Viewing data from:

NUVESSA

NDA

METRONIDAZOLE | N205223 | ALEMBIC THERAPEUTICS LLC

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2027

2028

2029

2030

2031

2032

Today

Feb. 19, 2028

Jun. 27, 2028

Feb. 2, 2028

Jun. 28, 2032

Jun. 28, 2032

Jun. 28, 2032

Jun. 28, 2032

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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Nuvessa (2023)

Total Spending

$110K

Total Claims

422

Beneficiaries

336

Avg Cost/Unit

$40.42

Spending Trend

$54K(2019)→$58K(2020)→$63K(2021)→$74K(2022)→$110K(2023)

YoY Change:+4.5%

5yr CAGR:+1.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

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
Feb 28, 2022	SUPPL -6	View Letter (PDF)
Dec 7, 2021	SUPPL -5	View Letter (PDF)
Aug 7, 2018	SUPPL -2	View Letter (PDF)
Mar 25, 2014	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 1.3%

RLD

7 patents0 exclusivities▴

GEL;VAGINAL | Approved: Mar 24, 2014

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7893097	Feb 19, 2028	—	—	Yes	—	—
8658678	Jun 27, 2028	—	—	—		—
8877792	Feb 2, 2028	—	—	Yes	—	—
8946276	Jun 28, 2032	—	—	—		—
9198858	Jun 28, 2032	—	—	—		—
10238634	Jun 28, 2032	—	—	Yes	—	—
10596155	Jun 28, 2032	—	—	Yes	—	—

Change History (2)

Recent changes detected for this application.

MODIFIEDApplicant Full Name7/1/2026

Alembic Therapeutics LLC replaced Chemo Research SL as the applicant for Nuvessa (metronidazole) NDA 205223.

Old: CHEMO RESEARCH SL

New: ALEMBIC THERAPEUTICS LLC

MODIFIEDApplicant7/1/2026

Alembic Therapeutics replaced Chemo Research SL as the listed applicant for Nuvessa (metronidazole) NDA 205223.

Old: CHEMO RESEARCH SL

New: ALEMBIC THERAP