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Last Updated: November 22, 2024

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. Twelve 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.

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Summary for BICNU
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 106
Patent Applications: 4,918
What excipients (inactive ingredients) are in BICNU?BICNU excipients list
DailyMed Link:BICNU at DailyMed
Drug patent expirations by year 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 ⤷  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 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

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