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Last Updated: October 1, 2022

SOLODYN Drug Patent Profile


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

Solodyn is a drug marketed by Bausch 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 Strength NDA ANDAs Submitted Submissiondate
SOLODYN Extended-release Tablet minocycline hydrochloride 105 mg 050808 1 2010-12-13
SOLODYN Extended-release Tablet minocycline hydrochloride 55 mg 050808 1 2010-12-02
SOLODYN Extended-release Tablet minocycline hydrochloride 80 mg 050808 1 2010-10-27
SOLODYN Extended-release Tablet minocycline hydrochloride 65 mg and 115 mg 050808 1 2009-11-19

US Patents and Regulatory Information for SOLODYN

SOLODYN is protected by eight US patents.

Patents protecting SOLODYN

Minocycline oral dosage forms for the treatment of acne
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS

Minocycline oral dosage forms for the treatment of acne
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Minocycline oral dosage forms for the treatment of acne
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Method for the treatment of acne
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Minocycline oral dosage forms for the treatment of acne
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Minocycline oral dosage forms for the treatment of acne
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Extended-release minocycline dosage forms
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATMENT OF ACNE

Method for the treatment of acne and certain dosage forms thereof
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-006 Aug 27, 2010 See Plans and Pricing See Plans and Pricing
Bausch SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
Colorcon
Johnson and Johnson
Moodys
Medtronic

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