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VIBRAMYCIN

NDA

DOXYCYCLINE HYCLATE | N050007 | PFIZER LABORATORIES DIV PFIZER INC

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

3 trials from ClinicalTrials.gov — 1 recruiting

Trial	Phase	Status	Sponsor	Enrollment	Dates
Duo: A Phase IIIb Individual-Level Randomized Controlled Trial of an Integrated Strategy NCT07658976	Phase 3	Not Yet Recruiting	HIV Prevention Trials Network	400	2026-09-01 → 2029-09-01
D-PLEX 302: Efficacy and Safety of D-PLEX in the Prevention of Sternal Infection Post Cardiac Surgery NCT03558984	Phase 3	Terminated	PolyPid Ltd.	2	2019-12-17 → 2022-10-24
Retrospective Study for Identificatiopn of a Link Between Doxycycline and COVID-19 Treatment NCT05445479	—	Withdrawn	Nantes University Hospital	—	2022-01-01 → 2022-01-01

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

Medicare Part D Spending

CMS annual spending data for Doxycycline Hyclate* (2023)

Total Spending

$117.3M

Total Claims

5,913,074

Beneficiaries

4,121,486

Avg Cost/Unit

$0.80

Spending Trend

$133.6M(2019)→$68K(2019)→$118.1M(2020)→$63K(2020)→$108.1M(2021)→$86K(2021)→$67K(2022)→$121.4M(2022)→$117.3M(2023)→$28K(2023)

YoY Change:-13.5%

5yr CAGR:-8.4%

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

13 letters from Drugs@FDA

Date	Submission	Document
Aug 12, 2025	SUPPL -40	View Letter (PDF)
Apr 8, 2025	SUPPL -39	View Letter (PDF)
Dec 26, 2019	SUPPL -34	View Letter (PDF)
Dec 7, 2018	SUPPL -33	View Letter (PDF)
Jul 28, 2017	SUPPL -32	View Letter (PDF)
Dec 29, 2016	SUPPL -31	View Letter (PDF)
Apr 5, 2016	SUPPL -30	View Letter (PDF)
Sep 16, 2014	SUPPL -27	View Letter (PDF)
Sep 9, 2013	SUPPL -26	View Letter (PDF)
May 1, 2013	SUPPL -25	View Letter (PDF)
Feb 13, 2008	SUPPL -20	View Letter (PDF)
Mar 16, 2004	SUPPL -16	View Letter (PDF)
Jun 18, 2002	SUPPL -14	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — EQ 50MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.

#002 — EQ 100MG BASE

RLD

0 patents0 exclusivities▾

CAPSULE;ORAL | Approved: Approved Prior to Jan 1, 1982