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ORACEA Drug Profile

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Which patents cover Oracea, and what substitute generic drugs are available?

Oracea is a drug marketed by Galderma Labs Lp and is included in one NDA. There are twelve patents protecting this drug and one Paragraph IV challenge.

This drug has forty patent family members in twelve countries.

The generic ingredient in ORACEA is doxycycline. There are twenty-seven drug master file entries for this compound. Thirty-nine suppliers are listed for this compound. There are four tentative approvals for this compound. Additional details are available on the doxycycline profile page.

Summary for Tradename: ORACEA

Patents:12
Applicants:1
NDAs:1
Suppliers / Packagers: see list4
Bulk Api Vendors: see list31
Clinical Trials: see list1
Patent Applications: see list1,300
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:ORACEA at DailyMed

Pharmacology for Tradename: ORACEA

Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes7,211,267► Subscribe ► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes8,470,364► SubscribeY ► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes8,206,740► SubscribeY ► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes9,241,946► Subscribe ► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 2006RXYesYes8,603,506► Subscribe ► Subscribe
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Expired Patents for Tradename: ORACEA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 20065,789,395► Subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 20065,919,775► Subscribe
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Paragraph IV activity for: ORACEA

Drugname Dosage Strength RLD Submissiondate
doxycyclineDelayed-release Capsules40 mgOracea12/11/2008

Non-Orange Book Patents for Tradename: ORACEA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,014,858Use methods of treating acne and telangiectasia► Subscribe
8,052,983Methods of treating acne► Subscribe
8,658,189Methods of treating acne► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: ORACEA

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)9808480► Subscribe
European Patent Office1615622► Subscribe
Spain2266499► Subscribe
Japan2012144554► Subscribe
European Patent Office1383508► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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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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