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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
Cantor Fitzgerald
Covington
AstraZeneca
Novartis
Colorcon
Julphar
Federal Trade Commission
Moodys
Harvard Business School

Generated: February 24, 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 four 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-four 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
Therapeutic Class:Antibacterials
Dermatological Agents
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 0299-3822-30
ORACEA doxycycline CAPSULE;ORAL 050805 NDA Galderma Laboratories, L.P. 0299-3822 N 0299-3822-02

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:

Daiichi Sankyo
Fuji
Citi
Accenture
Medtronic
Merck
Deloitte
QuintilesIMS
Chubb

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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