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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. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

Summary for NDA: 021449

Tradename:
HEPSERA
Applicant:
Gilead
Ingredient:
adefovir dipivoxil
Patents:1
Therapeutic Class:Antivirals
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)

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrength10MG
Approval Date:Sep 20, 2002TE:ABRLD:Yes
Patent:6,451,340Patent Expiration:Jul 23, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION

Expired Orange Book Patents for NDA: 021449

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 20024,724,233► subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 20025,663,159► subscribe
Gilead
HEPSERA
adefovir dipivoxil
TABLET;ORAL021449-001Sep 20, 20024,808,716► subscribe
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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.

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