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Last Updated: July 3, 2020

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050805


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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 are eleven patents 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 are twenty-eight drug master file entries for this compound. Thirty-eight 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:11
Formulation / Manufacturing:see details
Pharmacology for NDA: 050805
Medical Subject Heading (MeSH) Categories for 050805
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 0299-3822-02 12 TRAY in 1 BOX (0299-3822-02) > 8 CARTON in 1 TRAY > 1 BLISTER PACK in 1 CARTON > 2 CAPSULE in 1 BLISTER PACK
ORACEA doxycycline CAPSULE;ORAL 050805 NDA Galderma Laboratories, L.P. 0299-3822 0299-3822-04 4 CAPSULE in 1 BLISTER PACK (0299-3822-04)
Paragraph IV (Patent) Challenges for 050805
Tradename Dosage Ingredient NDA Submissiondate
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-12
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-11

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:May 26, 2006TE:RLD:Yes
Patent:  Start TrialPatent Expiration:Apr 5, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
Patent:  Start TrialPatent Expiration:Apr 5, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
Patent:  Start TrialPatent Expiration:Apr 5, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA

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