Viewing data from:

LIKMEZ

NDA

METRONIDAZOLE | N216755 | SAPTALIS PHARMACEUTICALS LLC

1 strength2 unique patents0 unique exclusivities

Patent Timeline

2 unique patents by expiration date

Active (2)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

11541035

Oct. 4, 2039

12257236

Jan. 16, 2039

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

1 case on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
SAPTALIS PHARMACEUTICALS, LLC et al v. MSN PHARMACEUTICALS, INC. et al 2:2026cv01084 2 patentsANDA 221087metronidazole	D.N.J.	2026-02-03	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

276 trials from ClinicalTrials.gov — 2 recruiting, 3 active, 183 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Optimizing the Antibiotic Treatment of Uncomplicated Acute Appendicitis NCT03236961	N/A	Active	Turku University Hospital	552	2017-04-03 → 2029-04-01
Regeneration of Immature Teeth. Case Series NCT03507556	N/A	Active	Jordan University of Science and Technology	40	2010-06-28 → 2030-12-01
Comparing No Mechanical Bowel Preparation With Oral Antibiotics Alone in Patients Undergoing Elective Colon Surgery NCT03663504	Phase 4	Active	Ottawa Hospital Research Institute	630	2018-10-23 → 2026-10
Antibiotics vs. Placebo in Acute Uncomplicated Appendicitis NCT03234296	N/A	By Invitation	Turku University Hospital	147	2017-08-09 → 2029-08-30
Vaginal Microbiota Transplant NCT04046900	Phase 1/2	Recruiting	Douglas Kwon	62	2021-04-22 → 2026-09-30
Evaluation of Safety,Pharmacokinetics and Efficacy of CAZ-AVI With Metronidazole in Children Aged 3 Months to 18 Years Old With Complicated Intra-abdominal Infections (cIAIs).NCT02475733	Phase 2	Completed	Pfizer	83	2015-08-01 → 2017-06-01
A Phase 3 Study Of Intravenous Metronidazole For Intrabdominal Infection NCT01473836	Phase 3	Completed	Pfizer	38	2011-11 → 2012-10
A Therapeutic Equivalence Study of Two Metronidazole 1%Topical Gel Treatments for Patients With Rosacea NCT01513863	Phase 1	Completed	Sun Pharmaceutical Industries, Inc.	602	2011-08 → 2012-09
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
15-day Sequential Therapy for Helicobacter Pylori Infection in Korea NCT01887249	Phase 4	Completed	Seoul National University Bundang Hospital	287	2010-05 → 2013-07

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs

Highest NADAC/Unit

$2.62

per ml

Lowest NADAC/Unit

$2.60

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
71656006620LIKMEZ 500 MG/5 ML SUSPENSION	$2.62	ML	Brand	—	2026-06-17
71656006675LIKMEZ 500 MG/5 ML SUSPENSION	$2.60	ML	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 (2 FSS)

Lowest Price

$152.15

Highest Price

$343.64

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
71656-0066-20LIKMEZ 100MG/ML SUSP,ORAL	$343.64	FSS	Saptalis Pharmaceuticals, LLC	03/14/2030
71656-0066-75LIKMEZ 100MG/ML SUSP,ORAL	$152.15	FSS	Saptalis Pharmaceuticals, LLC	03/14/2030

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

API Supply Chain2 active DMFs15 inactive

2 active API suppliers hold Drug Master Files for this ingredient. Limited supplier base — potential supply chain risk.

CORDEN PHARMA BERGAMO SPAMETRONIDAZOLE USP

DMF 36091979

UNICHEM LABORATORIES LTDMETRONIDAZOLE USP

DMF 162632002

RHONE POULENC INCInactiveMETRONIDAZOLE

DMF 7801964

COMPANHIA INDUSTRIAL PRODUTORA DE ANTIBIOTICOS SARLInactiveMETRONIDAZOLE

DMF 21861973

UNIQUE CHEMICALSInactiveMETRONIDAZOLE

DMF 36751979

MCGAW INCInactiveMETRONIDAZOLE INJECTION 0.5%,MNFG IN SOUTHERN CALIFORNIA FACILITIES

DMF 39041980

MEDIMPEX NORTH AMERICA INCInactiveMETRONIDAZOLE USP XX

DMF 46721982

TIANJIN HEBEI PHARMACEUTICAL FACTORYInactiveMETRONIDAZOLE

DMF 49271983

UNICHEM LABORATORIES LTDInactiveMETRONIDAZOLE USP

DMF 57831985

UNICHEM LABORATORIES LTDInactiveMETRONIDAZOLE BENZOATE

DMF 63561986

FDC PRIVATE LTDInactiveMETRONIDAZOLE U.S.P. XXI

DMF 70241987

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveMETRONIDAZOLE

DMF 92941991

SIFAVITOR SRLInactiveMETRONIDAZOLE BENZOATE

DMF 94061991

TIANJIN ZHONGAN PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 163802003

HEC PHARM COInactiveMETRONIDAZOLE USP, NON-STERILE BULK FORM

DMF 194422006

WUHAN WUYAO PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 234212009

HUBEI HONGYUAN PHARMACEUTICAL CO LTDInactiveMETRONIDAZOLE

DMF 266582012

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
Mar 4, 2025	SUPPL -4	View Letter (PDF)
Jul 9, 2024	SUPPL -3	View Letter (PDF)
May 15, 2024	SUPPL -1	View Letter (PDF)
Oct 3, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 500MG/5ML

RLD

2 patents0 exclusivities▴

SUSPENSION;ORAL | Approved: Sep 22, 2023

Patents (2) · 3 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
11541035	Oct 4, 2039	—	—	Yes	—	—
12257236	Jan 16, 2039	—	—	Yes		—