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Last Updated: November 2, 2024

CARMUSTINE Drug Patent Profile


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Which patents cover Carmustine, and when can generic versions of Carmustine launch?

Carmustine is a drug marketed by Accord Hlthcare, Alembic, Amneal, Dr Reddys, Hengrui Pharma, Ingenus Pharms Llc, Meitheal, MSN, Navinta Llc, Norvium Bioscience, and Penn Life. and is included in twelve NDAs.

The generic ingredient in CARMUSTINE 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 Carmustine

A generic version of CARMUSTINE was approved as carmustine by NAVINTA LLC on September 11th, 2018.

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Summary for CARMUSTINE
Drug patent expirations by year for CARMUSTINE
Drug Prices for CARMUSTINE

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Recent Clinical Trials for CARMUSTINE

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SponsorPhase
Ruijin HospitalN/A
First Affiliated Hospital Xi'an Jiaotong UniversityN/A
Children's Discovery InstitutePhase 1

See all CARMUSTINE clinical trials

Medical Subject Heading (MeSH) Categories for CARMUSTINE
Anatomical Therapeutic Chemical (ATC) Classes for CARMUSTINE

US Patents and Regulatory Information for CARMUSTINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Accord Hlthcare CARMUSTINE carmustine INJECTABLE;INJECTION 214117-001 Dec 27, 2022 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Meitheal CARMUSTINE carmustine INJECTABLE;INJECTION 213460-001 Aug 2, 2021 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys CARMUSTINE carmustine INJECTABLE;INJECTION 213207-001 Oct 22, 2020 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Accord Hlthcare CARMUSTINE carmustine POWDER;INTRAVENOUS 215000-001 May 16, 2022 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Msn CARMUSTINE carmustine INJECTABLE;INJECTION 214814-001 May 11, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Alembic CARMUSTINE carmustine INJECTABLE;INJECTION 215730-001 Oct 20, 2023 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Amneal CARMUSTINE carmustine INJECTABLE;INJECTION 211229-001 Oct 16, 2018 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 CARMUSTINE

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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