DACTINOMYCIN Drug Patent Profile
✉ Email this page to a colleague
When do Dactinomycin patents expire, and what generic alternatives are available?
Dactinomycin is a drug marketed by Am Regent, Eugia Pharma, Hikma, Hisun Pharm Hangzhou, Meitheal, and Xgen Pharms. and is included in six NDAs.
The generic ingredient in DACTINOMYCIN is dactinomycin. There are three drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the dactinomycin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Dactinomycin
A generic version of DACTINOMYCIN was approved as dactinomycin by EUGIA PHARMA on November 9th, 2017.
Summary for DACTINOMYCIN
US Patents: | 0 |
Applicants: | 6 |
NDAs: | 6 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 39 |
Clinical Trials: | 46 |
Patent Applications: | 3,832 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price information 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 |
---|---|
xiang yang | N/A |
University of Birmingham | Phase 1/Phase 2 |
Shengjing Hospital | Phase 4 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Am Regent | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 202562-001 | Aug 23, 2013 | DISCN | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
Hisun Pharm Hangzhou | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 207232-001 | Jul 16, 2019 | AP | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Eugia Pharma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203385-001 | Nov 9, 2017 | AP | RX | No | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Hikma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 090304-001 | Mar 16, 2010 | DISCN | 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 |