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SOLODYN Drug Profile

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Solodyn is a drug marketed by Medicis and is included in one NDA. It is available from two suppliers. There are nine patents protecting this drug and four Paragraph IV challenges.

This drug has thirteen patent family members in ten countries.

The generic ingredient in SOLODYN is minocycline hydrochloride. There are thirteen drug master file entries for this compound. Forty-six suppliers are listed for this compound. There are six tentative approvals for this compound. Additional details are available on the minocycline hydrochloride profile page.

Summary for Tradename: SOLODYN

Suppliers / Packagers: see list2
Bulk Api Vendors: see list74
Clinical Trials: see list13
Patent Applications: see list10,803
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:SOLODYN at DailyMed

Pharmacology for Tradename: SOLODYN

Drug ClassTetracycline-class Drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL050808-005Jul 23, 2009RXYesYes8,268,804► subscribe ► subscribe
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL050808-006Aug 27, 2010RXYesNo7,790,705► subscribe ► subscribe
minocycline hydrochloride
TABLET, EXTENDED RELEASE;ORAL050808-003May 8, 2006DISCNYesNo7,919,483► subscribe ► subscribe
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Paragraph IV activity for: SOLODYN

Drugname Dosage Strength RLD Submissiondate
minocycline hydrochlorideExtended-release Tablet105 rngSolodyn12/28/2010
minocycline hydrochlorideExtended-release Tablet55 mg and 80 mgSolodyn12/2/2010
minocycline hydrochlorideExtended-release Tablets65 mg and 115 mgSolodyn11/19/2009
minocycline hydrochlorideExtended-release Tablet45 mg, 90 mg and 135 mgSolodynPIV received prior to 2/5/2009

International Patent Family for Tradename: SOLODYN

Country Document Number Estimated Expiration
Norway20080444► subscribe
Japan5744976► subscribe
World Intellectual Property Organization (WIPO)2010017310► 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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