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

Serving leading biopharmaceutical companies globally:

Chubb
Cerilliant
McKinsey
Accenture
AstraZeneca
Citi
Chinese Patent Office
Daiichi Sankyo
Fish and Richardson
Dow

Generated: February 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 209347

« Back to Dashboard

NDA 209347 describes GANCICLOVIR, which is a drug marketed by Ranbaxy Labs Ltd, Fresenius Kabi Usa, Luitpold Pharms Inc, Mylan Labs Ltd, Par Sterile Products, Exela Pharma Scs Llc, Pharmascience Inc, and West-ward Pharms Int, and is included in eight NDAs. It is available from three suppliers. There is one patent protecting this drug. Additional details are available on the GANCICLOVIR profile page.

The generic ingredient in GANCICLOVIR is ganciclovir sodium. There are twenty-five drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.
Summary for 209347
Tradename:GANCICLOVIR
Applicant:Exela Pharma Scs Llc
Ingredient:ganciclovir
Patents:1
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 209347
Ingredient-typeNucleoside Analog
Mechanism of ActionDNA Polymerase Inhibitors
Medical Subject Heading (MeSH) Categories for 209347
Suppliers and Packaging for NDA: 209347
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
GANCICLOVIR ganciclovir SOLUTION;IV (INFUSION) 209347 NDA EXELA PHARMA SCIENCES, LLC 51754-2500 N 51754-2500-1
GANCICLOVIR ganciclovir SOLUTION;IV (INFUSION) 209347 NDA EXELA PHARMA SCIENCES, LLC 51754-2500 N 51754-2500-3

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:SOLUTION;IV (INFUSION)Strength500MG/250ML (2MG/ML)
Approval Date:Feb 17, 2017TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Sep 2, 2034Product Flag?YSubstance Flag?Delist Request?

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
Chinese Patent Office
Harvard Business School
Cantor Fitzgerald
Moodys
Fish and Richardson
McKinsey
Chubb
Deloitte

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.

botpot