DACARBAZINE - Generic Drug Details
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What are the generic sources for dacarbazine and what is the scope of patent protection?
Dacarbazine
is the generic ingredient in two branded drugs marketed by Abraxis Pharm, Fresenius Kabi Usa, Hikma, Hospira, Meitheal, and Bayer Hlthcare, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are nine drug master file entries for dacarbazine. Three suppliers are listed for this compound.
Summary for DACARBAZINE
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 6 |
NDAs: | 7 |
Drug Master File Entries: | 9 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 80 |
Clinical Trials: | 240 |
Patent Applications: | 5,498 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for DACARBAZINE |
What excipients (inactive ingredients) are in DACARBAZINE? | DACARBAZINE excipients list |
DailyMed Link: | DACARBAZINE at DailyMed |
Recent Clinical Trials for DACARBAZINE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Diwakar Davar | Phase 2 |
IDEAYA Biosciences | Phase 2/Phase 3 |
Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Phase 3 |
Pharmacology for DACARBAZINE
Drug Class | Alkylating Drug |
Mechanism of Action | Alkylating Activity |
Medical Subject Heading (MeSH) Categories for DACARBAZINE
Anatomical Therapeutic Chemical (ATC) Classes for DACARBAZINE
US Patents and Regulatory Information for DACARBAZINE
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | DACARBAZINE | dacarbazine | INJECTABLE;INJECTION | 075812-001 | Jun 15, 2001 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Abraxis Pharm | DACARBAZINE | dacarbazine | INJECTABLE;INJECTION | 070990-001 | Aug 28, 1986 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Bayer Hlthcare | DTIC-DOME | dacarbazine | INJECTABLE;INJECTION | 017575-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Fresenius Kabi Usa | DACARBAZINE | dacarbazine | INJECTABLE;INJECTION | 075371-001 | Aug 27, 1999 | RX | No | Yes | ⤷ 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 |
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