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Diazepam - Generic Drug Details

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

Diazepam is the generic ingredient in eight branded drugs marketed by Roche, Lannett Co Inc, West-ward Pharms Int, Valeant Pharms North, Abraxis Pharm, Hospira, Marsam Pharms Llc, Parenta Pharms, Us Army, Warner Chilcott, Watson Labs, Watson Labs Inc, Pharmacia And Upjohn, Actavis Elizabeth, Barr, Dava Pharms Inc, Duramed Pharms Barr, Ferndale Labs, Halsey, Ivax Sub Teva Pharms, Martec Usa Llc, Mayne Pharma, Mylan, Pioneer Pharms, Roxane, Teva Pharms, Upsher-smith Labs, Vintage Pharms, Virtus Pharms, and Quantum Pharmics, and is included in eighty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for diazepam. Forty-nine suppliers are listed for this compound.

Summary for diazepam

US Patents:	0
Tradenames:	8
Applicants:	30
NDAs:	82
Drug Master File Entries:	8
Suppliers / Packagers:	49
Bulk Api Vendors:	56
Clinical Trials:	84
Patent Applications:	6,411
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for diazepam
DailyMed Link:	diazepam at DailyMed

Pharmacology for diazepam

Ingredient-type	Benzodiazepines
Drug Class	Benzodiazepine Central alpha-2 Adrenergic Agonist
Mechanism of Action	Adrenergic alpha2-Agonists

Medical Subject Heading (MeSH) Categories for diazepam

Adjuvants, Anesthesia

Anesthetics, Intravenous

Anti-Anxiety Agents

Anticonvulsants

Antiemetics

GABA Modulators

Hypnotics and Sedatives

Muscle Relaxants, Central

Synonyms for diazepam

1-Methyl-5-phenyl-7-chloro-1,3-dihydro-2H-1,4-benzodiazepin-2-one

1-Methyl-5-phenyl-7-chloro-1,4-benzodiazepin-2-one

11100-37-1

2-((2-Ethylhexyloxy)carbonyl)benzoic acid

2H-1, 7-chloro-1,3-dihydro-1-methyl-5-phenyl-

2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-1-methyl-5-phenyl-

439-14-5

5-24-04-00300 (Beilstein Handbook Reference)

53320-84-6

7 -chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one

7-chloranyl-1-methyl-5-phenyl-3H-1,4-benzodiazepin-2-one

7-chloro-1-methyl-1,3-dihydro-5-phenyl-2H-1,4-benzodiazepin-2-one

7-Chloro-1-methyl-2-oxo-5-phenyl-3H-1,4-benzodiazepine

7-Chloro-1-methyl-5-3H-1,4-benzodiazepin-2(1H)-one

7-chloro-1-methyl-5-phenyl-1,3-dihydro-[1,4]benzodiazepin-2-one

7-Chloro-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one

7-chloro-1-methyl-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one

7-Chloro-1-methyl-5-phenyl-1,4-benzodiazepin-2-one

7-chloro-1-methyl-5-phenyl-1H-1,4-benzodiazepine-2(3H)on

7-Chloro-1-methyl-5-phenyl-1H-benzo[e][1,4]diazepin-2(3H)-one

7-Chloro-1-methyl-5-phenyl-2-oxo-2,3-dihydro-1H-benzo[f]-1,4-diazepine

7-chloro-1-methyl-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one

7-Chloro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one

7-chloro-1-methyl-5-phenyl-3H-1,4-benzodiazepin-2-one

7-Chloro-1-methyl-5-phenyl-3H-1,4-benzodiazepin-2(1H)-one

7-chloro-1,3-dihydro-1-methyl-5-phenyl-2H -1,4-benzodiazepin-2-one

7-Chloro-1,3-dihydro-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one

A3662/0155188

A826456

AAOVKJBEBIDNHE-UHFFFAOYSA-N

AB02310

AC-10561

AC1L1EZE

AK116444

AKOS003367969

Alboral

Aliseum

Alupram

Amiprol

AN-23449

An-Ding

Anlin

Ansilive

Ansiolin

Ansiolisina

Antenex

Anxicalm

Anxionil

Apaurin

Apo-diazepam

Apozepam

Armonil

Arzepam

Assival

Atensine

Atilen

Azedipamin

Baogin

BCP0726000176

BCP9000199

BDBM50000766

Bensedin

Benzopin

Best [Pharaceutical]

Betapam

Bialzepam

BIDD:GT0105

BIDD:PXR0158

BRD-K16508793-001-01-8

Britazepam

BRN 0754371

BSPBio_003279

C-17931

C06948

Calmaven

Calmocitene

Calmociteno

Calmod

Calmpose

CAS-439-14-5

Caudel

CC-26451

CCG-100997

CCRIS 6009

Centrazepam

Cercine

Ceregulart

CHEBI:49575

CHEMBL12

Chuansuan

Condition

CPD000058398

CS-0653

D-Pam

D00293

D07JVL

D0Y1YC

DB00829

DEA No. 2765

Desconet

Desloneg

Diacepan

Diaceplex

Dialag

Dialar

Diapam

Diapax

Diapine

Diaquel

Diastat

Diastat (TN)

Diastat Acudial

Diastat, Valium

Diatran

Diazapam

Diazem

Diazemuls

Diazemulus

Diazepam (intranasal, epilepsy)

Diazepam (JP17/USP/INN)

Diazepam [USAN:INN:BAN:JAN]

Diazepam 0.1 mg/ml in Methanol

Diazepam 1.0 mg/ml in Methanol

Diazepam Dak

Diazepam Desitin

Diazepam Elmu

Diazepam Fabra

Diazepam for system suitability, European Pharmacopoeia (EP) Reference Standard

Diazepam Intensol

Diazepam Nordic

Diazepam Rectubes

Diazepam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material

Diazepam solution, 1.0 mg/mL in methanol, analytical standard, for drug analysis

Diazepam Stada

Diazepam-Eurogenerics

Diazepam-Lipuro

Diazepam-ratiopharm

Diazepam, European Pharmacopoeia (EP) Reference Standard

Diazepam, United States Pharmacopeia (USP) Reference Standard

Diazepamu

Diazepamu [Polish]

Diazepamum

Diazepamum [INN-Latin]

Diazepan

Diazepan leo

Diazepin

Diazetard

Dienpax

Dipam

Dipaz

Dipezona

Disopam

DivK1c_000967

Dizac

Domalium

Doval

Drenian

DSSTox_CID_406

DSSTox_GSID_20406

DSSTox_RID_75566

DTXSID4020406

Ducene

Duksen

Dupin

Duxen

DZP

e-Pam

EINECS 207-122-5

Elcion CR

Eridan

Euphorin P

Eurosan

Evacalm

Faustal

Faustan

Faustan,

Freudal

Frustan

FT-0632135

Gewacalm

Gihitan

Gradual

GTPL3364

Gubex

HE004298

HE343443

HE349411

HMS2051N04

HMS3393N04

HMS503A15

Horizon

HSDB 3057

HY-17027

I06-0194

Iazepam

IDI1_000967

InChI=1/C16H13ClN2O/c1-19-14-8-7-12(17)9-13(14)16(18-10-15(19)20)11-5-3-2-4-6-11/h2-9H,10H2,1H

Jinpanfan

Kabivitrum

KBio1_000967

KBio3_002780

KBioGR_001012

Kiatrium

Kratium

Kratium 2

LA 111

LA III

LA-111

La-Iii

Lamra

Lembrol

Levium

Liberetas

Lizan

Lovium

LS-122

Mandro

Mandro-Zep

Mandrozep

MCULE-8990989144

Medipam

Mentalium

Metamidol

Methyl diazepinone

Methyldiazepinone

Methyldiazepinone (pharmaceutical)

Methyldiazepinone, pharmaceutical

Metil Gobanal

MLS000759402

MLS001424086

Mono (2-ethylhexyl) phthalate

Morosan

NC00247

NCGC00178168-01

NCGC00178168-02

NCGC00178168-03

NCGC00178168-04

NCGC00260007-01

Nellium

Nerozen

Nervium

neurolytr il

Neurolytril

NINDS_000967

Nivalen

Nixtensyn

Noan

Notense

Novazam

Novo-Dipam

Novodipam

NSC 169897

NSC-169897

NSC-77518

NSC169897

NSC77518

Oprea1_126223

Ortopsique

Paceum

Pacitran

Paralium

Paranten

Parzam

Paxate

Paxel

Paxum

Placidox 10

Placidox 2

Placidox 5

Plidan

Pms-Diazepam

Pomin

Pro pam

Prozepam

Psychopax

Q-pam

Q-Pam Relanium

Q3JTX2Q7TU

Quetinil

Quiatril

Quievita

Radizepam

Relaminal

Relanium

Reliver

Renborin

Ro 5-2805

Ro 5-2807

RO-5-2807

Ro-52807

Ruhsitus

S.A. R.L

S.a. r.l.

S.A.R.L.

SAM001246536

Saromet

SCHEMBL21442

Sedapam

Sedipam

Seduksen

Seduxen

Serenack

Serenamin

Serenzin

Servizepam

Setonil

Sibazon

Sibazone

Sico Relax

Simasedan

Sipam

SMR000058398

Solis

Sonacon

Spectrum3_001780

Spectrum4_000576

Spectrum5_001890

Stesolid

Stesolin

STK735517

T-quil

Tensium

Tensopam

Tox21_113071

Tox21_113071_1

Tox21_202458

Tranimul

Trankinon

Tranqdyn

Tranquase

Tranquirit

Tranquo-puren

Tranquo-tablinen

Trazepam

Umbrium

UNII-Q3JTX2Q7TU

Unisedil

Usempax ap

Valaxona

Valeo

Valiquid

Valitran

Valium

Valium (TN)

Valium R

Valrelease

Valuzepam

Vanconin

Vatran

Vazen

Vazepam

Velium

Vival

Vivol

W-5055

Winii

WLN: T67 GNV JN IHJ CG G1 KR

Wy 3467

WY-3467

ZB000640

Zepaxid

ZINC6427

Zipan

US Patents and Regulatory Information for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Valeant Pharms North	DIASTAT	diazepam	GEL;RECTAL	020648-002	Jul 29, 1997		DISCN	Yes	No
Watson Labs Inc	DIAZEPAM	diazepam	INJECTABLE;INJECTION	072370-001	Jan 29, 1993		DISCN	No	No
Mylan	DIAZEPAM	diazepam	TABLET;ORAL	070325-001	Sep 4, 1985	AB	RX	No	No
Mylan	DIAZEPAM	diazepam	TABLET;ORAL	070325-002	Sep 4, 1985	AB	RX	No	No

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Expired US Patents for diazepam

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche	VALIUM	diazepam	TABLET;ORAL	013263-004	Approved Prior to Jan 1, 1982
Valeant Pharms North	DIASTAT	diazepam	GEL;RECTAL	020648-004	Jul 29, 1997
Valeant Pharms North	DIASTAT	diazepam	GEL;RECTAL	020648-005	Jul 29, 1997
Roche	VALRELEASE	diazepam	CAPSULE, EXTENDED RELEASE;ORAL	018179-001	Approved Prior to Jan 1, 1982

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