XACIATO Drug Patent Profile

When do Xaciato patents expire, and when can generic versions of Xaciato launch?

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

This drug has thirteen 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-eight 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 HIKMA on April 25^th, 1988.

Summary for XACIATO

International Patents:	13
US Patents:	2
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for XACIATO

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

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	11,129,896
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	12,303,563		Y
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
Mexico	2018000800	FORMULACIONES Y TRATAMIENTOS TOPICOS. (TOPICAL FORMULATIONS AND TREATMENTS.)
Mexico	2018000800
Canada	3209380	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)
Portugal	3324938
World Intellectual Property Organization (WIPO)	2017015232
European Patent Office	3324938	FORMULATIONS ET TRAITEMENTS TOPIQUES (TOPICAL FORMULATIONS AND TREATMENTS)
Poland	3324938

Supplementary Protection Certificates for XACIATO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1304992	122013000081	Germany		PRODUCT NAME: CLINDAMYCIN (ALS CLINDAMYCIN-PHOSPHAT) UND TRETINOIN; NAT. REGISTRATION NO/DATE: 85210.00.00 20130611; FIRST REGISTRATION: IRLAND PA1332/043/001 20130322
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	CR 2013 00053	Denmark		PRODUCT NAME: CLINDAMYCIN (SOM CLINDAMYCIN PHOSPHATE) OG TRETINOIN; NAT. REG. NO/DATE: 48954 20130416; FIRST REG. NO/DATE: IE PA1332/043/001 20130322
1304992	C01304992/01	Switzerland		PRODUCT NAME: CLINDAMYCINI PHOSPHAS ET TRETINOINUM; REGISTRATION NO/DATE: SWISSMEDIC 62513 28.03.2014
1304992	PA2013025,C1304992	Lithuania		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
1304992	2013C/060	Belgium		PRODUCT NAME: CLINDAMYCINE (ALS CLINDAMYCINE FOSFAAT) EN TRETINOINE; AUTHORISATION NUMBER AND DATE: BE437507 20130506
1304992	2013/044	Ireland		PRODUCT NAME: CLINDAMYCIN AND TRETINOIN; REGISTRATION NO/DATE: PA1332/043/001 20130322

XACIATO Market Analysis and Financial Projection

Last updated: April 25, 2026

XACIATO: Investment Scenario and Fundamentals Analysis

What is XACIATO and how is it positioned?

No reliable public patent, regulatory, or product-sheet record is provided in the input to identify the active ingredient, dosage form, route, indication(s), approval jurisdiction, or regulatory status of XACIATO. Without that, a fundamentals view tied to (1) enforceable patent life, (2) exclusivity terms, (3) competitive landscape, (4) clinical-stage pipeline risk, and (5) revenue ceiling cannot be constructed to Bloomberg-grade standards.

What does the patent and exclusivity posture imply for returns?

No patent-family identifiers, assignee names, priority dates, application numbers, or jurisdictional filings are included for XACIATO. Without those, there is no basis to model:

• Remaining patent term by jurisdiction
• Patent term adjustments or compensatory extensions
• Pediatric exclusivity or supplementary protection certificates (SPCs)
• Orange-book style exclusivity triggers (US) or equivalent mechanisms (EU/UK)
• Infringement and validity risk tied to claim scope and design-around space

What is the competitive landscape and demand risk?

No data are provided for:

• The therapeutic target class
• Approved comparators and their market shares
• Practice guidelines alignment
• Pricing or reimbursement status
• Safety and tolerability profile
• Market access milestones or formulary positioning

Without these fundamentals, any “investment scenario” would be speculative rather than decision-grade.

What can be concluded about investment scenario outcomes?

Because the input does not include any verifiable facts identifying the drug entity behind XACIATO, the only complete and accurate conclusion is that an evidence-based investment and fundamentals analysis cannot be produced from the provided information.

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Key Takeaways

• XACIATO cannot be fundamentals-analyzed for investment purposes from the supplied input because it lacks the required identifiers and evidence needed to map patent/exclusivity, regulatory status, and competitive positioning.
• No enforceable IP, exclusivity, or commercial risk model can be built without active ingredient, jurisdictional regulatory record, and patent-family details.
• Any revenue or ROI forecast would be non-actionable and not grounded in verifiable sources.

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FAQs

1. What is XACIATO’s active ingredient and indication?
   Not provided in the input, so it cannot be determined.

2. What is XACIATO’s approval status by country?
   Not provided in the input, so it cannot be determined.

3. How much patent life remains for XACIATO?
   Not provided in the input, so it cannot be determined.

4. Who are the key competitors to XACIATO?
   Not provided in the input, so it cannot be determined.

5. What commercial assumptions would drive XACIATO’s revenue upside?
   Not provided in the input, so it cannot be determined.

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References (APA)

No sources were cited because no verifiable drug identifiers, patent records, regulatory references, or market data were provided in the input.