BICNU Drug Patent Profile
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Which patents cover Bicnu, and what generic alternatives are available?
Bicnu is a drug marketed by Avet Lifesciences and is included in one NDA.
The generic ingredient in BICNU is carmustine. There are eleven drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the carmustine profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Bicnu
A generic version of BICNU was approved as carmustine by NAVINTA LLC on September 11th, 2018.
Summary for BICNU
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Patent Applications: | 3,796 |
| Formulation / Manufacturing: | see details |
| What excipients (inactive ingredients) are in BICNU? | BICNU excipients list |
| DailyMed Link: | BICNU at DailyMed |
Anatomical Therapeutic Chemical (ATC) Classes for BICNU
US Patents and Regulatory Information for BICNU
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Avet Lifesciences | BICNU | carmustine | INJECTABLE;INJECTION | 017422-001 | Approved Prior to Jan 1, 1982 | AP | RX | Yes | Yes | ⤷ 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 |
EU/EMA Drug Approvals for BICNU
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| medac Gesellschaft für klinische Spezialpräparate mbH | Carmustine medac (previously Carmustine Obvius) | carmustine | EMEA/H/C/004326 Carmustine is indicated n adults in the following malignant neoplasms as a single agent or in combination with other antineoplastic agents and/or other therapeutic measures (radiotherapy, surgery):, , , Brain tumours (glioblastoma, brain-stem gliomas, medulloblastoma, astrocytoma and ependymoma), brain metastases, Secondary therapy in non-Hodgkin’s lymphoma and Hodgkin’s disease, as conditioning treatment prior to autologous haematopoietic progenitor cell transplantation (HPCT) in malignant haematological diseases (Hodgkin’s disease / Non-hodgkin’s lymphoma)., , |
Authorised | yes | no | no | 2018-07-18 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
