Adefovir dipivoxil - Generic Drug Details

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What are the generic drug sources for adefovir dipivoxil and what is the scope of freedom to operate?

Adefovir dipivoxil is the generic ingredient in two branded drugs marketed by Apotex, Sigmapharm Labs Llc, and Gilead, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for adefovir dipivoxil. Two suppliers are listed for this compound.

Summary for adefovir dipivoxil

US Patents:	0
Tradenames:	2
Applicants:	3
NDAs:	3
Drug Master File Entries:	8
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	122
Clinical Trials:	81
Patent Applications:	6,076
Drug Prices:	Drug price trends for adefovir dipivoxil
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for adefovir dipivoxil
What excipients (inactive ingredients) are in adefovir dipivoxil?	adefovir dipivoxil excipients list
DailyMed Link:	adefovir dipivoxil at DailyMed

See drug prices for adefovir dipivoxil

Recent Clinical Trials for adefovir dipivoxil

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Lai Wei	Phase 2
New Discovery LLC	Phase 4
Taipei Veterans General Hospital, Taiwan	Phase 4

See all adefovir dipivoxil clinical trials

Pharmacology for adefovir dipivoxil

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for adefovir dipivoxil

J05AF	Nucleoside and nucleotide reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for ADEFOVIR DIPIVOXIL

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
HEPSERA	Tablets	adefovir dipivoxil	10 mg	021449	1	2010-06-08

US Patents and Regulatory Information for adefovir dipivoxil

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Sigmapharm Labs Llc	ADEFOVIR DIPIVOXIL	adefovir dipivoxil	TABLET;ORAL	202051-001	Aug 29, 2013	AB	RX	No	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Apotex	ADEFOVIR DIPIVOXIL	adefovir dipivoxil	TABLET;ORAL	205459-001	Jul 6, 2018	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for adefovir dipivoxil

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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	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for adefovir dipivoxil

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Gilead Sciences Ireland UC	Hepsera	adefovir dipivoxil	EMEA/H/C/000485 Hepsera is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum-alanine-aminotransferase (ALT) levels and histological evidence of active liver inflammation and fibrosis. Initiation of Hepsera treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier to resistance is not available or appropriate (see section 5.1);decompensated liver disease in combination with a second agent without cross-resistance to Hepsera.	Withdrawn	no	no	no	2003-03-06
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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