onexton Drug Patent Profile
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When do Onexton patents expire, and when can generic versions of Onexton launch?
Onexton is a drug marketed by Bausch and is included in one NDA. There are five patents protecting this drug and two Paragraph IV challenges.
This drug has twenty patent family members in fourteen countries.
The generic ingredient in ONEXTON is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.
DrugPatentWatch® Generic Entry Outlook for Onexton
There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for onexton
International Patents: | 20 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 3 |
Clinical Trials: | 3 |
Patent Applications: | 7 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for onexton |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for onexton |
What excipients (inactive ingredients) are in onexton? | onexton excipients list |
DailyMed Link: | onexton at DailyMed |
Recent Clinical Trials for onexton
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Derm Research, PLLC | Phase 4 |
Actavis Inc. | Phase 3 |
Taro Pharmaceuticals USA | Phase 1 |
Pharmacology for onexton
Drug Class | Lincosamide Antibacterial |
Physiological Effect | Decreased Sebaceous Gland Activity |
Anatomical Therapeutic Chemical (ATC) Classes for onexton
Paragraph IV (Patent) Challenges for ONEXTON
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 |
US Patents and Regulatory Information for onexton
onexton is protected by eleven US patents.
Patents protecting onexton
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE VULGARIS
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE VULGARIS
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATMENT OF ACNE
Topical pharmaceutical formulations containing a low concentration of benzoyl peroxide in suspension in water and a water-miscible organic solvent
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
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 | ||
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 | ||
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 | ||
>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 onexton
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 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for onexton
See the table below for patents covering onexton around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Russian Federation | 2122412 | КОМПОЗИЦИИ КЛИНДАМИЦИНА И БЕНЗОИЛПЕРОКСИДА ДЛЯ ЛЕЧЕНИЯ АКНЕ, НАБОР ДЛЯ ПРИГОТОВЛЕНИЯ КОМПОЗИЦИИ, СПОСОБ ПОЛУЧЕНИЯ КОМПОЗИЦИИ, СПОСОБ ЛЕЧЕНИЯ АКНЕ (COMPOSITION OF CLINDAMYCIN AND BENZOYL PEROXIDE FOR ACNE TREATMENT, A SET FOR COMPOSITION PREPARING, A METHOD OF COMPOSITION PREPARING, METHOD OF TREATMENT OF PATIENTS WITH ACNE) | ⤷ Try a Trial |
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 |
Canada | 2130341 | COMPOSITIONS DE CLINDAMYCINE ET DE PEROXYDE DE BENZOYLE POURLE TRAITEMENT DE L'ACNE (COMPOSITIONS OF CLINDAMYCIN AND BENZOYL PEROXIDE FOR ACNE TREATMENT) | ⤷ 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 |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for onexton
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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |