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Last Updated: August 19, 2022

EVOMELA Drug Patent Profile


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Which patents cover Evomela, and what generic alternatives are available?

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

This drug has one hundred patent family members in twenty-one countries.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Evomela

A generic version of EVOMELA was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9th, 2009.

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Drug patent expirations by year for EVOMELA
Drug Prices for EVOMELA

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Recent Clinical Trials for EVOMELA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Ehsan MalekEarly Phase 1
Washington University School of MedicinePhase 1
Spectrum Pharmaceuticals, IncPhase 1/Phase 2

See all EVOMELA clinical trials

Pharmacology for EVOMELA
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity
Paragraph IV (Patent) Challenges for EVOMELA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
EVOMELA Injection melphalan hydrochloride 50 mg/vial 207155 1 2017-09-08

US Patents and Regulatory Information for EVOMELA

EVOMELA is protected by seven US patents and one FDA Regulatory Exclusivity.

Patents protecting EVOMELA

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA

Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Sulfoalkyl ether cyclodextrin compositions
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting EVOMELA

FOR HIGH-DOSE CONDITIONING TREATMENT PRIOR TO HEMATOPOIETIC PROGENITOR (STEM) CELL TRANSPLANTATION IN PATIENTS WITH MULTIPLE MYELOMA
Exclusivity Expiration: See Plans and Pricing

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Acrotech EVOMELA melphalan hydrochloride POWDER;INTRAVENOUS 207155-001 Mar 10, 2016 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for EVOMELA

See the table below for patents covering EVOMELA around the world.

Country Patent Number Title Estimated Expiration
Hong Kong 1219883 磺烷基醚環糊精組合物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) See Plans and Pricing
Japan 2017019879 スルホアルキルエーテルシクロデキストリン組成物 (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS) See Plans and Pricing
Australia 2013226073 Alkylated cyclodextrin compositions and processes for preparing and using the same See Plans and Pricing
Japan 5914328 See Plans and Pricing
Mexico 2010004900 COMPOSICIONES DE ETER-SULFOALQUILICO-CICLODEXTRINA. (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS.) See Plans and Pricing
China 114053423 磺烷基醚环糊精组合物 (Sulfoalkyl ether cyclodextrin compositions) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Medtronic
Mallinckrodt
Harvard Business School
Dow
Baxter
McKesson

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 verification 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.