TheraRadar
Data updated: Jun 28, 2026

DOXYCYCLINE HYCLATE · PH HEALTH

Generic · see DOXY 100
Infectious Disease Approved 1973-07-17

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.

Source: FDA Label
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
NDA
Small Molecule
73
Indications
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1973-07-17
Routes
INJECTION, ORAL, Injection
Dosage Forms
INJECTABLE, CAPSULE, TABLET, TABLET, DELAYED RELEASE, CAPSULE, COATED PELLETS, Injectable, CAPSULE, DELAYED RELEASE

Companies

PH HEALTH MUTUAL PHARM Teva PAR PHARM HEATHER WARNER CHILCOTT Sun Pharma INTERPHARM CHARTWELL MOLECULAR Lupin MACLEODS PHARMS LTD ASPIRO WATSON LABS INC CHARTWELL WEST-WARD PHARMS INT RISING HERITAGE Dr. Reddy's AJANTA PHARMA LTD PHARMOBEDIENT ALEMBIC HALSEY STRIDES PHARMA INTL AVET LIFESCIENCES PRINSTON INC ACELLA EPIC PHARMA LLC SUPERPHARM IMPAX LABS ZYDUS PHARMS BIONPHARMA AMNEAL Hikma AMNEAL PHARMS NOVEL LABS INC PRECISION DOSE INC SLATE RUN PHARMA PLIVA Aurobindo Pharma ZYDUS LIFESCIENCES CHANGZHOU PHARM ORYZA TORRENT STERISCIENCE KINDOS Viatris PVT FORM QUAD PHARMS BAUSCH Apotex ZHEJIANG YONGTAI GLAND NESHER PHARMS PRAXGEN STRIDES PHARMA RANBAXY LABS LTD HERITAGE PHARMA
Active Ingredient: DOXYCYCLINE HYCLATE

DOXYCYCLINE HYCLATE Approval History

1974
1975
1976
1977
1978
1979
1980
1981
1982
1983
1984
1985
1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
1014 FDA actions from 1973 to 2026
Apr 2026 SUPPL
Label · Labeling
Mar 2026 SUPPL
Label · Labeling
Feb 2026 ORIGINAL
Update

What DOXYCYCLINE HYCLATE Treats

28 indications

DOXYCYCLINE HYCLATE is approved for 28 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Rocky Mountain Spotted Fever
  • Typhus
  • Q Fever
  • Rickettsialpox
  • Mycoplasma pneumoniae Infection
  • Lymphogranuloma Venereum
  • Psittacosis
  • Trachoma
  • Inclusion Conjunctivitis
  • Nongonococcal Urethritis
  • Relapsing Fever
  • Chancroid
  • Plague
  • Tularemia
  • Cholera
  • Brucellosis
  • Bartonellosis
  • Granuloma Inguinale
  • Anthrax
  • Gonorrhea
  • Syphilis
  • Yaws
  • Listeriosis
  • Vincent's Infection
  • Actinomycosis
  • Clostridium Infection
  • Amebiasis
  • Malaria
Source: FDA Label

DOXYCYCLINE HYCLATE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

PIPERACILLIN AND TAZOBACTAM AND SODIUM CHLORIDE IN DUPLEX CONTAINER
B BRAUN
2025 7 indic.
ZEVTERA
ISTX
2024 5 indic.
Unlock 8 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to DOXYCYCLINE HYCLATE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

MONODOX
DOXYCYCLINE
20 shared
CHARTWELL RX
Shared indications:
Rocky Mountain Spotted FeverQ FeverRickettsialpox +17 more
DOXY 100
DOXYCYCLINE HYCLATE
18 shared
Fresenius Kabi
Shared indications:
Rocky Mountain Spotted FeverQ FeverRickettsialpox +15 more
DEMECLOCYCLINE HYDROCHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE
16 shared
EPIC PHARMA LLC
Shared indications:
Rocky Mountain Spotted FeverQ FeverRickettsialpox +13 more
View all 20 similar drugs Pro
📋

Clinical Trial Registry

7 trials
Trial Sponsor ID Phase Status Title
NCT03508232 DOXY-STEMI Ph 2 completed Doxycycline to Protect Heart Muscle After Heart Attacks
NCT04504123 202001041 Ph 2 recruiting MMP-9 Inhibition for Recalcitrant Wet AMD
NCT04582383 SD-ACNE R34AR074733-01A1 Ph 4 active not recruiting Comparative Effectiveness Study of Spironolactone Versus Doxycycline for Acne
NCT03397004 HHT 160517448 Award Number W81XWH-17-1-0429 Ph 2 completed Doxycycline for Hereditary Hemorrhagic Telangiectasia
NCT05399290 results posted STUDY00003269 Ph 4 completed Subantimicrobial Doxycycline in Acne
NCT04451330 DUAL results posted RD.06.SPR.202394 Ph 4 completed A Study to Compare Efficacy and Safety of Trifarotene Cream When Used With an Oral Antibiotic for the Treatment of Severe Acne Vulgaris (AV)
NCT00635609 results posted PR-08607 Ph 4 completed Treatment of Acne Vulgaris With Doryx Tablets Compared to Doxycyline Hyclate
🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DOXYCYCLINE HYCLATE FDA Label Details

Indications & Usage

FDA Label (PDF)

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Treatment: Doxycycline is indicated for the treatment of the following in...

Looking for the branded version?

DOXY 100

Full clinical data, patents, trials, and competitive landscape for doxycycline hyclate.

See DOXY 100

Data Sources

FDA Approval: ANDA216690 → Label: DailyMed (2024-09-18) → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.