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Serving leading biopharmaceutical companies globally:

Farmers Insurance
Citi
Daiichi Sankyo
McKesson
US Army
McKinsey
Colorcon
Moodys
Accenture
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Generated: October 20, 2017

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Minocycline hydrochloride - Generic Drug Details

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What are the generic sources for minocycline hydrochloride and what is the scope of minocycline hydrochloride freedom to operate?

Minocycline hydrochloride
is the generic ingredient in seven branded drugs marketed by Impax Labs, Medicis, Zydus Worldwide, Mylan Pharms Inc, Triax Pharms, Sun Pharm Inds, Sun Pharm Inds Ltd, Sandoz, Impax Labs Inc, Lupin Ltd, Par Pharm, Dr Reddys Labs Ltd, Lederle, Rempex Pharms Inc, Precision Dermat, Alkem Labs Ltd, Torrent Pharma Inc, Aurobindo Pharma Ltd, Watson Labs, Cnty Line Pharms, Sun Pharm Inds Inc, Aurobindo Pharma, Watson Labs Teva, Orapharma, Barr Labs Inc, and Sidmak Labs India, and is included in thirty-three NDAs. There are thirteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Minocycline hydrochloride has fifty-two patent family members in twenty-five countries.

There are thirteen drug master file entries for minocycline hydrochloride. Fifty suppliers are listed for this compound. There are seven tentative approvals for this compound.

Summary for Generic Name: minocycline hydrochloride

US Patents:13
Tradenames:7
Applicants:26
NDAs:33
Drug Master File Entries: see list13
Suppliers / Packagers: see list50
Bulk Api Vendors: see list45
Clinical Trials: see list2,451
Patent Applications: see list2,520
Therapeutic Class:Dental and Oral Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:minocycline hydrochloride at DailyMed

Pharmacology for Ingredient: minocycline hydrochloride

Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug

Tentative approvals for MINOCYCLINE HYDROCHLORIDE

Applicant Application No. Strength Dosage Form
u► SubscribeEQ 45MG BASETABLET, EXTENDED RELEASE;ORAL
u► SubscribeEQ 135MG BASETABLET, EXTENDED RELEASE;ORAL
u► SubscribeEQ 115MG BASETABLET, EXTENDED RELEASE;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Alkem Labs Ltd
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL204453-005Sep 28, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe
Medicis
SOLODYN
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL050808-004Jul 23, 2009RXYesNo► Subscribe► Subscribe ► Subscribe
Dr Reddys Labs Ltd
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET;ORAL065436-003Dec 26, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Precision Dermat
MINOCIN
minocycline hydrochloride
CAPSULE;ORAL050649-002May 31, 1990ABRXNoNo► Subscribe► Subscribe► Subscribe
Medicis
SOLODYN
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL050808-003May 8, 2006DISCNYesNo► Subscribe► Subscribe ► Subscribe
Lupin Ltd
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL091424-001Nov 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Ltd
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL091424-003Nov 30, 2011ABRXNoNo► Subscribe► Subscribe► Subscribe
Torrent Pharma Inc
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET;ORAL065156-002Jan 6, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Precision Dermat
MINOCIN
minocycline hydrochloride
CAPSULE;ORAL050649-003Feb 12, 2001DISCNYesNo► Subscribe► Subscribe► Subscribe
Sun Pharm Inds Ltd
XIMINO
minocycline hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL201922-005Jul 11, 2012RXNoNo► Subscribe► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: minocycline hydrochloride

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
9,744,179Tetracycline compositions► 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: minocycline hydrochloride

Country Document Number Estimated Expiration
Japan2005521467► Subscribe
World Intellectual Property Organization (WIPO)2011143503► Subscribe
European Patent Office2263596► Subscribe
Colombia5611079► Subscribe
European Patent Office2568987► Subscribe
Mexico2012012993► Subscribe
European Patent Office1489988► Subscribe
Argentina039205► Subscribe
New Zealand707329► Subscribe
Australia2011252919► 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:

AstraZeneca
Colorcon
Express Scripts
Queensland Health
Accenture
Cerilliant
Cantor Fitzgerald
Citi
Cipla
UBS

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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