TETRACYCLINE HYDROCHLORIDE - Generic Drug Details

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

Tetracycline hydrochloride is the generic ingredient in fourteen branded drugs marketed by Avet, Bristol, Warner Chilcott, Pharmacia And Upjohn, Solvay, Wyeth Ayerst, Apothecon, Angus, Abbott, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma Usa, Breckenridge, Chartwell Tetra, Elkins Sinn, Ferrante, Heather, Hikma, Impax Labs, Ivax Sub Teva Pharms, Mast Mm, Purepac Pharm, Pvt Form, Roxane, Strides Pharma, Sun Pharm Industries, Superpharm, Valeant Pharm Intl, Watson Labs, Pfipharmecs, Schiff And Co, Shire, Lederle, Pfizer, Storz, Endo Operations, Alpharma Us Pharms, and Proter, and is included in fifty-three NDAs. Additional information is available in the individual branded drug profile pages.

There are forty-nine drug master file entries for tetracycline hydrochloride. Eight suppliers are listed for this compound.

Summary for TETRACYCLINE HYDROCHLORIDE

US Patents:	0
Tradenames:	14
Applicants:	38
NDAs:	53
Drug Master File Entries:	49
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	84
Clinical Trials:	227
What excipients (inactive ingredients) are in TETRACYCLINE HYDROCHLORIDE?	TETRACYCLINE HYDROCHLORIDE excipients list
DailyMed Link:	TETRACYCLINE HYDROCHLORIDE at DailyMed

Recent Clinical Trials for TETRACYCLINE HYDROCHLORIDE

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

Sponsor	Phase
Lao-Oxford-Mahosot Hospital Wellcome Trust Research Unit	Phase 2/Phase 3
Mahidol Oxford Tropical Medicine Research Unit	Phase 2/Phase 3
Universidade Federal do Para	Phase 3

See all TETRACYCLINE HYDROCHLORIDE clinical trials

Pharmacology for TETRACYCLINE HYDROCHLORIDE

Drug Class

Tetracycline-class Antimicrobial

Anatomical Therapeutic Chemical (ATC) Classes for TETRACYCLINE HYDROCHLORIDE

A01AB	Antiinfectives and antiseptics for local oral treatment
A01A	STOMATOLOGICAL PREPARATIONS
A01	STOMATOLOGICAL PREPARATIONS
A	Alimentary tract and metabolism

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

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

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

S02AA	Antiinfectives
S02A	ANTIINFECTIVES
S02	OTOLOGICALS
S	Sensory organs

S03AA	Antiinfectives
S03A	ANTIINFECTIVES
S03	OPHTHALMOLOGICAL AND OTOLOGICAL PREPARATIONS
S	Sensory organs

US Patents and Regulatory Information for TETRACYCLINE HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Proter	TETRACYCLINE HYDROCHLORIDE	tetracycline hydrochloride	SUSPENSION;ORAL	060446-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pharmacia And Upjohn	PANMYCIN	tetracycline hydrochloride	TABLET;ORAL	061705-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Pfizer	TETRACYN	tetracycline hydrochloride	INJECTABLE;INJECTION	060096-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Warner Chilcott	CYCLOPAR	tetracycline hydrochloride	CAPSULE;ORAL	062332-002	Approved Prior to Jan 1, 1982		DISCN	No	No
Mast Mm	TETRACYCLINE HYDROCHLORIDE	tetracycline hydrochloride	CAPSULE;ORAL	062085-001	Approved Prior to Jan 1, 1982		DISCN	No	No