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Last Updated: May 27, 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

See drug prices for HEPSERA

Recent Clinical Trials for HEPSERA

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

SponsorPhase
Yeungnam UniversityPhase 4
Keimyung University Dongsan Medical CenterPhase 4
DongGuk 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 ⤷  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

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

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
European Patent Office 1256584 Procédé de préparation de l'adéfovir dipivoxil (Process for preparing Adefovir Dipivoxil) ⤷  Sign Up
Indonesia 28006 ⤷  Sign Up
Hong Kong 1091211 ⤷  Sign Up
Israel 78553 THERAPEUTIC COMPOSITIONS OF PHOSPHONYLMETHOXYALKYL ADENINES ⤷  Sign Up
Spain 2187991 ⤷  Sign Up
European Patent Office 0206459 9-(PHOSPHONYLMETHOXYALKYL) ADENINES, METHOD FOR THEIR PREPARATION AND THEIR USE ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HEPSERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0481214 300131 Netherlands ⤷  Sign Up 300131, 20110910, EXPIRES: 20160909
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 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
0481214 03C0034 France ⤷  Sign Up PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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 verification 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.