Benzoyl peroxide; clindamycin phosphate - Generic Drug Details
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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
International Patents: | 20 |
US Patents: | 9 |
Tradenames: | 5 |
Applicants: | 10 |
NDAs: | 18 |
Finished Product Suppliers / Packagers: | 14 |
Clinical Trials: | 12 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for benzoyl peroxide; clindamycin phosphate |
DailyMed Link: | benzoyl peroxide; clindamycin phosphate at DailyMed |
Recent Clinical Trials for benzoyl peroxide; clindamycin phosphate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Bausch Health Americas, Inc. | Phase 2 |
Icahn School of Medicine at Mount Sinai | Phase 2 |
Valeant Pharmaceuticals International, Inc. | Phase 2 |
See all benzoyl peroxide; clindamycin phosphate clinical trials
Pharmacology for benzoyl peroxide; clindamycin phosphate
Drug Class | Lincosamide Antibacterial |
Physiological Effect | Decreased Sebaceous Gland Activity Neuromuscular Blockade |
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
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 |
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 |
>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 |
---|---|---|---|
Russian Federation | 2010146038 | ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ | ⤷ Try a Trial |
Japan | 6006272 | ⤷ Try a Trial | |
Spain | 2773931 | ⤷ Try a Trial | |
European Patent Office | 2299810 | FORMULATIONS PHARMACEUTIQUES TOPIQUES CONTENANT UNE FAIBLE CONCENTRATION DE PEROXYDE DE BENZOYLE EN SUSPENSION DANS DE L'EAU ET UN SOLVANT ORGANIQUE MISCIBLE AVEC L'EAU (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT) | ⤷ 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 |
---|---|---|---|---|
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 |
1586316 | SPC/GB11/054 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: BROMFENAC 2-AMINO-3-(4-BROMOBENZOYL)PHENYLACETIC ACID OR A PHARMACOLOGICALLY ACCEPTABLE SALT THEREOF OR A HYDRATE THEREOF; REGISTERED: UK EU/1/11/692/001 20110523 |
1458369 | 122008000041 | Germany | ⤷ Try a Trial | PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218 |
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) |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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