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 |
Recent Clinical Trials for MELPHALAN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Rising Tide Foundation | Phase 1/Phase 2 |
| The Leukemia and Lymphoma Society | Phase 1/Phase 2 |
| St. Louis Children's Hospital Foundation | Phase 1/Phase 2 |
Medical Subject Heading (MeSH) Categories for MELPHALAN
Anatomical Therapeutic Chemical (ATC) Classes for MELPHALAN
US Patents and Regulatory Information for MELPHALAN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Gland Pharma Ltd | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 209826-001 | May 28, 2019 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
| Acrotech Biopharma | EVOMELA | melphalan hydrochloride | POWDER;INTRAVENOUS | 207155-001 | Mar 10, 2016 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 | |||
| >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
| 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 |
