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Last Updated: April 25, 2024

Carmustine - Generic Drug Details


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What are the generic 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, Mylan Labs Ltd, Navinta Llc, 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. Fourteen suppliers are listed for this compound.

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

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Pharmacology for carmustine
Drug ClassAlkylating Drug
Mechanism of ActionAlkylating Activity
Medical Subject Heading (MeSH) Categories 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
Penn Life CARMUSTINE carmustine INJECTABLE;INJECTION 209278-001 Apr 2, 2019 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Amneal CARMUSTINE carmustine INJECTABLE;INJECTION 211229-001 Oct 16, 2018 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Alembic CARMUSTINE carmustine INJECTABLE;INJECTION 215730-001 Oct 20, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Msn CARMUSTINE carmustine INJECTABLE;INJECTION 214814-001 May 11, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Dr Reddys CARMUSTINE carmustine INJECTABLE;INJECTION 213207-001 Oct 22, 2020 AP RX No 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 carmustine

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