➤ Get the DrugPatentWatch Daily Briefing

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

Serving leading biopharmaceutical companies globally:

McKinsey
Medtronic
Boehringer Ingelheim
AstraZeneca
Baxter
Moodys

Last Updated: April 15, 2021

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021449

➤ Get the DrugPatentWatch Daily Briefing
» See Plans and Pricing

« Back to Dashboard

NDA 021449 describes HEPSERA, which is a drug marketed by Gilead and is included in one NDA. It is available from one supplier. Additional details are available on the HEPSERA profile page.

The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.
Summary for 021449
Tradename:HEPSERA
Applicant:Gilead
Ingredient:adefovir dipivoxil
Patents:0
Formulation / Manufacturing:see details
Pharmacology for NDA: 021449
Suppliers and Packaging for NDA: 021449
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
HEPSERA adefovir dipivoxil TABLET;ORAL 021449 NDA Gilead Sciences, Inc. 61958-0501 61958-0501-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-0501-1)
Paragraph IV (Patent) Challenges for 021449
Tradename Dosage Ingredient NDA Submissiondate
HEPSERA TABLET;ORAL adefovir dipivoxil 021449 2010-06-08

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 20, 2002TE:ABRLD:Yes

Expired US Patents for NDA 021449

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   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:

Harvard Business School
Johnson and Johnson
Express Scripts
Moodys
AstraZeneca
McKinsey

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.