Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Farmers Insurance
Teva
AstraZeneca
Chubb
QuintilesIMS
Julphar
Federal Trade Commission
Colorcon
Baxter

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 203049

« Back to Dashboard

NDA 203049 describes ARGATROBAN, which is a drug marketed by Amneal Pharms Co, Fresenius Kabi Usa, Hikma Pharm Co Ltd, Hospira Inc, Mylan Institutional, Novartis Pharms Corp, Par Sterile Products, Teva Pharms Usa, Sandoz, Eagle Pharms, and Gland Pharma Ltd, and is included in twelve NDAs. It is available from eight suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the ARGATROBAN profile page.

The generic ingredient in ARGATROBAN is argatroban. There are eleven drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the argatroban profile page.
Summary for 203049
Tradename:ARGATROBAN
Applicant:Hikma Pharm Co Ltd
Ingredient:argatroban
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 203049
Mechanism of ActionThrombin Inhibitors
Suppliers and Packaging for NDA: 203049
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ARGATROBAN argatroban INJECTABLE;INJECTION 203049 NDA West-Ward Pharmaceuticals Corp 0143-9288 N 0143-9288-01
ARGATROBAN argatroban INJECTABLE;INJECTION 203049 NDA West-Ward Pharmaceuticals Corp 0143-9559 N 0143-9559-01

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength250MG/2.5ML (100MG/ML)
Approval Date:Jan 5, 2012TE:APRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INJECTIONStrength50MG/50ML (1MG/ML)
Approval Date:Sep 30, 2016TE:RLD:Yes

Complete Access Available with Subscription

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Cerilliant
Fish and Richardson
Harvard Business School
Chinese Patent Office
Moodys
Argus Health
UBS
Chubb
Medtronic

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 verifification 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.