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Tyvaso DPI

treprostinil · Inhalant

Prescription NDA TE TBD 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
Tyvaso DPI
Generic name
treprostinil
Dosage form
Inhalant
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
10
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 16 ug/1 349407 View
Treprostinil 32 ug/1 349407 View
Treprostinil 48 ug/1 349407 View
Treprostinil 64 ug/1 349407 View
Treprostinil 80 ug/1 349407 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Inhalant
Route of administration
Oral
Presentations
20

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
214324
Application type
NDA · New Drug Application
Approval date
May 23, 2022
Sponsor
UNITED THERAP
Products on application
5
Submissions recorded
1
Products approved under application 214324.
Product Trade name Form Strength Ingredient Status TE Flags
214324-001 TYVASO DPI POWDER TREPROSTINIL Prescription TBD RLD RS
214324-002 TYVASO DPI POWDER TREPROSTINIL Prescription — RLD RS
214324-003 TYVASO DPI POWDER TREPROSTINIL Prescription — RLD RS
214324-004 TYVASO DPI POWDER TREPROSTINIL Prescription — RLD RS
214324-005 TYVASO DPI POWDER TREPROSTINIL Prescription — RLD RS

Therapeutic equivalence

Source: Orange Book
TE code
TBD
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
11357782 May 14, 2027 001 No U-1849 April 24, 2025
11357782 May 14, 2027 002 No U-1849 April 24, 2025
11357782 May 14, 2027 003 No U-1849 April 24, 2025
11357782 May 14, 2027 004 No U-1849 April 24, 2025
11357782 May 14, 2027 005 No U-1849 April 24, 2025
9593066 December 15, 2028 001 Yes June 17, 2022
11723887 December 15, 2028 001 Yes August 15, 2023
11723887 December 15, 2028 002 Yes August 15, 2023
9593066 December 15, 2028 002 Yes June 17, 2022
9593066 December 15, 2028 003 Yes June 17, 2022
11723887 December 15, 2028 003 Yes August 15, 2023
11723887 December 15, 2028 004 Yes August 15, 2023
9593066 December 15, 2028 004 Yes June 17, 2022
9593066 December 15, 2028 005 Yes November 18, 2024
11723887 December 15, 2028 005 Yes November 18, 2024
10772883 June 11, 2030 001 No June 17, 2022
10772883 June 11, 2030 002 No June 17, 2022
10772883 June 11, 2030 003 No June 17, 2022
10772883 June 11, 2030 004 No June 17, 2022
10772883 June 11, 2030 005 No November 18, 2024
12679811 March 14, 2034 001 No U-1849 August 21, 2026
12679811 March 14, 2034 001 No U-3749 August 21, 2026
12679811 March 14, 2034 002 No U-1849 August 21, 2026
12679811 March 14, 2034 002 No U-3749 August 21, 2026
12679811 March 14, 2034 003 No U-1849 August 21, 2026
12679811 March 14, 2034 003 No U-3749 August 21, 2026
12679811 March 14, 2034 004 No U-1849 August 21, 2026
12679811 March 14, 2034 004 No U-3749 August 21, 2026
12679811 March 14, 2034 005 No U-1849 August 21, 2026
12679811 March 14, 2034 005 No U-3749 August 21, 2026
10421729 April 1, 2035 001 No June 17, 2022
10421729 April 1, 2035 002 No June 17, 2022
10421729 April 1, 2035 003 No June 17, 2022
10421729 April 1, 2035 004 No June 17, 2022
10421729 April 1, 2035 005 No November 18, 2024
11826327 February 3, 2042 001 No U-3749 November 28, 2023
11826327 February 3, 2042 002 No U-3749 November 28, 2023
11826327 February 3, 2042 003 No U-3749 November 28, 2023
11826327 February 3, 2042 004 No U-3749 November 28, 2023
11826327 February 3, 2042 005 No U-3749 November 18, 2024

Approval history

Source: Drugs@FDA
Most recent submissions on application 214324.
Type No. Action Status Date Review
Original application 1 Type 5 - New Formulation or New Manufacturer Approved May 23, 2022 Priority

Review documents

  • 0 · Original application · July 6, 2022
  • 0 · Original application · May 24, 2022
  • 0 · Original application · May 24, 2022

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
66302-616-03 66302-616 United Therapeutics Corporation 4 BLISTER PACK in 1 KIT (66302-616-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-632-03 66302-632 United Therapeutics Corporation 4 BLISTER PACK in 1 KIT (66302-632-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-648-03 66302-648 United Therapeutics Corporation 4 BLISTER PACK in 1 KIT (66302-648-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-664-03 66302-664 United Therapeutics Corporation 4 BLISTER PACK in 1 KIT (66302-664-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-680-03 66302-680 United Therapeutics Corporation 4 BLISTER PACK in 1 KIT (66302-680-03) / 7 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK October 24, 2024
66302-716-04 66302-716 United Therapeutics Corporation 1 BLISTER PACK in 1 KIT (66302-716-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-732-04 66302-732 United Therapeutics Corporation 1 BLISTER PACK in 1 KIT (66302-732-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-748-04 66302-748 United Therapeutics Corporation 1 BLISTER PACK in 1 KIT (66302-748-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-764-04 66302-764 United Therapeutics Corporation 1 BLISTER PACK in 1 KIT (66302-764-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK May 23, 2022
66302-780-04 66302-780 United Therapeutics Corporation 1 BLISTER PACK in 1 KIT (66302-780-04) / 4 BLISTER PACK in 1 BLISTER PACK / 4 INHALANT in 1 BLISTER PACK October 24, 2024
66302-616 66302-616 United Therapeutics Corporation — May 23, 2022
66302-632 66302-632 United Therapeutics Corporation — May 23, 2022
66302-648 66302-648 United Therapeutics Corporation — May 23, 2022
66302-664 66302-664 United Therapeutics Corporation — May 23, 2022
66302-680 66302-680 United Therapeutics Corporation — October 24, 2024
66302-716 66302-716 United Therapeutics Corporation — May 23, 2022
66302-732 66302-732 United Therapeutics Corporation — May 23, 2022
66302-748 66302-748 United Therapeutics Corporation — May 23, 2022
66302-764 66302-764 United Therapeutics Corporation — May 23, 2022
66302-780 66302-780 United Therapeutics Corporation — October 24, 2024

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.