You are 3 steps away
from making better decisions

Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKinsey
Harvard Business School
Mallinckrodt
Moodys

Last Updated: April 4, 2020

DrugPatentWatch Database Preview

HEPSERA Drug Profile


Email this page to a colleague

» See Plans and Pricing

« Back to Dashboard

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.

  Start Trial

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
DongGuk UniversityPhase 4
Yeungnam UniversityPhase 4
Daegu Catholic University Medical CenterPhase 4

See all HEPSERA clinical trials

Recent Litigation for HEPSERA

Identify potential future generic entrants

District Court Litigation
Case NameDate
United States v. Gilead Sciences, Inc.2019-11-06
Gilead Sciences v. Sigmapharm Labs2014-05-05
GILEAD SCIENCES, INC. v. SIGMAPHARM LABORATORIES, LLC2010-09-24

See all HEPSERA litigation

Synonyms for HEPSERA
((((2-(6-amino-9H-purin-9-yl)ethoxy)methyl)phosphoryl)bis(oxy))bis(methylene) bis(2,2-dimethylpropanoate)
(((2-(6-Amino-9H-purin-9-yl)ethoxy)methyl)phosphinylidene)bis(oxymethylene) 2,2-dimethylpropanoate
(((2-(6-AMINO-9H-PURIN-9-YL)ETHOXY)METHYL)PHOSPHORYL)BIS(OXY)BIS(METHYLENE) BIS(2,2-DIMETHYLPROPANOATE)
((2-(6-Amino-9H-purin-9-yl)ethoxy)methyl)phosphonic acid, diester with hydroxymethyl pivalate
[({[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}({[(2,2-dimethylpropanoyl)oxy]methoxy})phosphoryl)oxy]methyl 2,2-dimethylpropanoate
[2-(6-aminopurin-9-yl)ethoxymethyl-(2,2-dimethylpropanoyloxymethoxy)phosphoryl]oxymethyl 2,2-dimethylpropanoate
142340-99-6
2,2-dimethylpropanoic acid [2-(6-aminopurin-9-yl)ethoxymethyl-[(2,2-dimethyl-1-oxopropoxy)methoxy]phosphoryl]oxymethyl ester
3-{[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3-phosphanon-1-yl pivalate (non-preferred
3-{[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3?5-phosphanon-1-yl 2,2-dimethylpropanoate
3-{[2-(6-amino-9H-purin-9-yl)ethoxy]methyl}-8,8-dimethyl-3-oxido-7-oxo-2,4,6-trioxa-3lambda~5~-phosphanon-1-yl 2,2-dimethylpropanoate
340A996
9-(2-((Bis((pivaloyloxy)methoxy)phosphinyl)methoxy)ethyl)adenine
9-(2[bis(Pivaloyloxymethoxy)phosphorylmethoxy]ethyl)adenine
9-[2-[Bis(pivaloyloxymethoxy)phosphorylmethoxy]ethyl]adenine
A807894
AB0012816
AB01274706_02
AB01274706-01
AB07592
AB2000245
AC-1693
adefovir depivoxil
Adefovir di(pivaloyloxymethyl) ester
ADEFOVIR DIPIVOXIL
Adefovir Dipivoxil (Preveon, Hepsera)
Adefovir dipivoxil (USAN)
Adefovir dipivoxil [USAN]
Adefovir dipivoxil, Antibiotic for Culture Media Use Only
Adefovir dipivoxyl
Adefovir pivoxil
Adefovir pivoxil (JAN)
Adefovir-Dipivoxil(Preveon)
Adefovirdipivoxil
Adefovirdipivoxl
AK546547
AKOS005145737
ANW-43238
API0001387
ARONIS27063
B2222
BCP0726000157
BCP22959
BCP9000232
BCPP000434
BDBM50248359
bis-POM PMEA
Bis-POM PMEA, Adefovir Dipivoxil
Bis-POM PMEA;Preveon;Hepsera;Preveon;Hepsera
Bis(pivaloyloxymethyl)-9-(2-phosphonylmethoxyethyl)adenine
BIS(PIVALOYLOXYMETHYL)-9-[2-(PHOSPHONOMETHOXY)ETHYL]ADENINE
Bis(POM)-PMEA
Bis(pom)PMEA
BRD-K96159438-001-03-0
C-22950
C20H32N5O8P
CA0117
CAS-142340-99-6
CC-23770
CHEMBL922
CS-2240
CTK8B3813
D01655
DB00718
DSSTox_CID_26487
DSSTox_GSID_46487
DSSTox_RID_81658
DTXSID5046487
FT-0082875
FT-0631164
GP5823
GS 0840
GS 840
GS-0840
GS-3604
GS-840
Hepsera (TM)
Hepsera (TN)
HMS3604F09
HMS3655I04
HY-B0255
KS-00000L27
KS-000048K6
LS-173141
MCULE-6257358029
MFCD00869897
MLS003915635
MLS004774124
NCGC00164624-01
NCGC00164624-02
NCGC00164624-03
NCGC00164624-11
Piv2PMEA
Preveon
Propanoic acid, 2,2-dimethyl-, (((2-(6-amino-9H-purin-9-yl)ethoxy)methyl)phosphinylidene)bis(oxymethylene) ester
Propanoic acid,2,2-dimethyl-(((2-(6-amino-9H-purin-9-yl)ehtoxy)mehtyl)phosphinyldiene)bis(oxymehtylene)ester
PubChem14224
Q-101927
RTC-070886
s1718
SCHEMBL29729
SMR002530072
SR-01000931258
SR-01000931258-2
STL257088
SW219933-1
TC-070886
Tox21_112243
Tox21_112243_1
U6Q8Z01514
UNII-U6Q8Z01514
W-2203
YouHeDing
ZINC3930376
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 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 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 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

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Colorcon
Medtronic
McKinsey
Harvard Business School
Mallinckrodt
Moodys

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.