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Last Updated: June 24, 2021

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SOLODYN Drug Profile


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When do Solodyn patents expire, and what generic alternatives are available?

Solodyn is a drug marketed by Medicis and is included in one NDA. There are eight 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 fifteen drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

Paragraph IV (Patent) Challenges for SOLODYN
Tradename Dosage Ingredient NDA Submissiondate
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-13
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-12-02
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2010-10-27
SOLODYN TABLET, EXTENDED RELEASE;ORAL minocycline hydrochloride 050808 2009-11-19

US Patents and Regulatory Information for SOLODYN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 AB RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 AB RX Yes Yes   Try Before You Buy   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-007 Aug 27, 2010 AB RX Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-002 May 8, 2006 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for SOLODYN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-007 Aug 27, 2010   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-004 Jul 23, 2009   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009   Try Before You Buy   Try Before You Buy
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010   Try Before You Buy   Try Before You Buy
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for SOLODYN

Country Patent Number Estimated Expiration
Japan 5744976   Try Before You Buy
World Intellectual Property Organization (WIPO) 2010017310   Try Before You Buy
New Zealand 564093   Try Before You Buy
Japan 2013213047   Try Before You Buy
Canada 2613273   Try Before You Buy
China 101208097   Try Before You Buy
World Intellectual Property Organization (WIPO) 2007001961   Try Before You Buy
>Country >Patent Number >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Colorcon
Johnson and Johnson
Moodys
Medtronic

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