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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

RESTORIL Drug Profile

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Which patents cover Restoril, and when can generic versions of Restoril launch?

Restoril is a drug marketed by Specgx Llc and is included in one NDA.

The generic ingredient in RESTORIL is temazepam. There are seven drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the temazepam profile page.

Drug patent expirations by year for RESTORIL
Drug Prices for RESTORIL

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Recent Clinical Trials for RESTORIL

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

SponsorPhase
State University of New York - Upstate Medical UniversityPhase 2

See all RESTORIL clinical trials

Recent Litigation for RESTORIL

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 RESTORIL litigation

Pharmacology for RESTORIL
Drug ClassBenzodiazepine
Synonyms for RESTORIL
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 (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
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 RESTORIL
Tradename Dosage Ingredient NDA Submissiondate
RESTORIL CAPSULE;ORAL temazepam 018163 2006-11-01

US Patents and Regulatory Information for RESTORIL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-003 Oct 25, 1991 AB RX Yes No   Start Trial   Start Trial   Start Trial
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-002 Approved Prior to Jan 1, 1982 AB RX Yes Yes   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
Specgx Llc RESTORIL temazepam CAPSULE;ORAL 018163-004 Nov 2, 2004 AB RX Yes 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 RESTORIL

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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