Benzoyl peroxide; clindamycin phosphate - Generic Drug Details
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What are the generic drug 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 |
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 |
Stiefel | DUAC | benzoyl peroxide; clindamycin phosphate | GEL;TOPICAL | 050741-001 | Aug 26, 2002 | ⤷ 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 |
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 | 2645087 | ФАРМАЦЕВТИЧЕСКИЕ СОСТАВЫ ДЛЯ МЕСТНОГО ПРИМЕНЕНИЯ, СОДЕРЖАЩИЕ НИЗКУЮ КОНЦЕНТРАЦИЮ БЕНЗОИЛПЕРОКСИДА В СУСПЕНЗИИ В ВОДЕ И СМЕШИВАЮЩИМСЯ С ВОДОЙ ОРГАНИЧЕСКОМ РАСТВОРИТЕЛЕ (PHARMACEUTICAL FORMULATIONS FOR LOCAL APPLICATION CONTAINING LOW CONCENTRATIONS OF BENZOYL PEROXIDE IN SUSPENSION IN WATER AND WATER-MISCIBLE ORGANIC SOLVENT) | ⤷ Try a Trial |
Australia | 2009255679 | Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent | ⤷ Try a Trial |
Portugal | 2299810 | ⤷ Try a Trial | |
Japan | 2011522820 | ⤷ Try a Trial | |
Canada | 2723029 | 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 |
---|---|---|---|---|
0186118 | SPC/GB05/029 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: MESOTRIONE (2-(4-METHYLSULPHONYL-2-NITROBENZOYL)-1,3CYCLOHEXANEDIONE); REGISTERED: AU 2726 20001016; UK 0309 OF 2005 20050218 |
1458369 | CA 2008 00029 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ADAPALEN, BENZOYLPEROXID |
0137963 | 97C0042 | Belgium | ⤷ Try a Trial | PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121 |
0526708 | C300097 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: BOSENTAN, DESGEWENST IN DE VORM VAN EEN ZOUT OF EEN HYDRAAT OF IN DE VORM VAN EEN ESTER VAN DE HYDROXYLGROEP VAN DE 2-HYDROXYETHOXY REST MET EEN ZUUR MET DE FORMULE R5-OH, WAARIN R5 EEN C1-7-ALKANOYL, BENZOYL, OF HETEROCYCLYCARBONYL VOORSTELT; NATL. REGISTRATION NO/DATE: U/1/02/220/001 - 005 20020515; FIRST REGISTRATION: CH IKS 58841 01 - 02 20020228 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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