Viewing data from:

CONDYLOX

NDA

PODOFILOX | N019795 | TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D 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

1 petition from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Oclassen Pharmaceuticals, Inc. (Kleinfeld, Kaplan and Becker) - Citizen Petition FDA-1992-P-0110 · 5 docket documents Oclassen Pharmaceuticals, Inc., through counsel at Kleinfeld, Kaplan and Becker, petitioned the FDA to recognize Condylox (podofilox) 0.5% Solution as entitled to five-year marketing exclusivity under sections 505(j)(4)(D)(ii) and 505(c)(3)(D)(ii) of the Federal Food, Drug, and Cosmetic Act and to a	Other	2009-06-19	Granted	—

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

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Condylox (2024)

Total Spending

$36K

Total Claims

Beneficiaries

Avg Cost/Unit

$174.94

Spending Trend

$498K(2019)→$411K(2020)→$422K(2021)→$308K(2022)→$17K(2023)→$36K(2024)

YoY Change:-7.8%

5yr CAGR:-1.2%

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.

XIAN PHARMACEUTICAL FACTORYInactivePODOFILOX

DMF 101821993

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

Products (1)

#001 — 0.5%

RLD

0 patents0 exclusivities▴

SOLUTION;TOPICAL | Approved: Dec 13, 1990

No patent or exclusivity listings for this strength.