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Minocycline hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for minocycline hydrochloride?

Minocycline hydrochloride is the generic ingredient in six 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, Orapharma, Barr Labs Inc, and Sidmak Labs India, and is included in thirty-two NDAs. There are thirteen patents protecting this compound and four Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has forty-three patent family members in twenty-two countries.

There are thirteen drug master file entries for minocycline hydrochloride. Forty-eight suppliers are listed for this compound. There are six tentative approvals for this compound.

Summary for Generic Name: minocycline hydrochloride

Tradenames:6
Patents:14
Applicants:25
NDAs:32
Drug Master File Entries: see list13
Suppliers / Packagers: see list48
Bulk Api Vendors: see list45
Clinical Trials: see list1,058
Patent Applications: see list1,506
Therapeutic Class:Antibacterials
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. Form Dosage
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORALEQ 65MG BASE
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORALEQ 115MG BASE
► Subscribe► SubscribeTABLET, EXTENDED RELEASE; ORALEQ 55MG BASE
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sidmak Labs India
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL204394-007Dec 30, 2015RXNoNo► Subscribe► Subscribe
Impax Labs Inc
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL090024-003Feb 3, 2009DISCNNoNo► Subscribe► Subscribe
Barr Labs Inc
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL065485-005May 18, 2012DISCNNoNo► Subscribe► Subscribe
Sun Pharm Inds Ltd
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL091118-005Sep 25, 2014RXNoNo► Subscribe► Subscribe
Medicis
SOLODYN
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL050808-001May 8, 2006DISCNYesNo8,252,776► Subscribe ► Subscribe
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International Patent Family for Ingredient: minocycline hydrochloride

Country Document Number Estimated Expiration
Colombia5611079► Subscribe
World Intellectual Property Organization (WIPO)03082139► Subscribe
World Intellectual Property Organization (WIPO)2011143503► Subscribe
Japan6025712► Subscribe
Mexico2012012993► 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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