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XACIATO

NDA

CLINDAMYCIN PHOSPHATE | N215650 | ORGANON LLC

1 strength2 unique patents2 unique exclusivities

Patent Timeline

2 unique patents, 2 exclusivities by expiration date

Active (2)TodayExclusivity

2025

2026

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Today

11129896

Sep. 22, 2036

12303563

Sep. 22, 2036

Dec. 7, 2024

GAIN

Dec. 7, 2029

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

142 trials from ClinicalTrials.gov — 3 recruiting, 1 active, 104 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Use of Antibiotic Irrigation to Decrease Wound Infections in Pediatric Perforated Appendicitis NCT04039750	Phase 2	Active	Prisma Health-Upstate	200	2019-07-25 → 2026-12
Antibiotic Prophylaxis in Rhinoplasty NCT04194216	Phase 3	By Invitation	Stanford University	864	2020-05-20 → 2027-04-20
Anti-inflammatory Effects of Topical Erythromycin and Clindamycin in Acne Patients NCT03883269	Phase 4	Recruiting	Centre for Human Drug Research, Netherlands	30	2018-03-20 → 2019-12
Antibiotic Irrigations for Intra-Abdominal Drains NCT03476941	Phase 2	Recruiting	Paolo Goffredo	50	2019-04-01 → 2021-09-01
Comparison Between Oral Clindamycin Vs Metronidazole for the Treatment of Abnormal Vaginal Flora in High Risk Pregnancies NCT01722708	N/A	Completed	HaEmek Medical Center, Israel	166	2012-11-01 → 2025-12-30
Comparative Study of Efficacy of 10 mg Dequalinium Chloride (Fluomizin) in the Local Treatment of Bacterial Vaginosis NCT01125410	Phase 3	Completed	Medinova AG	321	2007-01 → 2009-02
A Pilot Study of Oral Clindamycin and Pyrimethamine for the Treatment of Toxoplasmic Encephalitis in Patients With AIDS NCT00000674	N/A	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	30	— → 1992-08
Comparing Healthcare Utilization Between Adenotonsillectomy Patients With and Without Postoperative Antibiotic Use NCT01561703	N/A	Completed	University of Missouri-Columbia	58	2012-03 → 2015-06
The Amputation Surgical Site Infection Trial (ASSIT)NCT02018094	Phase 4	Completed	Hull University Teaching Hospitals NHS Trust	160	2013-10-08 → 2017-01-02
W0261-101: A Phase 1, Single Center, Randomized, Open-Label Study to Evaluate the Bioavailability of Clindamycin From Clindamycin 1%-Benzoyl Peroxide 3% Gel, Topical Gel (Clindamycin 1%- Benzoyl Peroxide 5%), and Once Daily Gel (Clindamycin 1%-Benzoyl Peroxide 5%) in Subjects With Acne NCT01132443	Phase 1	Completed	Stiefel, a GSK Company	72	2010-05-06 → 2010-06-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$18.67

per gm

Lowest NADAC/Unit

$18.67

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
78206018901XACIATO 2% VAGINAL GEL	$18.67	GM	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$112.04

Highest Price

$147.74

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
78206-0189-01XACIATO 2% GEL,VAG	$147.74	FSS	Organon LLC	01/14/2027
78206-0189-01XACIATO 2% GEL,VAG	$112.04	Big4	Organon LLC	01/14/2027

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Xaciato (2024)

Total Spending

$14K

Total Claims

Beneficiaries

Avg Cost/Unit

$19.34

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain11 active DMFs14 inactive

11 active API suppliers hold Drug Master Files for this ingredient.

TRIFARMA SPACLINDAMYCIN PHOSPHATE USP

DMF 129221998

ZHEJIANG CANDORLY PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE U.S.P.

DMF 130821998

PHARMACIA AND UPJOHN CO LLC WHOLLY OWNED SUB OF PFIZER INCCLINDAMYCIN PHOSPHATE USP, KALAMAZOO

DMF 134131998

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)CLINDAMYCIN PHOSPHATE USP

DMF 144121999

CHONGQING CARELIFE PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE USP

DMF 163572003

ZHEJIANG TIANTAI PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE

DMF 174222004

ACS DOBFAR SPACLINDAMYCIN PHOSPHATE

DMF 187052005

XINYU PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE USP

DMF 243582010

ZYDUS LIFESCIENCES LTDCLINDAMYCIN PHOSPHATE USP

DMF 266692015

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE (PROCESS B)

DMF 272712013

HUBEI YITAI PHARMACEUTICAL CO LTDCLINDAMYCIN PHOSPHATE (NON-STERILE)

DMF 322552017

DELMAR CHEMICALS INCInactiveCLINDAMYCIN PHOSPHATE

DMF 71931987

AMERICAN CHEMICAL INDUSTRIAL CORPInactiveCLINDAMYCIN PHOSPHATE

DMF 73591988

PHARMACIA AND UPJOHN SUB PFIZER INCInactiveCLINDAMYCIN PHOSPHATE USP

DMF 134991998

ABBVIE INCInactiveCLINDAMYCIN PHOSPHATE

DMF 137031998

ROUSSELL UCLAFInactiveCLINDAMYCIN PHOSPHATE

DMF 137051998

GENZYME CORPInactiveCLINDAMYCIN PHOSPHATE

DMF 137251998

DELMAR CHEMICALS INCInactiveCLINDAMYCIN PHOSPHATE

DMF 137291998

ZHEJIANG TAIZHOU HISOAR PHARM CHEM CO LTDInactiveCLINDAMYCIN PHOSPHATE

DMF 147972000

DSM PHARMACEUTICALS INCInactiveCLINDAMYCIN PHOSPHATE

DMF 152902001

SUZHOU NUMBER 4 PHARMACEUTICAL FACTORYInactiveCLINDAMYCIN PHOSPHATE USP

DMF 162252002

HANGZHOU ZHONGMEI HUADONG PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN PHOSPHATE USP

DMF 170522003

UNION QUIMICO FARMACEUTICA SA (UQUIFA SA)InactiveCLINDAMYCIN PHOSPHATE USP (AR)

DMF 185332005

ZHEJIANG WEPON PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN PHOSPHATE

DMF 197412006

ZHEJIANG HISOAR PHARMACEUTICAL CO LTDInactiveCLINDAMYCIN PHOSPHATE

DMF 209372007

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

2 letters from Drugs@FDA

Date	Submission	Document
Apr 20, 2023	SUPPL -3	View Letter (PDF)
Dec 8, 2021	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 2% BASE

RLD

2 patents2 exclusivities▴

GEL;VAGINAL | Approved: Dec 7, 2021

Patents (2) · 1 use code

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11129896	Sep 22, 2036	—	—	—		—
12303563	Sep 22, 2036	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
GAIN	Dec 7, 2029	Active
NP	Dec 7, 2024	Expired