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BioPharmaceutical Business Intelligence

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  • Identify first generic entrants
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Serving leading biopharmaceutical companies globally:

Covington
Cantor Fitzgerald
Farmers Insurance
McKinsey
Teva
Deloitte
Cipla
Medtronic
Moodys
Colorcon

Generated: November 18, 2017

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DORYX Drug Profile

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What is the patent landscape for Doryx, and when can generic versions of Doryx launch?

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

This drug has two patent family members in two countries.

The generic ingredient in DORYX is doxycycline hyclate. There are twenty-seven drug master file entries for this compound. Ninety-three suppliers are listed for this compound. Additional details are available on the doxycycline hyclate profile page.
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Warner Chilcott
DORYX
doxycycline hyclate
CAPSULE, DELAYED RELEASE;ORAL062653-001Oct 30, 1985DISCNNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-007May 20, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-008May 20, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-001May 6, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-006Dec 19, 2014ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-003Jun 20, 2008ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-007May 20, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-004Apr 11, 2013ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-007May 20, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-007May 20, 2016RXYesNo► Subscribe► SubscribeY ► Subscribe
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Paragraph IV (Patent) Challenges for DORYX

Drugname Dosage Strength RLD Submissiondate
doxycycline hyclateDelayed-release Tablets50 mgDoryx11/5/2015
doxycycline hyclateDelayed-release Tablets80 mgDoryx7/1/2015
doxycycline hyclateDelayed-release Tablets200 mgDoryx5/19/2014
doxycycline hyclateDelayed-release Tablets75 mg and 100 mgDoryxPIV received prior to 2/5/2009
doxycycline hyclateDelayed-release Tablets150 mgDoryx12/19/2008
doxycycline hyclate (as of 6/10/14)Delayed-release Tablets200 mgDoryx8/12/2013

Non-Orange Book Patents for Tradename: DORYX

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
2,016,151,395► 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: DORYX

Country Document Number Estimated Expiration
World Intellectual Property Organization (WIPO)2006045152► Subscribe
Australia2005299253► 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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Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
US Department of Justice
US Army
Boehringer Ingelheim
Dow
Cipla
Federal Trade Commission
Covington
Johnson and Johnson

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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