➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

Moodys
Boehringer Ingelheim
Harvard Business School
McKinsey
Medtronic
Express Scripts

Last Updated: April 18, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206745

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 206745 describes ENTECAVIR, which is a drug marketed by Accord Hlthcare, Amneal Pharms, Aurobindo Pharma Ltd, Breckenridge, Brightgene, Casi Pharms Inc, Cipla, Hetero Labs Ltd V, Mylan, Par Pharm Inc, Pharmadax Inc, Prinston Inc, Sunshine, Teva Pharms Usa, Yaopharma Co Ltd, and Zydus Pharms, and is included in sixteen NDAs. It is available from twenty suppliers. Additional details are available on the ENTECAVIR profile page.

The generic ingredient in ENTECAVIR is entecavir. There are eighteen drug master file entries for this compound. Twenty-one suppliers are listed for this compound. Additional details are available on the entecavir profile page.
Summary for 206745
Tradename:ENTECAVIR
Applicant:Zydus Pharms
Ingredient:entecavir
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 206745
Suppliers and Packaging for NDA: 206745
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ENTECAVIR entecavir TABLET;ORAL 206745 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-920 68382-920-01 100 TABLET, FILM COATED in 1 BOTTLE (68382-920-01)
ENTECAVIR entecavir TABLET;ORAL 206745 ANDA Zydus Pharmaceuticals (USA) Inc. 68382-920 68382-920-06 30 TABLET, FILM COATED in 1 BOTTLE (68382-920-06)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength0.5MG
Approval Date:Jun 23, 2017TE:ABRLD:No

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength1MG
Approval Date:Jun 23, 2017TE:ABRLD:No

Complete Access Available with Subscription

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

Serving leading biopharmaceutical companies globally:

AstraZeneca
Medtronic
Moodys
Merck
McKesson
Johnson and Johnson

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.