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Last Updated: May 28, 2020

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Acyclovir - Generic Drug Details

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What are the generic drug sources for acyclovir and what is the scope of freedom to operate?

Acyclovir is the generic ingredient in seven branded drugs marketed by Actavis Elizabeth, Apotex, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Dava Pharms Inc, Heritage Pharms Inc, Ivax Sub Teva Pharms, Kenton, Lek Pharm, Mylan, Ranbaxy, Roxane, Teva, Teva Pharms, Watson Labs, Perrigo Uk Finco, Bausch, Fera Pharms Llc, Acp Nimble, Alembic Pharms Ltd, Amneal Pharms, Cipla, Fougera Pharms Inc, Glenmark Pharms Sa, Mylan Pharms Inc, Solaris Pharma Corp, Taro, Tolmar, Torrent, Xiromed, Actavis Mid Atlantic, Hi Tech Pharma, Epi Hlth, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms Ltd, Sun Pharm Inds Ltd, Yiling Pharm Ltd, Zydus Pharms, Abbvie, Eurohlth Intl Sarl, Apothecon, Athenex Inc, Aurobindo Pharma Ltd, Fresenius Kabi Usa, Hikma Pharms, Hospira, Mylan Labs Ltd, Teva Parenteral, and Glaxosmithkline, and is included in eighty-two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acyclovir has forty-six patent family members in twenty-nine countries.

There are fifty-six drug master file entries for acyclovir. Sixty suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for acyclovir

See drug prices for acyclovir

Drug Sales Revenue Trends for acyclovir

See drug sales revenues for acyclovir

Recent Clinical Trials for acyclovir

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

SponsorPhase
Peking Union Medical College HospitalPhase 4
Jilin Provincial Tumor HospitalPhase 4
Shanxi Dayi HospitalPhase 4

See all acyclovir clinical trials

Generic filers with tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGCAPSULE;ORAL
  Start Trial  Start Trial800MGTABLET;ORAL
  Start Trial  Start Trial400MGTABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for acyclovir
Synonyms for acyclovir
141294-79-3
1pwy
2-Amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-6H-purin-6-one
2-Amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-6H-purin-6-one
2-amino-9-((2-hydroxyethoxy)methyl)-1,9-dihydro-6H-purin-6-one
2-Amino-9-((2-hydroxyethoxy)methyl)-1H-purin-6(9H)-one
2-amino-9-((2-hydroxyethoxy)methyl)-3,9-dihydro-6H-purin-6-one
2-amino-9-((2-hydroxyethoxy)methyl)-3H-purin-6(9H)-one
2-Amino-9-(2-hydroxy-ethoxymethyl)-5,9-dihydro-purin-6-one
2-Amino-9-(2-hydroxy-ethoxymethyl)-5,9-dihydro-purin-6-one (ACV)
2-amino-9-(2-hydroxyethoxymethyl)-1H-purin-6-one
2-amino-9-(2-hydroxyethoxymethyl)-3H-purin-6-one
2-Amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-one
2-Amino-9-[(2-hydroxyethoxy)methyl]-1,9-dihydro-6H-purin-6-one #
2-amino-9-[(2-hydroxyethoxy)methyl]-3,9-dihydro-6H-purin-6-one
2-amino-9-[(2-hydroxyethoxy)methyl]-6,9-dihydro-3H-purin-6-one
2-amino-9-[(2-hydroxyethoxy)methyl]-9H-purin-6-ol
2-amino-9-[(2-hydroxyethoxy)methyl]hydropurin-6-one
2-amino-9-{[(2-hydroxyethyl)oxy]methyl}-1,9-dihydro-6H-purin-6-one
2-azanyl-9-(2-hydroxyethyloxymethyl)-3H-purin-6-one
277A893
32284-EP2281815A1
32284-EP2301933A1
32284-EP2311827A1
59277-89-3
6383-EP2270005A1
6383-EP2305243A1
6383-EP2305640A2
6383-EP2305808A1
6383-EP2314582A1
6383-EP2314585A1
69657-51-8
69657-51-8 (Na salt)
6H-Purin-6-one, 1,9-dihydro-2-amino-9-((2-hydroxyethoxy)methyl)-
6H-Purin-6-one, 2-amino-1,9-dihydro-9-((2-hydroxyethoxy)-methyl)-
6H-Purin-6-one, 2-amino-1,9-dihydro-9-((2-hydroxyethoxy)methyl)-
6H-Purin-6-one, 2-amino-1,9-dihydro-9-[(2-hydroxyethoxy)methyl]-
6H-Purin-6-one,2-amino-1,9-dihydro-9-((2-hydroxyethoxy)mehtyl)
9-((2-Hydroxyethoxy)methyl)guanine
9-(2-hydroxyethoxy methyl) guanine
9-(2-Hydroxyethoxy)methylguanine
9-(2-Hydroxyethoxymethyl)guanine
9-[(2-Hydroxyethoxy)-methyl]guanine
9-[(2-Hydroxyethoxy)methyl]guanine
9-HYROXYETHOXYMETHYLGUANINE
9(2-hydroxyethoxymethyl)guanine
A 4669
A832236
AB0012294
AB0068584
AC-8068
AC2
Acic
Acicloftal
Aciclovier
Aciclovir
Aciclovir (JP17/INN)
Aciclovir [INN]
Aciclovir 1.0 mg/ml in Dimethyl Sulfoxide
Aciclovir for peak identification 1, European Pharmacopoeia (EP) Reference Standard
Aciclovir for peak identification 2, European Pharmacopoeia (EP) Reference Standard
Aciclovir for system suitability, European Pharmacopoeia (EP) Reference Standard
Aciclovir, British Pharmacopoeia (BP) Reference Standard
Aciclovir, European Pharmacopoeia (EP) Reference Standard
Aciclovirum
Aciclovirum [INN-Latin]
Aciclovirum [Latin]
Activir
ACV & Pluronic F-68
ACV; Acycloguanosine; Acyclovir; NSC 645011; NSC-645011; NSC645011
Acyclo-V
AcycloFoam
Acycloguanosine
Acycloguanosine, >=99% (HPLC), powder
Acycloguanosine, 98%
Acyclovir (Aciclovir)
Acyclovir (USP)
Acyclovir [USAN:USP]
Acyclovir [USAN]
Acyclovir & Pluronic F-68
Acyclovir Lauriad
Acyclovir-side chain-2-3H
ACYCLOVIR-SIDECHAIN-2-3H
Acyclovir, Pharmaceutical Secondary Standard; Certified Reference Material
Acyclovir, United States Pharmacopeia (USP) Reference Standard
Acyclovir(Aciclovir)
AK-24687
AKOS000656213
AKOS015995680
AKOS022135433
AM20100442
ANW-43941
ARONIS27002
BBL009642
BCP11036
BDBM50021776
BDBM50103518
BIDD:GT0646
BPBio1_000014
BR-24687
BRD-K32318651-001-17-9
BSPBio_000012
BSPBio_003348
BW 248U
BW-248-U
BW-248U
BW-248U74
C06810
C8H11N5O3
Cargosil
CAS-59277-89-3
CCG-39909
CCRIS 1953
CHEBI:2453
CHEMBL184
CID 2022
CPD000058225
CS-1353
CTK3J2211
Cyclovir
D00222
DB00787
DivK1c_000185
DRG-0008
DSSTox_CID_2556
DSSTox_GSID_22556
DSSTox_RID_76626
DTXSID1022556
EBD48195
EINECS 261-685-1
EU-0100037
F2173-0946
FT-0082883
FT-0621607
FT-0657847
Genvir
GTPL4829
Hascovir
HMS1568A14
HMS1922E08
HMS2090G09
HMS2095A14
HMS2234K21
HMS3259N10
HMS3260G15
HMS3269M15
HMS3372K02
HMS3413D21
HMS3655C14
HMS3677D21
HMS3712A14
HMS500J07
HSDB 6511
HY-17422
IDI1_000185
InChI=1/C8H11N5O3/c9-8-11-6-5(7(15)12-8)10-3-13(6)4-16-2-1-14/h3,14H,1-2,4H2,(H3,9,11,12,15
J10243
KBio1_000185
KBio2_002219
KBio2_004787
KBio2_007355
KBio3_002850
KBioGR_000889
KBioSS_002219
KS-00000FAT
KS-000048I2
KS-1027
KSC492E1D
Lopac-A-4669
Lopac0_000037
LP00037
LS-127209
M-1904
Maynar
MCULE-2703274259
MFCD00057880
MKUXAQIIEYXACX-UHFFFAOYSA-N
MLS000069633
NC00717
NCGC00015061-01
NCGC00015061-02
NCGC00015061-03
NCGC00015061-04
NCGC00015061-05
NCGC00015061-06
NCGC00015061-07
NCGC00015061-08
NCGC00015061-09
NCGC00015061-10
NCGC00015061-12
NCGC00015061-13
NCGC00022426-03
NCGC00093555-01
NCGC00093555-02
NCGC00093555-03
NCGC00093555-04
NCGC00167756-01
NCGC00167756-02
NCGC00260722-01
NCGC00381719-03
NINDS_000185
NSC 645011
NSC-645011
NSC-758477
NSC645011
NSC758477
Opera_ID_1674
Pharmakon1600-01503603
Poviral
Prestwick_6
Prestwick0_000086
Prestwick1_000086
Prestwick2_000086
Prestwick3_000086
PubChem9572
Q-200591
Q147101
s1807
SAM002589967
SBB063281
SC-05587
SCHEMBL3175
SCHEMBL9828560
Sitavig
Sitavig (TN)
Sitavir
SMP1_000007
SMR000058225
SPBio_001466
SPBio_001951
Spectrum_001739
SPECTRUM1503603
Spectrum2_001563
Spectrum3_001874
Spectrum4_000225
Spectrum5_001093
SR-01000075540
SR-01000075540-1
SR-01000075540-3
SR-01000075540-5
ST024744
STK796771
STL257059
STL301862
SW196324-3
Tox21_110075
Tox21_110075_1
Tox21_500037
UNII-X4HES1O11F
Vipral
Virolex
Viropump
Virorax
W-248-U
Wellcome-248U
X4HES1O11F
ZINC1530555
Zovir
Zovirax
Zovirax (TN)
Zovirax Oral Acyclovir (ACV) Suspension
Zyclir

US Patents and Regulatory Information for acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Teva ACYCLOVIR acyclovir CAPSULE;ORAL 074578-001 Apr 22, 1997 AB RX No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074930-001 May 13, 1998 AP RX No Yes   Start Trial   Start Trial   Start Trial
Epi Hlth SITAVIG acyclovir TABLET;BUCCAL 203791-001 Apr 12, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Kenton ACYCLOVIR acyclovir CAPSULE;ORAL 075090-001 Jan 26, 1999 AB RX No No   Start Trial   Start Trial   Start Trial
Hospira ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 075065-001 Feb 25, 1999 DISCN No No   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 acyclovir

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ZOVIRAX acyclovir OINTMENT;TOPICAL 018604-001 Mar 29, 1982   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991   Start Trial   Start Trial
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002   Start Trial   Start Trial
Mylan ZOVIRAX acyclovir TABLET;ORAL 020089-002 Apr 30, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for acyclovir

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0809498 10C0038 France   Start Trial PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498 SPC/GB10/012 United Kingdom   Start Trial PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
>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:

Express Scripts
Boehringer Ingelheim
Baxter
Harvard Business School
McKesson
Dow

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.