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. Twenty-seven 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 30th, 1991.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for SOLODYN?
- What are the global sales for SOLODYN?
- What is Average Wholesale Price for SOLODYN?
Summary for SOLODYN
International Patents: | 12 |
US Patents: | 8 |
Applicants: | 1 |
NDAs: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 95 |
Clinical Trials: | 19 |
Patent Applications: | 2,938 |
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 |



Recent Clinical Trials for SOLODYN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Dr. Reddy's Laboratories Limited | Phase 1 |
Journey Medical Corporation | Phase 1 |
University of North Carolina, Chapel Hill | Phase 2 |
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.
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 | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-006 | Aug 27, 2010 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-005 | Jul 23, 2009 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-006 | Aug 27, 2010 | DISCN | Yes | No | ⤷ Try for Free | ⤷ Try for Free | ⤷ Try for Free | ||||
>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 | 050808-006 | Aug 27, 2010 | ⤷ Try for Free | ⤷ Try for Free |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-004 | Jul 23, 2009 | ⤷ Try for Free | ⤷ Try for Free |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-001 | May 8, 2006 | ⤷ Try for Free | ⤷ Try for Free |
Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-003 | May 8, 2006 | ⤷ Try for Free | ⤷ Try for Free |
>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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Norway | 20080444 | ⤷ Try for Free | |
Japan | 5744976 | ⤷ Try for Free | |
Japan | 2013213047 | METHOD FOR TREATMENT OF ACNE | ⤷ Try for Free |
Canada | 2613273 | METHODE DE TRAITEMENT DE L'ACNE (METHOD FOR THE TREATMENT OF ACNE) | ⤷ Try for Free |
>Country | >Patent Number | >Title | >Estimated Expiration |
Market Dynamics and Financial Trajectory for the Drug: Solodyn
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