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Serving leading biopharmaceutical companies globally:

Daiichi Sankyo
QuintilesIMS
Argus Health
Baxter
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McKesson
Teva
UBS
Accenture
Cantor Fitzgerald

Generated: December 17, 2017

DrugPatentWatch Database Preview

Doxycycline - Generic Drug Details

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What are the generic drug sources for doxycycline and what is the scope of doxycycline patent protection?

Doxycycline
is the generic ingredient in seventeen branded drugs marketed by Alembic Pharms Ltd, G And W Labs Inc, Impax Labs Inc, Lupin Ltd, Mayne Pharma Inc, Mylan Pharms Inc, Par Pharm, Sandoz Inc, Sun Pharm Inds Ltd, Watson Labs, Zydus Pharms Usa Inc, Aqua Pharms, Galderma Labs Lp, Rachelle, Chartwell Life Sci, Pfizer, Heritage Pharms Inc, Lannett, Mylan, Sun Pharm Industries, Pliva, Mayne Pharma Intl, Warner Chilcott, Medicis, Teva, Actavis Labs Fl Inc, Amneal Pharms, Halsey, Heather, Hikma Intl Pharms, Interpharm, Mutual Pharm, Pvt Form, Ranbaxy, Superpharm, Fresenius Kabi Usa, Mylan Labs Ltd, West-ward Pharms Int, Tolmar, Mayne Pharma, Actavis Elizabeth, Prinston Inc, Aqua Pharms Llc, Amneal Pharms Co, Caribe Holdings, Epic Pharma Llc, Ivax Sub Teva Pharms, Larken Labs, Novel Labs Inc, Vintage Pharms, and Collagenex, and is included in ninety-eight NDAs. There are seventeen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Doxycycline has forty-six patent family members in twelve countries.

There are twenty-seven drug master file entries for doxycycline. Forty-three suppliers are listed for this compound. There are four tentative approvals for this compound.

Pharmacology for doxycycline

Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug

Medical Subject Heading (MeSH) Categories for doxycycline

Tentative approvals for DOXYCYCLINE

Applicant Application No. Strength Dosage Form
u► Subscribe40MGCAPSULE;ORAL
u► Subscribe40MGCAPSULE; ORAL
u► Subscribe40MGCAPSULE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Impax Labs IncDOXYCYCLINE HYCLATEdoxycycline hyclateTABLET, DELAYED RELEASE;ORAL090505-001Dec 28, 2010DISCNNoNo► Subscribe► Subscribe► Subscribe
Pvt FormDOXYCYCLINE HYCLATEdoxycycline hyclateCAPSULE;ORAL062631-001Jul 24, 1986DISCNNoNo► Subscribe► Subscribe► Subscribe
Actavis Labs Fl IncDOXYCYCLINE HYCLATEdoxycycline hyclateTABLET;ORAL062421-001Feb 2, 1983ABRXNoNo► Subscribe► Subscribe► Subscribe
LannettDOXYCYCLINEdoxycyclineTABLET;ORAL065285-001Dec 8, 2005ABRXNoNo► Subscribe► Subscribe► Subscribe
MylanDOXYCYCLINEdoxycyclineTABLET;ORAL065377-001Nov 7, 2006ABRXNoNo► Subscribe► Subscribe► Subscribe
Hikma Intl PharmsDOXYCYCLINE HYCLATEdoxycycline hyclateTABLET;ORAL065095-001Jul 2, 2003ABRXNoYes► Subscribe► Subscribe► Subscribe
Amneal PharmsDOXYCYCLINE HYCLATEdoxycycline hyclateCAPSULE;ORAL207289-001Jun 27, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne PharmaDORYX MPCdoxycycline hyclateTABLET, DELAYED RELEASE;ORAL050795-007May 20, 2016RXYesNo► Subscribe► SubscribeY► Subscribe
InterpharmDOXYCYCLINE HYCLATEdoxycycline hyclateCAPSULE;ORAL062763-002Sep 2, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Heritage Pharms IncDOXYCYCLINEdoxycyclineTABLET;ORAL091605-002Dec 20, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: doxycycline

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Galderma Labs LpORACEAdoxycyclineCAPSULE;ORAL050805-001May 26, 2006► Subscribe► Subscribe
Galderma Labs LpORACEAdoxycyclineCAPSULE;ORAL050805-001May 26, 2006► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: doxycycline

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
7,014,858Use methods of treating acne and telangiectasia► Subscribe
8,658,189Methods of treating acne► Subscribe
8,052,983Methods of treating acne► 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 Ingredient: doxycycline

Country Document Number Estimated Expiration
South Korea20040007488► Subscribe
European Patent Office1615622► Subscribe
Portugal1615622► Subscribe
Japan2010053155► Subscribe
Canada2803922► Subscribe
Denmark1615622► Subscribe
Canada2719162► Subscribe
Spain2534827► Subscribe
South Korea100926326► Subscribe
Canada2440472► 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:

Medtronic
Fuji
Johnson and Johnson
Healthtrust
Express Scripts
Accenture
Argus Health
Dow
Covington
Deloitte

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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