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Last Updated: July 12, 2020

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HEPSERA Drug 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. Three suppliers are listed for this compound. Additional details are available on the adefovir dipivoxil profile page.

US ANDA 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
Keimyung University Dongsan Medical CenterPhase 4
DongGuk UniversityPhase 4
Yeungnam UniversityPhase 4

See all HEPSERA clinical trials

Paragraph IV (Patent) Challenges for HEPSERA
Tradename Dosage Ingredient NDA Submissiondate
HEPSERA TABLET;ORAL adefovir dipivoxil 021449 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   Start Trial   Start Trial   Start 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   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for HEPSERA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0481214 300131 Netherlands   Start Trial 300131, 20110910, EXPIRES: 20160909
0481214 03C0034 France   Start Trial PRODUCT NAME: ADEFOVIR DIPIVOXIL; REGISTRATION NO/DATE: EU/1/03/251/001 20030306
0481214 91036 Luxembourg   Start Trial 91036, EXPIRES: 20160910
0481214 C300131 Netherlands   Start 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 SPC/GB03/030 United Kingdom   Start 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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Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKinsey
Harvard Business School
Mallinckrodt
Moodys

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