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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

18 trials from ClinicalTrials.gov — 10 recruiting, 5 active, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Clinical Study of SHR-1316 (SC) Combined With Carboplatin and Etoposide as First-line Treatment for Extensive Stage Small Cell Lung Cancer NCT07009457	Phase 1	Active	Suzhou Suncadia Biopharmaceuticals Co., Ltd.	24	2025-06-16 → 2028-09
A Phase III, Open-Label Study of Maintenance Lurbinectedin in Combination With Atezolizumab Compared With Atezolizumab in Participants With Extensive-Stage Small-Cell Lung Cancer NCT05091567	Phase 3	Active	Hoffmann-La Roche	660	2021-11-18 → 2028-02-28
Study of Pembrolizumab/Vibostolimab (MK-7684A) in Combination With Concurrent Chemoradiotherapy Followed by Pembrolizumab/Vibostolimab Versus Concurrent Chemoradiotherapy Followed by Durvalumab in Participants With Stage III Non-small Cell Lung Cancer (MK-7684A-006)NCT05298423	Phase 3	Active	Merck Sharp & Dohme LLC	611	2022-05-03 → 2026-08-19
DAREON™-7: A Study to Test How Well Different Doses of BI 764532 in Addition to Chemotherapy Are Tolerated by People With Advanced Neuroendocrine Cancers NCT06132113	Phase 1	Active	Boehringer Ingelheim	55	2024-01-22 → 2027-12-31
Total Marrow and Lymphoid Irradiation and Chemotherapy Before DSCT in Treating Patients With High-Risk ALL or AML NCT02094794	Phase 2	Active	City of Hope Medical Center	108	2014-05-12 → 2027-05-04
Safety and Efficacy of BNT327, an Investigational Therapy in Combination With Chemotherapy for Patients With Untreated Small-cell Lung Cancer NCT06712355	Phase 3	Recruiting	BioNTech SE	621	2025-02-03 → 2029-03
A UGT1A1 Genotype-Directed Study of Belinostat Pharmacokinetics and Toxicity NCT06406465	Phase 2	Recruiting	National Cancer Institute (NCI)	60	2026-07-07 → 2028-07-30
Evaluating the Addition of the Immunotherapy Drug Atezolizumab to Standard Chemotherapy Treatment for Advanced or Metastatic Neuroendocrine Carcinomas That Originate Outside the Lung NCT05058651	Phase 2/3	Recruiting	National Cancer Institute (NCI)	189	2022-06-28 → 2028-10-01
DAREON ® -Lung-1: A Study in People With Advanced Small Cell Lung Cancer to Compare Obrixtamig Plus Atezolizumab, Carboplatin, and Etoposide Treatment With Standard Chemotherapy NCT07472517	Phase 3	Recruiting	Boehringer Ingelheim	670	2026-04-13 → 2029-07-30
A Study Comparing Tarlatamab, Durvalumab, Carboplatin, and Etoposide Versus Durvalumab, Carboplatin, and Etoposide in First-line Extensive Stage Small-Cell Lung Cancer (ES-SCLC)NCT07005128	Phase 3	Recruiting	Amgen	330	2025-08-18 → 2029-07-15

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

Medicare Part D Spending

CMS annual spending data for Condylox (2023)

Total Spending

$17K

Total Claims

Beneficiaries

Avg Cost/Unit

$189.69

Spending Trend

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

YoY Change:+2.0%

5yr CAGR:+0.9%

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.

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.