Viewing data from:

VIBRAMYCIN

NDA

DOXYCYCLINE | N050006 | PFIZER LABORATORIES DIV PFIZER 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Citizen Petition from Strides Pharma Inc. FDA-2025-P-0100 Strides Pharma Inc. filed this citizen petition requesting that the FDA determine whether Pfizer's Reference Listed Drug Vibramycin doxycycline oral suspension 25 mg base per 5 mL, approved under NDA 050006, was voluntarily withdrawn from sale for safety or efficacy reasons, as the product currently	505(q)	2025-01-10	Withdrawn	Strides Pharma Inc.

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Vibramycin (2023)

Total Spending

$5K

Total Claims

Beneficiaries

Avg Cost/Unit

$1.10

Spending Trend

$207K(2019)→$139K(2019)→$1K(2020)→$195K(2020)→$171K(2021)→$31K(2022)→$771.42(2023)→$5K(2023)

YoY Change:-1.2%

5yr CAGR:+0.8%

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

API Supply Chain8 active DMFs8 inactive

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

HOVIONE FARMACIENCIA SADOXYCYCLINE MONOHYDRATE

DMF 137101998

YANGZHOU LIBERTY PHARMACEUTICAL CO LTDDOXYCYCLINE MONOHYDRATE

DMF 139441999

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE

DMF 189592005

HOVIONE FARMACIENCIA SADOXYCYCLINE MONOHYDRATE MICRONIZED

DMF 236382010

RAKS PHARMA PVT LTDDOXYCYCLINE USP

DMF 250622011

RAKS PHARMA PVT LTDDOXYCYCLINE HYCLATE, USP

DMF 259552012

CHANGZHOU PHARMACEUTICAL FACTORYDOXYCYCLINE (ROUTE CODE: DX)

DMF 392922023

MAITHRI DRUGS PRIVATE LTDDOXYCYCLINE MONOHYDRATE USP

DMF 418462025

CHEMWERTH INCInactiveDOXYCYCLINE MONOHYDRATE

DMF 72811988

HENAN KAIFENG PHARMACEUTICAL FACTORYInactiveDOXYCYCLINE HYDROCHLORIDE

DMF 128641998

KUNSHAN ORIENTAL PHARMACEUTICAL CO LTDInactiveDOXYCYCLINE USP, NON-STERILE BULK DRUG

DMF 130401998

ANKERMAN SPAInactiveDOXYCYCLINE

DMF 134501998

WATSON LABORATORIES INCInactiveDOXYCYCLINE

DMF 135001998

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveDOXYCYCLINE USP

DMF 142951999

HENAN KAIFENG PHARMACEUTICAL FACTORYInactiveDOXYCYCLINE HYDROCHLORIDE

DMF 170942004

HUASHU PHARMACEUTICAL CORPInactiveDOXYCYCLINE MONOHYDRATE

DMF 183132005

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 -96	View Letter (PDF)
Apr 8, 2025	SUPPL -95	View Letter (PDF)
Dec 26, 2019	SUPPL -92	View Letter (PDF)
Dec 7, 2018	SUPPL -91	View Letter (PDF)
Jul 28, 2017	SUPPL -89	View Letter (PDF)
Dec 29, 2016	SUPPL -88	View Letter (PDF)
Apr 5, 2016	SUPPL -87	View Letter (PDF)
Sep 16, 2014	SUPPL -86	View Letter (PDF)
Sep 9, 2013	SUPPL -85	View Letter (PDF)
Apr 30, 2013	SUPPL -84	View Letter (PDF)
Feb 13, 2008	SUPPL -79	View Letter (PDF)
Mar 16, 2004	SUPPL -76	View Letter (PDF)
Jun 18, 2002	SUPPL -74	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 25MG BASE/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

FOR SUSPENSION;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.