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Last Updated: July 13, 2020

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DORYX Drug Profile


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When do Doryx patents expire, and when can generic versions of Doryx launch?

Doryx is a drug marketed by Mayne Pharma Intl, Warner Chilcott, and Mayne Pharma. and is included in three NDAs. There are five patents protecting this drug and seven Paragraph IV challenges.

This drug has two patent family members in two countries.

The generic ingredient in DORYX is doxycycline hyclate. There are twenty-eight drug master file entries for this compound. Seventy-four suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.

US ANDA Litigation and Generic Entry Outlook for Doryx

A generic version of DORYX was approved as doxycycline hyclate by CARIBE HOLDINGS on November 8th, 1982.

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Paragraph IV (Patent) Challenges for DORYX
Tradename Dosage Ingredient NDA Submissiondate
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2017-09-28
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-11-05
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2015-07-01
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2014-05-19
DORYX MPC TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19
DORYX TABLET, DELAYED RELEASE;ORAL doxycycline hyclate 050795 2008-12-19

US Patents and Regulatory Information for DORYX

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mayne Pharma Intl DORYX doxycycline hyclate CAPSULE, DELAYED RELEASE;ORAL 050582-002 Aug 13, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-008 May 20, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-001 May 6, 2005 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-006 Dec 19, 2014 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-003 Jun 20, 2008 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Mayne Pharma DORYX MPC doxycycline hyclate TABLET, DELAYED RELEASE;ORAL 050795-007 May 20, 2016 DISCN Yes No   Start Trial   Start Trial Y   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:

Moodys
Dow
AstraZeneca
Express Scripts
Colorcon
Johnson and Johnson

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