MELPHALAN HYDROCHLORIDE - Generic Drug Details

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What are the generic drug sources for melphalan hydrochloride and what is the scope of patent protection?

Melphalan hydrochloride is the generic ingredient in five branded drugs marketed by Apotex, Actavis Llc, Almaject, Arthur Grp, Bpi Labs, Dr Reddys, Endo Operations, Fresenius Kabi Usa, Gland Pharma Ltd, Hetero Labs, Hikma, Ingenus Pharms Llc, Meitheal, Mylan Institutional, Sagent Pharms Inc, Uswm, Delcath Systems Inc, and Acrotech Biopharma, and is included in twenty-one NDAs. There are eighteen patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Melphalan hydrochloride has one hundred and twenty-eight patent family members in twenty-six countries.

There are nine drug master file entries for melphalan hydrochloride. Sixteen suppliers are listed for this compound.

Summary for MELPHALAN HYDROCHLORIDE

International Patents:	128
US Patents:	18
Tradenames:	5
Applicants:	18
NDAs:	21
Drug Master File Entries:	9
Finished Product Suppliers / Packagers:	16
Raw Ingredient (Bulk) Api Vendors:	24
Clinical Trials:	869
Patent Applications:	1,438
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for MELPHALAN HYDROCHLORIDE
What excipients (inactive ingredients) are in MELPHALAN HYDROCHLORIDE?	MELPHALAN HYDROCHLORIDE excipients list
DailyMed Link:	MELPHALAN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for MELPHALAN HYDROCHLORIDE

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

Sponsor	Phase
The Leukemia and Lymphoma Society	Phase 1/Phase 2
St. Louis Children's Hospital Foundation	Phase 1/Phase 2
Rising Tide Foundation	Phase 1/Phase 2

See all MELPHALAN HYDROCHLORIDE clinical trials

Pharmacology for MELPHALAN HYDROCHLORIDE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for MELPHALAN HYDROCHLORIDE

L01AA	Nitrogen mustard analogues
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090303-001	Oct 28, 2010	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Actavis Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	POWDER;INTRAVENOUS	209323-001	Mar 6, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Delcath Systems Inc	HEPZATO	melphalan hydrochloride	POWDER;INTRA-ARTERIAL	201848-001	Aug 14, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for MELPHALAN HYDROCHLORIDE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Apotex	ALKERAN	melphalan hydrochloride	INJECTABLE;INJECTION	020207-001	Nov 18, 1992	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for MELPHALAN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Japan	6444548		⤷ Sign Up
South Korea	101633479		⤷ Sign Up
South Korea	101314803		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for MELPHALAN HYDROCHLORIDE

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2701720	CR 2022 00054	Denmark	⤷ Sign Up	PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818
2701720	3/2023	Austria	⤷ Sign Up	PRODUCT NAME: MELPHALANFLUFENAMID-HYDROCHLORID; REGISTRATION NO/DATE: EU/1/22/1669 (MITTEILUNG) 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

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