Drug
Who makes treprostinil?
6 companies list treprostinil as a human prescription drug, including under the names Orenitram, Remodulin, TYVASO, Tyvaso DPI, Yutrepia. Forms: capsule; inhalant; injection; injection, solution; kit; tablet, extended release. Routes: intravenous, oral, respiratory (inhalation), subcutaneous.
Labellers from the openFDA NDC Directory. A labeller is the firm named on the label, not necessarily the site that made the product, and a listing is not an FDA approval. Data as of 24 Sept 2026. Methodology
Companies listing treprostinil
| Company | Forms | Application | NDCs | Registered sites |
|---|---|---|---|---|
| United Therapeutics CorporationUnited States | inhalant; injection, solution; kit; tablet, extended release | NDANDA021272, NDA022387, NDA203496 | 32 | 4 |
| Dr. Reddy's Laboratories LimitedIndia | injection, solution | ANDAANDA210214 | 4 | 15 |
| Alembic Pharmaceuticals LimitedIndia | injection, solution | ANDAANDA211574 | 4 | 7 |
| Sandoz Industrial Products S.AAustria | injection | ANDAANDA203649 | 4 | 5 |
| Liquidia CorporationUnited States | capsule | NDANDA213005 | 4 | 1 |
| Teva Parenteral Medicines, Inc. | injection, solution | ANDAANDA206648 | 4 | 0 |
Bulk ingredient listings
- MSN Laboratories Private Limited,India · 2 NDC
- Chirogate International Inc.Taiwan · 1 NDC
- NURAY CHEMICALS PRIVATE LIMITEDIndia · 1 NDC
Orange Book patents
13 unexpired patents list treprostinil as the active ingredient, expiring between May 2027 and Feb 2042. Application holder: UNITED THERAPEUTICS CORP.
Enquiry
Common questions
- Who makes treprostinil?
- 6 companies list treprostinil as a human prescription drug in the openFDA NDC Directory, led by United Therapeutics Corporation, Dr. Reddy's Laboratories Limited, Alembic Pharmaceuticals Limited, Sandoz Industrial Products S.A, Liquidia Corporation. Each is the labeller, the firm named on the label; the product may be made at a site registered to another company.
- Is there a generic Orenitram?
- 4 companies list treprostinil under an abbreviated new drug application (ANDA), the application type used for generics, and 2 under an NDA or BLA. Listing status is from the NDC Directory; it is not a statement of availability.
- Who supplies treprostinil active ingredient?
- 3 companies list treprostinil as a bulk ingredient, including MSN Laboratories Private Limited,, Chirogate International Inc., NURAY CHEMICALS PRIVATE LIMITED.