XACIATO Drug Patent Profile

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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-one 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.

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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:	2,341
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

Drug patent expirations by year for XACIATO

Pharmacology for XACIATO

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

US Patents and Regulatory Information for XACIATO

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

Patents protecting XACIATO

Topical formulations and treatments
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: METHOD OF TREATING BACTERIAL VAGINOSIS BY SINGLE DOSE ADMINISTRATION OF A CLINDAMYCIN PHARMACEUTICAL GEL FORMULATION

FDA Regulatory Exclusivity protecting XACIATO

NEW PRODUCT
Exclusivity Expiration: ⤷ Sign Up

GENERATING ANTIBIOTIC INCENTIVES NOW
Exclusivity Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Organon Llc	XACIATO	clindamycin phosphate	GEL;VAGINAL	215650-001	Dec 7, 2021		RX	Yes	Yes	⤷ 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

International Patents for XACIATO

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

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Country	Patent Number	Title	Estimated Expiration
Mexico	2018000800	FORMULACIONES Y TRATAMIENTOS TOPICOS. (TOPICAL FORMULATIONS AND TREATMENTS.)	⤷ Sign Up
European Patent Office	3324938	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)	⤷ Sign Up
Canada	2993012	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)	⤷ Sign Up
Portugal	3324938		⤷ Sign Up
Poland	3324938		⤷ Sign Up
Lithuania	3324938		⤷ Sign Up
Hungary	E056401		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for XACIATO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	92401	Luxembourg	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINE(EN TANT QUE PHOPSHATE DE CLINDAMYCINE)ET TRETINOINE
1304992	122013000081	Germany	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
1304992	2013/044	Ireland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322
1304992	C01304992/01	Switzerland	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	C300617	Netherlands	⤷ Sign Up	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	SPC/GB13/061	United Kingdom	⤷ Sign Up	PRODUCT NAME: CLINDAMYCIN PHOSPHATE IN COMBINATION WITH TRETINOIN.; REGISTERED: IE PA1332/043/001 20130322; UK PL15142/0249 20130624
1304992	PA2013025,C1304992	Lithuania	⤷ Sign Up	PRODUCT NAME: CLINDAMYCINUM + TRETINOINUM; REGISTRATION NO/DATE: LT/1/13/3279/001, 2013 04 26 LT/1/13/3279/002, 2013 04 26 PA1332/043/001 20130323
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description