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Minocycline hydrochloride - Generic Drug Details

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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 patent family members in twenty-two countries.

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

Summary for Generic Name: minocycline hydrochloride

Drug Master File Entries: see list13
Suppliers / Packagers: see list46
Bulk Api Vendors: see list45
Clinical Trials: see list1,056
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

Drug ClassTetracycline-class Drug


Applicant Application No. Form Dosage
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Precision Dermat
minocycline hydrochloride
CAPSULE;ORAL050649-003Feb 12, 2001DISCNNo► subscribe► subscribe
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL050808-002May 8, 2006DISCNNo5,908,838► subscribe ► subscribe
Sun Pharm Inds Ltd
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL091118-005Sep 25, 2014RXNo► subscribe► subscribe
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International Patent Family for Ingredient: minocycline hydrochloride

Country Document Number Estimated Expiration
Japan2008543936► subscribe
Colombia5611079► subscribe
Canada2479995► 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.