CHLORDIAZEPOXIDE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for chlordiazepoxide hydrochloride and what is the scope of patent protection?

Chlordiazepoxide hydrochloride is the generic ingredient in seven branded drugs marketed by Abbott, Rachelle, Ascot, Barr, Chartwell Rx, Ferrante, Halsey, Impax Labs, Ivax Sub Teva Pharms, Lederle, Mast Mm, Mylan, Parke Davis, Pioneer Pharms, Purepac Pharm, Roxane, Superpharm, Teva, Upsher Smith Labs, Usl Pharma, Vangard, Watson Labs, West Ward, Bausch, Valeant Pharm Intl, Alra, Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, and Winder Labs Llc, and is included in ninety-three NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for CHLORDIAZEPOXIDE HYDROCHLORIDE

US Patents:	0
Tradenames:	7
Applicants:	38
NDAs:	93
Finished Product Suppliers / Packagers:	15
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	8
What excipients (inactive ingredients) are in CHLORDIAZEPOXIDE HYDROCHLORIDE?	CHLORDIAZEPOXIDE HYDROCHLORIDE excipients list
DailyMed Link:	CHLORDIAZEPOXIDE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for CHLORDIAZEPOXIDE HYDROCHLORIDE

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

Sponsor	Phase
Mayo Clinic	Phase 4
Oregon Health and Science University	Phase 2
Taipei City Hospital	Phase 2/Phase 3

See all CHLORDIAZEPOXIDE HYDROCHLORIDE clinical trials

Pharmacology for CHLORDIAZEPOXIDE HYDROCHLORIDE

Drug Class

Benzodiazepine

Anatomical Therapeutic Chemical (ATC) Classes for CHLORDIAZEPOXIDE HYDROCHLORIDE

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for CHLORDIAZEPOXIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
West Ward	CHLORDIAZEPOXIDE HYDROCHLORIDE	chlordiazepoxide hydrochloride	CAPSULE;ORAL	085000-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Lederle	CHLORDIAZEPOXIDE HYDROCHLORIDE	chlordiazepoxide hydrochloride	CAPSULE;ORAL	087231-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Nuvo Pharms Inc	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	211421-001	Jul 7, 2020	AB	RX	No	No
Ascot	CHLORDIAZEPOXIDE HYDROCHLORIDE	chlordiazepoxide hydrochloride	CAPSULE;ORAL	087525-001	Jan 7, 1982		DISCN	No	No
Upsher Smith Labs	CHLORDIAZEPOXIDE HYDROCHLORIDE	chlordiazepoxide hydrochloride	CAPSULE;ORAL	084920-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for CHLORDIAZEPOXIDE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-002	Approved Prior to Jan 1, 1982	4,316,897
Bausch	LIBRIUM	chlordiazepoxide hydrochloride	INJECTABLE;INJECTION	012301-001	Approved Prior to Jan 1, 1982	4,316,897
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-003	Approved Prior to Jan 1, 1982	4,316,897
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	012249-001	Approved Prior to Jan 1, 1982	4,316,897