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Last Updated: May 29, 2020

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DENAVIR Drug Profile


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When do Denavir patents expire, and when can generic versions of Denavir launch?

Denavir is a drug marketed by Mylan and is included in one NDA. There is one patent protecting this drug.

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

The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the penciclovir profile page.

US ANDA Litigation and Generic Entry Outlook for Denavir

Denavir was eligible for patent challenges on September 24, 2000.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 17, 2020. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for DENAVIR
Drug Prices for DENAVIR

See drug prices for DENAVIR

Generic Entry Opportunity Date for DENAVIR
Generic Entry Date for DENAVIR*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CREAM;TOPICAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for DENAVIR

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

SponsorPhase
Squarex, LLCPhase 2

See all DENAVIR clinical trials

Recent Litigation for DENAVIR

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 DENAVIR litigation

Pharmacology for DENAVIR
Synonyms for DENAVIR
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 (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
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 DENAVIR

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 DENAVIR

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
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 DENAVIR

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 98C0015 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
0141927 SPC/GB96/014 United Kingdom   Start Trial SPC/GB96/014: 20040810, EXPIRES: 20090809
0182024 SPC/GB94/002 United Kingdom   Start Trial SPC/GB94/002: 20050910, EXPIRES: 20081209
0141927 97C0033 Belgium   Start Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; 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:

Johnson and Johnson
McKinsey
Express Scripts
Mallinckrodt
McKesson
Boehringer Ingelheim

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.