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Last Updated: April 8, 2020

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Clobazam - Generic Drug Details

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

Clobazam is the generic ingredient in three branded drugs marketed by Aquestive Therap, Amneal Pharms Llc, Bionpharma Inc, Hetero Labs Ltd Iii, Hikma, Lupin Ltd, Mylan, Taro, Teva Pharms Usa, Upsher Smith Labs, Vistapharm, Lundbeck Pharms Llc, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Lannett Co Inc, Micro Labs, Piramal Hlthcare Uk, and Zydus Pharms, and is included in twenty-seven NDAs. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Clobazam has one hundred and thirty-nine patent family members in eighteen countries.

There are ten drug master file entries for clobazam. Twenty suppliers are listed for this compound.

Drug Prices for clobazam

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Recent Clinical Trials for clobazam

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

SponsorPhase
Zogenix International Limited, Inc., a subsidiary of Zogenix, Inc.Phase 3
Elizabeth ThielePhase 3
Eisai Inc.Phase 4

See all clobazam clinical trials

Recent Litigation for clobazam

Identify potential future generic entrants

District Court Litigation
Case NameDate
Aquestive Therapeutics, Inc. v. BioDelivery Sciences International, Inc.2019-11-11
Aquestive Therapeutics, Inc. v. Biodelivery Sciences International, Inc.2018-10-30
MONOSOL RX, LLC v. BIODELIVERY SCIENCES INTERNATIONAL, INC.2017-09-14

See all clobazam litigation

PTAB Litigation
PetitionerDate
Dr. Reddy’s Laboratories, Inc.2017-06-12
2017-06-09
2016-11-04

See all clobazam litigation

Pharmacology for clobazam
Synonyms for clobazam
1-phenyl 5-methyl 8-chloro 1,2,4,5-tetrahydo 2,4-dioxo 3H-1,5-benzodiazepine
1-phenyl 5-methyl 8-chloro 1,2,4,5-tetrahydro 2,4-dioxo 3H-1,5-benzodiazepine
1-phenyl-5-methyl-8-chloro-1,2,4,5- tetrahydro-2,4-diketo-3H-1,5-benzodiazepine
1-Phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-diketo-3H-1,5-benzodiazepine
1-Phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3H-1, 5-benzodiazepine
1-Phenyl-5-methyl-8-chloro-1,2,4,5-tetrahydro-2,4-dioxo-3H-1,5-benzodiazepine
1-Phenyl-5-methyl-8-chloro-1,4,5-tetrahydro-2,4-dioxo-3H-1,5-benzodiazepine
1H-1,4(3H,5H)-dione, 7-chloro-1-methyl-5-phenyl-
1H-1,5-Benzodiazepine-2,4(3H,5H)-dione, 7-chloro-1-methyl-5-phenyl-
22316-47-8
2MRO291B4U
5-24-08-00034 (Beilstein Handbook Reference)
7-chloro-1-methyl-5-phenyl-1,5-benzodiazepine-2,4-dione
7-Chloro-1-methyl-5-phenyl-1,5-dihydro-benzo[b][1,4]diazepine-2,4-dione
7-Chloro-1-methyl-5-phenyl-1H-1,4-(3H,5H)-dione
7-Chloro-1-methyl-5-phenyl-1H-1,4(3H,5H)-dione
7-Chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4-(3H,5H)-dione
7-Chloro-1-methyl-5-phenyl-1H-1,5-benzodiazepine-2,4(3H,5H)-dione
7-chloro-1-methyl-5-phenyl-2,3,4,5-tetrahydro-1H-1,5-benzodiazepine-2,4-dione
AKOS025401921
API0002059
BDBM50247888
BRN 0758410
C-18778
Caastilium
CAS-22316-47-8
CCRIS 7506
CHEBI:31413
CHEMBL70418
Chlorepin
Clobazam (JAN/USAN/INN)
Clobazam [USAN:BAN:INN]
Clobazam [USAN:INN:BAN]
Clobazam 0.1 mg/ml in Methanol
Clobazam 1.0 mg/ml in Methanol
Clobazam solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material
Clobazamum
Clobazamum [INN-Latin]
Clobazepam
Clobazepam|||Frisium
Clorepin
CS-6756
CXOXHMZGEKVPMT-UHFFFAOYSA-N
D01253
DB-045870
DB00349
DEA No. 2751
DSSTox_CID_26759
DSSTox_GSID_46759
DSSTox_RID_81883
DTXSID2046759
EINECS 244-908-7
Frisium
FT-0603208
GTPL7149
H 4723
H-4723
HR 376
HR-376
HSDB 8343
HY-A0041
LM 2717
LM-2717
LS-34098
MLS003899217
Mystan (TN)
NCGC00168249-01
Noiafren
NSC 336279
NSC-336279
NSC336279
Odipam
Onfi
Onfi (TN)
Perizam
Q412164
RU-4723
SCHEMBL43038
SMR000058811
SR-01000937603
SR-01000937603-2
Tapclob
Tox21_112608
UNII-2MRO291B4U
Urbadan
Urbanil
Urbanol
Urbanyl
WLN: T67 GNV JVN IHJ CG G1 KR
ZINC1175

US Patents and Regulatory Information for clobazam

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Ltd CLOBAZAM clobazam TABLET;ORAL 210545-001 Dec 14, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Hikma CLOBAZAM clobazam TABLET;ORAL 208785-002 Oct 22, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Accord Hlthcare CLOBAZAM clobazam TABLET;ORAL 212398-001 May 23, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Llc CLOBAZAM clobazam SUSPENSION;ORAL 210039-001 Oct 22, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd Iii CLOBAZAM clobazam TABLET;ORAL 209795-002 Oct 22, 2018 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

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
Baxter
Boehringer Ingelheim
McKinsey
Colorcon

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