MELPHALAN - Generic Drug Details
✉ Email this page to a colleague
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, Oncopeptides Ab, 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, Delcath Systems Inc, and Acrotech Biopharma, and is included in twenty-three NDAs. There are twenty-four patents protecting this compound. Additional information is available in the individual branded drug profile pages.There are twelve drug master file entries for melphalan. One supplier is listed for this compound.
Summary for MELPHALAN
US Patents: | 24 |
Tradenames: | 6 |
Applicants: | 19 |
NDAs: | 23 |
Drug Master File Entries: | 12 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 71 |
Clinical Trials: | 861 |
Patent Applications: | 3,304 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for MELPHALAN |
What excipients (inactive ingredients) are in MELPHALAN? | MELPHALAN excipients list |
DailyMed Link: | MELPHALAN at DailyMed |
Recent Clinical Trials for MELPHALAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
German Cancer Research Center | Phase 1 |
University Hospital Heidelberg | Phase 1 |
University Hospital Dresden | Phase 1 |
Pharmacology for MELPHALAN
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for MELPHALAN
US Patents and Regulatory Information for MELPHALAN
EU/EMA Drug Approvals for MELPHALAN
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 |
Make Better Decisions: Try a trial or see plans & pricing
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.