Route of administration
Oral
Presentations
4

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
Prostacyclin Receptor Agonist [EPC] EPC 3 members — no class page
Prostacyclin Receptor Agonists [MoA] MoA 3 members — no class page

Regulatory status

Source: Drugs@FDANDC Directory
Application number
207947
Application type
NDA · New Drug Application
Approval date
December 21, 2015
Sponsor
ACTELION
Products on application
10
Submissions recorded
10
Products approved under application 207947.
Product Trade name Form Strength Ingredient Status TE Flags
207947-001 UPTRAVI TABLET SELEXIPAG Prescription AB RLD
207947-002 UPTRAVI TABLET SELEXIPAG Prescription AB RLD RS
207947-003 UPTRAVI TABLET SELEXIPAG Prescription AB RLD
207947-004 UPTRAVI TABLET SELEXIPAG Prescription AB RLD
207947-005 UPTRAVI TABLET SELEXIPAG Prescription AB RLD
207947-006 UPTRAVI TABLET SELEXIPAG Prescription AB RLD
207947-007 UPTRAVI TABLET SELEXIPAG Prescription AB RLD
207947-008 UPTRAVI TABLET SELEXIPAG Prescription AB RLD
207947-010 UPTRAVI TABLET SELEXIPAG Prescription — RLD
207947-011 UPTRAVI TABLET SELEXIPAG Prescription — RLD

Therapeutic equivalence

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

What this rating means: Therapeutically equivalent — bioequivalence demonstrated by in vivo or in vitro testing

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
7205302 October 31, 2026 001 Yes U-1797 January 19, 2016
7205302 October 31, 2026 002 Yes U-1797 January 19, 2016
7205302 October 31, 2026 003 Yes U-1797 January 19, 2016
7205302 October 31, 2026 004 Yes U-1797 January 19, 2016
7205302 October 31, 2026 005 Yes U-1797 January 19, 2016
7205302 October 31, 2026 006 Yes U-1797 January 19, 2016
7205302 October 31, 2026 007 Yes U-1797 January 19, 2016
7205302 October 31, 2026 008 Yes U-1797 January 19, 2016
7205302 October 31, 2026 010 Yes U-1797 June 18, 2026
7205302 October 31, 2026 011 Yes U-1797 June 18, 2026
7205302*PED April 30, 2027 001 No —
7205302*PED April 30, 2027 002 No —
7205302*PED April 30, 2027 003 No —
7205302*PED April 30, 2027 004 No —
7205302*PED April 30, 2027 005 No —
7205302*PED April 30, 2027 006 No —
7205302*PED April 30, 2027 007 No —
7205302*PED April 30, 2027 008 No —
7205302*PED April 30, 2027 010 No —
7205302*PED April 30, 2027 011 No —
9173881 August 12, 2029 001 No U-1798 January 19, 2016
9173881 August 12, 2029 002 No U-1798 January 19, 2016
9173881 August 12, 2029 003 No U-1798 January 19, 2016
9173881 August 12, 2029 004 No U-1798 January 19, 2016
9173881 August 12, 2029 005 No U-1798 January 19, 2016
9173881 August 12, 2029 006 No U-1798 January 19, 2016
9173881 August 12, 2029 007 No U-1798 January 19, 2016
9173881 August 12, 2029 008 No U-1798 January 19, 2016
9173881 August 12, 2029 010 No U-1798 June 18, 2026
9173881 August 12, 2029 011 No U-1798 June 18, 2026
9173881*PED February 12, 2030 001 No —
9173881*PED February 12, 2030 002 No —
9173881*PED February 12, 2030 003 No —
9173881*PED February 12, 2030 004 No —
9173881*PED February 12, 2030 005 No —
9173881*PED February 12, 2030 006 No —
9173881*PED February 12, 2030 007 No —
9173881*PED February 12, 2030 008 No —
9173881*PED February 12, 2030 010 No —
9173881*PED February 12, 2030 011 No —
9284280 June 25, 2030 001 No U-1831 April 12, 2016
9284280 June 25, 2030 002 No U-1831 April 12, 2016
9284280 June 25, 2030 003 No U-1831 April 12, 2016
9284280 June 25, 2030 004 No U-1831 April 12, 2016
9284280 June 25, 2030 005 No U-1831 April 12, 2016
9284280 June 25, 2030 006 No U-1831 April 12, 2016
9284280 June 25, 2030 007 No U-1831 April 12, 2016
9284280 June 25, 2030 008 No U-1831 April 12, 2016
9284280 June 25, 2030 010 No U-1831 June 18, 2026
9284280 June 25, 2030 011 No U-1831 June 18, 2026
8791122 August 1, 2030 001 Yes January 19, 2016
8791122 August 1, 2030 002 Yes January 19, 2016
8791122 August 1, 2030 003 Yes January 19, 2016
8791122 August 1, 2030 004 Yes January 19, 2016
8791122 August 1, 2030 005 Yes January 19, 2016
8791122 August 1, 2030 006 Yes January 19, 2016
8791122 August 1, 2030 007 Yes January 19, 2016
8791122 August 1, 2030 008 Yes January 19, 2016
8791122 August 1, 2030 010 Yes June 18, 2026
8791122 August 1, 2030 011 Yes June 18, 2026
9284280*PED December 25, 2030 001 No —
9284280*PED December 25, 2030 002 No —
9284280*PED December 25, 2030 003 No —
9284280*PED December 25, 2030 004 No —
9284280*PED December 25, 2030 005 No —
9284280*PED December 25, 2030 006 No —
9284280*PED December 25, 2030 007 No —
9284280*PED December 25, 2030 008 No —
9284280*PED December 25, 2030 010 No —
9284280*PED December 25, 2030 011 No —
8791122*PED February 1, 2031 001 No —
8791122*PED February 1, 2031 002 No —
8791122*PED February 1, 2031 003 No —
8791122*PED February 1, 2031 004 No —
8791122*PED February 1, 2031 005 No —
8791122*PED February 1, 2031 006 No —
8791122*PED February 1, 2031 007 No —
8791122*PED February 1, 2031 008 No —
8791122*PED February 1, 2031 010 No —
8791122*PED February 1, 2031 011 No —
10828298 December 1, 2036 001 No U-2991 December 2, 2020
10821108 December 1, 2036 001 No U-2992 December 2, 2020
10828298 December 1, 2036 002 No U-2991 December 2, 2020
10821108 December 1, 2036 002 No U-2992 December 2, 2020
10821108 December 1, 2036 003 No U-2992 December 2, 2020
10828298 December 1, 2036 003 No U-2991 December 2, 2020
10828298 December 1, 2036 004 No U-2991 December 2, 2020
10821108 December 1, 2036 004 No U-2992 December 2, 2020
10821108 December 1, 2036 005 No U-2992 December 2, 2020
10828298 December 1, 2036 005 No U-2991 December 2, 2020
10821108 December 1, 2036 006 No U-2992 December 2, 2020
10828298 December 1, 2036 006 No U-2991 December 2, 2020
10821108 December 1, 2036 007 No U-2992 December 2, 2020
10828298 December 1, 2036 007 No U-2991 December 2, 2020
10828298 December 1, 2036 008 No U-2991 December 2, 2020
10821108 December 1, 2036 008 No U-2992 December 2, 2020
10828298 December 1, 2036 010 No U-2991 June 18, 2026
10821108 December 1, 2036 010 No U-2992 June 18, 2026
10828298 December 1, 2036 011 No U-2991 June 18, 2026
10821108 December 1, 2036 011 No U-2992 June 18, 2026
10828298*PED June 1, 2037 001 No —
10821108*PED June 1, 2037 001 No —
10828298*PED June 1, 2037 002 No —
10821108*PED June 1, 2037 002 No —
10821108*PED June 1, 2037 003 No —
10828298*PED June 1, 2037 003 No —
10828298*PED June 1, 2037 004 No —
10821108*PED June 1, 2037 004 No —
10821108*PED June 1, 2037 005 No —
10828298*PED June 1, 2037 005 No —
10821108*PED June 1, 2037 006 No —
10828298*PED June 1, 2037 006 No —
10821108*PED June 1, 2037 007 No —
10828298*PED June 1, 2037 007 No —
10828298*PED June 1, 2037 008 No —
10821108*PED June 1, 2037 008 No —
10821108*PED June 1, 2037 010 No —
10828298*PED June 1, 2037 010 No —
10821108*PED June 1, 2037 011 No —
10828298*PED June 1, 2037 011 No —
Regulatory exclusivity periods.
Code Expires Product
NPP May 23, 2029 001
NPP May 23, 2029 002
NPP May 23, 2029 003
NPP May 23, 2029 004
NPP May 23, 2029 005
NPP May 23, 2029 006
NPP May 23, 2029 007
NPP May 23, 2029 008
NS May 23, 2029 010
NS May 23, 2029 011
PED November 23, 2029 001
PED November 23, 2029 002
PED November 23, 2029 003
PED November 23, 2029 004
PED November 23, 2029 005
PED November 23, 2029 006
PED November 23, 2029 007
PED November 23, 2029 008
PED November 23, 2029 010
PED November 23, 2029 011

Approval history

Source: Drugs@FDA
Most recent submissions on application 207947.
Type No. Action Status Date Review
Supplement 15 Labeling Approved May 23, 2026 Standard
Supplement 14 Efficacy Approved May 23, 2026 Priority
Supplement 9 Labeling Approved October 25, 2021 Standard
Supplement 10 Labeling Approved August 19, 2021 Standard
Supplement 8 Efficacy Approved January 30, 2021 Standard
Supplement 7 Labeling Approved September 4, 2019 Standard
Supplement 5 Labeling Approved December 20, 2017 Standard
Supplement 3 Labeling Approved September 28, 2017 Standard
Supplement 1 Labeling Approved July 21, 2017 Standard
Original application 1 Type 1 - New Molecular Entity Approved December 21, 2015 Standard

Review documents

  • 0 · Supplement · September 11, 2026
  • 0 · Supplement · September 11, 2026
  • 0 · Supplement · May 27, 2026
  • 0 · Supplement · May 27, 2026
  • 0 · Supplement · October 26, 2021
  • 0 · Supplement · October 26, 2021
  • 0 · Supplement · August 24, 2021
  • 0 · Supplement · August 20, 2021
  • 0 · Supplement · February 1, 2021
  • 0 · Supplement · February 1, 2021
  • 0 · Supplement · September 5, 2019
  • 0 · Supplement · September 5, 2019
  • 0 · Supplement · December 27, 2017
  • 0 · Supplement · December 22, 2017
  • 0 · Supplement · September 29, 2017
  • 0 · Supplement · September 29, 2017
  • 0 · Supplement · July 25, 2017
  • 0 · Supplement · July 25, 2017
  • 0 · Original application · January 28, 2016
  • 0 · Original application · January 28, 2016
  • 0 · Original application · December 22, 2015
  • 0 · Original application · December 22, 2015

Adverse event reports

Source: openFDA FAERS
25,685
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: SELEXIPAG. 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
66215-910-14 66215-910 Actelion Pharmaceuticals US, Inc. 1 BOTTLE in 1 CARTON (66215-910-14) / 140 TABLET, FILM COATED in 1 BOTTLE May 23, 2026
66215-915-14 66215-915 Actelion Pharmaceuticals US, Inc. 1 BOTTLE in 1 CARTON (66215-915-14) / 140 TABLET, FILM COATED in 1 BOTTLE May 23, 2026
66215-910 66215-910 Actelion Pharmaceuticals US, Inc. — May 23, 2026
66215-915 66215-915 Actelion Pharmaceuticals US, Inc. — May 23, 2026

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.