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Generated: December 17, 2018

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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 Pharms Inc and is included in one NDA. There are two patents protecting this drug.

This drug has one hundred and five patent family members in thirty-four countries.

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

Drug patent expirations by year 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.

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)-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-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)-& Human interferon-alpha
6H-Purin-6-one, 2-amino-1,9-dihydro-9-(4-hydroxy-3-(hydroxymethyl)butyl)-& Human interferon-beta
6H-Purin-6-one, 2-amino-1,9-dihydro-9-(4-hydroxy-3-(hydroxymethyl)butyl)-& Human interferon-gamma
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]-, SODIUM SALT, HYDRATE(1:1:1)
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 (mono-hydrochloride salt)
A824740
AB00698242-05
AB01275514_02
AB01275514-01
AB01566918_01
AC-8067
AC1L1ITE
Adenovir
AKOS007930676
AKOS026750166
AN-8357
API0003773
BC201722
BDBM50210804
BRL 39123
BRL-39123
C-15663
C07417
C10H15N5O3
CAS-39809-25-1
CCG-101000
CCG-213029
CCRIS 9213
CHEBI:7956
CHEMBL1540
CPD000466317
CS-1355
CTK8G2293
D05407
D07BYK
D0M1EQ
DB00299
Denavir (TN)
DR000691
DSSTox_CID_26491
DSSTox_GSID_46491
DSSTox_RID_81662
DTXSID9046491
FT-0080010
FT-0601627
HE249224
HE290229
HE295891
HMS2051D06
HMS2090H11
HMS2232A11
HMS3371P04
HMS3393D06
HMS3652H07
HSDB 8123
HY-17424
I14-2420
IN1162
J90026
JNTOCHDNEULJHD-UHFFFAOYSA-N
KS-00000GW1
KS-5016
LS-127198
MB2488
MFCD00866931
MLS000759422
MLS001424110
MolPort-003-849-798
MolPort-006-167-513
NC00250
NCGC00164630-01
NCGC00263533-01
NSC-759624
NSC759624
P2164
PE2
Penciceovir
penciclovir
Penciclovir (USAN/INN)
Penciclovir [USAN:INN:BAN]
Penciclovir & Human interferon-alpha
Penciclovir & Human interferon-beta
Penciclovir & Human interferon-gamma
Penciclovir sodium
Penciclovir-d4 (deuterated)
Penciclovirum
Penciclovirum [INN-Latin]
Pencyclovir
Pharmakon1600-01502320
s4184
SAM001246580
SBB067261
SC-13987
SCHEMBL19236307
SCHEMBL3494
SMR000466317
SR-01000763121
SR-01000763121-3
Tox21_112248
Tox21_112248_1
UNII-359HUE8FJC
Vectavir
W-5154
ZB000435
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 Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for DENAVIR

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc DENAVIR penciclovir CREAM;TOPICAL 020629-001 Sep 24, 1996 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for DENAVIR

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C0033 Belgium ➤ Try a Free Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228
C0015 Belgium ➤ Try a Free Trial PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
C/GB96/014 United Kingdom ➤ Try a Free Trial SPC/GB96/014: 20040810, EXPIRES: 20090809
C/GB94/002 United Kingdom ➤ Try a Free Trial SPC/GB94/002: 20050910, EXPIRES: 20081209
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
Fuji
Baxter
Colorcon
Federal Trade Commission
Teva
Boehringer Ingelheim
Citi

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 verifification 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.