Last Updated: November 8, 2026

Details for New Drug Application (NDA): 050805

NDA 050805 describes ORACEA, which is a drug marketed by Galderma Labs Lp and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug and one Paragraph IV challenge. Additional details are available on the ORACEA profile page.

The generic ingredient in ORACEA is doxycycline. There is one drug master file entry for this compound. Forty suppliers are listed for this compound. Additional details are available on the doxycycline profile page.

Summary for 050805

Tradename:	ORACEA
Applicant:	Galderma Labs Lp
Ingredient:	doxycycline
Patents:	1

Pharmacology for NDA: 050805

Medical Subject Heading (MeSH) Categories for 050805

Anti-Bacterial Agents
Antimalarials

Suppliers and Packaging for NDA: 050805

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
ORACEA	doxycycline	CAPSULE;ORAL	050805	NDA	Galderma Laboratories, L.P.	0299-3822	0299-3822-30	30 CAPSULE in 1 BOTTLE (0299-3822-30)
ORACEA	doxycycline	CAPSULE;ORAL	050805	NDA AUTHORIZED GENERIC	Mayne Pharma Inc.	68308-668	68308-668-30	30 CAPSULE in 1 BOTTLE (68308-668-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	CAPSULE;ORAL			Strength	40MG
Approval Date:	May 26, 2006	TE:	AB	RLD:	Yes
Patent:	7,749,532	Patent Expiration:	Dec 19, 2027	Product Flag?	Y	Substance Flag?		Delist Request?
Patented Use:	TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA

Expired US Patents for NDA 050805

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,603,506	⤷ Start Trial
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	7,211,267	⤷ Start Trial
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,394,406	⤷ Start Trial
Galderma Labs Lp	ORACEA	doxycycline	CAPSULE;ORAL	050805-001	May 26, 2006	8,709,478	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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