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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Temazepam - Generic Drug Details

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

Temazepam is the generic ingredient in three branded drugs marketed by Specgx Llc, Quantum Pharmics, Actavis Elizabeth, Alembic Pharms Ltd, Amneal Pharms, Duramed Pharms Barr, Mylan, Novel Labs Inc, Prinston Inc, Sandoz, Sun Pharm Industries, Usl Pharma, and Watson Labs, and is included in twenty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for temazepam. Thirty suppliers are listed for this compound.

Drug Prices for temazepam

See drug prices for temazepam

Drug Sales Revenue Trends for temazepam

See drug sales revenues for temazepam

Recent Clinical Trials for temazepam

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

SponsorPhase
Saint-Joseph UniversityPhase 3
Massachusetts General HospitalN/A
University of SurreyPhase 1

See all temazepam clinical trials

Recent Litigation for temazepam

Identify potential future generic entrants

District Court Litigation
Case NameDate
Tyco Healthcare Group v. Mutual Pharmaceutical Co2013-05-06
TYCO HEALTHCARE GROUP LP v. PHARMACEUTICAL HOLDINGS CORPORATION2007-03-20

See all temazepam litigation

Pharmacology for temazepam
Drug ClassBenzodiazepine
Medical Subject Heading (MeSH) Categories for temazepam
Synonyms for temazepam
1-methyl-7-chloro-3-hydroxy-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepine-2-one
1,3-Dihydro-7-chloro-3-hydroxy-1-methyl-5-phenyl-2H-1,4-benzodiazepin-2-one
2H-1, 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 1,3-dihydro-7-chloro-3-hydroxy-1-methyl-5-phenyl-
2H-1,4-Benzodiazepin-2-one, 7-chloro-1,3-dihydro-3-hydroxy-1-methyl-5-phenyl-
3-hydroxy-1,3-dihydro-1-methyl-7-chloro-5-phenyl-2H-1,4-benzodiazepin-2-one
3-Hydroxydiazepam
5-25-02-00242 (Beilstein Handbook Reference)
7-CHLORO-1,3-DIHYDRO-3-HYDROXY-1-METHYL-5-PHENYL-2H-1,4-BENZODIAZEPIN-2-ONE
7-Chloro-3-hydroxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
7-Chloro-3-hydroxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one #
7-chloro-3-hydroxy-1-methyl-5-phenyl-2,3-dihydro-1H-1,4-benzodiazepin-2-one
7-chloro-3-hydroxy-1-methyl-5-phenyl-3H-1,4-benzodiazepin-2-one
846-50-4
AB01563160_01
AC1L1K92
AN-20538
Apo-Temazepam
BDBM50408032
BRN 0759300
C07125
CAS-846-50-4
CCG-213642
CCRIS 1954
Cerepax
CHEBI:9435
CHEMBL967
Crisonar
D00370
Dasuen
DB00231
DEA No. 2925
Diazepam, 3-hydroxy
DivK1c_000989
DSSTox_CID_1309
DSSTox_GSID_21309
DSSTox_RID_76071
DTXSID8021309
EINECS 212-688-1
ER 115
Euhypnos
Euipnos
FT-0674841
Gelthix
GTPL7300
HMS503E19
Hydroxydiazepam
IDI1_000989
K-3917
K3917
KBio1_000989
Lenal
Levanxene
Levanxol
Levanzene
LS-7712
Mabertin
Methyloxazepam
MLS003899242
N-Methyloxazepam
NCGC00159440-02
NCGC00159440-03
NCGC00257598-01
Neodorm SP
NINDS_000989
Nocturne
Nomapam
Norkotral Tema
Normison
Normitab
Nortem
Novo-Temazepam
NSC 246303
NSC-246303
NSC246303
Oxydiazepam
Perdorm
Planum
Pronervon T
Remestan
Restoril
Restoril (TN)
Ro 5-5345
Ro-5-5345
Ro-5-5354
SaH 47-603
SCHEMBL29463
SEQDDYPDSLOBDC-UHFFFAOYSA-N
Signopam
SMR000238146
Strazepam
Temador
Temaz
temazep von ct
Temazepam (USP/INN)
Temazepam [USAN:INN:BAN]
Temazepam [USAN:USP:INN:BAN]
Temazepam 1.0 mg/ml in Methanol
Temazepam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Temazepam, analytical standard
Temazepam, British Pharmacopoeia (BP) Reference Standard
Temazepam, pharmaceutical grade
Temazepam, United States Pharmacopeia (USP) Reference Standard
Temazepam; T8275_Sigma; Divk1c_000989; Ninds_000989
Temazepamum
Temazepamum [INN-Latin]
Temtabs
Tenox
Tox21_111670
Tox21_200044
Uvamin Retard
WLN: T67 GNV JN IHJ CG G1 IQ KR
WY 2917
WY 3917
Wy-3917
Paragraph IV (Patent) Challenges for TEMAZEPAM
Tradename Dosage Ingredient NDA Submissiondate
RESTORIL CAPSULE;ORAL temazepam 018163 2006-11-01

US Patents and Regulatory Information for temazepam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Quantum Pharmics TEMAZ temazepam CAPSULE;ORAL 070547-001 Oct 15, 1985 DISCN No No   Start Trial   Start Trial   Start Trial
Novel Labs Inc TEMAZEPAM temazepam CAPSULE;ORAL 071457-002 Jun 22, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Sun Pharm Industries TEMAZEPAM temazepam CAPSULE;ORAL 071174-001 Jul 10, 1986 DISCN No No   Start Trial   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-001 Approved Prior to Jan 1, 1982 AB RX Yes No   Start Trial   Start Trial   Start Trial
Prinston Inc TEMAZEPAM temazepam CAPSULE;ORAL 201781-002 Jun 4, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd TEMAZEPAM temazepam CAPSULE;ORAL 211542-001 Nov 23, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Prinston Inc TEMAZEPAM temazepam CAPSULE;ORAL 201781-001 Jun 4, 2015 AB RX 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 temazepam

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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