Desipramine hydrochloride - Generic Drug Details

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

Desipramine hydrochloride is the generic ingredient in three branded drugs marketed by Sanofi Aventis Us, Actavis Totowa, Alembic, Amneal Pharms Co, Ani Pharms, Chartwell Rx, Heritage, Novast Labs, Usl Pharma, and Validus Pharms, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for desipramine hydrochloride. Ten suppliers are listed for this compound.

Summary for desipramine hydrochloride

US Patents:	0
Tradenames:	3
Applicants:	10
NDAs:	18
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	10
Raw Ingredient (Bulk) Api Vendors:	89
Clinical Trials:	61
Patent Applications:	2,258
What excipients (inactive ingredients) are in desipramine hydrochloride?	desipramine hydrochloride excipients list
DailyMed Link:	desipramine hydrochloride at DailyMed

Recent Clinical Trials for desipramine hydrochloride

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

Sponsor	Phase
University College, London	Phase 3
London North West Healthcare NHS Trust	Phase 3
University Hospital Plymouth NHS Trust	Phase 3

See all desipramine hydrochloride clinical trials

Pharmacology for desipramine hydrochloride

Drug Class

Tricyclic Antidepressant

Medical Subject Heading (MeSH) Categories for desipramine hydrochloride

Adrenergic Uptake Inhibitors

Antidepressive Agents, Tricyclic

Enzyme Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for desipramine hydrochloride

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

US Patents and Regulatory Information for desipramine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-006	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Alembic	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	209785-005	Jul 7, 2021	AB	RX	No	No
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-003	Approved Prior to Jan 1, 1982	AB	RX	Yes	No
Amneal Pharms Co	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	208105-001	Mar 17, 2016	AB	RX	No	No
Ani Pharms	DESIPRAMINE HYDROCHLORIDE	desipramine hydrochloride	TABLET;ORAL	071803-003	Dec 8, 1987		DISCN	No	No

Expired US Patents for desipramine hydrochloride

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-001	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-006	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-004	Approved Prior to Jan 1, 1982
Sanofi Aventis Us	PERTOFRANE	desipramine hydrochloride	CAPSULE;ORAL	013621-001	Approved Prior to Jan 1, 1982
Validus Pharms	NORPRAMIN	desipramine hydrochloride	TABLET;ORAL	014399-001	Approved Prior to Jan 1, 1982