ALKERAN Drug Patent Profile
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Which patents cover Alkeran, and when can generic versions of Alkeran launch?
Alkeran is a drug marketed by Apotex and is included in two NDAs.
The generic ingredient in ALKERAN is melphalan. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the melphalan profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Alkeran
A generic version of ALKERAN was approved as melphalan by ALVOGEN on March 22nd, 2017.
Summary for ALKERAN
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 71 |
Clinical Trials: | 183 |
Patent Applications: | 3,229 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information for ALKERAN |
What excipients (inactive ingredients) are in ALKERAN? | ALKERAN excipients list |
DailyMed Link: | ALKERAN at DailyMed |
Recent Clinical Trials for ALKERAN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Baptist Health South Florida | Phase 2 |
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Phase 2 |
Baptist Health South Florida | Phase 1/Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ALKERAN
US Patents and Regulatory Information for ALKERAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Apotex | ALKERAN | melphalan hydrochloride | INJECTABLE;INJECTION | 020207-001 | Nov 18, 1992 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Apotex | ALKERAN | melphalan | TABLET;ORAL | 014691-002 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
>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 ALKERAN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Apotex | ALKERAN | melphalan hydrochloride | INJECTABLE;INJECTION | 020207-001 | Nov 18, 1992 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ALKERAN
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 |
International Patents for ALKERAN
See the table below for patents covering ALKERAN around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Portugal | 89028 | PROCESSO PARA A PREPARACAO DE DERIVADOS DE 4-{BIS(2-CLORO-ETIL)AMINO}-L-FENILALANINA (MELFALAN) E DE COMPOSICOES FARMACEUTICAS QUE OS CONTEM | ⤷ Try a Trial |
Hungary | T48198 | ⤷ Try a Trial | |
European Patent Office | 0317281 | PHARMACEUTICAL FORMULATIONS CONTAINING MELPHALAN OR MELPHALAN HYDROCHLORIDE, AS WELL AS MELPHALAN AND MELPHALAN HYDROCHLORIDE AND PROCESSES FOR PREPARING THEM | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ALKERAN
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
2701720 | CA 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
2701720 | 301206 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REGISTRATION NO/DATE: EU/1/22/1669 20220818 |
2701720 | CR 2022 00054 | Denmark | ⤷ Try a Trial | PRODUCT NAME: MELPHALAN FLUFENAMIDE HYDROCHLORIDE; REG. NO/DATE: EU/1/22/1669 20220818 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |