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Doxycycline - Generic Drug Details

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

This ingredient has forty patent family members in twelve countries.

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

Summary for Generic Name: doxycycline

Tradenames:17
Patents:16
Applicants:47
NDAs:89
Drug Master File Entries: see list27
Suppliers / Packaging: see list39
Therapeutic Class:Antibacterials
Dermatological Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: doxycycline

Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug

Tentative approvals for DOXYCYCLINE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE;ORAL40MG
<disabled><disabled>CAPSULE; ORAL40MG
<disabled><disabled>CAPSULE;ORAL40MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Heritage Pharms Inc
DOXYCYCLINE
doxycycline
TABLET;ORAL091605-003Dec 20, 2011RXNo► subscribe► subscribe
Mayne Pharma
DORYX MPC
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-008May 20, 2016RXNo9,295,652► subscribeY ► subscribe
Interpharm
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL062763-002Sep 2, 1988DISCNNo► 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 Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 20065,789,395► subscribe
Galderma Labs Lp
ORACEA
doxycycline
CAPSULE;ORAL050805-001May 26, 20065,919,775► 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
8,658,189Methods of treating acne► subscribe
7,014,858Use methods of treating acne and telangiectasia► 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
Portugal1383508► subscribe
Japan2002513386► subscribe
European Patent Office1716856► 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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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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