CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE - Generic Drug Details

What are the generic drug sources for chlordiazepoxide hydrochloride; clidinium bromide and what is the scope of freedom to operate?

Chlordiazepoxide hydrochloride; clidinium bromide is the generic ingredient in two branded drugs marketed by Alembic, Alkem Labs Ltd, Amneal, Aurobindo Pharma Ltd, Chartwell Rx, Corepharma, Dr Reddys, Micro Labs, Misemer, Nuvo Pharms Inc, Teva Pharms Usa, Torrent, Winder Labs Llc, and Bausch, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

Fifteen suppliers are listed for this compound.

Summary for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

US Patents:	0
Tradenames:	2
Applicants:	14
NDAs:	14
Finished Product Suppliers / Packagers:	15
DailyMed Link:	CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE at DailyMed

Pharmacology for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Drug Class	Anticholinergic Benzodiazepine
Mechanism of Action	Cholinergic Antagonists
Physiological Effect	Decreased Parasympathetic Acetylcholine Activity Digestive/GI System Activity Alteration GI Motility Alteration

Anatomical Therapeutic Chemical (ATC) Classes for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

US Patents and Regulatory Information for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Nuvo Pharms Inc	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	211421-001	Jul 7, 2020	AB	RX	No	No
Misemer	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	210579-001	Jul 29, 2020	AB	RX	No	No
Corepharma	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	215453-001	Jul 29, 2022	AB	RX	No	No
Micro Labs	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	215835-001	Jul 19, 2022	AB	RX	No	No
Alkem Labs Ltd	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	214065-001	Apr 26, 2021	AB	RX	No	No
Amneal	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	215555-001	Oct 25, 2021	AB	RX	No	No
Winder Labs Llc	CHLORDIAZEPOXIDE HYDROCHLORIDE AND CLIDINIUM BROMIDE	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	212344-001	Jul 8, 2024	AB	RX	No	No

Expired US Patents for CHLORDIAZEPOXIDE HYDROCHLORIDE; CLIDINIUM BROMIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	LIBRAX	chlordiazepoxide hydrochloride; clidinium bromide	CAPSULE;ORAL	012750-001	Approved Prior to Jan 1, 1982