Viewing data from:

VELETRI

NDA

EPOPROSTENOL SODIUM | N022260 | ACTELION PHARMACEUTICALS US INC

2 strengths2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Expiring < 1yr (2)Today

2027

Today

8318802

Mar. 15, 2027

8598227

Feb. 2, 2027

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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Actelion Pharmaceuticals Ltd. v. Mylan Pharmaceuticals Inc. 1:2020cv00110 2 patentsANDA 213913epoprostenol sodium	WVND	2020-06-09	Terminated 2024-03-18	—

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

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 Veletri (2023)

Total Spending

$760K

Total Claims

254

Beneficiaries

Avg Cost/Unit

$52.78

Spending Trend

$493K(2019)→$146K(2020)→$546K(2021)→$743K(2022)→$760K(2023)

YoY Change:+8.8%

5yr CAGR:+2.0%

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

5 letters from Drugs@FDA

Date	Submission	Document
Oct 23, 2020	SUPPL -12	View Letter (PDF)
Dec 20, 2018	SUPPL -10	View Letter (PDF)
Apr 1, 2011	SUPPL -4	View Letter (PDF)
Aug 30, 2010	SUPPL -2	View Letter (PDF)
Jul 1, 2008	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 1.5MG BASE/VIAL

RLDAP2

2 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Jun 27, 2008

Patents (2)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
8318802	Mar 15, 2027	—	—	Yes	—	—
8598227	Feb 2, 2027	—	—	—	—	—

#002 — EQ 0.5MG BASE/VIAL

RLDAP2

2 patents0 exclusivities▾

INJECTABLE;INJECTION | Approved: Jun 28, 2012