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Generated: November 17, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 021449

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NDA 021449 describes HEPSERA, which is a drug marketed by Gilead and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. 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. Four 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:1
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 Excella GmbH 46014-0501 46014-0501-1 30 TABLET in 1 BOTTLE, PLASTIC (46014-0501-1)
HEPSERA adefovir dipivoxil TABLET;ORAL 021449 NDA Gilead Sciences, Inc. 61958-0501 61958-0501-1 30 TABLET in 1 BOTTLE, PLASTIC (61958-0501-1)

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 20, 2002TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jul 23, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION

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

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