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, Mylan Labs Ltd, Navinta Llc, 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. Fourteen 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.
Summary for CARMUSTINE
| US Patents: | 0 |
| Applicants: | 11 |
| NDAs: | 12 |
| Finished Product Suppliers / Packagers: | 12 |
| Raw Ingredient (Bulk) Api Vendors: | 106 |
| Clinical Trials: | 231 |
| Patent Applications: | 3,707 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information 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 |
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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Meitheal | CARMUSTINE | carmustine | INJECTABLE;INJECTION | 213460-001 | Aug 2, 2021 | 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 | |||
| Accord Hlthcare | CARMUSTINE | carmustine | POWDER;INTRAVENOUS | 215000-001 | May 16, 2022 | RX | Yes | Yes | ⤷ 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 | |||
| >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 |
