Viewing data from:

DORYX

NDA

DOXYCYCLINE HYCLATE | N050582 | MAYNE PHARMA INTERNATIONAL PTY LTD

2 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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Doryx (2023)

Total Spending

$18K

Total Claims

Beneficiaries

—

Avg Cost/Unit

$32.60

Spending Trend

$120K(2019)→$101K(2020)→$86K(2021)→$78K(2022)→$18K(2023)

YoY Change:-9.4%

5yr CAGR:-5.7%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain9 active DMFs10 inactive

7 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

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

10 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -32	View Letter (PDF)
Mar 4, 2020	SUPPL -31	View Letter (PDF)
Feb 8, 2018	SUPPL -30	View Letter (PDF)
Sep 4, 2015	SUPPL -29	View Letter (PDF)
Mar 24, 2011	SUPPL -28	View Letter (PDF)
Feb 13, 2008	SUPPL -27	View Letter (PDF)
May 17, 2005	SUPPL -24	View Letter (PDF)
Feb 27, 2004	SUPPL -22	View Letter (PDF)
Jun 8, 2003	SUPPL -21	View Letter (PDF)
Jun 18, 2002	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 100MG BASE

RLD

0 patents0 exclusivities▴

CAPSULE, DELAYED RELEASE;ORAL | Approved: Jul 22, 1985

No patent or exclusivity listings for this strength.

#002 — EQ 75MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE, DELAYED RELEASE;ORAL | Approved: Aug 13, 2001