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Chinese Patent Office
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Generated: January 21, 2019

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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 melphalan hydrochloride freedom to operate?

Melphalan hydrochloride is the generic ingredient in three branded drugs marketed by Apotex Inc, Actavis Llc, Dr Reddys Labs Ltd, Fresenius Kabi Usa, Mylan Institutional, Par Sterile Products, Sagent Pharms, West-ward Pharms Int, and Spectrum Pharms, and is included in ten 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 fifty-five patent family members in seventeen countries.

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

Pharmacology for melphalan hydrochloride
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

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
Spectrum Pharms EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
West-ward Pharms Int MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090303-001 Oct 28, 2010 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex Inc ALKERAN melphalan hydrochloride INJECTABLE;INJECTION 020207-001 Nov 18, 1992 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Spectrum Pharms EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Par Sterile Products MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 204773-001 Aug 22, 2016 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Fresenius Kabi Usa MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 203393-001 Dec 22, 2017 AP RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free 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 hundreds of leading biopharmaceutical companies globally:

Dow
Boehringer Ingelheim
US Department of Justice
Chubb
Julphar
US Army
Moodys
Express Scripts
Baxter

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