COSMEGEN Drug Patent Profile
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When do Cosmegen patents expire, and what generic alternatives are available?
Cosmegen is a drug marketed by Recordati Rare and is included in one NDA.
The generic ingredient in COSMEGEN 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 Cosmegen
A generic version of COSMEGEN was approved as dactinomycin by EUGIA PHARMA on November 9th, 2017.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for COSMEGEN?
- What are the global sales for COSMEGEN?
- What is Average Wholesale Price for COSMEGEN?
Summary for COSMEGEN
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 39 |
| Clinical Trials: | 16 |
| Patent Applications: | 4,762 |
| Drug Prices: | Drug price information for COSMEGEN |
| What excipients (inactive ingredients) are in COSMEGEN? | COSMEGEN excipients list |
| DailyMed Link: | COSMEGEN at DailyMed |
Recent Clinical Trials for COSMEGEN
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Phase 2 |
| National Pediatric Cancer Foundation | Phase 2 |
| Tufts Medical Center | Phase 3 |
Pharmacology for COSMEGEN
| Drug Class | Actinomycin |
| Mechanism of Action | Nucleic Acid Synthesis Inhibitors Protein Synthesis Inhibitors |
US Patents and Regulatory Information for COSMEGEN
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Recordati Rare | COSMEGEN | dactinomycin | INJECTABLE;INJECTION | 050682-001 | Approved Prior to Jan 1, 1982 | DISCN | Yes | 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 |
