You’re using a public version of DrugPatentWatch with 5 free searches available | Register to unlock more free searches. CREATE FREE ACCOUNT

Last Updated: March 28, 2024

Benzoyl peroxide; clindamycin phosphate - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for benzoyl peroxide; clindamycin phosphate and what is the scope of patent protection?

Benzoyl peroxide; clindamycin phosphate is the generic ingredient in five branded drugs marketed by Bausch, Actavis Labs Ut Inc, Chartwell Rx, Encube, Glenmark Pharms, Mylan Pharms Inc, Padagis Israel, Taro, Zydus Pharms, and Stiefel, and is included in eighteen NDAs. There are nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Benzoyl peroxide; clindamycin phosphate has twenty patent family members in fourteen countries.

Fourteen suppliers are listed for this compound.

Summary for benzoyl peroxide; clindamycin phosphate
Recent Clinical Trials for benzoyl peroxide; clindamycin phosphate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Bausch Health Americas, Inc.Phase 2
Icahn School of Medicine at Mount SinaiPhase 2
Valeant Pharmaceuticals International, Inc.Phase 2

See all benzoyl peroxide; clindamycin phosphate clinical trials

Pharmacology for benzoyl peroxide; clindamycin phosphate
Paragraph IV (Patent) Challenges for BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ONEXTON Gel benzoyl peroxide; clindamycin phosphate 1.2%/3.75% 050819 1 2015-09-30
ONEXTON Gel benzoyl peroxide; clindamycin phosphate 1.2%/2.5% 050819 1 2012-12-20
DUAC Gel benzoyl peroxide; clindamycin phosphate 1% / 5% 050741 1 2008-12-11

US Patents and Regulatory Information for benzoyl peroxide; clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Taro CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 208683-001 Jun 5, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Pharms CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 210794-001 Dec 28, 2018 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for benzoyl peroxide; clindamycin phosphate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
Stiefel DUAC benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050741-001 Aug 26, 2002 ⤷  Try a Trial ⤷  Try a Trial
Bausch ONEXTON benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-002 Nov 24, 2014 ⤷  Try a Trial ⤷  Try a Trial
Bausch ACANYA benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050819-001 Oct 23, 2008 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for benzoyl peroxide; clindamycin phosphate

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2009148584 ⤷  Try a Trial
Mexico 2010013152 FORMULACIONES FARMACEUTICAS TOPICAS QUE CONTIENEN UNA BAJA CONCENTRACION DE PEROXIDO DE BENZOILO EN SUSPENSION EN AGUA Y UN SOLVENTE ORGANICO MISCIBE EN AGUA. (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT.) ⤷  Try a Trial
Russian Federation 2013122395 ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ ⤷  Try a Trial
Portugal 2299810 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for benzoyl peroxide; clindamycin phosphate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1667986 92172 Luxembourg ⤷  Try a Trial PRODUCT NAME: SOLVAT ACETONIQUE DU CABAZITAXEL, OU DESIGNE SOLVAT ACETONIQUE DU DIMETHOXY DOCETAXEL OU SOLVAT ACETONIQUE DU (2R,3S)-3-TERT-BUTOXYCARBONYLAMINO-2-HYDROXY-3-PHENYLPROPIONATE DE 4-ACETOXY-2A-BENZOYLOXY-5BETA,20-EPOXY-1-HYDROXY-7BETA,10A-DIMETHOXY-9-OXO-TAX-11-ENE-13A-YLE(ACETONATE DU CABAZITAXEL)
1458369 C01458369/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009
1458369 SPC/GB10/005 United Kingdom ⤷  Try a Trial PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
0591275 SPC/GB05/030 United Kingdom ⤷  Try a Trial PRODUCT NAME: NITISINONE (2-(2-NITRO-4-TRIFLUOROMETHYLBENZOYL)-1,3-CYCLOHEXANEDIONE) OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: UK EU/1/04/303/001 20050221; UK EU/1/04/303/002 20050221; UK EU/1/04/303/003 20050221
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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

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 verification 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.