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Serving 500+ biopharmaceutical companies globally:

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Generated: September 25, 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, 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, Novel Labs Inc, Heather, Interpharm, Ivax Sub Teva Pharms, Mayne Pharma Inc, Superpharm, Caribe Holdings, 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 sixty-seven 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-one suppliers are listed for this compound.

Summary for Generic Name: doxycycline hyclate

Tradenames:14
Patents:5
Applicants:44
NDAs:67
Drug Master File Entries: see list27
Suppliers / Packagers: see list91
Bulk Api Vendors: see list65
Clinical Trials: see list215
Patent Applications: see list2,219
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:doxycycline hyclate at DailyMed

Pharmacology for Ingredient: 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;ORAL062396-002Nov 7, 1984ABRXNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma Inc
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET;ORAL208765-002Jun 14, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Medicis
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE, DELAYED RELEASE;ORAL065281-002Dec 21, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
DORYX
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-002May 6, 2005ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Sun Pharm Inds
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL062676-001Jul 10, 1986ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL090431-002Dec 28, 2010ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
DOXYCYCLINE HYCLATE
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL090431-005May 19, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Interpharm
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL062763-001Sep 2, 1988DISCNNoNo► Subscribe► Subscribe► Subscribe
Mayne Pharma
DORYX
doxycycline hyclate
TABLET, DELAYED RELEASE;ORAL050795-006Dec 19, 2014ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Heather
DOXYCYCLINE HYCLATE
doxycycline hyclate
CAPSULE;ORAL062463-001Dec 7, 1983DISCNNoNo► 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
Australia2005299253► Subscribe
World Intellectual Property Organization (WIPO)2006045152► 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 500+ biopharmaceutical companies globally:

Healthtrust
Mallinckrodt
Cerilliant
Baxter
Federal Trade Commission
Accenture
Chinese Patent Office
Julphar
Teva
Chubb

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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