Viewing data from:

COSMEGEN

NDA

DACTINOMYCIN | N050682 | RECORDATI RARE DISEASES 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
Citizen Petition from PharmaForce, Inc. FDA-2009-P-0367 · 6 docket documents PharmaForce, Inc. filed this citizen petition on July 31, 2009, requesting that the FDA declare Dactinomycin Injection, 0.5 mg/mL suitable for consideration in an abbreviated new drug application (ANDA) under Section 505(j)(2)(C). The proposed product is a ready-to-use aqueous solution based on the	Other	2009-08-10	Withdrawn	PharmaForce, Inc.

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

Clinical Trials

39 trials from ClinicalTrials.gov — 1 recruiting, 3 active, 24 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
International Pleuropulmonary Blastoma (PPB) Treatment and Biology Registry NCT01464606	N/A	Active	Children's Hospitals and Clinics of Minnesota	156	2009-12-22 → 2028-12
Risk-Adapted Focal Proton Beam Radiation and/or Surgery in Patients With Low, Intermediate and High Risk Rhabdomyosarcoma Receiving Standard or Intensified Chemotherapy NCT01871766	Phase 2	Active	St. Jude Children's Research Hospital	115	2013-12-04 → 2030-06
Combination Chemotherapy With or Without Temsirolimus in Treating Patients With Intermediate Risk Rhabdomyosarcoma NCT02567435	Phase 3	Active	National Cancer Institute (NCI)	325	2016-06-01 → 2026-10-27
A Study of Pembrolizumab Plus Local Chemotherapy Using Isolated Limb Infusion (ILI) for Patients With Sarcoma in the Arm or Leg NCT04332874	Phase 2	Recruiting	Memorial Sloan Kettering Cancer Center	30	2020-04-01 → 2027-04-01
Addition of Ipilimumab (MDX-010) To Isolated Limb Infusion (ILI) With Standard Melphalan and Dactinomycin In The Treatment of Advanced Unresectable Melanoma of The Extremity NCT01323517	Phase 2	Completed	Memorial Sloan Kettering Cancer Center	26	2011-02 → 2017-08-14
High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma NCT00354744	Phase 3	Completed	Children's Oncology Group	109	2006-07 → 2019-06-30
Dactinomycin in Treating Patients With Persistent or Recurrent Gestational Trophoblastic Neoplasia NCT00003688	Phase 2	Completed	Gynecologic Oncology Group	—	1999-10
Dactinomycin or Methotrexate in Treating Patients With Low-Risk Gestational Trophoblastic Neoplasia NCT01535053	Phase 3	Completed	GOG Foundation	57	2012-06-18 → 2020-07-17
Vincristine, Dactinomycin, and Doxorubicin With or Without Radiation Therapy or Observation Only in Treating Younger Patients Who Are Undergoing Surgery for Newly Diagnosed Stage I, Stage II, or Stage III Wilms' Tumor NCT00352534	Phase 3	Completed	Children's Oncology Group	808	2006-11-06 → 2026-03-31
Combination Chemotherapy in Treating Children With Metastatic Rhabdomyosarcoma or Other Malignant Mesenchymal Tumors NCT00025441	Phase 2	Completed	Societe Internationale d'Oncologie Pediatrique	—	1998-11 → 2010-03

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

Medicare Part B Spending

CMS physician-administered drug spending for COsmegen (2024)

Total Spending

$137K

Total Claims

Beneficiaries

ASP Price

$474.09

Spending Trend

$220K(2019)→$430K(2020)→$332K(2021)→$138K(2022)→$148K(2023)→$137K(2024)

YoY Change:-28.7%

5yr CAGR:-17.3%

HCPCS: J9120 — Injection, dactinomycin, 0.5 mg

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain3 active DMFs1 inactive

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

SIGMA ALDRICH ISRAEL LTDDACTINOMYCIN USP

DMF 35381979

ZHEJIANG HISUN PHARMACEUTICAL CO LTDDACTINOMYCIN USP

DMF 206582007

CONCORD BIOTECH LTDDACTINOMYCIN USP

DMF 342472019

SIGMA CHEMICAL COInactiveDACTINOMYCIN

DMF 136331998

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

Approval Letters

9 letters from Drugs@FDA

Date	Submission	Document
Oct 26, 2018	SUPPL -34	View Letter (PDF)
Oct 26, 2018	SUPPL -33	View Letter (PDF)
Feb 7, 2012	SUPPL -30	View Letter (PDF)
Feb 7, 2012	SUPPL -29	View Letter (PDF)
Mar 17, 2009	SUPPL -25	View Letter (PDF)
Aug 19, 2005	SUPPL -22	View Letter (PDF)
Dec 6, 2004	SUPPL -21	View Letter (PDF)
Mar 26, 2003	SUPPL -20	View Letter (PDF)
Oct 28, 2002	SUPPL -19	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.