ROMIDEPSIN - Generic Drug Details
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What are the generic drug sources for romidepsin and what is the scope of freedom to operate?
Romidepsin
is the generic ingredient in two branded drugs marketed by Bristol-myers, Fresenius Kabi Usa, and Teva Pharms Usa Inc, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.There are three drug master file entries for romidepsin. Three suppliers are listed for this compound.
Summary for ROMIDEPSIN
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 3 |
NDAs: | 3 |
Drug Master File Entries: | 3 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 43 |
Clinical Trials: | 100 |
Patent Applications: | 6,714 |
Drug Prices: | Drug price trends for ROMIDEPSIN |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ROMIDEPSIN |
What excipients (inactive ingredients) are in ROMIDEPSIN? | ROMIDEPSIN excipients list |
DailyMed Link: | ROMIDEPSIN at DailyMed |
Recent Clinical Trials for ROMIDEPSIN
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Peking Union Medical College Hospital | Phase 1/Phase 2 |
ANRS, Emerging Infectious Diseases | Phase 1 |
INSERM SC10-US19 | Phase 1 |
Pharmacology for ROMIDEPSIN
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
ISTODAX | Injection | romidepsin | 10 mg/vial | 022393 | 1 | 2013-11-05 |
US Patents and Regulatory Information for ROMIDEPSIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Fresenius Kabi Usa | ROMIDEPSIN | romidepsin | POWDER;INTRAVENOUS | 206254-001 | Oct 12, 2021 | AP | RX | No | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
Teva Pharms Usa Inc | ROMIDEPSIN | romidepsin | SOLUTION;INTRAVENOUS | 208574-001 | Mar 13, 2020 | DISCN | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | AP | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ROMIDEPSIN
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | ⤷ Subscribe | ⤷ Subscribe |
Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | ⤷ Subscribe | ⤷ Subscribe |
Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | ⤷ Subscribe | ⤷ Subscribe |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ROMIDEPSIN
Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
---|---|---|---|---|---|---|---|---|---|
Celgene Europe Ltd. | Istodax | romidepsin | EMEA/H/C/002122 treatment of peripheral T-cell lymphoma (PTCL), |
Refused | no | no | yes | 2013-02-12 | |
>Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
ROMIDEPSIN Market Analysis and Financial Projection Experimental
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