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Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
Cipla
Daiichi Sankyo
Fish and Richardson
Healthtrust
McKinsey
Mallinckrodt
Cerilliant
Farmers Insurance

Generated: May 25, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050819

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NDA 050819 describes ONEXTON, which is a drug marketed by Dow Pharm and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the ONEXTON profile page.

The generic ingredient in ONEXTON is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Eleven suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 050819
Tradename:ONEXTON
Applicant:Dow Pharm
Ingredient:benzoyl peroxide; clindamycin phosphate
Patents:6
Formulation / Manufacturing:see details
Pharmacology for NDA: 050819
Ingredient-typeLincosamides
Physiological EffectDecreased Sebaceous Gland Activity
Suppliers and Packaging for NDA: 050819
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819 NDA Valeant Pharmaceuticals North America LLC 0187-3050 N 0187-3050-35
ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819 NDA Valeant Pharmaceuticals North America LLC 0187-3050 N 0187-3050-35

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:GEL;TOPICALStrength2.5%;EQ 1.2% BASE
Approval Date:Oct 23, 2008TE:ABRLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Aug 5, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ Try a Free TrialPatent Expiration:Jun 3, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ Try a Free TrialPatent Expiration:Jun 3, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE

Expired US Patents for NDA 050819

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 ➤ Try a Free Trial ➤ Try a Free Trial
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Deloitte
Dow
Colorcon
Cipla
Moodys
Cerilliant
Merck
Accenture

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