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 twelve patent family members in nine countries.

The generic ingredient in SOLODYN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Solodyn

A generic version of SOLODYN was approved as minocycline hydrochloride by WATSON LABS on December 30^th, 1991.

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Summary for SOLODYN

International Patents:	12
US Patents:	8
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	95
Clinical Trials:	19
Patent Applications:	2,826
Drug Prices:	Drug price information for SOLODYN
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for SOLODYN
What excipients (inactive ingredients) are in SOLODYN?	SOLODYN excipients list
DailyMed Link:	SOLODYN at DailyMed

Drug patent expirations by year for SOLODYN

Recent Clinical Trials for SOLODYN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Journey Medical Corporation	Phase 1
Dr. Reddy's Laboratories Limited	Phase 1
National Jewish Health	Phase 2

See all SOLODYN clinical trials

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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Minocycline oral dosage forms for the treatment of acne
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE

Method for the treatment of acne
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE

Minocycline oral dosage forms for the treatment of acne
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE

Extended-release minocycline dosage forms
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ACNE

Method for the treatment of acne and certain dosage forms thereof
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Glossary

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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		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-006	Aug 27, 2010		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-005	Jul 23, 2009		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-003	May 8, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-001	May 8, 2006	⤷ Sign Up	⤷ Sign Up
Bausch	SOLODYN	minocycline hydrochloride	TABLET, EXTENDED RELEASE;ORAL	050808-002	May 8, 2006	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for SOLODYN

See the table below for patents covering SOLODYN around the world.

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Country	Patent Number	Title	Estimated Expiration
Japan	5744976		⤷ Sign Up
Japan	2013213047	METHOD FOR TREATMENT OF ACNE	⤷ Sign Up
European Patent Office	1898925	MÉTHODE DE TRAITEMENT DE L'ACNÉ (METHOD FOR THE TREATMENT OF ACNE)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration