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EVOCLIN

NDA

CLINDAMYCIN PHOSPHATE | N050801 | NORVIUM BIOSCIENCE 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

3 cases on OB patents from PACER

Case	Court	Filed	Status	Judge
Delcor Asset Corporation et al v. Glenmark Pharmaceuticals Limited et al 1:2017cv01653 2 patentsANDA 210778clindamycin phosphate	D. Del.	2017-11-15	Terminated 2019-03-05	—
Delcor Asset Corporation et al v. Taro Pharmaceutical Industries, Ltd. et al 1:2017cv00970	D. Del.	2017-07-17	Terminated 2018-02-06	—
Delcor Asset Corporation et al v. Taro Pharmaceutical Industries Ltd. et al 1:2017cv05405	S.D.N.Y.	2017-07-17	Terminated 2019-10-16	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Stiefel Laboratories, Inc. [Buchanan Ingersoll & Rooney] - Citizen Petition FDA-2009-P-0120 · 3 docket documents Stiefel Laboratories, Inc., through counsel at Buchanan Ingersoll & Rooney, filed this citizen petition under section 505(j) of the Federal Food, Drug and Cosmetic Act regarding Evoclin (clindamycin phosphate 1% topical aerosol foam), NDA 50-801, to request that FDA clarify and apply the 30-month st	505(q)	2009-03-04	Denied	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

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.

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

5 letters from Drugs@FDA

Date	Submission	Document
Apr 20, 2018	SUPPL -18	View Letter (PDF)
Jan 25, 2012	SUPPL -15	View Letter (PDF)
Dec 22, 2010	SUPPL -11	View Letter (PDF)
Jul 13, 2006	SUPPL -6	View Letter (PDF)
Oct 22, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

AEROSOL, FOAM;TOPICAL | Approved: Oct 22, 2004

No patent or exclusivity listings for this strength.