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NONOXYNOL-9 | N018683 | MAYER LABORATORIES INC

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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Pharmacists Planning Services, Inc. (PPSI) - Citizen Petition FDA-2011-P-0083 · 4 docket documents Pharmacists Planning Services, Inc. filed this citizen petition under 21 CFR 10.20 and 10.30 requesting that the FDA Commissioner issue a Federal Regulation to immediately remove Nonoxynol-9 (N-9) from condoms in the United States marketplace. The petitioner argues that N-9 does not provide addition	Other	2011-03-02	Withdrawn	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

8 trials from ClinicalTrials.gov, 8 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Postcoital Testing Study of the SILCS Diaphragm Used With 3% N-9 Gel, ContraGel, or No Gel NCT02309554	Phase 1	Completed	CONRAD	27	2014-12 → 2016-03
Identification of Novel Biomarkers of Cervicovaginal Mucosal Inflammation NCT01593124	Phase 2	Completed	CONRAD	20	2012-05 → 2013-04
Contraceptive Effectiveness and Safety of the SILCS Diaphragm NCT00578877	Phase 2/3	Completed	CONRAD	450	2008-01 → 2009-11
Study of the Safety and Contraceptive Efficacy of C31G Compared to Conceptrol®NCT00274261	Phase 3	Completed	Premier Research	1,565	2004-06 → 2008-09
A Study of the Effects of Advantage 24 on the Rectum NCT00000929	Phase 1	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	70	— → 1999-07
Effectiveness of BenZalkonium Chloride Gel as Vaginal Contraceptive: a Multicentric Randomized Controlled Trial NCT00692952	Phase 2	Completed	Shanghai Institute of Planned Parenthood Research	240	2004-03 → 2005-11
A Pilot Study for Toxicity Evaluation of HIV Rectal Microbicides NCT00389311	Early Phase 1	Completed	Johns Hopkins University	12	2007-04 → 2009-06
A Study of Nonoxynol-9 (N-9) and HIV Infection NCT00000926	Phase 3	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	4,400	— → 2001-02

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

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 1GM

RLD

0 patents0 exclusivities▴

SPONGE;VAGINAL | Approved: Apr 1, 1983

No patent or exclusivity listings for this strength.