Viewing data from:

PYLERA

NDA

BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE | N050786 | LABORATOIRES JUVISE PHARMACEUTICALS

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

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

1 trial from ClinicalTrials.gov

Trial	Phase	Status	Sponsor	Enrollment	Dates
H. Pylori Eradication Using Pyklear in Adults in El Paso, Texas: a Pilot Study NCT01335334	Phase 4	UNKNOWN	The University of Texas Health Science Center, Houston	50	2011-03 → 2011-08

Source: ClinicalTrials.gov. Trials matched by ingredient name; data refreshed each weekday and may lag the registry.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-08-26 | 3 NDCs (2 brand, 1 generic)

Highest NADAC/Unit

$2.43

per ea

Lowest NADAC/Unit

$2.38

per ea

Brand NDCs

Generic NDCs

Avg Brand: $2.43

Avg Generic: $2.38

2% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
61269038112PYLERA 140-125-125 MG CAPSULE	$2.43	EA	Brand	$2.38	2026-08-19
61269038012PYLERA 140-125-125 MG CAPSULE	$2.43	EA	Brand	$2.38	2026-08-19
61269038512BISMUTH-METRONIDAZOLE-TETRACYCLINE 140-125-125 MG CAPSULE	$2.38	EA	Generic	—	2026-08-19

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

$193.71

Highest Price

$288.90

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
61269-0380-12PYLERA CAPSULES	$227.01	Big4	H2-Pharma, LLC	10/01/2026
61269-0380-12PYLERA CAPSULES	$288.90	FSS	H2-Pharma, LLC	10/01/2026
61269-0385-12BISMUTH 140MG/METRONIDAZOLE 125MG/TETRACYCLIN	$193.71	Big4	H2-Pharma, LLC	10/01/2026
61269-0385-12BISMUTH 140MG/METRONIDAZOLE 125MG/TETRACYCLIN	$195.70	FSS	H2-Pharma, LLC	10/01/2026

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

Medicare Part D Spending

CMS annual spending data for Pylera (2024)

Total Spending

$168K

Total Claims

538

Beneficiaries

514

Avg Cost/Unit

$2.48

Spending Trend

$5.4M(2019)→$4.0M(2020)→$3.9M(2021)→$4.4M(2022)→$2.0M(2023)→$168K(2024)

YoY Change:-66.8%

5yr CAGR:-24.9%

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

API Supply Chain0 active DMFs1 inactive

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

OMICRON QUIMICA SAInactiveBISMUTH SUBCITRATE

DMF 127231997

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

Approval Letters

14 letters from Drugs@FDA

Date	Submission	Document
Nov 28, 2025	SUPPL -30	View Letter (PDF)
Apr 8, 2025	SUPPL -29	View Letter (PDF)
Sep 20, 2024	SUPPL -27	View Letter (PDF)
Jul 9, 2024	SUPPL -26	View Letter (PDF)
Dec 21, 2021	SUPPL -25	View Letter (PDF)
Mar 9, 2021	SUPPL -23	View Letter (PDF)
Oct 11, 2018	SUPPL -19	View Letter (PDF)
Jan 30, 2018	SUPPL -17	View Letter (PDF)
Jun 2, 2017	SUPPL -16	View Letter (PDF)
Jan 27, 2017	SUPPL -12	View Letter (PDF)
Jan 25, 2013	SUPPL -7	View Letter (PDF)
Jan 24, 2011	SUPPL -3	View Letter (PDF)
May 29, 2007	SUPPL -1	View Letter (PDF)
Oct 2, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 140MG;125MG;125MG

RLDAB

0 patents0 exclusivities▴

CAPSULE;ORAL | Approved: Sep 28, 2006

No patent or exclusivity listings for this strength.