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Last Updated: March 29, 2024

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 29th, 2013.

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Drug patent expirations by year for HEPSERA
Drug Prices for HEPSERA

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Recent Clinical Trials for HEPSERA

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

SponsorPhase
Yeungnam University HospitalPhase 4
Daegu Catholic University Medical CenterPhase 4
Yeungnam UniversityPhase 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

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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

EU/EMA Drug Approvals for HEPSERA

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.

Country Patent Number Title Estimated Expiration
Greece 861089 THERAPEUTIC APPLICATION OF PHOSPONYLMETHOXY ALKYL ADEMINES ⤷  Try a Trial
Japan S61275218 THERAPEUTICAL APPLICATION OF ADENINE DERIVATIVE ⤷  Try a Trial
China 1202829 ⤷  Try a Trial
China 1900090 ⤷  Try a Trial
New Zealand 501659 Methods of nucleotide analogue 9-[2[[bis[(pivaloyloxy)-methoxy]phosphinyljmethoxyjethyl] adenine ("adefovir dipivoxil" or "AD") synthesis ⤷  Try a Trial
European Patent Office 1256585 Procédé de préparation de la 9-(2-(diéthylphosphonomethoxy)éthyl)-adénine (Process for preparing 9-(2-(diethylphosphonomethoxy)ethyl)-adenine) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HEPSERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0481214 91036 Luxembourg ⤷  Try a Trial 91036, EXPIRES: 20160910
0481214 C300131 Netherlands ⤷  Try a Trial 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 300131 Netherlands ⤷  Try a Trial 300131, 20110910, EXPIRES: 20160909
0481214 03C0034 France ⤷  Try a Trial PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
0481214 SPC/GB03/030 United Kingdom ⤷  Try a Trial PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTERED: UK EU/1/03/251/001 20030306
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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