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-eight 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.
Summary for SOLODYN
| International Patents: | 12 |
| US Patents: | 8 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 95 |
| Clinical Trials: | 19 |
| Patent Applications: | 3,003 |
| Formulation / Manufacturing: | see details |
| 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 |
|---|---|
| Journey Medical Corporation | Phase 1 |
| Dr. Reddy's Laboratories Limited | Phase 1 |
| St. Louis Children's Hospital | Phase 2 |
Pharmacology for SOLODYN
| Drug Class | Tetracycline-class Drug |
| Physiological Effect | Decreased Prothrombin Activity |
Anatomical Therapeutic Chemical (ATC) Classes for SOLODYN
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Minocycline oral dosage forms for the treatment of acne
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Method for the treatment of acne
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Minocycline oral dosage forms for the treatment of acne
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Minocycline oral dosage forms for the treatment of acne
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Extended-release minocycline dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Method for the treatment of acne and certain dosage forms thereof
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
| 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-006 | Aug 27, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-005 | Jul 23, 2009 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-006 | Aug 27, 2010 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >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 | 050808-005 | Jul 23, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-004 | Jul 23, 2009 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-001 | May 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| Bausch | SOLODYN | minocycline hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 050808-003 | May 8, 2006 | ⤷ Try a Trial | ⤷ Try a Trial |
| >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 |
|---|---|---|---|
| China | 101208097 | Method for the treatment of acne | ⤷ Try a Trial |
| World Intellectual Property Organization (WIPO) | 2010017310 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2007001961 | ⤷ Try a Trial | |
| Australia | 2006262428 | Method for the treatment of acne | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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