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Serving leading biopharmaceutical companies globally:

Citi
Cerilliant
Deloitte
Daiichi Sankyo
Chinese Patent Office
Federal Trade Commission
Fuji
Moodys
Harvard Business School
Novartis

Generated: January 16, 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 three 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. Ten 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 0187-3050-50 1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) > 50 g in 1 BOTTLE, PUMP
ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819 NDA Valeant Pharmaceuticals North America LLC 0187-3050 0187-3050-50 1 BOTTLE, PUMP in 1 CARTON (0187-3050-50) > 50 g in 1 BOTTLE, PUMP

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:➤ SubscribePatent Expiration:Aug 5, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ SubscribePatent Expiration:Jun 3, 2029Product Flag?Substance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:➤ SubscribePatent 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 ➤ Subscribe ➤ Subscribe
Dow Pharm ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ➤ Subscribe ➤ Subscribe
Dow Pharm ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving leading biopharmaceutical companies globally:

Merck
Dow
US Army
Fuji
Harvard Business School
Chinese Patent Office
Cipla
Chubb
Moodys

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.

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