CARMUSTINE - Generic Drug Details

What are the generic sources for carmustine and what is the scope of freedom to operate?

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

US Patents:	0
Tradenames:	3
Applicants:	13
NDAs:	14
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	12
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	231
Patent Applications:	5,399
Drug Prices:	Drug price trends for CARMUSTINE
What excipients (inactive ingredients) are in CARMUSTINE?	CARMUSTINE excipients list
DailyMed Link:	CARMUSTINE at DailyMed

See drug prices for CARMUSTINE

Recent Clinical Trials for CARMUSTINE

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

Sponsor	Phase
Ruijin Hospital	N/A
First Affiliated Hospital Xi'an Jiaotong University	N/A
Children's Discovery Institute	Phase 1

See all CARMUSTINE clinical trials

Pharmacology for CARMUSTINE

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Medical Subject Heading (MeSH) Categories for CARMUSTINE

Antineoplastic Agents, Alkylating

Anatomical Therapeutic Chemical (ATC) Classes for CARMUSTINE

L01AD	Nitrosoureas
L01A	ALKYLATING AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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
Alembic	CARMUSTINE	carmustine	INJECTABLE;INJECTION	215730-001	Oct 20, 2023	AP	RX	No	No
Penn Life	CARMUSTINE	carmustine	INJECTABLE;INJECTION	209278-001	Apr 2, 2019	AP	RX	No	No
Meitheal	CARMUSTINE	carmustine	INJECTABLE;INJECTION	213460-001	Aug 2, 2021	AP	RX	No	No
Accord Hlthcare	CARMUSTINE	carmustine	POWDER;INTRAVENOUS	215000-002	May 16, 2022		DISCN	Yes	No
Dr Reddys	CARMUSTINE	carmustine	INJECTABLE;INJECTION	213207-001	Oct 22, 2020	AP	RX	No	No
Avet Lifesciences	BICNU	carmustine	INJECTABLE;INJECTION	017422-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes

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
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996
Azurity	GLIADEL	carmustine	IMPLANT;INTRACRANIAL	020637-001	Sep 23, 1996

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