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Serving leading biopharmaceutical companies globally:

Argus Health
Queensland Health
Julphar
Novartis
Johnson and Johnson
US Department of Justice
Colorcon
Teva
Cipla
Express Scripts

Generated: December 13, 2017

DrugPatentWatch Database Preview

EVOMELA Drug Profile

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When do Evomela patents expire, and when can generic versions of Evomela launch?

Evomela is a drug marketed by Spectrum Pharms and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

This drug has thirty-six patent family members in fourteen countries.

The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
Drug patent expirations by year for EVOMELA

Pharmacology for EVOMELA

Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Spectrum PharmsEVOMELAmelphalan hydrochloridePOWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Spectrum PharmsEVOMELAmelphalan hydrochloridePOWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Spectrum PharmsEVOMELAmelphalan hydrochloridePOWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Spectrum PharmsEVOMELAmelphalan hydrochloridePOWDER;IV (INFUSION)207155-001Mar 10, 2016RXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
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Paragraph IV (Patent) Challenges for EVOMELA

Drugname Dosage Strength RLD Submissiondate
melphalan hydrochlorideInjection50 mg/vialEvomela9/8/2017

Non-Orange Book Patents for Tradename: EVOMELA

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 Tradename: EVOMELA

Country Document Number Estimated Expiration
Japan4923144► Subscribe
Australia2013226073► Subscribe
Russian Federation2615385► Subscribe
China101959508► Subscribe
Hong Kong1219883► Subscribe
Israel208956► Subscribe
Japan2010539193► Subscribe
South Korea101314803► Subscribe
Japan2016166368► Subscribe
Canada2771879► 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:

QuintilesIMS
Chinese Patent Office
Fuji
US Army
Queensland Health
Citi
Colorcon
McKinsey
Cerilliant
AstraZeneca

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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