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Serving leading biopharmaceutical companies globally:

McKesson
Colorcon
US Army
Julphar
Queensland Health
Citi
QuintilesIMS
Chubb
Daiichi Sankyo
Harvard Business School

Generated: October 24, 2017

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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 West-ward Pharms Int, Apotex Inc, Actavis Llc, Spectrum Pharms, Mylan Institutional, Par Sterile Products, and Sagent Pharms, and is included in eight NDAs. There are three patents protecting this compound. 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 Generic Name: melphalan hydrochloride

US Patents:3
Tradenames:3
Applicants:7
NDAs:8
Drug Master File Entries: see list12
Suppliers / Packagers: see list7
Bulk Api Vendors: see list8
Clinical Trials: see list2,895
Patent Applications: see list492
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:melphalan hydrochloride at DailyMed

Pharmacology for Ingredient: melphalan hydrochloride

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
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;INJECTION090270-001Jun 9, 2009APRXNoYes► Subscribe► Subscribe► Subscribe
Par Sterile Products
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION204773-001Aug 22, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
West-ward Pharms Int
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION090303-001Oct 28, 2010APRXNoNo► Subscribe► Subscribe► Subscribe
Mylan Institutional
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION090299-001Oct 27, 2009DISCNNoNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
EVOMELA
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Sagent Pharms
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION201379-001Feb 28, 2017APRXNoNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
EVOMELA
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► Subscribe► Subscribe
Actavis Llc
MELPHALAN HYDROCHLORIDE
melphalan hydrochloride
INJECTABLE;INJECTION206018-001Dec 19, 2016APRXNoNo► Subscribe► Subscribe► Subscribe
Spectrum Pharms
EVOMELA
melphalan hydrochloride
POWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► SubscribeY ► Subscribe
Apotex Inc
ALKERAN
melphalan hydrochloride
INJECTABLE;INJECTION020207-001Nov 18, 1992DISCNYesNo► Subscribe► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: melphalan hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Apotex Inc
ALKERAN
melphalan hydrochloride
INJECTABLE;INJECTION020207-001Nov 18, 1992► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
7,635,773Sulfoalkyl ether cyclodextrin compositions► Subscribe
9,750,822Sulfoalkyl ether cyclodextrin compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: melphalan hydrochloride

Country Document Number Estimated Expiration
European Patent Office2748205► Subscribe
China105288650► Subscribe
Japan4923144► Subscribe
Eurasian Patent Organization201000828► Subscribe
South Korea20150004797► Subscribe
Mexico2010004900► Subscribe
Japan2017019879► Subscribe
Australia2009241858► Subscribe
Canada2702603► Subscribe
European Patent Office2268269► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Serving leading biopharmaceutical companies globally:

Healthtrust
US Department of Justice
Harvard Business School
Deloitte
Chinese Patent Office
Federal Trade Commission
Covington
Teva
Cerilliant
Julphar

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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