TREPROSTINIL Drug Patent Profile
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Which patents cover Treprostinil, and when can generic versions of Treprostinil launch?
Treprostinil is a drug marketed by Alembic Global, Dr Reddys, Par Sterile Products, Sandoz, and Teva Pharms Usa. and is included in five NDAs.
The generic ingredient in TREPROSTINIL is treprostinil. There are nineteen drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the treprostinil profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Treprostinil
A generic version of TREPROSTINIL was approved as treprostinil by SANDOZ on November 30th, 2017.
Summary for TREPROSTINIL
Recent Clinical Trials for TREPROSTINIL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Insmed Incorporated | Phase 2/Phase 3 |
| Mayo Clinic | Phase 2 |
| Mardi Gomberg -Maitland | Phase 2 |
Pharmacology for TREPROSTINIL
| Drug Class | Prostacycline Vasodilator |
| Physiological Effect | Vasodilation |
Anatomical Therapeutic Chemical (ATC) Classes for TREPROSTINIL
Paragraph IV (Patent) Challenges for TREPROSTINIL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| TYVASO | Inhalation Solution | treprostinil | 0.6 mg/mL, 2.9 mL ampules | 022387 | 1 | 2015-04-13 |
| REMODULIN | Injection | treprostinil | 1 mg/mL, 2.5 mg/mL, and 5 mg/mL, 20 mL vial | 021272 | 1 | 2012-12-07 |
| REMODULIN | Injection | treprostinil | 10 mg/mL, 20 mL vial | 021272 | 1 | 2011-12-02 |
US Patents and Regulatory Information for TREPROSTINIL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alembic Global | TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 211574-001 | Feb 11, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 206648-002 | Sep 26, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys | TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 210214-003 | May 22, 2020 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Alembic Global | TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 211574-004 | Feb 11, 2021 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Par Sterile Products | TREPROSTINIL | treprostinil | INJECTABLE;IV (INFUSION), SUBCUTANEOUS | 209382-004 | Sep 24, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for TREPROSTINIL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| SciPharm Sàrl | Trepulmix | treprostinil | EMEA/H/C/005207 Treatment of adult patients with WHO Functional Class (FC) III or IV and:inoperable chronic thromboembolic pulmonary hypertension (CTEPH), orpersistent or recurrent CTEPH after surgical treatmentto improve exercise capacity. |
Authorised | no | no | yes | 2020-04-03 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
