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Last Updated: November 12, 2019

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Nefazodone hydrochloride - Generic Drug Details

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

Nefazodone hydrochloride is the generic ingredient in two branded drugs marketed by Ani Pharms Inc, Dr Reddys Labs Inc, Fosun Pharma, Ivax Sub Teva Pharms, Mylan, Roxane, Sun Pharm Inds Ltd, Teva, Watson Labs, and Bristol Myers Squibb, and is included in ten NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for nefazodone hydrochloride. Three suppliers are listed for this compound. There are two tentative approvals for this compound.

Recent Clinical Trials for nefazodone hydrochloride

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

SponsorPhase
Instituto Nacional de Salud Publica, MexicoPhase 3
Laboratorios Grossman, S.A.Phase 3
VA Office of Research and DevelopmentPhase 2

See all nefazodone hydrochloride clinical trials

Generic filers with tentative approvals for NEFAZODONE HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial250MGTABLET;ORAL
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL

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

Pharmacology for nefazodone hydrochloride
Synonyms for nefazodone hydrochloride
1-(3-(4-(3-Chlorophenyl)piperazin-1-yl)propyl)-3-ethyl-4-(2-phenoxyethyl)-1H-1,2,4-triazol-5(4H)-one hydrochloride
1-(3-(4-(m-Chlorophenyl)-1-piperazinyl)propyl)-3-ethyl-4-(2-phenoxyethyl)-delta(sup 2)-1,2,4-triazolin-5-one monohydrochloride
2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl- 2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one hydrochloride
2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3h-1,2,4-triaz
2-[3-[4-(3-Chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-3H-1,2,4-triazol-3-one hydrochloride
2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-4-(2-phenoxyethyl)-1,2,4-triazol-3-one hydrochloride
2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-5-ethyl-4-(2-phenoxyethyl)-2H-1,2,4-triazol-3(4H)-one hydrochloride
2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-5-ethyl-4-(2-phenoxyethyl)-1,2,4-triazol-3-one hydrochloride
2-[3-[4-(3-chlorophenyl)piperazin-1-yl]propyl]-5-ethyl-4-(2-phenoxyethyl)-1,2,4-triazol-3-one;hydrochloride
2-{3-[4-(3-chlorophenyl)piperazin-1-yl]propyl}-5-ethyl-4-(2-phenoxyethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one hydrochloride
27X63J94GR
3H-1,2,4-Triazol-3-one, 2-(3-(4-(3-chlorophenyl)-1-piperazinyl))propyl)-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-, monohydrochloride
3H-1,2,4-Triazol-3-one, 2-(3-(4-(3-chlorophenyl)-1-piperazinyl)propyl)-5-ethyl-2,4-dihydro-4-(2-phenoxyethyl)-, monohydrochloride
752N996
82752-99-6
83366-66-9 (Parent)
A840427
AB0012498
AC-1373
AC1L1HZ6
AKOS015846321
AN-14998
ANW-44895
API0003524
AX8232012
B7183
BG0403
BMY 13754
BMY 13754-1
BMY-13754
BMY-13754-1
BR-72861
C25H32ClN5O2.HCl
C25H33Cl2N5O2
CAS-82752-99-6
CCG-100923
CHEBI:7495
CHEMBL1200492
CPD000449297
CS-4860
CTK8B4390
D00819
DSSTox_CID_26088
DSSTox_GSID_46088
DSSTox_RID_81328
DTXSID8046088
Dutonin
DYCKFEBIOUQECE-UHFFFAOYSA-N
FT-0601548
HY-B1396
I14-2088
J10172
KB-213403
KS-00001FBT
KS-1088
LS-156498
Menfazona
MFCD00935760
MJ 13,754-1
MJ 13754-1
MJ-13754-1
MLS000758241
MLS000759458
MLS001401457
MolPort-003-983-466
NC00173
NCGC00165846-02
NCGC00165846-04
Nefadar
Nefazodone (hydrochloride)
Nefazodone Hcl
nefazodone hydrochlo
Nefazodone hydrochloride (USAN)
Nefazodone hydrochloride [USAN:USP]
Nefazodone hydrochloride [USAN]
Nefazodone Hydrochloride 1.0 mg/ml in Methanol (as free base)
Nefazodone hydrochloride, >=98% (HPLC), solid
Nefazodone hydrochloride, United States Pharmacopeia (USP) Reference Standard
nefazodone-d5 hcl
Nefazodone(hydrochloride)
Reseril
Rulivan
SAM001246653
SAM001247036
SC-18178
SCHEMBL41119
Serazone
Serzone
Serzone (TN)
SMR000449297
SR-01000759312
SR-01000759312-6
ST24021030
TL8005461
Tox21_111735
Tox21_111735_1
Tox21_113574
TR-025850
UNII-27X63J94GR
VA11367
Paragraph IV (Patent) Challenges for NEFAZODONE HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
SERZONE TABLET;ORAL nefazodone hydrochloride 020152

US Patents and Regulatory Information for nefazodone hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Inc NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076309-004 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-001 Dec 22, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Fosun Pharma NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076302-001 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Bristol Myers Squibb SERZONE nefazodone hydrochloride TABLET;ORAL 020152-002 Dec 22, 1994 DISCN Yes No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076072-003 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Fosun Pharma NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076302-005 Sep 16, 2003 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan NEFAZODONE HYDROCHLORIDE nefazodone hydrochloride TABLET;ORAL 076129-003 Sep 16, 2003 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 nefazodone hydrochloride

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