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AVOPEF

NDA

ETOPOSIDE | N220200 | AVYXA HOLDINGS 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
Citizen Petition from Kleinfeld, Kaplan and Becker FDA-1995-P-0359 · 5 docket documents Law offices Kleinfeld, Kaplan and Becker filed this petition on behalf of an unnamed company seeking ANDA approval for oral dosage forms of cyclophosphamide and etoposide under 21 U.S.C. §355(j). The petitioner requests that the FDA issue guidance specifying that human bioavailability or bioequivale	Other	2017-04-04	Granted	Kleinfeld, Kaplan and Becker

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

Clinical Trials

500 trials from ClinicalTrials.gov, 81 active, 419 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Adcetris (Brentuximab Vedotin), Combination Chemotherapy, and Radiation Therapy in Treating Younger Patients With Stage IIB, IIIB and IV Hodgkin Lymphoma NCT01920932	Phase 2	Active	St. Jude Children's Research Hospital	77	2013-08-12 → 2028-05
Comparing Photon Therapy To Proton Therapy To Treat Patients With Lung Cancer NCT01993810	Phase 3	Active	Radiation Therapy Oncology Group	330	2014-01-03 → 2028-11-30
Sirolimus in Combination With Metronomic Chemotherapy in Children With Recurrent and/or Refractory Solid and CNS Tumors NCT02574728	Phase 2	Active	Emory University	46	2015-06 → 2026-06
Protocol for the Study and Treatment of Participants With Intraocular Retinoblastoma NCT01783535	Phase 2	Active	St. Jude Children's Research Hospital	174	2013-06-19 → 2027-02-21
Blinatumomab in Treating Younger Patients With Relapsed B-cell Acute Lymphoblastic Leukemia NCT02101853	Phase 3	Active	National Cancer Institute (NCI)	669	2014-12-17 → 2026-09-16
Very Early PET-response Adapted Targeted Therapy for Advanced Hodgkin Lymphoma: a Single -Arm Phase II Study NCT03517137	Phase 2	Active	European Organisation for Research and Treatment of Cancer - EORTC	150	2019-08-01 → 2026-11-16
UARK 2008-02 A Trial for High-risk Myeloma Evaluating Accelerating and Sustaining Complete Remission NCT00869232	Phase 2	Active	University of Arkansas	90	2008-10 → 2028-10
Combined Chemotherapy With or Without Zoledronic Acid for Patients With Osteosarcoma NCT00470223	Phase 3	Active	UNICANCER	318	2007-03 → 2026-12
Total Therapy for Infants With Acute Lymphoblastic Leukemia (ALL) I NCT02553460	Phase 1/2	Active	St. Jude Children's Research Hospital	50	2016-01-29 → 2031-10
Testing the Addition of an Anti-cancer Drug, M3814, to the Usual Treatment (Mitoxantrone, Etoposide, and Cytarabine) for Relapsed or Refractory Acute Myeloid Leukemia NCT03983824	Phase 1	Active	National Cancer Institute (NCI)	48	2020-05-05 → 2027-06-30

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

API Supply Chain6 active DMFs7 inactive

6 active API suppliers hold Drug Master Files for this ingredient.

JIANGSU HENGRUI PHARMACEUTICALS CO LTDETOPOSIDE USP

DMF 86471990

NIPPON KAYAKU CO LTDETOPOSIDE

DMF 89461991

TAPI NL BVETOPOSIDE

DMF 99661992

CIPLA LTDETOPOSIDE USP

DMF 106421993

SICHUAN HUIYU PHARMACEUTICAL CO LTDETOPOSIDE

DMF 409282025

SHANDONG ANHONG PHARMACEUTICAL CO LTDETOPOSIDE

DMF 413082025

SANDOZ LTD PHARMACEUTICAL DIV CHEMICAL DEVELOPMENTInactiveETOPOSIDE (VP 16-213) (ETHYLIDENE)

DMF 43851981

OMNICHEM NVInactiveETOPOSIDE

DMF 86961990

PLANTEX LTD CHEMICAL AND PHARMACEUTICAL WORKSInactiveETOPOSIDE

DMF 95461992

PHARMACEUTICAL FACTORY SHANGHAI INSTITUTE PHARMACEUTICAL INDUSTRYInactiveETOPOSIDE

DMF 101911993

RP SCHERER CANADA INCInactiveETOPOSIDE 50MG SOFT-GELATIN CAPSULE

DMF 139861999

QILU PHARMACEUTICAL CO LTDInactiveETOPOSIDE (NON-STERILE API)

DMF 243322010

SEACROSS PHARMA USA INCInactiveETOPOSIDE

DMF 387792023

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Feb 18, 2026	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 100MG/5ML (20MG/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: Feb 13, 2026

No patent or exclusivity listings for this strength.