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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Argus Health
Mallinckrodt
Express Scripts
US Army
Farmers Insurance
Deloitte
Chinese Patent Office
Queensland Health
Fuji

Generated: November 22, 2017

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Doxycycline hyclate - Generic Drug Details

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What are the generic drug sources for doxycycline hyclate and what is the scope of doxycycline hyclate freedom to operate?

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

Doxycycline hyclate has two patent family members in two countries.

There are twenty-seven drug master file entries for doxycycline hyclate. Ninety-three suppliers are listed for this compound.

Pharmacology for doxycycline hyclate

Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma Intl Pharms
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL062396-001May 7, 1984ABRXNoNo► Subscribe► Subscribe► Subscribe
Watson Labs
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL061717-001Approved Prior to Jan 1, 1982DISCNNoNo► Subscribe► Subscribe► Subscribe
Fresenius Kabi Usa
DOXY 100
doxycycline hyclate
INJECTABLE;INJECTION062475-001Dec 9, 1983APRXNoYes► Subscribe► Subscribe► Subscribe
Pfizer
VIBRAMYCIN
doxycycline hyclate
INJECTABLE;INJECTION050442-001Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Hikma Intl Pharms
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL062396-002Nov 7, 1984ABRXNoNo► Subscribe► Subscribe► Subscribe
Pliva
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE, COATED PELLETS;ORAL063187-001Jun 30, 1992DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer
VIBRAMYCIN
doxycycline hyclate
INJECTABLE;INJECTION050442-002Approved Prior to Jan 1, 1982DISCNYesNo► Subscribe► Subscribe► Subscribe
Heritage Pharms Inc
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL200856-003Apr 30, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Pfizer
VIBRAMYCIN
doxycycline hyclate
CAPSULE;ORAL050007-002Approved Prior to Jan 1, 1982ABRXYesYes► Subscribe► Subscribe► Subscribe
Mylan Pharms Inc
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL091052-001Feb 8, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: doxycycline hyclate

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 Ingredient: doxycycline hyclate

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:

Cerilliant
Daiichi Sankyo
Covington
McKinsey
UBS
Cipla
Merck
US Department of Justice
Mallinckrodt
Federal Trade Commission

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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