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PHOSPHOLINE IODIDE

NDA

ECHOTHIOPHATE IODIDE | N011963 | FERA PHARMACEUTICALS LLC

4 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 Phospholine Iodide (2023)

Total Spending

$942K

Total Claims

368

Beneficiaries

Avg Cost/Unit

$511.79

Spending Trend

$342K(2022)→$942K(2023)

YoY Change:-0.3%

5yr CAGR:-0.3%

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

API Supply Chain1 active DMF

1 active API supplier hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CURIA NEW YORK INCECHOTHIOPHATE IODIDE DRUG SUBSTANCE

DMF 205462007

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 1, 2021	SUPPL -52	View Letter (PDF)
Jul 6, 2018	SUPPL -48	View Letter (PDF)
Mar 23, 2006	SUPPL -34	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (4)

Sort:

#001 — 0.125%

RLD

0 patents0 exclusivities▴

FOR SOLUTION;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — 0.03%

0 patents0 exclusivities▾

FOR SOLUTION;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

#003 — 0.25%

0 patents0 exclusivities▾

FOR SOLUTION;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982

#004 — 0.06%

0 patents0 exclusivities▾

FOR SOLUTION;OPHTHALMIC | Approved: Approved Prior to Jan 1, 1982