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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
McKesson
Express Scripts
Federal Trade Commission
QuintilesIMS
AstraZeneca
UBS
Accenture

Generated: September 21, 2018

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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.

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
Fresenius Kabi Usa MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 203393-001 Dec 22, 2017 AP RX No No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Spectrum Pharms EVOMELA melphalan hydrochloride POWDER;IV (INFUSION) 207155-001 Mar 10, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Spectrum Pharms EVOMELA melphalan hydrochloride POWDER;IV (INFUSION) 207155-001 Mar 10, 2016 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ 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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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Fish and Richardson
McKesson
Express Scripts
Federal Trade Commission
QuintilesIMS
AstraZeneca
UBS
Accenture

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.