DACTINOMYCIN - Generic Drug Details
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What are the generic 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.Four suppliers are listed for this compound.
Summary for DACTINOMYCIN
| US Patents: | 0 |
| Tradenames: | 2 |
| Applicants: | 7 |
| NDAs: | 7 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 1 |
| Clinical Trials: | 50 |
| Patent Applications: | 8,155 |
| 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 |
|---|---|
| Children's Oncology Group | PHASE3 |
| St. Jude Children's Research Hospital | Phase 1/Phase 2 |
| xiang yang | N/A |
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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Hisun Pharm Hangzhou | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 207232-001 | Jul 16, 2019 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Hikma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 090304-001 | Mar 16, 2010 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Xgen Pharms | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203999-001 | May 20, 2019 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Am Regent | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 202562-001 | Aug 23, 2013 | DISCN | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Meitheal | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 213463-001 | Nov 13, 2020 | AP | RX | No | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | |||
| Recordati Rare | COSMEGEN | dactinomycin | INJECTABLE;INJECTION | 050682-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | No | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| >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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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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