EVOMELA Drug Patent Profile

✉ Email this page to a colleague

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

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

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

The generic ingredient in EVOMELA is melphalan hydrochloride. There are twelve drug master file entries for this compound. Sixteen 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 9^th, 2009.

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for EVOMELA?
What are the global sales for EVOMELA?
What is Average Wholesale Price for EVOMELA?

Summary for EVOMELA

International Patents:	101
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	25
Clinical Trials:	20
Patent Applications:	923
Drug Prices:	Drug price information for EVOMELA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for EVOMELA
What excipients (inactive ingredients) are in EVOMELA?	EVOMELA excipients list
DailyMed Link:	EVOMELA at DailyMed

Drug patent expirations by year for EVOMELA

Recent Clinical Trials for EVOMELA

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

Sponsor	Phase
Ehsan Malek	Early Phase 1
Washington University School of Medicine	Phase 1
National Cancer Institute (NCI)	Phase 1/Phase 2

See all EVOMELA clinical trials

Pharmacology for EVOMELA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating 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.

Patents protecting EVOMELA

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Injectable nitrogen mustard compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Injectable melphalan compositions comprising a cyclodextrin derivative and methods of making and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Sulfoalkyl ether cyclodextrin compositions
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Alkylated cyclodextrin compositions and processes for preparing and using the same
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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.

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
China	105288650	Sulfoalkyl ether cyclodextrin compositions	⤷ Sign Up
World Intellectual Property Organization (WIPO)	2013130666		⤷ Sign Up
Canada	2702603	COMPOSITIONS DE CYCLODEXTRINE A GROUPEMENTS ETHER SULFOALKYLIQUE (SULFOALKYL ETHER CYCLODEXTRIN COMPOSITIONS)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for EVOMELA

Subscribe to access the full database, or Sign Up
Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	CA 2022 00054	Denmark	⤷ Sign Up	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	23C1000	France	⤷ Sign Up	PRODUCT NAME: MELPHALAN FLUFENAMIDE ET SES SELS PHARMACEUTIQUEMENT ACCEPTABLES, TELS QUE LE CHLORHYDRATE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720	122023000007	Germany	⤷ Sign Up	PRODUCT NAME: MELPHALANFLUFENAMID HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 20220817
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description