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Last Updated: November 22, 2024

Carmustine - Generic Drug Details


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What are the generic drug sources for carmustine and what is the scope of patent protection?

Carmustine is the generic ingredient in three branded drugs marketed by Azurity, Avet Lifesciences, Accord Hlthcare, Alembic, Amneal, Dr Reddys, Hengrui Pharma, Ingenus Pharms Llc, Meitheal, MSN, Navinta Llc, Norvium Bioscience, and Penn Life, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for carmustine. Twelve suppliers are listed for this compound.

Summary for carmustine
Drug Prices for carmustine

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Recent Clinical Trials for carmustine

Identify potential brand extensions & 505(b)(2) entrants

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

See all carmustine clinical trials

Pharmacology for carmustine
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
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
Navinta Llc CARMUSTINE carmustine INJECTABLE;INJECTION 210179-001 Sep 11, 2018 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
Penn Life CARMUSTINE carmustine INJECTABLE;INJECTION 209278-001 Apr 2, 2019 AP RX 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
Accord Hlthcare CARMUSTINE carmustine POWDER;INTRAVENOUS 215000-002 May 16, 2022 DISCN Yes 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

Expired US Patents for carmustine

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Azurity GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 ⤷  Sign Up ⤷  Sign Up
Azurity GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 ⤷  Sign Up ⤷  Sign Up
Azurity GLIADEL carmustine IMPLANT;INTRACRANIAL 020637-001 Sep 23, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent 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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