HEPSERA Drug Patent Profile

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Which patents cover Hepsera, and when can generic versions of Hepsera launch?

Hepsera is a drug marketed by Gilead and is included in one NDA.

The generic ingredient in HEPSERA is adefovir dipivoxil. There are eight drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Hepsera

A generic version of HEPSERA was approved as adefovir dipivoxil by SIGMAPHARM LABS LLC on August 29^th, 2013.

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Summary for HEPSERA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	121
Clinical Trials:	19
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for HEPSERA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for HEPSERA
What excipients (inactive ingredients) are in HEPSERA?	HEPSERA excipients list
DailyMed Link:	HEPSERA at DailyMed

Drug patent expirations by year for HEPSERA

Recent Clinical Trials for HEPSERA

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

Sponsor	Phase
Yeungnam University	Phase 4
Keimyung University Dongsan Medical Center	Phase 4
DongGuk University	Phase 4

See all HEPSERA clinical trials

Paragraph IV (Patent) Challenges for HEPSERA

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 HEPSERA

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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
Gilead	HEPSERA	adefovir dipivoxil	TABLET;ORAL	021449-001	Sep 20, 2002	AB	RX	Yes	Yes	⤷ 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 HEPSERA

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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 HEPSERA

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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

International Patents for HEPSERA

See the table below for patents covering HEPSERA around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	H04230694	PRODRUG OF PHOSPHONATE	⤷ Sign Up
South Africa	9806614		⤷ Sign Up
Egypt	18436	THERAPEUTICAL APPLICATION OF PHOSPONYLMETHOXY-ALKYL ADENINES	⤷ Sign Up
Canada	2596497	COMPOSITIONS D'ANALOGUE DE NUCLEOTIDE (NUCLEOTIDE ANALOG COMPOSITIONS)	⤷ Sign Up
China	1763056		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for HEPSERA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0481214	C300131	Netherlands	⤷ Sign Up	PRODUCT NAME: ADEFOVIR DIPIVOXIL, DESGEWENST IN DE VORM VAN FARMACEUTISCH AANVAARDBARE ZUURADDITIE ZOUTEN, METAALZOUTEN EN SOLVATEN HIERVAN; NAT. REGISTRATION NO/DATE: EU/1/03/251/001 20030306; FIRST REGISTRATION: EU/1/03/251/001 20030306
0481214	03C0034	France	⤷ Sign Up	PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
0481214	300131	Netherlands	⤷ Sign Up	300131, 20110910, EXPIRES: 20160909
0481214	SPC/GB03/030	United Kingdom	⤷ Sign Up	PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306
0481214	91036	Luxembourg	⤷ Sign Up	91036, EXPIRES: 20160910
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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Summary for HEPSERA

Recent Clinical Trials for HEPSERA

Paragraph IV (Patent) Challenges for HEPSERA

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