Identifying Possible Price Fixing in the market of Ethacrynic Acid 25 MG tablets

 

Executive Summary

Ethacrynic Acid 25 MG tablets is the generic form of Edecrin, a loop diuretic that was originally approved by the FDA in 1967.  Ethacrynic Acid is the only loop diuretic that does not contain sulfa, so there are no substitutes for patients that need a loop diuretic but are sensitive to sulfa.

There are multiple generic manufacturers of Ethacrynic Acid 25 MG tablets.  However, data from the National Average Drug Acquisition Cost provided by the Centers for Medicare and Medicaid Services show that the prices fluctuate over time but consistently move in lockstep.  Given the significant fluctuation in prices, the only rational conclusion is that the generic drug makers are colluding to fix the price at an artificially high level.

 

Background

Etacrynic acid (INN) or ethacrynic acid (USAN), trade name Edecrin, is a loop diuretic used to treat high blood pressure and the swelling caused by diseases like congestive heart failure, liver failure, and kidney failure.

Unlike the other loop diuretics, etacrynic acid is not a sulfonamide and thus, its use is not contraindicated in those with sulfa allergies.[1]

Edecrin was originally approved by the FDA on 1/10/1967[2] for New Drug Application (NDA) 016092 by Company BAUSCH.

Pricing Analysis

NADAC (National Average Drug Acquisition Cost) was downloaded from Data.Medicaid.gov NADAC (National Average Drug Acquisition Cost) | Data.Medicaid.gov.  Refer to https://data.medicaid.gov/api/views/a4y5-998d/files/97a8d110-e14b-4bb7-a22b-7a2bd8c8679f?download=true&filename=NADAC%20Methodology.pdf  for additional information regarding the NADAC methodology.

NADAC data was combined with data from ndclist.com (Search Results for Ethacrynic Acid | National Drug Codes List (ndclist.com)) to determine the drug manufacturers based on the NDC codes.

The table below shows the per tablet pricing.  Some patients require a two tablets per day so if, for example, the price shown is $10.00, the monthly cost for that patient is $600.00.

Company Name	National Drug Code (NDC)	Effective Date of Per Unit Cost	National Average Drug Acquisition Cost per unit
West-ward Pharmaceuticals Corp.	00054041525	9/19/2018	10.01
Edenbridge Pharmaceuticals, Llc	42799040501	9/19/2018	10.01
Oceanside Pharmaceuticals	68682001110	9/19/2018	10.01
Alvogen, Inc.	47781049701	10/10/2018	10.01
Par Pharmaceutical, Inc.	49884027601	11/14/2018	10.01
Amneal Pharmaceuticals Ny Llc	69238112601	2/27/2019	10.01
West-ward Pharmaceuticals Corp.	00054041525	4/22/2020	9.81
Edenbridge Pharmaceuticals, Llc	42799040501	4/22/2020	9.81
Alvogen, Inc.	47781049701	4/22/2020	9.81
Par Pharmaceutical, Inc.	49884027601	4/22/2020	9.81
Sciegen Pharmaceuticals Inc	50228033410	4/22/2020	9.81
Lupin Pharmaceuticals, Inc.	68180015901	4/22/2020	9.81
Oceanside Pharmaceuticals	68682001110	4/22/2020	9.81
Amneal Pharmaceuticals Ny Llc	69238112601	4/22/2020	9.81
West-ward Pharmaceuticals Corp.	00054041525	5/20/2020	5.76
Edenbridge Pharmaceuticals, Llc	42799040501	5/20/2020	5.76
Alvogen, Inc.	47781049701	5/20/2020	5.76
Par Pharmaceutical, Inc.	49884027601	5/20/2020	5.76
Sciegen Pharmaceuticals Inc	50228033410	5/20/2020	5.76
Lupin Pharmaceuticals, Inc.	68180015901	5/20/2020	5.76
Oceanside Pharmaceuticals	68682001110	5/20/2020	5.76
Amneal Pharmaceuticals Ny Llc	69238112601	5/20/2020	5.76
West-ward Pharmaceuticals Corp.	00054041525	7/22/2020	3.45
Edenbridge Pharmaceuticals, Llc	42799040501	7/22/2020	3.45
Alvogen, Inc.	47781049701	7/22/2020	3.45
Par Pharmaceutical, Inc.	49884027601	7/22/2020	3.45
Sciegen Pharmaceuticals Inc	50228033410	7/22/2020	3.45
Lupin Pharmaceuticals, Inc.	68180015901	7/22/2020	3.45
Oceanside Pharmaceuticals	68682001110	7/22/2020	3.45
Amneal Pharmaceuticals Ny Llc	69238112601	7/22/2020	3.45
Trupharma Llc	52817036790	7/29/2020	3.45
West-ward Pharmaceuticals Corp.	00054041525	8/19/2020	5.08
Edenbridge Pharmaceuticals, Llc	42799040501	8/19/2020	5.08
Alvogen, Inc.	47781049701	8/19/2020	5.08
Par Pharmaceutical, Inc.	49884027601	8/19/2020	5.08
Sciegen Pharmaceuticals Inc	50228033410	8/19/2020	5.08
Trupharma Llc	52817036790	8/19/2020	5.08
Lupin Pharmaceuticals, Inc.	68180015901	8/19/2020	5.08
Oceanside Pharmaceuticals	68682001110	8/19/2020	5.08
Amneal Pharmaceuticals Ny Llc	69238112601	8/19/2020	5.08
Upsher-smith Laboratories, Llc	00832169011	9/16/2020	5.08
West-ward Pharmaceuticals Corp.	00054041525	2/17/2021	5.69
Upsher-smith Laboratories, Llc	00832169011	2/17/2021	5.69
Edenbridge Pharmaceuticals, Llc	42799040501	2/17/2021	5.69
Alvogen, Inc.	47781049701	2/17/2021	5.69
Par Pharmaceutical, Inc.	49884027601	2/17/2021	5.69
Sciegen Pharmaceuticals Inc	50228033410	2/17/2021	5.69
Trupharma Llc	52817036790	2/17/2021	5.69
Lupin Pharmaceuticals, Inc.	68180015901	2/17/2021	5.69
Oceanside Pharmaceuticals	68682001110	2/17/2021	5.69
Amneal Pharmaceuticals Ny Llc	69238112601	2/17/2021	5.69

 

As shown, the prices consistently move in lock-step.  For example, on 7/22/2020 the price was $3.45 per tablet from all manufacturers.  However, as of 2/17/2021 the price is $5.69 from all manufacturers.  This price change represents a 65% increase in a 6 month period.

Conclusion

Edecrin was approved by the FDA over 54 years ago.  There are 10 manufacturers of its generic equivalent.  However, based on the most recent data all are charging identical prices which are 65% higher than the prices 6 months earlier.  The only rational explanation is that the competitors are artificially inflating the price to benefit each other at the expense of patients that are dependent on the medication.

 

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[1] https://en.wikipedia.org/wiki/Etacrynic_acid, visited 3/7/2021

[2] Drugs@FDA: FDA-Approved Drugs, visited 3/7/2021