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
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 |
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 |
Pharmacology for carmustine
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating 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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