Viewing data from:

ALKERAN

NDA

MELPHALAN HYDROCHLORIDE | N020207 | APOTEX 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 Axinn, Veltrop & Harkrider LLP FDA-2016-P-3598 · 5 docket documents On October 27, 2016, Chad A. Landmon, filing on behalf of a client through the law firm Axinn, Veltrop & Harkrider LLP, submitted a citizen petition requesting that the FDA designate Evomela (melphalan hydrochloride) for Injection, 50 mg base per vial, approved under NDA 207155 by Spectrum Pharmaceu	505(q)	2016-10-28	Granted	Axinn, Veltrop & Harkrider LLP

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

Clinical Trials

500 trials from ClinicalTrials.gov — 16 recruiting, 35 active, 325 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Trial Evaluating MGTA-456 in Patients With High-Risk Malignancy NCT03674411	Phase 2	Active	Masonic Cancer Center, University of Minnesota	22	2019-01-02 → 2026-12-01
CD34+ (Malignant) Stem Cell Selection for Patients Receiving Allogenic Stem Cell Transplant NCT02061800	Phase 1/2	Active	Diane George	14	2013-06-03 → 2026-07
Targeting the IPA and Matching for the Non-Inherited Maternal Antigen for Haplo-Cord Transplantation NCT01810588	Phase 2	Active	Weill Medical College of Cornell University	270	2012-10-16 → 2028-04
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia NCT01885689	Phase 2	Active	City of Hope Medical Center	72	2014-02-10 → 2026-09-21
Allogeneic Hematopoietic Stem Cell Transplant for Patients With Primary Immune Deficiencies NCT01652092	N/A	Active	Masonic Cancer Center, University of Minnesota	57	2012-09-04 → 2026-12
Trial for Patients Not Qualifying for TT4 and TT5 Protocols Because of Prior Therapy NCT00871013	Phase 2	Active	University of Arkansas	160	2009-03 → 2027-12
Carfilzomib in Treatment Patients Under 65 Years With High Risk Smoldering Multiple Myeloma NCT02415413	Phase 2	Active	PETHEMA Foundation	90	2015-05 → 2027-06
Donor Peripheral Stem Cell Transplant in Treating Patients With Advanced Hematologic Cancer or Other Disorders NCT00544115	Phase 2	Active	City of Hope Medical Center	260	2001-10-16 → 2027-03-29
PHP and Immunotherapy in Metastasized UM NCT04283890	Phase 1/2	Active	Leiden University Medical Center	83	2019-12-04 → 2029-12
2015-12: A Study Exploring the Use of Early and Late Consolidation/Maintenance Therapy NCT03004287	Phase 2	Active	University of Arkansas	50	2017-07-01 → 2027-10

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

API Supply Chain9 active DMFs2 inactive

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

OLON SPAMELPHALAN HYDROCHLORIDE

DMF 208832007

EMCURE PHARMACEUTICALS LTDMELPHALAN HYDROCHLORIDE

DMF 250402011

FARMABIOS SPAMELPHALAN HYDROCHLORIDE

DMF 257912012

NERPHARMA SRLMELPHALAN HYDROCHLORIDE DRUG SUBSTANCE

DMF 273062013

BIOPHORE INDIA PHARMACEUTICALS PVT LTDMELPHALAN HYDROCHLORIDE

DMF 274852013

SHILPA PHARMA LIFESCIENCES LTDMELPHALAN HYDROCHLORIDE (MPH)

DMF 289302015

HETERO LABS LTDMELPHALAN HYDROCHLORIDE

DMF 295372015

NAVINTA LLCMELPHALAN HYDROCHLORIDE

DMF 297662015

APITORIA PHARMA PRIVATE LTDMELPHALAN HYDROCHLORIDE

DMF 371792022

XIAN LIBANG PHARMACEUTICAL CO LTDInactiveMELPHALAN HYDROCHLORIDE (NON STERILE BULK DRUG SUBSTANCE)

DMF 236672010

GRANULES INDIA LTDInactiveMELPHALAN HYDROCHLORIDE

DMF 360962021

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

Approval Letters

5 letters from Drugs@FDA

Date	Submission	Document
Jun 14, 2011	SUPPL -16	View Letter (PDF)
May 4, 2011	SUPPL -17	View Letter (PDF)
Jun 15, 2005	SUPPL -12	View Letter (PDF)
May 29, 2003	SUPPL -7	View Letter (PDF)
Jan 7, 2002	SUPPL -5	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 50MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

INJECTABLE;INJECTION | Approved: Nov 18, 1992

No patent or exclusivity listings for this strength.