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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Healthtrust
Chubb
Merck
Cerilliant
Farmers Insurance
UBS
Dow
US Army

Generated: July 15, 2018

DrugPatentWatch Database Preview

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 three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Melphalan hydrochloride has thirty-seven patent family members in fourteen 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;IV (INFUSION) 207155-001 Mar 10, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Fresenius Kabi Usa MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 203393-001 Dec 22, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Sagent Pharms MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 201379-001 Feb 28, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
West-ward Pharms Int MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090303-001 Oct 28, 2010 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
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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Non-Orange Book US Patents for melphalan hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,635,773 Sulfoalkyl ether cyclodextrin compositions ➤ Sign Up
9,750,822 Sulfoalkyl ether cyclodextrin compositions ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Harvard Business School
Argus Health
Cantor Fitzgerald
McKinsey
Chubb
Colorcon
Cerilliant
Citi
Covington

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.