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Serving leading biopharmaceutical companies globally:

Argus Health
Mallinckrodt
Julphar
Baxter
Covington
McKinsey
QuintilesIMS
AstraZeneca
Cipla
Johnson and Johnson

Generated: February 21, 2018

DrugPatentWatch Database Preview

ORACEA Drug Profile

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Which patents cover Oracea, and when can generic versions of Oracea launch?

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

This drug has thirty-five patent family members in twelve countries.

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 ORACEA
Drug patent expirations by year for ORACEA
Pharmacology for ORACEA
Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug
Medical Subject Heading (MeSH) Categories for ORACEA

US Patents and Regulatory Information for ORACEA

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for ORACEA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Delayed-release Capsules 40 mg ➤ Subscribe 12/11/2008

Non-Orange Book US Patents for 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
7,014,858 Use methods of treating acne and telangiectasia ➤ Sign Up
8,052,983 Methods of treating acne ➤ Sign Up
8,658,189 Methods of treating acne ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ORACEA

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Julphar
Dow
Boehringer Ingelheim
Accenture
Express Scripts
Daiichi Sankyo
Federal Trade Commission
McKinsey

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