Viewing data from:

TINDAMAX

NDA

TINIDAZOLE | N021618 | MISSION PHARMACAL CO

2 strengths0 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

24 trials from ClinicalTrials.gov, 13 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Treatment of Bacterial Vaginosis With Oral Tinidazole NCT00229216	Phase 3	Completed	Mission Pharmacal	200	2005-01 → 2007-06
The Epidemiology and Optimal Treatment of Helicobacter Pylori in Myanmar NCT04132479	Phase 4	Completed	Kirby Institute	313	2018-01-01 → 2019-04-09
Sequential Therapy Versus Quadruple Therapy as Second Line Treatment After Failure of the Standard Triple Therapy for H Pylori Infection NCT01481844	Phase 3	Completed	Soroka University Medical Center	101	2011-11 → 2014-12
Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments NCT00313131	Phase 3	Completed	Université de Sherbrooke	1,524	2004-01 → 2005-05
Treatment of Bacterial Vaginosis (BV) With Tinidazole NCT00334633	Phase 4	Completed	University of Alabama at Birmingham	593	2004-11 → 2009-12
Comparison of Daily Single Dose Triple and Conventional Triple Therapies for Helicobacter Pylori Infection NCT02711176	Phase 4	Completed	Zahra Vahdat Shariatpanahi	212	2016-09 → 2017-03-27
Crossover Bioequivalence Study of Tinidazole 500 mg Tablets Under Fed Conditions NCT01591889	Phase 1	Completed	Roxane Laboratories	28	2009-09 → 2009-09
Sequential Therapy Versus Triple Therapy for Helicobacter Pylori Eradication: a Placebo-controlled Trial NCT00403364	Phase 2/3	Completed	IRCCS Azienda Ospedaliero-Universitaria di Bologna	300	2003-07 → 2006-02
NGU: Doxycycline (Plus or Minus Tinidazole) Versus Azithromycin (Plus or Minus Tinidazole)NCT00322465	Phase 2	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	305	2006-11 → 2009-04
Pilot Human Study of Tinidazole Efficacy For Radical Cure Of Plasmodium Vivax NCT00811096	Phase 2	Completed	Walter Reed Army Institute of Research (WRAIR)	20	2008-11 → 2009-04

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

$2.12

per ea

Lowest NADAC/Unit

$2.12

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
44523045012TINIDAZOLE 500 MG TABLET	$2.12	EA	Generic	—	2026-06-17
44523045020TINIDAZOLE 500 MG TABLET	$2.12	EA	Generic	—	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 | 4 NDCs (2 FSS, 2 Big4)

Lowest Price

$19.79

Highest Price

$20.30

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
44523-0450-12TINIDAZOLE 500MG TAB	$19.79	FSS	Mission Pharmacal Company	09/14/2028
44523-0450-12TINIDAZOLE 500MG TAB	$19.79	Big4	Mission Pharmacal Company	09/14/2028
44523-0450-20TINIDAZOLE 500MG TAB	$20.30	FSS	Mission Pharmacal Company	09/14/2028
44523-0450-20TINIDAZOLE 500MG TAB	$20.30	Big4	Mission Pharmacal Company	09/14/2028

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

Medicare Part D Spending

CMS annual spending data for Tinidazole (2024)

Total Spending

$387K

Total Claims

9,278

Beneficiaries

7,323

Avg Cost/Unit

$3.07

Spending Trend

$24K(2019)→$66K(2020)→$238K(2021)→$356K(2022)→$385K(2023)→$387K(2024)

YoY Change:-13.8%

5yr CAGR:-3.5%

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

API Supply Chain1 active DMF5 inactive

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

ZHEJIANG SUPOR PHARMACEUTICALS CO LTDTINIDAZOLE (NON-STERILE DRUG SUBSTANCE)

DMF 188242005

PFIZER INCInactiveTINIDAZOLE BULK

DMF 17041971

PFIZER LABORATORIES DIV PFIZER INCInactiveTINIDAZOLE

DMF 62261985

FARCHEMIA SRLInactiveTINIDAZOLE USP XXI

DMF 62751986

PFIZER SAInactiveTINIDAZOLE

DMF 65441986

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveTINIDAZOLE

DMF 103501993

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 20, 2021	SUPPL -8	View Letter (PDF)
Oct 14, 2020	SUPPL -7	View Letter (PDF)
Jun 10, 2019	SUPPL -6	View Letter (PDF)
May 29, 2007	SUPPL -3	View Letter (PDF)
May 26, 2004	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 250MG

RLDAB

0 patents0 exclusivities▴

TABLET;ORAL | Approved: May 17, 2004

No patent or exclusivity listings for this strength.

#002 — 500MG

RLDAB

0 patents0 exclusivities▾

TABLET;ORAL | Approved: May 17, 2004