MELPHALAN Drug Patent Profile
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When do Melphalan patents expire, and what generic alternatives are available?
Melphalan is a drug marketed by Alvogen, 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 eighteen NDAs. There is one patent protecting this drug.
The generic ingredient in MELPHALAN is melphalan hydrochloride. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the melphalan hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Melphalan
A generic version of MELPHALAN was approved as melphalan hydrochloride by MYLAN INSTITUTIONAL on June 9th, 2009.
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Questions you can ask:
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Summary for MELPHALAN
| US Patents: | 0 |
| Applicants: | 16 |
| NDAs: | 18 |
| Raw Ingredient (Bulk) Api Vendors: | 71 |
| Clinical Trials: | 869 |
| Patent Applications: | 4,543 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for MELPHALAN |
| DailyMed Link: | MELPHALAN at DailyMed |
Recent Clinical Trials for MELPHALAN
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 |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Alvogen | MELPHALAN | melphalan | TABLET;ORAL | 207809-001 | Mar 22, 2017 | RX | No | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Apotex | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | SOLUTION;INTRAVENOUS | 217110-001 | Aug 18, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Fresenius Kabi Usa | MELPHALAN HYDROCHLORIDE | melphalan hydrochloride | INJECTABLE;INJECTION | 203393-001 | Dec 22, 2017 | 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
| 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 |
