Viewing data from:

CLINDAGEL

NDA

CLINDAMYCIN PHOSPHATE | N050782 | BAUSCH HEALTH US LLC

1 strength0 unique patents0 unique exclusivities

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

154 trials from ClinicalTrials.gov — 10 recruiting, 3 active, 105 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib NCT06120140	Phase 2	Active	Janssen Research & Development, LLC	305	2024-02-16 → 2030-06-30
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
Clindamycin and Triamcinolone in People With Glioblastoma to Prevent Skin-Related Side Effects of Tumor Treating Fields NCT04469075	Phase 2	Active	Memorial Sloan Kettering Cancer Center	48	2020-07-09 → 2027-07
Antibiotic Prophylaxis in Rhinoplasty NCT04194216	Phase 3	By Invitation	Stanford University	864	2020-05-20 → 2027-04-20
Or v IV Antibiotics for Infection NCT04723940	Phase 3	By Invitation	Rothman Institute Orthopaedics	308	2021-01-25 → 2028-01-25
Moxifloxacin Versus Clindamycin in the Management of Odontogenic Maxillofacial Infectious Processes NCT07810244	N/A	Not Yet Recruiting	Nishtar Medical University	60	2026-10-01 → 2027-02-15
Clascoterone Versus Clindamycin Added to Adapalene/Benzoyl Peroxide for Moderate Facial Acne NCT07881315	Phase 4	Not Yet Recruiting	Allied Hospital Faisalabad	118	2026-11 → 2027-05
Study to Assess Safety, Pharmacokinetics, and Treatment Effect of Cabtreo NCT07524946	Phase 4	Recruiting	Bausch Health Americas, Inc.	100	2026-04-01 → 2027-12
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
Laparoscopic Antibiotic Lavage to Prevent Intra-abdominal Abscess Formation in Complicated Appendicitis NCT06841003	Phase 3	Recruiting	Spaarne Gasthuis	752	2025-02-24 → 2027-06

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

VA Federal Supply Schedule

Government-negotiated contract prices | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$109.20

Highest Price

$1605.93

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
16781-0462-75CLINDAGEL 1%	$109.20	Big4	Bausch Health US, LLC	04/30/2026
16781-0462-75CLINDAGEL 1%	$1605.93	FSS	Bausch Health US, LLC	04/30/2026
68682-0462-75CLINDAMYCIN PO4 1% GEL,TOP	$151.42	Big4	Bausch Health US, LLC	04/30/2026
68682-0462-75CLINDAMYCIN PO4 1% GEL,TOP	$279.32	FSS	Bausch Health US, LLC	04/30/2026

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

Medicare Part D Spending

CMS annual spending data for Clindagel (2024)

Total Spending

$71K

Total Claims

Beneficiaries

Avg Cost/Unit

$22.28

Spending Trend

$871K(2019)→$473K(2020)→$538K(2021)→$409K(2022)→$297K(2023)→$71K(2024)

YoY Change:-9.4%

5yr CAGR:+0.1%

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

1 letter from Drugs@FDA

Date	Submission	Document
Nov 27, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 1% BASE

RLDAB2

0 patents0 exclusivities▴

GEL;TOPICAL | Approved: Nov 27, 2000

No patent or exclusivity listings for this strength.