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OmniRx › Tools › Generic competition check › Treprostinil

Generic competition · all medicines · read 12 November 2026

Is there a generic of Treprostinil, and who makes it?

Treprostinil appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming. Where both are dated, the first generic approval came 15.5 years after the first brand approval. This is the Orange Book's listing, not a forecast.

Compiled and checked by Vincent Wesley Couey (ORCID 0009-0005-6869-308X) from the Orange Book data files, downloaded 12 November 2026.

Not medical advice. This page reports what the FDA's Orange Book lists, not what a pharmacy has in stock, what anything costs, or whether a generic is right for you. Ask your pharmacist or prescriber about your own medicine.
Treprostinil4 dosage-form groups in the Orange Book
4generic makers listed
  1. Treprostinil appears in 4 dosage-form groups in the FDA Orange Book as of 12 November 2026, with 4 generic makers listed as marketed across them.
  2. 2 groups have a brand listed as marketed and no generic listed as marketed. The data does not state why, and it does not state that one is coming.
  3. Where both are dated, the first generic approval came 15.5 years after the first brand approval.
  4. Patents and exclusivities are shown as listed by the application holder; the Orange Book does not rule on them, and a listed patent is not a statement that a generic is blocked. This says nothing about price, supply or quality.

Injectable, Intravenous, Subcutaneous

Four or more generic makers listed

Brand listed as marketed: Remodulin. 4 generic makers with 16 generic products listed as marketed; the first generic approval is dated 30 November 2017.

200020052010201520202025203004brand 2002Sandoz Inc, first approval 30 November 2017Teva Pharmaceuticals Usa, first approval 26 September 2019Dr Reddys Laboratories Ltd, first approval 22 May 2020Alembic Global Holding Sa, first approval 11 February 2021data datePatent 8658694 listed to expire 5 September 2028Patent 8653137 listed to expire 5 September 2028Patent 9593066 listed to expire 15 December 2028Patent 11723887 listed to expire 15 December 2028Patent 7999007 listed to expire 29 March 2029
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end
Generic maker (applicant)First approvalProducts
Sandoz Inc30 November 20174
Teva Pharmaceuticals Usa26 September 20194
Dr Reddys Laboratories Ltd22 May 20204
Alembic Global Holding Sa11 February 20214

Patents and exclusivities still listed

  • 5 September 2028Patent 8658694
  • 5 September 2028Patent 8653137
  • 15 December 2028Patent 9593066 drug substance
  • 15 December 2028Patent 11723887 drug substance
  • 29 March 2029Patent 7999007 drug product

Powder, Inhalation

Brand listed, no generic listed as marketed

Brand listed as marketed: Tyvaso Dpi. No generic is listed as marketed.

20202025203020352040204501brand 2022data datePatent 11357782 listed to expire 14 May 2027Patent 9593066 listed to expire 15 December 2028Patent 11723887 listed to expire 15 December 2028Patent 10772883 listed to expire 11 June 2030Patent 12679811 listed to expire 14 March 2034Patent 10421729 listed to expire 1 April 2035Patent 11826327 listed to expire 3 February 2042
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 14 May 2027Patent 11357782
  • 15 December 2028Patent 9593066 drug substance
  • 15 December 2028Patent 11723887 drug substance
  • 11 June 2030Patent 10772883 drug product
  • 14 March 2034Patent 12679811
  • 1 April 2035Patent 10421729 drug product
  • 3 February 2042Patent 11826327

Solution, Intravenous, Subcutaneous

Nothing listed as marketed

Every brand product here is listed as discontinued. No generic is listed as marketed.

201520202025203001brand 2018data date
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

No unexpired patent or exclusivity is listed against the marketed brand products in this group.

Solution, Inhalation

Brand listed, no generic listed as marketed

Brand listed as marketed: Tyvaso. No generic is listed as marketed.

20052010201520202025203020352040204501brand 2009data datePatent 10376525 listed to expire 14 May 2027Patent 9339507 listed to expire 10 March 2028Patent 9358240 listed to expire 5 May 2028Patent 9593066 listed to expire 15 December 2028Patent 11723887 listed to expire 15 December 2028Patent 11826327 listed to expire 3 February 2042
generic makers listed as marketed, by first approvallisted patent expiryexclusivity end

Patents and exclusivities still listed

  • 14 May 2027Patent 10376525
  • 10 March 2028Patent 9339507 drug product
  • 5 May 2028Patent 9358240
  • 15 December 2028Patent 9593066 drug substance
  • 15 December 2028Patent 11723887 drug substance
  • 3 February 2042Patent 11826327

US Food and Drug Administration, Orange Book data files, downloaded 12 November 2026. A listed patent is not a ruling that a generic is blocked, and no figure here says anything about price, supply or quality. Check the Orange Book.

Where can you go from this result?

Open it in the check to search another medicine, or see every brand with no generic listed. The FDA explains generic approval in how generic drugs are approved and the FDA generic drug facts, and the Orange Book itself is the FDA Orange Book. To check what is available now, ask your pharmacist, and see the FDA drug shortages page.