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Last Updated: May 26, 2022

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

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 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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
Gilead HEPSERA adefovir dipivoxil TABLET;ORAL 021449-001 Sep 20, 2002 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for HEPSERA

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

Country Patent Number Title Estimated Expiration
Australia 580151 See Plans and Pricing
Japan H0692307 See Plans and Pricing
Australia 5632886 See Plans and Pricing
Canada 1272956 UTILISATION THERAPEUTIQUE DE PHOSPHONYLMETHOXY-ALKYL- ADENINES (THERAPEUTICAL APPLICATION OF PHOSPHONYLMETHOXY-ALKYL ADENINES) See Plans and Pricing
Philippines 23112 THERAPEUTICAL APPLICATION OF PHOSPHONYLMETHOXYALKYL ADENINES See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for HEPSERA

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

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