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Chubb
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Dow
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Teva
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Generated: November 18, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050808

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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 nine 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 fourteen drug master file entries for this compound. Fifty-four 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:9
Formulation / Manufacturing:see details
Pharmacology for NDA: 050808
Ingredient-typeTetracyclines
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EXTENDED RELEASE;ORALStrengthEQ 45MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons**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:➤ Sign UpPatent Expiration:Feb 19, 2018Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
Patent:➤ Sign UpPatent Expiration:Jun 24, 2025Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ Sign UpPatent Expiration:Mar 7, 2027Product 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 050808-006 Aug 27, 2010 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-002 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-001 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-003 May 8, 2006 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-004 Jul 23, 2009 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-005 Jul 23, 2009 ➤ Sign Up ➤ Sign Up
Medicis SOLODYN minocycline hydrochloride TABLET, EXTENDED RELEASE;ORAL 050808-008 Aug 27, 2010 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Moodys
AstraZeneca
Merck
Julphar
Farmers Insurance
US Army
US Department of Justice
UBS

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