CHLORDIAZEPOXIDE HYDROCHLORIDE - Generic Drug Details

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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.

There are two drug master file entries for chlordiazepoxide hydrochloride. Fourteen suppliers are listed for this compound.

Summary for CHLORDIAZEPOXIDE HYDROCHLORIDE

US Patents:	0
Tradenames:	7
Applicants:	38
NDAs:	93
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	14
Raw Ingredient (Bulk) Api Vendors:	1
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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Alembic	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	216969-001	Sep 15, 2023	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell Rx	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	213530-001	Oct 20, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Valeant Pharm Intl	LIBRIUM	chlordiazepoxide hydrochloride	CAPSULE;ORAL	085472-001	Approved Prior to Jan 1, 1982	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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 CHLORDIAZEPOXIDE HYDROCHLORIDE

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

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