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

Serving hundreds of leading biopharmaceutical companies globally:

Citi
Fish and Richardson
Cantor Fitzgerald
Cerilliant
Julphar
UBS
Cipla
Daiichi Sankyo
Johnson and Johnson

Generated: April 22, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206652

« Back to Dashboard

NDA 206652 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Casi Pharms Inc, Cipla Ltd, Hetero Labs Ltd V, Par Pharm Inc, Prinston Inc, Teva Pharms Usa, and Zydus Pharms Usa Inc, and is included in ten NDAs. It is available from fourteen suppliers. Additional details are available on the ENTECAVIR profile page.

The generic ingredient in ENTECAVIR is entecavir. There are seventeen drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 206652
Tradename:ENTECAVIR
Applicant:Amneal Pharms
Ingredient:entecavir
Patents:0
Therapeutic Class:Antivirals
Formulation / Manufacturing:see details
Pharmacology for NDA: 206652
Suppliers and Packaging for NDA: 206652
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR entecavir TABLET;ORAL 206652 ANDA AvKARE, Inc. 42291-261 N 42291-261-30
ENTECAVIR entecavir TABLET;ORAL 206652 ANDA AvKARE, Inc. 42291-262 N 42291-262-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Nov 12, 2015TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Nov 12, 2015TE:ABRLD:No

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
Express Scripts
Colorcon
Citi
Moodys
Accenture
Dow
Healthtrust
Queensland Health

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.