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VALSTAR PRESERVATIVE FREE

NDA

VALRUBICIN | N020892 | ENDO OPERATIONS LTD

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 Lachman Consultant Services Inc. FDA-2012-P-1029 · 4 docket documents Lachman Consultant Services Inc. filed this petition on behalf of a client under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Valrubicin Solution for Intravesical Instillation at a strength of 800 mg/20 ml suitable for submission in an ANDA, represe	Other	2012-10-19	Granted	Lachman Consultant Services Inc.

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

Clinical Trials

6 trials from ClinicalTrials.gov, 4 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Phase I Study of Percutaneous Valrubicin for Upper Tract Urothelial Carcinoma NCT01606345	Phase 1	Completed	H. Lee Moffitt Cancer Center and Research Institute	4	2012-07 → 2016-04
Chemotherapy in Treating Patients With Early-Stage Bladder Cancer NCT00003129	Phase 2	Completed	Eastern Cooperative Oncology Group	75	1998-09-01 → 2009-05-01
AD 32 With or Without BCG After Surgery in Treating Patients With Newly Diagnosed or Recurrent Superficial Bladder Cancer NCT00003759	Phase 2	Completed	Anthra Pharmaceuticals	—	1998-11 → 2002-11
Intravesical AD 32 (Valrubicin) in Patients With Carcinoma in Situ (CIS) of the Bladder Who Have Failed or Have Recurrence Following Treatment With Bacillus Calmette-guerin (BCG)NCT01316874	Phase 2/3	Completed	Endo USA Inc., a Keenova Therapeutics Company	90	1993-11 → 1997-04
Efficacy Study of Recombinant Adenovirus for Non Muscle Invasive Bladder Cancer NCT01438112	Phase 2/3	Terminated	CG Oncology, Inc.	22	2014-03 → 2016-06
Surgery With or Without Chemotherapy in Treating Patients With Newly Diagnosed or Recurrent Bladder Cancer NCT00003725	Phase 3	UNKNOWN	Anthra Pharmaceuticals	300	1996-12

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

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$3636.18

Highest Price

$5427.14

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
67979-0001-01VALSTAR VIAL	$5427.14	FSS	Endo USA, Inc.	04/30/2026
67979-0001-01VALSTAR VIAL	$3636.18	Big4	Endo USA, Inc.	04/30/2026

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

API Supply Chain3 active DMFs

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

TAPI NL BVVALRUBICIN (AD-32)

DMF 124051997

SYNBIAS PHARMA AGVALRUBICIN USP

DMF 269182013

DZD (HEZE) PHARMACEUTICAL CO LTDVALRUBICIN

DMF 345212020

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

Approval Letters

4 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 40MG/ML

RLDAO

0 patents0 exclusivities▴

SOLUTION;INTRAVESICAL | Approved: Sep 25, 1998

No patent or exclusivity listings for this strength.