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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Queensland Health
McKesson
Daiichi Sankyo
Fuji
US Army
Chubb
Merck
AstraZeneca
Colorcon

Generated: December 11, 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 Sun Pharm Inds Ltd, Cnty Line Pharms, Precision Dermat, Triax Pharms, Aurobindo Pharma, Impax Labs, Sun Pharm Inds Inc, Torrent Pharma Inc, Watson Labs, Watson Labs Teva, Zydus Worldwide, Lederle, Rempex Pharms Inc, Orapharma, Alkem Labs Ltd, Aurobindo Pharma Ltd, Barr Labs Inc, Impax Labs Inc, Lupin Ltd, Mylan Pharms Inc, Sandoz, Sidmak Labs India, Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Medicis, Par Pharm, and Sun Pharm Industries, and is included in thirty-four 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-four suppliers are listed for this compound. There are seven tentative approvals for this compound.

Pharmacology for minocycline hydrochloride

Ingredient-typeTetracyclines
Drug ClassTetracycline-class Drug

Medical Subject Heading (MeSH) Categories for minocycline hydrochloride

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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds LtdXIMINOminocycline hydrochlorideCAPSULE, EXTENDED RELEASE;ORAL201922-005Jul 11, 2012RXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MedicisSOLODYNminocycline hydrochlorideTABLET, EXTENDED RELEASE;ORAL050808-008Aug 27, 2010RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
MedicisSOLODYNminocycline hydrochlorideTABLET, EXTENDED RELEASE;ORAL050808-006Aug 27, 2010ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Torrent Pharma IncMINOCYCLINE HYDROCHLORIDEminocycline hydrochlorideTABLET;ORAL065156-003Jan 6, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MedicisSOLODYNminocycline hydrochlorideTABLET, EXTENDED RELEASE;ORAL050808-007Aug 27, 2010ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
MedicisSOLODYNminocycline hydrochlorideTABLET, EXTENDED RELEASE;ORAL050808-005Jul 23, 2009RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
SandozMINOCYCLINE HYDROCHLORIDEminocycline hydrochlorideTABLET, EXTENDED RELEASE;ORAL090422-002Aug 13, 2009ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MedicisSOLODYNminocycline hydrochlorideTABLET, EXTENDED RELEASE;ORAL050808-008Aug 27, 2010RXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
MedicisSOLODYNminocycline hydrochlorideTABLET, EXTENDED RELEASE;ORAL050808-002May 8, 2006DISCNYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax LabsMINOCYCLINE HYDROCHLORIDEminocycline hydrochlorideCAPSULE;ORAL065005-001Mar 23, 1999ABRXNoNo► Subscribe► Subscribe► Subscribe► 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
Australia2006262428► Subscribe
Canada2799079► Subscribe
New Zealand707329► Subscribe
Spain2613738► Subscribe
Portugal2568987► Subscribe
World Intellectual Property Organization (WIPO)2010017310► Subscribe
Denmark2568987► Subscribe
Japan5744976► Subscribe
Japan2016145253► Subscribe
Japan6025712► 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:

Federal Trade Commission
Fuji
Moodys
QuintilesIMS
Boehringer Ingelheim
US Army
Cipla
Dow
Accenture
Covington

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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