Viewing data from:

ORACEA

NDA

DOXYCYCLINE | N050805 | GALDERMA LABORATORIES LP

1 strength1 unique patent0 unique exclusivities

Patent Timeline

1 unique patent by expiration date

Active (1)Today

2027

2028

Today

7749532

Dec. 19, 2027

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

2 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Galderma Laboratories L.P. et al v. Amneal Pharmaceuticals LLC et al 1:2016cv00207 10 patentsANDA 203278doxycycline	D. Del.	2016-03-31	Terminated 2018-09-04	—
Mylan Pharmaceuticals Inc. v. Galderma Laboratories Inc. et al 1:2010cv00892 5 patentsANDA 90855doxycycline	D. Del.	2010-10-18	Terminated 2012-05-25	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

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 Oracea (2023)

Total Spending

$3.9M

Total Claims

3,150

Beneficiaries

905

Avg Cost/Unit

$28.31

Spending Trend

$4.4M(2019)→$3.9M(2020)→$3.6M(2021)→$3.4M(2022)→$3.9M(2023)

YoY Change:+6.4%

5yr CAGR:+5.1%

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

6 letters from Drugs@FDA

Date	Submission	Document
Apr 8, 2025	SUPPL -20	View Letter (PDF)
Dec 21, 2021	SUPPL -11	View Letter (PDF)
Jul 29, 2013	SUPPL -8	View Letter (PDF)
Nov 8, 2012	SUPPL -7	View Letter (PDF)
May 17, 2010	SUPPL -2	View Letter (PDF)
May 30, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG

RLDAB

1 patent0 exclusivities▴

CAPSULE;ORAL | Approved: May 26, 2006

Patents (1)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7749532	Dec 19, 2027	—	—	Yes		—