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NDA

DOXYCYCLINE HYCLATE | N050744 | COLLAGENEX INC

1 strength0 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

2 petitions from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from CollaGenex Pharmaceuticals, Inc FDA-2002-P-0290 · 12 docket documents CollaGenex Pharmaceuticals, Inc. filed this citizen petition under sections 505(j)(2)(A) and 505(j)(7)(C) of the Food, Drug, and Cosmetic Act requesting that the FDA refuse to approve any ANDA for a generic version of Periostat (doxycycline hyclate) 20 mg capsules that was voluntarily withdrawn from	505(q) Stay Request	2018-03-29	Granted	CollaGenex Pharmaceuticals, Inc
Citizen Petition from CollaGenex Pharmaceuticals, Inc. FDA-2003-P-0008 · 12 docket documents CollaGenex Pharmaceuticals, Inc. filed this citizen petition under Section 505(j) of the Food, Drug, and Cosmetic Act requesting that FDA refuse to approve Mutual Pharmaceutical Company's ANDA for doxycycline hyclate tablets as a generic equivalent to CollaGenex's Periostat 20 mg tablets, arguing th	505(q)	2017-11-27	Denied	CollaGenex Pharmaceuticals, Inc.

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

Clinical Trials

18 trials from ClinicalTrials.gov, 15 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Evaluation of Doxycycline Post-exposure Prophylaxis to Reduce Sexually Transmitted Infections in PrEP Users and HIV-infected Men Who Have Sex With Men NCT03980223	Phase 4	Completed	University of California, San Francisco	641	2019-11-26 → 2023-06-12
Effects of Low-Dose Doxycycline on Oral Bone Loss NCT00066027	Phase 3	Completed	University of Nebraska	128	2002-06-01 → 2005-10-01
The Efficacy and Safety of Ilaprazole/Doxycycline-based Bismuth-containing Quadruple Therapy on Hp Infected Duodenal Ulcers NCT03342456	Phase 4	Completed	The Third Xiangya Hospital of Central South University	184	2017-12-13 → 2019-09-20
A Clinical Trial of YH14642 in Patients With Chronic Periodontal Disease NCT01499225	Phase 2	Completed	Yuhan Corporation	162	2011-12
Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate NCT00635609	Phase 4	Completed	Warner Chilcott	93	2008-03 → 2008-09
A Treatment for Severe Inflammatory Acne Subjects NCT02899000	Phase 4	Completed	Galderma R&D	186	2016-07-29 → 2017-06-27
A 24 Month Study, to Compare the Efficacy of Doxycycline vs. Placebo for Improving Filarial Lymphedema in Mali NCT02927496	Phase 3	Completed	The Task Force for Global Health	220	2018-06-19 → 2020-12-19
Non-Invasive Treatment of Abdominal Aortic Aneurysm Clinical Trial NCT01756833	Phase 2	Completed	University of Maryland, Baltimore	261	2013-05 → 2019-07-23
Doxycycline to Protect Heart Muscle After Heart Attacks NCT03508232	Phase 2	Completed	University of Alberta	174	2020-01-06 → 2025-08-26
A 24 Month Study to Compare Efficacy of Doxycycline vs Placebo for Improving Filarial Lymphedema in Sri Lanka NCT02929134	Phase 3	Completed	The Task Force for Global Health	219	2018-02-16 → 2020-06-15

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

API Supply Chain10 active DMFs10 inactive

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

YANGZHOU LIBERTY PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE

DMF 131741998

HOVIONE PHARMASCIENCE LTDDOXYCYCLINE HYCLATE

DMF 137141998

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE HYCLATE

DMF 137711998

RAKS PHARMA PVT LTDDOXYCYCLINE HYCLATE, USP

DMF 259552012

GLAND PHARMA LTDDOXYCYCLINE HYCLATE USP

DMF 330932018

YANCHENG SUHAI PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE

DMF 364912021

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE HYCLATE (ROUTE CODE: YDX)

DMF 407092024

MAITHRI DRUGS PRIVATE LTDDOXYCYCLINE HYCLATE USP

DMF 416892025

YANGZHOU LIBERTY PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE (FOR USE IN THE MANUFACTURE OF PARENTERAL PREPARATIONS)

DMF 418042025

SHANDONG GUOBANG PHARMACEUTICAL CO LTDDOXYCYCLINE HYCLATE

DMF 425672025

HOUBA INCInactiveDOXYCYCLINE HYCLATE

DMF 132021998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 133211998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 133701998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 134551998

PFIZER INCInactiveDOXYCYCLINE HYCLATE

DMF 134921998

HOVIONE FARMACIENCIA SAInactiveDOXYCYCLINE HYCLATE

DMF 136361998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveDOXYCYCLINE HYCLATE USP

DMF 137161998

YANCHENG SUHAI PHARMACEUTICAL CO LTDInactiveDOXYCYCLINE HYCLATE USP

DMF 161912002

KUNSHAN CHEMICALS AND PHARMACEUTICAL CO LTDInactiveDOXYCYCLINE HYCLATE USP

DMF 180042005

HUASHU PHARMACEUTICAL CORPInactiveDOXYCYCLINE HYCLATE

DMF 183142005

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Sep 30, 1998	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 20MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 30, 1998

No patent or exclusivity listings for this strength.