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TREPROSTINIL

ANDA

TREPROSTINIL | A206648 | TEVA PHARMACEUTICALS USA

4 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: REMODULIN(TE code: AP)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
UNITED THERAPEUTICS CORPORATION v. TEVA PHARMACEUTICALS USA, INC. 3:2014cv05498 5 patentsANDA 206648, 203649Treprostinil Sodium	D.N.J.	2014-09-02	Terminated 2016-01-15	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

API Supply Chain12 active DMFs

9 active API suppliers hold Drug Master Files for this ingredient.

CHIROGATE INTERNATIONAL INCTREPROSTINIL

DMF 284582014

CHANGZHOU BOHIV PHARMACEUTICAL TECHNOLOGY CO LTDTREPROSTINIL INTERMEDIATE (PG14-15A)

DMF 299152015

MSN LABORATORIES PRIVATE LTDTREPROSTINIL DIETHANOLAMINE [ROUTE CODE TB]

DMF 300002015

DR REDDYS LABORATORIES LTDTREPROSTINIL

DMF 301062016

MSN LABORATORIES PRIVATE LTDTREPROSTINIL DIETHANOLAMINE (CRYSTALLINE) [ROUTE CODE "VM"]

DMF 303142016

TIEN (TIANJIN) PHARMACEUTICAL CO LTDTREPROSTINIL DIETHANOLAMINE

DMF 315242017

MSN LABORATORIES PRIVATE LTDTREPROSTINIL

DMF 315732017

APOTEX INCTREPROSTINIL DIETHANOLAMINE

DMF 320862017

EMCURE PHARMACEUTICALS LTDTREPROSTINIL

DMF 329922018

MANNKIND CORPTREPROSTINIL INHALATION POWDER

DMF 331692018

SHANGHAI FOREFRONT PHARMACEUTICAL CO LTDTREPROSTINIL SODIUM 5.5 HYDRATE

DMF 347862021

TIEN (TIANJIN) PHARMACEUTICAL CO LTDTREPROSTINIL

DMF 424372025

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Products (4)

Sort:

#001 — 1MG/ML

0 patents0 exclusivities▴

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 26, 2019

No patent or exclusivity listings for this strength.

#002 — 2.5MG/ML

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 26, 2019

#003 — 5MG/ML

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 26, 2019

#004 — 10MG/ML

0 patents0 exclusivities▾

INJECTABLE;INTRAVENOUS, SUBCUTANEOUS | Approved: Sep 26, 2019