Dactinomycin - Generic Drug Details
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What are the generic drug sources for dactinomycin and what is the scope of freedom to operate?
Dactinomycin
is the generic ingredient in two branded drugs marketed by Recordati Rare, Am Regent, Eugia Pharma, Hikma, Hisun Pharm Hangzhou, Meitheal, and Xgen Pharms, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for dactinomycin. Six suppliers are listed for this compound.
Summary for dactinomycin
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 7 |
NDAs: | 7 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 6 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 47 |
Patent Applications: | 2,820 |
Drug Prices: | Drug price trends for dactinomycin |
What excipients (inactive ingredients) are in dactinomycin? | dactinomycin excipients list |
DailyMed Link: | dactinomycin at DailyMed |
Recent Clinical Trials for dactinomycin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
St. Jude Children's Research Hospital | Phase 1/Phase 2 |
xiang yang | N/A |
University of Birmingham | Phase 1/Phase 2 |
Pharmacology for dactinomycin
Drug Class | Actinomycin |
Mechanism of Action | Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors |
Medical Subject Heading (MeSH) Categories for dactinomycin
Anatomical Therapeutic Chemical (ATC) Classes for dactinomycin
US Patents and Regulatory Information for dactinomycin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 090304-001 | Mar 16, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Meitheal | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 213463-001 | Nov 13, 2020 | AP | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Am Regent | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 202562-001 | Aug 23, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
Eugia Pharma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385-001 | Nov 9, 2017 | AP | 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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