Get our Free Patent Expiration, Litigation, and Drug Price Updates

Serving hundreds of leading biopharmaceutical companies globally:

US Department of Justice
McKesson
McKinsey
Accenture
Boehringer Ingelheim
Cantor Fitzgerald

Generated: April 21, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050808

« Back to Dashboard

NDA 050808 describes SOLODYN, which is a drug marketed by Medicis and is included in one NDA. It is available from three suppliers. There are eight patents protecting this drug and four Paragraph IV challenges. Additional details are available on the SOLODYN profile page.

The generic ingredient in SOLODYN is minocycline hydrochloride. There are fifteen drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the minocycline hydrochloride profile page.
Summary for 050808
Tradename:SOLODYN
Applicant:Medicis
Ingredient:minocycline hydrochloride
Patents:8
Formulation / Manufacturing:see details
Pharmacology for NDA: 050808
Medical Subject Heading (MeSH) Categories for 050808
Suppliers and Packaging for NDA: 050808
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808 NDA AUTHORIZED GENERIC Impax Generics 0115-9935 0115-9935-08 1 BOTTLE in 1 CARTON (0115-9935-08) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE
SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808 NDA AUTHORIZED GENERIC Impax Generics 0115-9936 0115-9936-08 1 BOTTLE in 1 CARTON (0115-9936-08) > 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET, EXTENDED RELEASE;ORALStrengthEQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**
Approval Date:May 8, 2006TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ Try a Free TrialPatent Expiration:Mar 7, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ Try a Free TrialPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired US Patents for NDA 050808

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010 ➤ Try a Free Trial ➤ Try a Free Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 ➤ Try a Free Trial ➤ Try a Free Trial
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-004 Jul 23, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

Subscribe to access the full database, or try a Free Trial

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Deloitte
QuintilesIMS
Merck
Queensland Health
Daiichi Sankyo

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 verifification 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.