Valrubicin - Generic Drug Details
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What are the generic sources for valrubicin and what is the scope of freedom to operate?
Valrubicin
is the generic ingredient in two branded drugs marketed by Hikma and Endo Pharm, and is included in two NDAs. Additional information is available in the individual branded drug profile pages.There are two drug master file entries for valrubicin. Two suppliers are listed for this compound.
Summary for valrubicin
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 2 |
NDAs: | 2 |
Drug Master File Entries: | 2 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 58 |
Clinical Trials: | 6 |
Patent Applications: | 7,289 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for valrubicin |
What excipients (inactive ingredients) are in valrubicin? | valrubicin excipients list |
DailyMed Link: | valrubicin at DailyMed |
Recent Clinical Trials for valrubicin
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
H. Lee Moffitt Cancer Center and Research Institute | Phase 1 |
Endo Pharmaceuticals | Phase 1 |
Endo Pharmaceuticals | Phase 3 |
Anatomical Therapeutic Chemical (ATC) Classes for valrubicin
US Patents and Regulatory Information for valrubicin
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Hikma | VALRUBICIN | valrubicin | SOLUTION;INTRAVESICAL | 206430-001 | Apr 19, 2019 | AO | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Endo Pharm | VALSTAR PRESERVATIVE FREE | valrubicin | SOLUTION;INTRAVESICAL | 020892-001 | Sep 25, 1998 | AO | RX | Yes | Yes | ⤷ 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 |