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

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Last Updated: November 17, 2019

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Clobazam - Generic Drug Details

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What are the generic drug 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, Lupin Ltd, Mylan, Taro, Upsher Smith Labs, Vistapharm, West-ward Pharms Int, Lundbeck Pharms Llc, Accord Hlthcare, Alkem Labs Ltd, Amneal Pharms Co, Breckenridge, Hetero Labs Ltd Iii, Micro Labs, Piramal Hlthcare Uk, and Zydus Pharms, and is included in twenty-four 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-six patent family members in eighteen countries.

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

Drug Prices for clobazam

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Recent Clinical Trials for clobazam

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

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Recent Litigation for clobazam

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District Court Litigation
Case NameDate
Aquestive Therapeutics, Inc. v. Biodelivery Sciences International, Inc.2018-10-30
INDIVIOR INC. v. ALVOGEN PINE BROOK, INC.2017-09-14
INDIVIOR INC. v. DR. REDDY'S LABORATORIES S.A.2017-09-14

See all clobazam litigation

PTAB Litigation
PetitionerDate
Dr. Reddy’s Laboratories, Inc.2017-06-12
Par Pharmaceutical, Inc.2017-06-09
Mylan Technologies, Inc.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
AC1L1EGZ
AKOS025401921
AN-5939
API0002059
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
DB00349
DEA No. 2751
DSSTox_CID_26759
DSSTox_GSID_46759
DSSTox_RID_81883
DTXSID2046759
EINECS 244-908-7
Frisium
Frisium, Urbanol, Onfi
FT-0603208
GTPL7149
H 4723
H-4723
HR 376
HR-376
HSDB 8343
HY-A0041
LM 2717
LM-2717
LS-34098
MLS003899217
Mystan
Mystan (TN)
NCGC00168249-01
Noiafren
NSC 336279
NSC-336279
NSC336279
Odipam
Onfi
Onfi (TN)
RU-4723
SCHEMBL43038
SMR000058811
SR-01000937603
SR-01000937603-2
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 SUSPENSION;ORAL 210546-001 Dec 28, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Lundbeck Pharms Llc ONFI clobazam TABLET;ORAL 202067-003 Oct 21, 2011 AB RX Yes Yes   Start Trial   Start Trial   Start Trial
Piramal Hlthcare Uk CLOBAZAM clobazam TABLET;ORAL 209808-001 Oct 22, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Micro Labs CLOBAZAM clobazam TABLET;ORAL 211711-002 Jan 30, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Amneal Pharms Co CLOBAZAM clobazam TABLET;ORAL 209718-001 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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