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

Ingredient-type	Nucleoside Analog
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

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:	RX	Dosage:	TABLET;ORAL			Strength	10MG
Approval Date:	Sep 20, 2002	TE:	AB	RLD:	Yes
Patent:	➤ Try a Free Trial	Patent Expiration:	Jul 23, 2018	Product Flag?	Y	Substance Flag?	Y	Delist Request?
Patented Use:	THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION

Expired US Patents for NDA 021449

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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
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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