DEMECLOCYCLINE HYDROCHLORIDE - Generic Drug Details

What are the generic sources for demeclocycline hydrochloride and what is the scope of freedom to operate?

Demeclocycline hydrochloride is the generic ingredient in two branded drugs marketed by Lederle, Corepharma, Amneal Pharm, Barr, Epic Pharma Llc, and Impax Labs, and is included in eight NDAs. Additional information is available in the individual branded drug profile pages.

There are nine drug master file entries for demeclocycline hydrochloride. Five suppliers are listed for this compound.

Summary for DEMECLOCYCLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	2
Applicants:	6
NDAs:	8
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	5
Patent Applications:	1,371
What excipients (inactive ingredients) are in DEMECLOCYCLINE HYDROCHLORIDE?	DEMECLOCYCLINE HYDROCHLORIDE excipients list
DailyMed Link:	DEMECLOCYCLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DEMECLOCYCLINE HYDROCHLORIDE

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

Sponsor	Phase
Massachusetts General Hospital	Phase 1
Fundação de Amparo à Pesquisa do Estado de São Paulo	Phase 4
Federal University of São Paulo	Phase 4

See all DEMECLOCYCLINE HYDROCHLORIDE clinical trials

Pharmacology for DEMECLOCYCLINE HYDROCHLORIDE

Drug Class

Tetracycline-class Antimicrobial

Medical Subject Heading (MeSH) Categories for DEMECLOCYCLINE HYDROCHLORIDE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for DEMECLOCYCLINE HYDROCHLORIDE

D06AA	Tetracycline and derivatives
D06A	ANTIBIOTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J01AA	Tetracyclines
J01A	TETRACYCLINES
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DEMECLOCYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Epic Pharma Llc	DEMECLOCYCLINE HYDROCHLORIDE	demeclocycline hydrochloride	TABLET;ORAL	065447-002	Aug 18, 2015	AB	RX	No	No
Impax Labs	DEMECLOCYCLINE HYDROCHLORIDE	demeclocycline hydrochloride	TABLET;ORAL	065094-001	Mar 22, 2004		DISCN	No	No
Amneal Pharm	DEMECLOCYCLINE HYDROCHLORIDE	demeclocycline hydrochloride	TABLET;ORAL	065425-002	Feb 27, 2008	AB	RX	No	Yes
Lederle	DECLOMYCIN	demeclocycline hydrochloride	CAPSULE;ORAL	050262-001	Approved Prior to Jan 1, 1982		DISCN	No	No