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Last Updated: February 28, 2021

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Melphalan hydrochloride - Generic Drug Details

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What are the generic sources for melphalan hydrochloride and what is the scope of freedom to operate?

Melphalan hydrochloride is 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 five 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.

Recent Clinical Trials for melphalan hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Poitiers University HospitalPhase 3
Intergroupe Francophone du MyelomePhase 3
GlycoMimetics IncorporatedPhase 2

See all melphalan hydrochloride clinical trials

Pharmacology for melphalan hydrochloride
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
EVOMELA POWDER;INTRAVENOUS melphalan hydrochloride 207155 2017-09-08

US Patents and Regulatory Information for melphalan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Twi Pharms MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 211463-001 Sep 13, 2019 DISCN No No   Start Trial   Start Trial   Start Trial
Fresenius Kabi Usa MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 203393-001 Dec 22, 2017 AP RX No No   Start Trial   Start Trial   Start Trial
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Actavis Llc MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 206018-001 Dec 19, 2016 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

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
AstraZeneca
Merck
Baxter
Johnson and Johnson

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