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 freedom to operate?
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 |
---|---|
Valeant Pharmaceuticals International, Inc. | Phase 2 |
Bausch Health Americas, Inc. | Phase 2 |
Icahn School of Medicine at Mount Sinai | 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 |
Anatomical Therapeutic Chemical (ATC) Classes 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Encube | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 212433-001 | Apr 28, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch | ACANYA | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-001 | Oct 23, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Bausch | ONEXTON | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-002 | Nov 24, 2014 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Bausch | ACANYA | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-001 | Oct 23, 2008 | AB | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
Padagis Israel | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 090979-001 | Jun 26, 2012 | AB | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Encube | CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 207194-001 | Aug 19, 2019 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bausch | BENZACLIN | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050756-002 | Apr 20, 2007 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
>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 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | ACANYA | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-001 | Oct 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
Bausch | ONEXTON | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050819-002 | Nov 24, 2014 | ⤷ Sign Up | ⤷ Sign Up |
Stiefel | DUAC | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050741-001 | Aug 26, 2002 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Spain | 2773931 | ⤷ Sign Up | |
Brazil | PI0913326 | formulações farmacêuticas tópicas contendo uma baixa concentração de peróxido de benzoíla em suspensão aquosa e um solvente orgânico miscível em água | ⤷ Sign Up |
Japan | 6006272 | ⤷ Sign Up | |
Japan | 2011522820 | ⤷ Sign Up | |
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) | ⤷ Sign Up |
Russian Federation | 2013122395 | ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ | ⤷ Sign Up |
South Korea | 20110014651 | TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING A LOW CONCENTRATION OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND A WATER-MISCIBLE ORGANIC SOLVENT | ⤷ Sign Up |
>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 | ⤷ Sign Up | 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 |
1458369 | C01458369/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: ADAPALENUM + BENZOYLIS PEROXIDUM; REGISTRATION NUMBER/DATE: SWISSMEDIC 58460 19.05.2009 |
1586316 | 122011100019 | Germany | ⤷ Sign Up | PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518 |
0186118 | SPC/GB05/029 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218 |
1458369 | SPC/GB10/005 | United Kingdom | ⤷ Sign Up | PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111 |
1458369 | 122008000041 | Germany | ⤷ Sign Up | PRODUCT NAME: ADAPALEN IN KOMBINATION MIT BENZOYLPEROXID; NAT. REGISTRATION NO/DATE: 67913.00.00 20080229; FIRST REGISTRATION: DAENEMARK 40440 20071218 |
1458369 | CA 2008 00029 | Denmark | ⤷ Sign Up | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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