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Serving hundreds of leading biopharmaceutical companies globally:

Cantor Fitzgerald
Accenture
Covington
Chinese Patent Office
McKinsey
Queensland Health
Express Scripts
US Army
Julphar

Generated: August 15, 2018

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 three suppliers. There are ten 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-seven drug master file entries for this compound. Forty-five 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:10
Formulation / Manufacturing:see details
Pharmacology for NDA: 050805
Ingredient-typeTetracyclines
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 N 0299-3822-02
ORACEA doxycycline CAPSULE;ORAL 050805 NDA Galderma Laboratories, L.P. 0299-3822 N 0299-3822-04

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:CAPSULE;ORALStrength40MG
Approval Date:May 26, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Apr 5, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
Patent:➤ Try a Free TrialPatent Expiration:Apr 5, 2022Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
Patent:➤ Try a Free TrialPatent Expiration:Dec 19, 2027Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA

Expired US Patents for NDA 050805

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Covington
Teva
Cipla
Medtronic
Accenture
Express Scripts
Merck
US Army
Chinese Patent Office

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