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GLIADEL

NDA

CARMUSTINE | N020637 | AZURITY 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

188 trials from ClinicalTrials.gov — 3 recruiting, 6 active, 126 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of the Impact of CD34+ Cell Dose on Absolute Lymphocyte Count Following High-Dose Therapy and Autologous Stem Cell Transplantation for Relapsed and Refractory Diffuse Large B-cell Lymphoma (DLBCL)NCT02570542	Phase 2	Active	Memorial Sloan Kettering Cancer Center	59	2015-10 → 2026-10
Gene Therapy in Treating Patients With Human Immunodeficiency Virus-Related Lymphoma Receiving Stem Cell Transplant NCT02797470	Phase 1/2	Active	AIDS Malignancy Consortium	11	2016-06-23 → 2036-03
High Dose Therapy and Autologous Stem Cell Transplantation Followed by Infusion of Chimeric Antigen Receptor (CAR) Modified T-Cells Directed Against CD19+ B-Cells for Relapsed and Refractory Aggressive B Cell Non-Hodgkin Lymphoma NCT01840566	Phase 1	Active	Memorial Sloan Kettering Cancer Center	17	2013-04 → 2027-04
Autologous Stem Cell Transplant for Neurologic Autoimmune Diseases NCT00716066	Phase 2	Active	Fred Hutchinson Cancer Center	53	2008-06 → 2030-01-31
Combination Chemotherapy With or Without Autologous Stem Cell Transplant in Treating Patients With Central Nervous System B-Cell Lymphoma NCT01511562	Phase 2	Active	Alliance for Clinical Trials in Oncology	113	2012-09 → 2027-05-02
Ibrutinib Before and After Stem Cell Transplant in Treating Patients With Relapsed or Refractory Diffuse Large B-cell Lymphoma NCT02443077	Phase 3	Active	National Cancer Institute (NCI)	94	2016-10-12 → 2026-12-23
Auto Stem Cell Transplant for Lymphoma Patients NCT03125642	Phase 2	Recruiting	Masonic Cancer Center, University of Minnesota	150	2017-04-20 → 2027-04-30
A Study Comparing GLIADEL to Stereotactic Radiosurgery in Metastatic Brain Disease NCT04222062	Phase 2	Recruiting	University of Nebraska	100	2020-11-06 → 2029-12
SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem Cells NCT04150042	Phase 1	Recruiting	General Oncology, Inc.	24	2021-01-13 → 2028-12
Stem Cell Transplantation With or Without Rituximab in Treating Patients With Relapsed or Progressive B-Cell Diffuse Large Cell Lymphoma NCT00052923	Phase 3	Completed	Eastern Cooperative Oncology Group	427	2003-03

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

VA Federal Supply Schedule

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

Lowest Price

$27988.20

Highest Price

$27998.20

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
24338-0050-08GLIADEL 7.7MG IMPLANT WAFER	$27998.20	Big4	Azurity Pharmaceuticals, Inc.	07/31/2026
24338-0050-08GLIADEL 7.7MG IMPLANT WAFER	$27988.20	FSS	Azurity Pharmaceuticals, Inc.	07/31/2026

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

API Supply Chain12 active DMFs1 inactive

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

JOHNSON MATTHEY PHARMACEUTICAL MATERIALSCARMUSTINE

DMF 102901993

AMPAC FINE CHEMICALS LLCCARMUSTINE (BCNU)

DMF 131691998

CHEMPACIFIC CORPCARMUSTINE DRUG SUBSTANCE

DMF 226372009

EMCURE PHARMACEUTICALS LTDCARMUSTINE USP

DMF 229052009

AGNO PHARMACARMUSTINE USP

DMF 301842017

MSN LABORATORIES PRIVATE LTDCARMUSTINE USP

DMF 311562016

JIANGSU HENGRUI PHARMACEUTICALS CO LTDCARMUSTINE USP NON STERILE BULK DRUG SUBSTANCE

DMF 320312017

APITORIA PHARMA PRIVATE LTDCARMUSTINE USP

DMF 323432017

NERPHARMA SRLCARMUSTINE DRUG SUBSTANCE

DMF 329222018

INTAS PHARMACEUTICALS LTDCARMUSTINE USP

DMF 337302019

NATCO PHARMA LTDCARMUSTINE

DMF 345472020

VANNSH LIFE SCIENCES PRIVATE LTDCARMUSTINE USP

DMF 386862023

BRISTOL LABORATORIES INC DIV BRISTOL MYERS COInactiveCARMUSTINE (BCNU) BULK & CARMUSTINE (BCNU) FOR INJ

DMF 20381973

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Dec 7, 2018	SUPPL -29	View Letter (PDF)
Nov 24, 2014	SUPPL -27	View Letter (PDF)
Aug 20, 2013	SUPPL -26	View Letter (PDF)
Jan 8, 2007	SUPPL -22	View Letter (PDF)
Mar 10, 2003	SUPPL -16	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 7.7MG

RLD

0 patents0 exclusivities▴

IMPLANT;INTRACRANIAL | Approved: Sep 23, 1996

No patent or exclusivity listings for this strength.