➤ Get the DrugPatentWatch Daily Briefing

Get Daily Updates on Generic Entry, Litigation, Biosimilars, and more …

Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Express Scripts
AstraZeneca
McKinsey
Colorcon

Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 020221


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

NDA 020221 describes ETHYOL, which is a drug marketed by Clinigen and is included in one NDA. It is available from one supplier. Additional details are available on the ETHYOL profile page.

The generic ingredient in ETHYOL is amifostine. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the amifostine profile page.
Summary for 020221
Tradename:ETHYOL
Applicant:Clinigen
Ingredient:amifostine
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 020221
Medical Subject Heading (MeSH) Categories for 020221
Suppliers and Packaging for NDA: 020221
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ETHYOL amifostine INJECTABLE;INJECTION 020221 NDA Cumberland Pharmaceuticals Inc. 66220-017 66220-017-03 3 VIAL, SINGLE-USE in 1 CARTON (66220-017-03) > 10 mL in 1 VIAL, SINGLE-USE
Paragraph IV (Patent) Challenges for 020221
Tradename Dosage Ingredient NDA Submissiondate
ETHYOL INJECTABLE;INJECTION amifostine 020221 2004-04-16

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength500MG/VIAL
Approval Date:Dec 8, 1995TE:APRLD:Yes

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:INJECTABLE;INJECTIONStrength375MG/VIAL
Approval Date:Sep 10, 1999TE:RLD:No

Expired US Patents for NDA 020221

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 1995   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 1995   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-001 Dec 8, 1995   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999   Start Trial   Start Trial
Clinigen ETHYOL amifostine INJECTABLE;INJECTION 020221-002 Sep 10, 1999   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Moodys
Medtronic
Merck
Dow
Harvard Business School

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.