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Last Updated: September 22, 2021

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ORACEA Drug Patent 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 two Paragraph IV challenges.

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-nine suppliers are listed for this compound. Additional details are available on the doxycycline profile page.

DrugPatentWatch® 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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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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Galderma Labs Lp ORACEA doxycycline CAPSULE;ORAL 050805-001 May 26, 2006 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for ORACEA

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

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Serving leading biopharmaceutical companies globally:

Merck
Boehringer Ingelheim
McKinsey
Moodys
Johnson and Johnson
Medtronic

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