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Last Updated: January 17, 2020

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Adefovir dipivoxil - Generic Drug Details

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What are the generic drug sources for adefovir dipivoxil and what is the scope of patent protection?

Adefovir dipivoxil is the generic ingredient in two branded drugs marketed by Apotex, Sigmapharm Labs Llc, and Gilead, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for adefovir dipivoxil. Three suppliers are listed for this compound.

Drug Prices for adefovir dipivoxil

See drug prices for adefovir dipivoxil

Recent Clinical Trials for adefovir dipivoxil

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

SponsorPhase
Beijing Ditan HospitalPhase 4
Asian-Pacific Alliance of Liver Disease, BeijingPhase 4
Hebei Medical University Pharmaceutical FactoryPhase 4

See all adefovir dipivoxil clinical trials

Recent Litigation for adefovir dipivoxil

Identify potential future generic entrants

District Court Litigation
Case NameDate
Gilead Sciences v. Sigmapharm Labs2014-05-05
GILEAD SCIENCES, INC. v. SIGMAPHARM LABORATORIES, LLC2010-09-24

See all adefovir dipivoxil litigation

Synonyms for adefovir dipivoxil
((((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
9-[2-[BIS[(PIVALOYLOXY)METHOXY]PHOSPHINYL]METHOXY]ETHYL]ADENINE
A807894
AB0012816
AB01274706_02
AB01274706-01
AB07592
AB2000245
AC-1693
AC1L1U36
adefovir depivoxil
Adefovir di(pivaloyloxymethyl) ester
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)
Adefovirdipivoxl
AK546547
AKOS005145737
AN-6719
ANW-43238
API0001387
ARONIS27063
B2222
BC206225
BCP0726000157
BCP22959
BCP9000232
BCPP000434
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
Hepsera (TM)
Hepsera (TN)
HMS3604F09
HMS3655I04
HY-B0255
I06-1150
I14-3234
KS-00000L27
KS-000048K6
LS-173141
MCULE-6257358029
MFCD00869897
MLS003915635
MLS004774124
NCGC00164624-01
NCGC00164624-02
NCGC00164624-03
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
RP17773
RTC-070886
s1718
SCHEMBL29729
SMR002530072
SR-01000931258
SR-01000931258-2
STL257088
SW219933-1
TC-070886
TL8000938
Tox21_112243
Tox21_112243_1
U6Q8Z01514
UNII-U6Q8Z01514
W-2203
YouHeDing
ZINC3930376
Paragraph IV (Patent) Challenges for ADEFOVIR DIPIVOXIL
Tradename Dosage Ingredient NDA Submissiondate
HEPSERA TABLET;ORAL adefovir dipivoxil 021449 2010-06-08

US Patents and Regulatory Information for adefovir dipivoxil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 205459-001 Jul 6, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Sigmapharm Labs Llc ADEFOVIR DIPIVOXIL adefovir dipivoxil TABLET;ORAL 202051-001 Aug 29, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
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 adefovir dipivoxil

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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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

Serving leading biopharmaceutical companies globally:

Merck
McKesson
Harvard Business School
McKinsey
Medtronic
AstraZeneca

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