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Melphalan hydrochlorideis the generic ingredient in three branded drugs marketed by Apotex, Actavis Llc, Alvogen, Bpi Labs Llc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Gland Pharma Ltd, Ingenus Pharms Llc, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Twi Pharms, Uswm, West-ward Pharms Int, and Acrotech, and is included in seventeen NDAs. There are four patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.
Melphalan hydrochloride has seventy-four patent family members in eighteen countries.
There are twelve drug master file entries for melphalan hydrochloride. Ten suppliers are listed for this compound.
Summary for melphalan hydrochloride
|Drug Master File Entries:||12|
|Suppliers / Packagers:||10|
|Bulk Api Vendors:||16|
|Formulation / Manufacturing:||see details|
|Patent Litigation and PTAB cases:||See patent lawsuits and PTAB cases for melphalan hydrochloride|
|DailyMed Link:||melphalan hydrochloride at DailyMed|
Recent Clinical Trials for melphalan hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
|Sahlgrenska University Hospital, Sweden||Phase 1|
|Oncopeptides AB||Phase 3|
|Prof. Beck Popovic Maja||Phase 2|
Pharmacology for melphalan hydrochloride
|Drug Class||Alkylating Drug |
|Mechanism of Action||Alkylating Activity |
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||TE||Type||RLD||RS||Patent No.||Patent Expiration||Product||Substance||Delist Req.||Exclusivity Expiration|
|Acrotech||EVOMELA||melphalan hydrochloride||POWDER;INTRAVENOUS||207155-001||Mar 10, 2016||RX||Yes||Yes||Start Trial||Start Trial||Y||Start Trial|
|Ingenus Pharms Llc||MELPHALAN HYDROCHLORIDE||melphalan hydrochloride||INJECTABLE;INJECTION||210947-001||Feb 18, 2020||AP||RX||No||No||Start Trial||Start Trial||Start Trial|
|Mylan Institutional||MELPHALAN HYDROCHLORIDE||melphalan hydrochloride||INJECTABLE;INJECTION||090270-001||Jun 9, 2009||AP||RX||No||Yes||Start Trial||Start Trial||Start Trial|
|Gland Pharma Ltd||MELPHALAN HYDROCHLORIDE||melphalan hydrochloride||INJECTABLE;INJECTION||209826-001||May 28, 2019||AP||RX||No||No||Start Trial||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Applicant||Tradename||Generic Name||Dosage||NDA||Approval Date||Patent No.||Patent Expiration|
|Apotex||ALKERAN||melphalan hydrochloride||INJECTABLE;INJECTION||020207-001||Nov 18, 1992||Start Trial||Start Trial|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>Patent No.||>Patent Expiration|
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