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ONEXTON Drug Patent Profile

When do Onexton patents expire, and what generic alternatives are available?

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

See drug prices for ONEXTON

See drug sales revenues for ONEXTON

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

See all ONEXTON clinical trials

Pharmacology for ONEXTON

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity

Anatomical Therapeutic Chemical (ATC) Classes for ONEXTON

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

G01AA	Antibiotics
G01A	ANTIINFECTIVES AND ANTISEPTICS, EXCL. COMBINATIONS WITH CORTICOSTEROIDS
G01	GYNECOLOGICAL ANTIINFECTIVES AND ANTISEPTICS
G	Genito-urinary system and sex hormones

J01FF	Lincosamides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

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			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y
Bausch	ONEXTON	benzoyl peroxide; clindamycin phosphate	GEL;TOPICAL	050819-002	Nov 24, 2014	AB	RX	Yes	Yes			Y

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

International Patents for ONEXTON

See the table below for patents covering ONEXTON around the world.

Country	Patent Number	Title	Estimated Expiration
Singapore	48195	Compositions of clyndamycin and benzoyl peroxide for acne treatment
World Intellectual Property Organization (WIPO)	2009148584
Spain	2773931
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)
Canada	2130341	COMPOSITIONS DE CLINDAMYCINE ET DE PEROXYDE DE BENZOYLE POURLE TRAITEMENT DE L'ACNE (COMPOSITIONS OF CLINDAMYCIN AND BENZOYL PEROXIDE FOR ACNE TREATMENT)

Supplementary Protection Certificates for ONEXTON

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0137963	97C0042	Belgium		PRODUCT NAME: 2-(2-BENZOYL-SUBSTITUE)-1,3-CYCLOHEXANE-DIONES; REGISTRATION NO/DATE: 8452/B 19930121
1458369	SPC/GB10/005	United Kingdom		PRODUCT NAME: ADAPALENE AND BENZOYL PEROXIDE; REGISTERED: DK 40440 20071218; UK PL10590/0057 20091111
1586316	SPC/GB11/054	United Kingdom		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
1586316	122011100019	Germany		PRODUCT NAME: BROMFENAC (2-AMINO-3-(4-BROMOBENZOYL)PHENYLESSIGSAEURE); REGISTRATION NO/DATE: EU/1/11/692/001 20110518
0526708	C300097	Netherlands		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