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Last Updated: October 30, 2020

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ORACEA Drug Profile

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When do Oracea patents expire, 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 eleven patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-seven patent family members in thirteen countries.

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.

US ANDA Litigation and Generic Entry Outlook for Oracea

A generic version of ORACEA was approved as doxycycline by WEST-WARD PHARMS INT on March 9th, 1988.

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Drug patent expirations by year for ORACEA
Drug Prices for ORACEA

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Drug Sales Revenue Trends for ORACEA

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Recent Clinical Trials for ORACEA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wake Forest University Health SciencesPhase 4
The Skin of Color SocietyPhase 4
Derm Research, PLLCPhase 4

See all ORACEA clinical trials

Pharmacology for ORACEA
Paragraph IV (Patent) Challenges for ORACEA
Tradename Dosage Ingredient NDA Submissiondate
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-12
ORACEA CAPSULE;ORAL doxycycline 050805 2008-12-11

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   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes   Start Trial   Start Trial   Start Trial
>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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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
McKinsey
Moodys
Johnson and Johnson
Medtronic

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