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Last Updated: December 7, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 050819

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NDA 050819 describes ONEXTON, which is a drug marketed by Bausch and is included in one NDA. It is available from three suppliers. There are five 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. Sixteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
Summary for 050819
Tradename:ONEXTON
Applicant:Bausch
Ingredient:benzoyl peroxide; clindamycin phosphate
Patents:8
Pharmacology for NDA: 050819
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 0187-3050-35 3.5 g in 1 TUBE (0187-3050-35)
ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819 NDA Valeant Pharmaceuticals North America LLC 0187-3050 0187-3050-35 3.5 g in 1 TUBE (0187-3050-35)
Paragraph IV (Patent) Challenges for 050819
Tradename Dosage Ingredient NDA Submissiondate
ONEXTON GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2015-09-30
ACANYA GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2015-09-30
ONEXTON GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2012-12-20
ACANYA GEL;TOPICAL benzoyl peroxide; clindamycin phosphate 050819 2012-12-20

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:  Start TrialPatent Expiration:Jun 3, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Patent:  Start TrialPatent Expiration:Aug 5, 2029Product Flag?YSubstance Flag?Delist Request?
Patented Use:TREATMENT OF ACNE
Patent:  Start 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
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014   Start Trial   Start Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008   Start Trial   Start Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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