MELPHALAN - Generic Drug Details

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

Melphalan is the generic ingredient in six branded drugs marketed by Apotex, Alvogen, 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-three NDAs. There are eighteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twelve drug master file entries for melphalan.

Summary for MELPHALAN

US Patents:	18
Tradenames:	6
Applicants:	19
NDAs:	23
Drug Master File Entries:	12
Raw Ingredient (Bulk) Api Vendors:	71
Clinical Trials:	869
Patent Applications:	7,510
Drug Prices:	Drug price trends for MELPHALAN
What excipients (inactive ingredients) are in MELPHALAN?	MELPHALAN excipients list
DailyMed Link:	MELPHALAN at DailyMed

See drug prices for MELPHALAN

Recent Clinical Trials for MELPHALAN

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

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

See all MELPHALAN clinical trials

Medical Subject Heading (MeSH) Categories for MELPHALAN

Antineoplastic Agents, Alkylating
Myeloablative Agonists

Anatomical Therapeutic Chemical (ATC) Classes for MELPHALAN

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

US Patents and Regulatory Information for MELPHALAN

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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
Acrotech Biopharma	EVOMELA	melphalan hydrochloride	POWDER;INTRAVENOUS	207155-001	Mar 10, 2016		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Hikma	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	090303-001	Oct 28, 2010	AP	RX	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	Y			⤷ Sign Up
Actavis Llc	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	POWDER;INTRAVENOUS	209323-001	Mar 6, 2020		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	215024-001	May 23, 2024	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Meitheal	MELPHALAN HYDROCHLORIDE	melphalan hydrochloride	INJECTABLE;INJECTION	212960-001	May 28, 2021	AP	RX	No	No	⤷ 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

EU/EMA Drug Approvals for MELPHALAN

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ADIENNE S.r.l. S.U.	Phelinun	melphalan	EMEA/H/C/005173 High-dose of Phelinun used alone or in combination with other cytotoxic medicinal products and/or total body irradiation is indicated in the treatment of:multiple myeloma,malignant lymphoma (Hodgkin, non-Hodgkin lymphoma),acute lymphoblastic and myeloblastic leukemia,childhood neuroblastoma,ovarian cancer,mammary adenocarcinoma.Phelinun in combination with other cytotoxic medicinal products is indicated as reduced intensity conditioning (RIC) treatment prior to allogeneic haematopoietic stem cell transplantation (allo-HSCT) in malignant haematological diseases in adults.Phelinun in combination with other cytotoxic medicinal products is indicated as conditioning regimen prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in the paediatric population as:Myeloablative conditioning (MAC) treatment in case of malignant haematological diseasesRIC treatment in case of non-malignant haematological diseases.	Authorised	no	no	no	2020-11-16
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

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