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Last Updated: March 19, 2024

MELPHALAN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Melphalan Hydrochloride, and what generic alternatives are available?

Melphalan Hydrochloride is a drug marketed by Actavis Llc, Almaject, Arthur Grp, Bpi Labs, Dr Reddys, Fresenius Kabi Usa, Gland Pharma Ltd, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Par Sterile Products, Sagent Pharms Inc, Uswm, and Apotex. and is included in seventeen NDAs. There is one patent protecting this drug.

This drug has one patent family member in one country.

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Melphalan Hydrochloride

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

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Drug patent expirations by year for MELPHALAN HYDROCHLORIDE
Recent Clinical Trials for MELPHALAN HYDROCHLORIDE

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SponsorPhase
University Hospital DresdenPhase 1
German Cancer Research CenterPhase 1
University Hospital HeidelbergPhase 1

See all MELPHALAN HYDROCHLORIDE clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for MELPHALAN HYDROCHLORIDE
Paragraph IV (Patent) Challenges for MELPHALAN HYDROCHLORIDE
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 MELPHALAN HYDROCHLORIDE

MELPHALAN HYDROCHLORIDE is protected by one US patents.

Patents protecting MELPHALAN HYDROCHLORIDE


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Patent Expiration: ⤷  Try a Trial

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Actavis Llc MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 206018-001 Dec 19, 2016 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 209826-001 May 28, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Bpi Labs MELPHALAN HYDROCHLORIDE melphalan hydrochloride INJECTABLE;INJECTION 209197-001 May 8, 2020 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 MELPHALAN HYDROCHLORIDE

See the table below for patents covering MELPHALAN HYDROCHLORIDE around the world.

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2017002030 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for MELPHALAN HYDROCHLORIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2701720 CA 2022 00054 Denmark ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720 301206 Netherlands ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818
2701720 CR 2022 00054 Denmark ⤷  Try a Trial PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.