Amitriptyline hydrochloride; chlordiazepoxide - Generic Drug Details

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

Amitriptyline hydrochloride; chlordiazepoxide is the generic ingredient in three branded drugs marketed by Anda Repository, Chartwell Rx, Heritage Pharma, Micro Labs, Mylan Pharms Inc, and Usl Pharma, and is included in eleven NDAs. Additional information is available in the individual branded drug profile pages.

Two suppliers are listed for this compound.

Summary for amitriptyline hydrochloride; chlordiazepoxide

US Patents:	0
Tradenames:	3
Applicants:	6
NDAs:	11
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
DailyMed Link:	amitriptyline hydrochloride; chlordiazepoxide at DailyMed

Recent Clinical Trials for amitriptyline hydrochloride; chlordiazepoxide

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

Sponsor	Phase
Federal University of São Paulo	Phase 4
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4

See all amitriptyline hydrochloride; chlordiazepoxide clinical trials

Pharmacology for amitriptyline hydrochloride; chlordiazepoxide

Drug Class

Benzodiazepine Tricyclic Antidepressant

Anatomical Therapeutic Chemical (ATC) Classes for amitriptyline hydrochloride; chlordiazepoxide

N05BA	Benzodiazepine derivatives
N05B	ANXIOLYTICS
N05	PSYCHOLEPTICS
N	Nervous system

N06AA	Non-selective monoamine reuptake inhibitors
N06A	ANTIDEPRESSANTS
N06	PSYCHOANALEPTICS
N	Nervous system

US Patents and Regulatory Information for amitriptyline hydrochloride; chlordiazepoxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	071297-001	Dec 10, 1986	AB	RX	No	Yes
Mylan Pharms Inc	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	071297-002	Dec 10, 1986	AB	RX	No	No
Heritage Pharma	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	072053-001	Dec 16, 1988		DISCN	No	No
Micro Labs	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	211925-002	Feb 2, 2022	AB	RX	No	No
Anda Repository	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	070766-001	Dec 10, 1986		DISCN	No	No
Chartwell Rx	CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	072277-001	May 9, 1988		DISCN	No	No
Chartwell Rx	LIMBITROL	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	016949-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No

Expired US Patents for amitriptyline hydrochloride; chlordiazepoxide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Chartwell Rx	LIMBITROL	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	016949-001	Approved Prior to Jan 1, 1982
Chartwell Rx	LIMBITROL DS	amitriptyline hydrochloride; chlordiazepoxide	TABLET;ORAL	016949-002	Approved Prior to Jan 1, 1982