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PIPERONYL BUTOXIDE; PYRETHRINS | N021043 | BAYER HEALTHCARE LLC

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

16 trials from ClinicalTrials.gov — 7 recruiting, 3 active, 5 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Comparison Between ROLL Versus Magnetic Seed for Preoperative Localization of Non-palpable Breast Lesion by Randomized Clinical Study.NCT05942118	—	Active	Istituti Clinici Scientifici Maugeri SpA	262	2023-05-31 → 2028-05-31
ELIXIR MDTM Satisfaction Clinical Trial NCT07676643	N/A	Active	Elixir MD Inc	148	2025-12-09 → 2026-10
Light Therapy in End Stage Kidney Disease NCT06310161	N/A	Active	University of Pennsylvania	60	2026-02-01 → 2026-10-01
Effect of Different Cavity Designs on the Clinical Performance of 3D- Printed Resin Composite Partial-Coverage Restorations in Vital Molars NCT07667946	N/A	Not Yet Recruiting	Cairo University	50	2026-07 → 2028-01
Evaluation of Instrumentation Time and Obturation Quality Using Two Different Pediatric Rotary File Systems in Primary Molar Pulpectomy NCT07672990	N/A	Not Yet Recruiting	Cairo University	30	2026-09 → 2027-09
Locating Biomarkers in OCD Through Behavioral Tasks NCT03313622	—	Not Yet Recruiting	Baylor College of Medicine	20	2027-03 → 2028-03
PDT vs Peels for Treatment of Actinic Keratoses NCT04429308	Phase 2	Not Yet Recruiting	Northwestern University	60	2026-08 → 2027-12
Development Of Neuroimaging Methods To Assess The Neurobiology Of Addiction NCT02535702	N/A	Recruiting	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	192	2016-06-28 → 2026-12-31
A Novel Intraoperative Fluorescence-guided System for Evaluating Margins During Breast-conserving Surgery for Breast Cancer NCT07352930	N/A	Recruiting	Guangdong Provincial People's Hospital	172	2026-04-01 → 2027-03-31
Study of Out of Specification for Tisagenlecleucel NCT04094311	Phase 3	Recruiting	Novartis Pharmaceuticals	200	2019-11-21 → 2027-03-31

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
May 30, 2006	SUPPL -6	View Letter (PDF)
Dec 30, 2004	SUPPL -5	View Letter (PDF)
Mar 7, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 4%;EQ 0.33% BASE

0 patents0 exclusivities▴

AEROSOL;TOPICAL | Approved: Mar 7, 2000

No patent or exclusivity listings for this strength.