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Generated: September 18, 2018

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Vardenafil hydrochloride - Generic Drug Details

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

Vardenafil hydrochloride is the generic ingredient in three branded drugs marketed by Bayer Hlthcare and Teva Pharms, and is included in three NDAs. There are five patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

There are five drug master file entries for vardenafil hydrochloride. Five suppliers are listed for this compound. There are three tentative approvals for this compound.

Pharmacology for vardenafil hydrochloride
Synonyms for vardenafil hydrochloride
1-((3-(3,4-Dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)-as-triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethylpiperazine
1193386-64-9
2-(2-Ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo(5,1-f)triazin-4(3H)-one
2-(2-ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one
2-(2-ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one hydrochloride
2-(2-ethoxy-5-((4-ethylpiperazin-1-yl)sulfonyl)phenyl)-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one hydrochloride trihydrate
2-(2-Ethoxy-5-(4-ethyl-piperazine-1-sulfonyl)-phenyl)-5-methyl-7-propyl-3H-imidazo(5,1-f)(1,2,4)triazin-4-one, hydrochloride
2-(2-Ethoxy-5-(4-ethylpiperazin-1-yl-1-sulfonyl)phenyl)-5-methyl-7-propyl-3H-imidazo(5,1-f)(1,2,4)triazin-4-one
2-(2-Ethoxy-5-(4-ethylpiperazin-1-yl-1-sulfonyl)phenyl)-5-methyl-7-propyl-3H-imidazo(5,1-f)(1,2,4)triazin-4-one dihydrochloride
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H -imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride
2-[2-Ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f](1,2,4]triazine-4-one dihydrochioride
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one hydrochloride
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazine-4-one
2-[2-Ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochioride
2-[2-ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one dihydrochloride
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one trihydrate hydrochloride
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one; 2-oxidanylpropane-1,2,3-tricarboxylic acid
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one dihydrochloride
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one trihydrate hydrochloride
2-[2-ethoxy-5-(4-ethylpiperazin-1-yl)sulfonylphenyl]-5-methyl-7-propyl-3H-imidazo[5,1-f][1,2,4]triazin-4-one;dihydrochloride
2-[2-ethoxy-5-(4-ethylpiperazine-1-sulfonyl)phenyl]-5-methyl-7-propyl-1H,4H-imidazo[4,3-f][1,2,4]triazin-4-one
2-[2-ethoxy-5-(4ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazine-4-one dihydrochloride
2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one trihydrate hydrochloride
2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one; 2-hydroxypropane-1,2,3-tricarboxylic acid
2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-imidazo[5,1-f][1,2,4]triazin-4-one
2-[2ethoxy-5-(4-ethyl-piperazine-1-sulphonyl)-phenyl]-5-methyl-7-propyl-3h-imidazo[5,1-f][1,2,4]triazin-4-one hydrochloride
2-{2-ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl}-5-methyl-7-propyl-1H,4H-imidazo[4,3-f][1,2,4]triazin-4-one
2-{2-ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl}-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4-ol
2-{2-ETHOXY-5-[(4-ETHYLPIPERAZIN-1-YL)SULFONYL]PHENYL}-5-METHYL-7-PROPYLIMIDAZO[5,1-F][1,2,4]TRIAZIN-4(1H)-ONE
2-{2-ethoxy-5-[(4-ethylpiperazine-1-)sulfonyl]phenyl}-5-methyl-7-propyl-3H,4H-imidazo[1,5-a][1,2,4]triazin-4-one
224785-90-4
224785-90-4 (base)
224785-91-5
224789-15-5
224789-15-5 (di-hcl)
224V155
330808-88-3
4-[4-Ethoxy-3-(5-methyl-4-oxo-7-propyl-3,4-dihydro-imidazo[5,1-f][1,2,4]triazin-2-yl)-benzenesulfonyl]-1-ethyl-piperazin-1-ium; chloride
4146AH
4CH-016055
5M8S2CU0TS
5O8R96XMH7
785V904
785V915
789V155
85V904
A816221
A816222
AB0012239
AB00698215-08
AB01274740_02
AB01274740_03
AB01274740-01
AB01275440-01
AB2000617
AC1L3808
AC1L3UZG
AC1OCFGQ
AJ-70562
AK143286
AK143287
AKOS005574038
AKOS015895117
AKOS015966861
AKOS015994765
AKOS022186043
AKOS025312515
AKOS032400217
Ambap224789-15-5
AN-29465
AN-29466
AN-29467
API0004574
API0008769
AS-12621
AS-14122
AT-4121
BAY 38-9456
BAY-38-9456
BAY38-9456
BC677643
BCP0726000254
BDBM14776
BDBM50111900
BRD-K13926615-003-01-7
BSPBio_002392
C23H32N6O4S.ClH.3H2O
C23H32N6O4S.HCl
C23H33ClN6O4S
CAS-1193386-64-9
CCG-101107
CCG-213406
CCG-221149
CHEBI:46295
CHEMBL1339
CHEMBL1520
CHEMBL1874590
CHEMBL2106480
cid_23581791
citric acid;2-[2-ethoxy-5-(4-ethylpiperazino)sulfonyl-phenyl]-5-methyl-7-propyl-1H-imidazo[5,1-f][1,2,4]triazin-4-one
CPD000469155
CS-2548
CS-2765
CTK8E8157
D02731
D03260
D08668
D09989
D0C9SY
DB00862
DR003011
DSSTox_CID_26696
DSSTox_GSID_46696
DSSTox_RID_81830
DTXSID0046696
DTXSID3048318
EC 607-088-5
FT-0631204
FT-0675781
FT-0675782
GS-6519
GTPL7320
HE071086
HMS2052I11
HMS2089K04
HMS2231I08
HMS3371J22
HMS3394I11
HSDB 7304
HY-B0442
HY-B0442A
I06-0385
IF61NL91H3
IMI044
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one, 2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-
Imidazo[5,1-f][1,2,4]triazin-4(1H)-one,2-[2-ethoxy-5-[(4-ethyl-1-piperazinyl)sulfonyl]phenyl]-5-methyl-7-propyl-,hydrochloride, hydrate (1:1:3)
IN013972
IN013973
IN014948
J-014730
J-014731
J-014734
KS-00000H95
KS-00000XJE
KS-1318
KS-5073
Levitra
Levitra (TN)
Levitra hydrochloride
Levitra;Vivanza
LS-111467
LS-181806
MCULE-5211071344
MCULE-5671555647
MFCD08458876
MLS001401365
MLS006011996
MolPort-002-672-272
MolPort-003-666-657
MolPort-003-986-627
MolPort-005-975-775
MolPort-006-167-644
MolPort-009-198-806
MolPort-020-313-423
MolPort-023-220-212
MolPort-027-845-948
NC00357
NCGC00167533-01
NCGC00167533-02
NCGC00167533-03
NOIHTGOGFDFCBN-UHFFFAOYSA-N
NSC-759103
NSC759103
Pharmakon1600-01505374
Piperazine, 1-((3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)(1,2,4)triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethyl-
Piperazine, 1-((3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)(1,2,4)triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethyl-, dihydrochloride
Piperazine, 1-((3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo(5,1-f)(1,2,4)triazin-2-yl)-4-ethoxyphenyl)sulfonyl)-4-ethyl-, monohydrochloride
piperazine, 1-[[3-(1,4-dihydro-5-methyl-4-oxo-7-propylimidazo[5,1-f][1,2,4]triazin-2-yl)-4-ethoxyphenyl]sulfonyl]-4-ethyl-,monohydrochloride
s2515
SAM001246573
SBI-0206836.P001
SCHEMBL5685
SCHEMBL5772
SCHEMBL973820
SECKRCOLJRRGGV-UHFFFAOYSA-N
SMR000469155
SMR004703549
ST51052749
Staxyn
Staxyn (TN)
STK642629
STOCK6S-20068
TL8001885
Tox21_112530
Tox21_112530_1
UCE6F4125H
UNII-5M8S2CU0TS
UNII-5O8R96XMH7
UNII-IF61NL91H3
UNII-UCE6F4125H
Vardenafil
Vardenafil (hydrochloride)
Vardenafil (INN)
Vardenafil (Vivanza)
Vardenafil [USAN:INN:BAN]
VARDENAFIL CITRATE
Vardenafil dihydrochloride
Vardenafil dihydrochloride [USAN]
Vardenafil Dihydrochloride 1.0 mg/ml in Methanol (as free base)
Vardenafil Dihydrochloride Salt
Vardenafil dihydrochloride solution, 1.0 mg/mL in methanol (as free base), ampule of 1 mL, certified reference material
Vardenafil dihydrochoride (USAN)
Vardenafil HCL
Vardenafil HCl Trihydrate
Vardenafil hydrochloride (USAN)
Vardenafil hydrochloride [USAN]
Vardenafil hydrochloride hydrate
Vardenafil hydrochloride hydrate (JAN)
Vardenafil hydrochloride trihydrate
Vardenafil Hydrochloride Trihydrate (Vivanza
Vardenafil ODT
VARDENAFIL, LEVITRA
Vardenafildihydrochloride
Vardenafilhydrochloridetrihydrate
VARDENAFILHYDROCHLORIDETRIHYDRATE(SUBJECTTOPATENTFREE)
Vardenafilum
VDN
Vivanza
X5251
XCMULUAPJXCOHI-UHFFFAOYSA-N
Z2790753946
ZINC18324776
Tentative approvals for VARDENAFIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial2.5MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial20MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET;ORAL

US Patents and Regulatory Information for vardenafil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-004 Aug 19, 2003 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ Try a Free Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-003 Aug 19, 2003 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Bayer Hlthcare LEVITRA vardenafil hydrochloride TABLET;ORAL 021400-002 Aug 19, 2003 RX Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y Y ➤ 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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Serving hundreds of leading biopharmaceutical companies globally:

Dow
Teva
Chubb
Covington
Medtronic
Boehringer Ingelheim
Fuji
UBS
Deloitte

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