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MINOCIN

NDA

MINOCYCLINE HYDROCHLORIDE | N050649 | BAUSCH HEALTH US LLC

3 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Aurobindo Pharmaceuticals Ltd. - Citizen Petition FDA-2007-P-0192 · 5 docket documents Aurobindo Pharmaceuticals Limited filed this citizen petition on May 1, 2007, requesting that the FDA determine whether Minocycline Hydrochloride, Minocin Capsules EQ 75 mg Base (NDA 050649) manufactured by Triax Pharmaceuticals Ltd. was voluntarily withdrawn from sale for safety or effectiveness re	505(q)	2008-04-24	Granted	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

188 trials from ClinicalTrials.gov — 2 recruiting, 1 active, 126 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Regeneration of Immature Teeth. Case Series NCT03507556	N/A	Active	Jordan University of Science and Technology	40	2010-06-28 → 2030-12-01
Minocycline Plus Amiodarone Versus Amiodarone Alone for the Prevention of Atrial Fibrillation After Cardiac Surgery NCT01422148	Phase 2	Not Yet Recruiting	Baystate Medical Center	60	2025-07 → 2028-01-24
Treatment of Rheumatoid Arthritis With DMARDs: Predictors of Response NCT03414502	Phase 3	Recruiting	University of Nebraska	400	2007-12-10 → 2029-03
Minocycline as Adjunctive Treatment for Treatment Resistant Depression NCT03947827	Phase 3	Completed	Centre for Addiction and Mental Health	76	2020-02-01 → 2025-01-07
Periocline as an Adjunct to Scaling and Root Planing for Adult Periodontitis NCT00529555	Phase 3	Completed	Sunstar Americas	602	2006-01 → 2008-12
Minocycline and Perfusion Pressure Augmentation in Acute Spinal Cord Injury NCT00559494	Phase 1/2	Completed	University of Calgary	52	2004-06 → 2010-08
A Prospective Trial of Nasal Mupirocin, Hexachlorophene Body Wash, and Systemic Antibiotics for Prevention of Recurrent Methicillin Resistant Staphylococcus Aureus Infections NCT01049438	N/A	Completed	Natividad Medical Center	31	2006-08 → 2009-09
Minocycline as an Adjunct for the Treatment of Depressive Symptoms: Pilot Randomized Controlled Trial NCT02263872	Phase 4	Completed	Pakistan Institute of Living and Learning	41	2014-10 → 2016-08
National Institute of Neurological Disorders and Stroke (NINDS) Parkinson's Disease Neuroprotection Trial NCT00063193	Phase 2	Completed	University of Rochester	195	2003-05 → 2005-07
A Study to Compare FCD105 Foam to Minocycline 3% Foam, Adapalene 0.3% Foam and Vehicle Foam.NCT04104685	Phase 2	Completed	Vyne Therapeutics Inc.	446	2019-09-18 → 2020-03-03

Source: ClinicalTrials.gov. Trials matched by ingredient name.

API Supply Chain9 active DMFs7 inactive

7 active API suppliers hold Drug Master Files for this ingredient.

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE

DMF 137381998

CIPAN - COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SAMINOCYCLINE HYDROCHLORIDE

DMF 137581998

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE)

DMF 148022000

IDT AUSTRALIA LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 150142000

ZHEJIANG HISUN PHARMACEUTICAL CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 260502012

HOVIONE FARMACIENCIA SAMINOCYCLINE HYDROCHLORIDE MICRONIZED

DMF 290032015

ZHEJIANG MEDICINE CO LTDMINOCYCLINE HYDROCHLORIDE

DMF 326642018

CURIA ITALY SRLMINOCYCLINE HYDROCHLORIDE (DIHYDRATE) MICRONIZED

DMF 332792018

ZHEJIANG CHANGHAI PHARMACEUTICALS CO LTDMINOCYCLINE HYDROCHLORIDE USP

DMF 359392022

PARKE DAVIS AND COInactiveMINOCYCLINE HYDROCHLORIDE CAP

DMF 24081975

FINE CHEMICALS CORPInactiveMINOCYCLINE HYDROCHLORIDE

DMF 71991987

LEDERLE LABORATORIESInactiveMINOCYCLINE HYDROCHLORIDE

DMF 134041998

NIPPON KAYAKU CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137481998

KYOWA HAKKO KOGYO CO LTDInactiveMINOCYCLINE HYDROCHLORIDE

DMF 137551998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveMINOCYCLINE HYDROCHLORIDE USP

DMF 151712000

HOVIONE FARMACIENCIA SAInactiveMINOCYCLINE

DMF 342172019

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

17 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -29	View Letter (PDF)
Jul 22, 2024	SUPPL -28	View Letter (PDF)
Jul 21, 2017	SUPPL -27	View Letter (PDF)
Dec 15, 2016	SUPPL -26	View Letter (PDF)
Mar 11, 2015	SUPPL -25	View Letter (PDF)
Sep 17, 2010	SUPPL -23	View Letter (PDF)
Jul 1, 2008	SUPPL -22	View Letter (PDF)
Jun 4, 2007	SUPPL -21	View Letter (PDF)
Apr 9, 2007	SUPPL -19	View Letter (PDF)
Feb 2, 2007	SUPPL -20	View Letter (PDF)
Oct 20, 2005	SUPPL -18	View Letter (PDF)
Feb 17, 2005	SUPPL -15	View Letter (PDF)
Jun 1, 2004	SUPPL -17	View Letter (PDF)
Jun 1, 2004	SUPPL -16	View Letter (PDF)
May 31, 2002	SUPPL -11	View Letter (PDF)
Feb 1, 2002	SUPPL -5	View Letter (PDF)
Feb 1, 2002	SUPPL -7	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (3)

Sort:

#001 — EQ 50MG BASE

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: May 31, 1990

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

RLDAB

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: May 31, 1990

#003 — EQ 75MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Feb 12, 2001