Viewing data from:

FLOLAN

NDA

EPOPROSTENOL SODIUM | N020444 | GLAXOSMITHKLINE LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Flolan (2023)

Total Spending

$471K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$46.20

Spending Trend

$68K(2019)→$63K(2020)→$142K(2021)→$166K(2022)→$471K(2023)

YoY Change:+4.8%

5yr CAGR:-1.3%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain4 active DMFs2 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

EVERLIGHT CHEMICAL INDUSTRIAL CORPInactiveEPOPROSTENOL SODIUM

DMF 213112008

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Aug 26, 2021	SUPPL -25	View Letter (PDF)
Dec 20, 2018	SUPPL -24	View Letter (PDF)
Oct 26, 2018	SUPPL -23	View Letter (PDF)
May 16, 2018	SUPPL -22	View Letter (PDF)
Mar 31, 2011	SUPPL -18	View Letter (PDF)
Mar 17, 2008	SUPPL -16	View Letter (PDF)
Apr 14, 2000	SUPPL -3	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 0.5MG BASE/VIAL

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Sep 20, 1995

No patent or exclusivity listings for this strength.

#002 — EQ 1.5MG BASE/VIAL

RLD

0 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Sep 20, 1995