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EPOPROSTENOL SODIUM

ANDA

EPOPROSTENOL SODIUM | A210473 | SUN PHARMACEUTICAL INDUSTRIES LTD

2 strengths0 unique patents0 unique exclusivities

Reference Listed Drug: VELETRI(TE code: AP2)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
ACTELION PHARMACEUTICALS LTD. v. SUN PHARMACEUTICAL INDUSTRIES, INC. et al 3:2017cv05015 1 patentANDA 210473epoprostenol sodium	D.N.J.	2017-07-07	Terminated 2019-08-21	—

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (2 FSS)

Lowest Price

$19.97

Highest Price

$39.94

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
62756-0059-40EPOPROSTENOL NA (EQV-VELETRI) 0.5MG/VIL INJ	$19.97	FSS	Sun Pharmaceutical Industries, Inc.	07/14/2026
62756-0060-40EPOPROSTENOL NA (EQV-VELETRI) 1.5MG/VIL INJ	$39.94	FSS	Sun Pharmaceutical Industries, Inc.	07/14/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain4 active DMFs3 inactive

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

PHARMACIA AND UPJOHN SUB PFIZER INCEPOPROSTENOL SODIUM (U-53,217A)

DMF 60651985

CAYMAN PHARMA SROEPOPROSTENOL SODIUM

DMF 215842008

MSN LABORATORIES PRIVATE LTDEPOPROSTENOL SODIUM [ROUTE CODE - ED]

DMF 274202013

SUN PHARMACEUTICAL INDUSTRIES LTDEPOPROSTENOL SODIUM

DMF 302632017

JOHNSON MATTHEY PHARMA SERVICESInactiveEPOPROSTENOL SODIUM

DMF 180192005

SAI LIFE SCIENCES LTDInactiveEPOPROSTENOL SODIUM, NON-STERILE

DMF 199712006

EVERLIGHT CHEMICAL INDUSTRIAL CORPInactiveEPOPROSTENOL SODIUM

DMF 213112008

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 2, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.5MG BASE/VIAL

AP2

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jan 15, 2021

No patent or exclusivity listings for this strength.

#002 — EQ 1.5MG BASE/VIAL

AP2

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jan 15, 2021