Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 12, 2019

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Oxazepam - Generic Drug Details

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

Oxazepam is the generic ingredient in three branded drugs marketed by Actavis Elizabeth, Am Therap, Frontida Biopharm, Ivax Sub Teva Pharms, Mylan, Sandoz, Watson Labs, Watson Labs Teva, Alpharma Us Pharms, Quantum Pharmics, Parke Davis, and Sun Pharm Industries, and is included in twenty-four NDAs. Additional information is available in the individual branded drug profile pages.

There are eight drug master file entries for oxazepam. Five suppliers are listed for this compound.

Drug Prices for oxazepam

See drug prices for oxazepam

Recent Clinical Trials for oxazepam

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

SponsorPhase
National Institute on Drug Abuse (NIDA)Phase 1
Embera NeuroTherapeutics, Inc.Phase 1
University of KentuckyPhase 0

See all oxazepam clinical trials

Pharmacology for oxazepam
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for oxazepam
Synonyms for oxazepam
(.+/-.)-Oxazepam
(+-)-7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
(+-)-Oxazepam
(RS)-Oxazepam
(Z)-7-chloro-3-hydroxy-5-phenyl-1H-benzo[e][1,4]diazepin-2(3H)-one
1,3-Dihydro-7-chloro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
2H-1, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-, (+-)-
2H-1,4-Benzodiazepin-2-one,7-chloro-1,3-dihydro-3-hydroxy-5-phenyl-
3-hydroxy-1,3-dihydro-7-chloro-5-phenyl-2H-1,4-benzodiazepin-2-one
3-hydroxy-5-phenyl-7-chloro-2,3-dihydro-1H-1,4-benzodiazepin-2-one
3-Hydroxynordiazepam
35295-88-6
604-75-1
604O751
61036-43-9
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4 [2H]-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-1,4 [2Hl-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepin-2-one
7-Chloro-1,3-dihydro-3-hydroxy-5-phenyl-2H-1,4-benzodiazepine-2-one
7-Chloro-1,4-benzodiazepine-2-one
7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-1,4-benzodiazepin-2-one
7-Chloro-3-hydroxy-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
7-CHLORO-3-HYDROXY-5-PHENYL-1,3-DIHYDRO-2H-BENZO[E][1,4]DIAZEPIN-2-ONE
7-Chloro-3-hydroxy-5-phenyl-1,3-dihydro-benzo[e][1,4]diazepin-2-one
7-Chloro-3-hydroxy-5-phenyl-1,4-benzodiazepin-2-one
7-chloro-3-hydroxy-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one
7-chloro-5-phenyl-3H-1,4-benzodiazepine-2,3-diol
Abboxampam
Abboxapam
AC1L1IKD
ADIMAYPTOBDMTL-UHFFFAOYSA-
ADIMAYPTOBDMTL-UHFFFAOYSA-N
Adumbran
Alepam
AN-16712
Ansioxacepam
Anxiolit
Anxiolit retard
API0003709
Aplakil
Apo-astress
Astress
Azutranguil
Azutranquil
BDBM85031
Bonare
C07359
CAS_604-75-1
CAS-604-75-1
CB 8092
CCRIS 488
CHEBI:7823
CHEMBL568
D00464
DB00842
DEA No. 2835
DivK1c_000986
Drimuel
Droxacepam
DSSTox_CID_1087
DSSTox_GSID_21087
DSSTox_RID_75934
DTXSID1021087
Durazepam
EINECS 210-076-9
FT-0673333
GTPL7253
Hi-Long
Hilong
HMS503E13
HSDB 3140
IDI1_000986
InChI=1/C15H11ClN2O2/c16-10-6-7-12-11(8-10)13(9-4-2-1-3-5-9)18-15(20)14(19)17-12/h1-8,15,20H,(H,17,19)
Isodin
KBio1_000986
Lederpam
Limbial
LS-34236
LS-44
MFCD00057903
Murelax
N-Desmethyltemazepam
NCGC00159323-02
NCGC00159323-03
NCGC00159323-04
NCGC00257352-01
NCGC00258254-01
Nesontil
NINDS_000986
Noctazepam
Nortemazepam
Nozepam
NSC 169448
NSC_4616
NSC-169448
NSC169448
Oprea1_501459
Ossazepam
Ossazepam [DCIT]
Oxa-puren
Oxanid
Oxazepam (JAN/USP/INN)
Oxazepam [USAN:INN:BAN:JAN]
Oxazepam [USAN:USP:INN:BAN:JAN]
Oxazepam 0.1 mg/ml in Methanol
Oxazepam 1.0 mg/ml in Methanol
Oxazepam for peak identification, European Pharmacopoeia (EP) Reference Standard
Oxazepam solution, 1 mg/mL in methanol, ampule of 1 mL, certified reference material
Oxazepam solution, drug standard, 1.0 mg/mL in methanol
Oxazepam, European Pharmacopoeia (EP) Reference Standard
Oxazepamum
Oxazepamum [INN-Latin]
Oxazipam
Oxozepam
p acienx
Pacienx
Praxiten
Propax
Psicopax
Psiquiwas
QUEN
Quilibrex
Ro 5-6789
Rondar
SCHEMBL27435
Sedigoa
Serax
Serax (TN)
Serenal
Serenid
Serenid-D
Serepax
Seresta
Serpax
Sigacalm
Sobril
SR-01000942251
SR-01000942251-1
Tacepam
Tarchomin
Tazepam
Tox21_111572
Tox21_112819
Tox21_200700
Tox21_303501
tranquo-buscopan- wirkstoff
Tranquo-buscopan-wirkstoff
Uskan
Vaben
WLN: T67 GMV JN IHJ CG IQ KR
Wy 3498
WY-3498
Wy-3498 stic
Z 10 tr
Z10-Tr
Zaxopam
Paragraph IV (Patent) Challenges for OXAZEPAM
Tradename Dosage Ingredient NDA Submissiondate
SERAX CAPSULE;ORAL oxazepam 015539
SERAX TABLET;ORAL oxazepam 015539

US Patents and Regulatory Information for oxazepam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Therap OXAZEPAM oxazepam CAPSULE;ORAL 071957-001 Mar 3, 1988 DISCN No No   Start Trial   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-004 Approved Prior to Jan 1, 1982 DISCN No No   Start Trial   Start Trial   Start Trial
Actavis Elizabeth OXAZEPAM oxazepam CAPSULE;ORAL 072253-003 Apr 14, 1988 AB RX No No   Start Trial   Start Trial   Start Trial
Parke Davis OXAZEPAM oxazepam TABLET;ORAL 071508-001 Feb 2, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Frontida Biopharm OXAZEPAM oxazepam CAPSULE;ORAL 071026-001 Aug 10, 1987 DISCN No No   Start Trial   Start Trial   Start Trial
Quantum Pharmics ZAXOPAM oxazepam CAPSULE;ORAL 070641-001 Mar 1, 1988 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 oxazepam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-002 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-006 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Alpharma Us Pharms SERAX oxazepam CAPSULE;ORAL 015539-004 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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