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Last Updated: August 17, 2022

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, Almaject, Bpi Labs Llc, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Nanjing, Par Sterile Products, Sagent Pharms Inc, Uswm, and Acrotech, and is included in eighteen NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Melphalan hydrochloride has one hundred patent family members in twenty-one countries.

There are nine drug master file entries for melphalan hydrochloride. Nine suppliers are listed for this compound.

Recent Clinical Trials for melphalan hydrochloride

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

SponsorPhase
ADC TherapeuticsPhase 1
Peking University People's HospitalPhase 1
CASI Pharmaceuticals, Inc.Phase 1

See all melphalan hydrochloride clinical trials

Pharmacology for melphalan hydrochloride
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity
Anatomical Therapeutic Chemical (ATC) Classes for melphalan hydrochloride
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EVOMELA Injection melphalan hydrochloride 50 mg/vial 207155 1 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
Ingenus Pharms Llc MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 210947-001 Feb 18, 2020 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Fresenius Kabi Usa MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 203393-001 Dec 22, 2017 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for melphalan hydrochloride

Country Patent Number Title Estimated Expiration
Australia 2009241858 Sulfoalkyl ether cyclodextrin compositions See Plans and Pricing
Russian Federation 2747757 КОМПОЗИЦИИ АЛКИЛИРОВАННОГО ЦИКЛОДЕКСТРИНА И СПОСОБЫ ИХ ПОЛУЧЕНИЯ И ПРИМЕНЕНИЯ (COMPOSITIONS OF ALKYLATED CYCLODEXTRIN AND METHODS OF THEIR PREPARATION AND APPLICATION) See Plans and Pricing
Mexico 2010004900 COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.) See Plans and Pricing
South Korea 101633479 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
McKesson
AstraZeneca
Merck
Baxter
Johnson and Johnson

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