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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

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part B Spending

CMS physician-administered drug spending for COsmegen (2023)

Total Spending

$148K

Total Claims

Beneficiaries

ASP Price

—

HCPCS: J9120 — Injection, dactinomycin, 0.5 mg

Source: CMS Medicare Part B Spending by Drug (2023). 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

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#001 — 0.5MG/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**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