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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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Pylera (2023)

Total Spending

$2.0M

Total Claims

2,120

Beneficiaries

2,056

Avg Cost/Unit

$7.48

Spending Trend

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

YoY Change:-6.5%

5yr CAGR:-1.1%

Source: CMS Medicare Part D Spending by Drug (2023). 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.