XACIATO Drug Patent Profile

Which patents cover Xaciato, and what generic alternatives are available?

Xaciato is a drug marketed by Organon Llc and is included in one NDA. There is one patent protecting this drug.

This drug has twelve patent family members in ten countries.

The generic ingredient in XACIATO is clindamycin phosphate. There are fifty-five drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the clindamycin phosphate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Xaciato

A generic version of XACIATO was approved as clindamycin phosphate by ALMAJECT on July 24^th, 1987.

Summary for XACIATO

International Patents:	12
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Patent Applications:	2,548
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for XACIATO
What excipients (inactive ingredients) are in XACIATO?	XACIATO excipients list
DailyMed Link:	XACIATO at DailyMed

See drug prices for XACIATO

Pharmacology for XACIATO

Drug Class	Lincosamide Antibacterial
Physiological Effect	Decreased Sebaceous Gland Activity Neuromuscular Blockade

Anatomical Therapeutic Chemical (ATC) Classes for XACIATO

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

US Patents and Regulatory Information for XACIATO

XACIATO is protected by one US patents and two FDA Regulatory Exclusivities.

Patents protecting XACIATO

FDA Regulatory Exclusivity protecting XACIATO

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes

International Patents for XACIATO

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

Country	Patent Number	Title	Estimated Expiration
Canada	2993012	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)
Mexico	2022001736	FORMULACIONES Y TRATAMIENTOS TOPICOS. (TOPICAL FORMULATIONS AND TREATMENTS.)
Portugal	3324938
World Intellectual Property Organization (WIPO)	2017015232
European Patent Office	3324938	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)

Supplementary Protection Certificates for XACIATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	C300617	Netherlands		PRODUCT NAME: COMBINATIE VAN CLINDAMYCINE, DESGEWENST IN DE VORM VAN CLINDAMYCINEFOSFAAT EN TRETINOINE; NAT. REGISTRATION NO/DATE: RVG 109745 20130626; FIRST REGISTRATION: PA1332/043/001 20130322
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	92401	Luxembourg		PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE