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Last Updated: April 9, 2020

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PENCICLOVIR - Generic Drug Details

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

Penciclovir is the generic ingredient in one branded drug marketed by Mylan and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Penciclovir has seventy-one patent family members in twenty-seven countries.

There are three drug master file entries for penciclovir. One supplier is listed for this compound.

Drug Prices for PENCICLOVIR

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Recent Clinical Trials for PENCICLOVIR

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

SponsorPhase
Squarex, LLCPhase 2
EMSPhase 3
NovartisPhase 4

See all PENCICLOVIR clinical trials

Recent Litigation for PENCICLOVIR

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Ranbaxy Laboratories Limited2007-03-09
NOVARTIS PHARMACEUTICALS CORPORATION v. ROXANE LABORATORIES, INC.
NOVARTIS PHARMACEUITCALS CORPORATION v. ROXANE LABORATORIES, INC.

See all PENCICLOVIR litigation

Pharmacology for PENCICLOVIR
Synonyms for PENCICLOVIR
2-[2-(2-Amino-6-hydroxy-purin-9-yl)-ethyl]-propane-1,3-diol
2-Amino-1,9-dihydro-9-[4-hydroxy-3-(hydroxymethyl)butyl]-6H-purin-6-one
2-amino-9-(4-hydroxy-3-(hydroxymethyl)butyl)-1,9-dihydro-6H-purin-6-one
2-amino-9-(4-hydroxy-3-(hydroxymethyl)butyl)-1H-purin-6(9H)-one
2-amino-9-(4-hydroxy-3-(hydroxymethyl)butyl)-3H-purin-6(9H)-one
2-Amino-9-(4-hydroxy-3-hydroxymethyl-butyl)-1,9-dihydro-purin-6-one
2-Amino-9-(4-hydroxy-3-hydroxymethyl-butyl)-1,9-dihydro-purin-6-one (PCV)
2-Amino-9-(4-hydroxy-3-hydroxymethyl-butyl)-1,9-dihydro-purin-6-one(PCV, Penciclovir)
2-amino-9-[4-hydroxy-3-(hydroxymethyl)butyl]-1,9-dihydro-6H-purin-6-one
2-amino-9-[4-hydroxy-3-(hydroxymethyl)butyl]-1H-purin-6-one
2-Amino-9-[4-hydroxy-3-(hydroxymethyl)butyl]-3,9-dihydro-6H-purin-6-one
2-amino-9-[4-hydroxy-3-(hydroxymethyl)butyl]-3,9-dihydropurin-6-one
2-amino-9-[4-hydroxy-3-(hydroxymethyl)butyl]-3H-purin-6-one
2-amino-9-[4-hydroxy-3-(hydroxymethyl)butyl]-6,9-dihydro-3H-purin-6-one
2-azanyl-9-[3-(hydroxymethyl)-4-oxidanyl-butyl]-3H-purin-6-one
359HUE8FJC
39809-25-1
6H-Purin-6-one, 2-amino-1,9-dihydro-9-(4-hydroxy-3-(hydroxymethyl)butyl)-
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[4-hydroxy-3-(hydroxymethyl)butyl]-
809P251
9-(4-HYDROXY-3-(HYDROXYMETHYL)BUT-1-YL)GUANINE
9-(4-Hydroxy-3-(hydroxymethyl)butyl)guanine
9-(4-hydroxy-3-hydroxymethylbut-1-yl)-guanine
9-(4-hydroxy-3-hydroxymethylbut-1-yl)guanine
9-[2-hydroxy-1-(hydroxymethyl)-ethoxymethyl]guanine
9-[4-hydroxy-3-(hydroxymethyl)but-1-yl]guanine
9-[4-Hydroxy-3-(hydroxymethyl)butyl]guanine
97845-62-0
A824740
AB00698242-05
AB01275514_02
AB01275514-01
AB01566918_01
AC-8067
Adenovir
AK546699
AKOS007930676
AKOS026750166
API0003773
BCP13112
BDBM50210804
BRL 39123
BRL 39123;VSA 671
BRL-39123
C-15663
C07417
C10H15N5O3
CAS-39809-25-1
CCG-101000
CCG-213029
CCRIS 9213
CHEBI:7956
CHEMBL1540
CPD000466317
CS-1355
CTK8G2293
D05407
DB00299
Denavir
Denavir (TN)
DSSTox_CID_26491
DSSTox_GSID_46491
DSSTox_RID_81662
DTXSID9046491
FT-0080010
FT-0601627
HMS2051D06
HMS2090H11
HMS2232A11
HMS3371P04
HMS3393D06
HMS3652H07
HMS3713P14
HSDB 8123
HY-17424
J90026
JNTOCHDNEULJHD-UHFFFAOYSA-N
KS-00000GW1
KS-5016
LS-127198
MB2488
MLS000759422
MLS001424110
NC00250
NCGC00164630-01
NCGC00263533-01
NCGC00386270-02
NSC-759624
NSC759624
P2164
PCV
PE2
Penciceovir
Penciclovir (USAN/INN)
Penciclovir [USAN:INN:BAN]
Penciclovir-d4 (deuterated)
Penciclovir,(S)
Penciclovirum
Penciclovirum [INN-Latin]
Pencyclovir
Pharmakon1600-01502320
Q420364
s4184
SAM001246580
SC-13987
SCHEMBL19236307
SCHEMBL3494
SMR000466317
SR-01000763121
SR-01000763121-3
SR-05000001512
SR-05000001512-1
SR-05000001512-2
SW197630-2
Tox21_112248
Tox21_112248_1
UNII-359HUE8FJC
Vectavir
VSA 671
W-5154
ZINC1899

US Patents and Regulatory Information for PENCICLOVIR

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 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 PENCICLOVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
Mylan DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for PENCICLOVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0141927 97C0033 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228
0182024 SPC/GB94/002 United Kingdom   Start Trial SPC/GB94/002: 20050910, EXPIRES: 20081209
0296560 98C0015 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

AstraZeneca
Johnson and Johnson
Moodys
Mallinckrodt
Baxter
Harvard Business School

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