DACTINOMYCIN Drug Patent Profile
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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. Six 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.
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Questions you can ask:
- What is the 5 year forecast for DACTINOMYCIN?
- What are the global sales for DACTINOMYCIN?
- What is Average Wholesale Price for DACTINOMYCIN?
Summary for DACTINOMYCIN
| US Patents: | 0 |
| Applicants: | 6 |
| NDAs: | 6 |
| Finished Product Suppliers / Packagers: | 4 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 47 |
| Patent Applications: | 1,968 |
| 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 |
|---|---|
| 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Am Regent | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 202562-001 | Aug 23, 2013 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Hisun Pharm Hangzhou | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 207232-001 | Jul 16, 2019 | AP | RX | 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 | |||
| Hikma | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 090304-001 | Mar 16, 2010 | DISCN | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Xgen Pharms | DACTINOMYCIN | dactinomycin | INJECTABLE;INJECTION | 203999-001 | May 20, 2019 | AP | RX | 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 | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
