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Serving leading biopharmaceutical companies globally:

Fish and Richardson
Daiichi Sankyo
Express Scripts
Fuji
Chinese Patent Office
Mallinckrodt
Chubb
Covington
Farmers Insurance
QuintilesIMS

Generated: January 18, 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, Mylan Institutional, Par Sterile Products, Sagent Pharms, West-ward Pharms Int, and Spectrum Pharms, and is included in eight 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-six patent family members in fourteen countries.

There are twelve drug master file entries for melphalan hydrochloride. Seven suppliers are listed for this compound.
Summary for melphalan hydrochloride
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
Mylan Institutional MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090270-001 Jun 9, 2009 AP RX No Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Mylan Institutional MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090299-001 Oct 27, 2009 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Apotex Inc ALKERAN melphalan hydrochloride INJECTABLE;INJECTION 020207-001 Nov 18, 1992 DISCN Yes No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Spectrum Pharms EVOMELA melphalan hydrochloride POWDER;IV (INFUSION) 207155-001 Mar 10, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Spectrum Pharms EVOMELA melphalan hydrochloride POWDER;IV (INFUSION) 207155-001 Mar 10, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Spectrum Pharms EVOMELA melphalan hydrochloride POWDER;IV (INFUSION) 207155-001 Mar 10, 2016 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
West-ward Pharms Int MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 090303-001 Oct 28, 2010 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Actavis Llc MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 206018-001 Dec 19, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Sagent Pharms MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 201379-001 Feb 28, 2017 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Par Sterile Products MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 204773-001 Aug 22, 2016 AP RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
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 ➤ Subscribe
9,750,822 Sulfoalkyl ether cyclodextrin compositions ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for melphalan hydrochloride

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Serving leading biopharmaceutical companies globally:

Express Scripts
Johnson and Johnson
US Army
Farmers Insurance
Citi
AstraZeneca
Accenture
Novartis
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.

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