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NDA

RADIUM RA-223 DICHLORIDE | N203971 | BAYER HEALTHCARE PHARMACEUTICALS 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

3 trials from ClinicalTrials.gov — 1 recruiting, 1 active

Trial	Phase	Status	Sponsor	Enrollment	Dates
Testing the Addition of a New Anti-cancer Drug, Radium-223 Dichloride, to the Usual Treatment (Cabozantinib) for Advanced Renal Cell Cancer That Has Spread to the Bone, RadiCaL Study NCT04071223	Phase 2	Active	National Cancer Institute (NCI)	134	2020-07-29 → 2026-10-01
AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)NCT07611110	Phase 3	Recruiting	AstraZeneca	670	2026-05-04 → 2029-12-20
Radiation Medication (Radium-223 Dichloride) Versus Radium-223 Dichloride Plus Radiation Enhancing Medication (M3814) Versus Radium-223 Dichloride Plus M3814 Plus Avelumab (a Type of Immunotherapy) for Advanced Prostate Cancer Not Responsive to Hormonal Therapy NCT04071236	Phase 1/2	Suspended	National Cancer Institute (NCI)	90	2020-10-14 → 2027-04-30

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

Approval Letters

5 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 162mCi/6ML (27mCi/ML)

RLD

0 patents0 exclusivities▴

SOLUTION;INTRAVENOUS | Approved: May 15, 2013

No patent or exclusivity listings for this strength.