ROMIDEPSIN Drug Patent Profile
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When do Romidepsin patents expire, and when can generic versions of Romidepsin launch?
Romidepsin is a drug marketed by Fresenius Kabi Usa and Teva Pharms Usa Inc and is included in two NDAs.
The generic ingredient in ROMIDEPSIN is romidepsin. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the romidepsin profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Romidepsin
A generic version of ROMIDEPSIN was approved as romidepsin by FRESENIUS KABI USA on October 12th, 2021.
Summary for ROMIDEPSIN
| US Patents: | 0 |
| Applicants: | 2 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Clinical Trials: | 99 |
| Patent Applications: | 4,960 |
| Drug Prices: | Drug price information 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 |
|---|---|
| ANRS, Emerging Infectious Diseases | Phase 1 |
| INSERM SC10-US19 | Phase 1 |
| Sun Yat-sen University | Phase 2 |
Pharmacology for ROMIDEPSIN
Anatomical Therapeutic Chemical (ATC) Classes for ROMIDEPSIN
Paragraph IV (Patent) Challenges 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 | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa Inc | ROMIDEPSIN | romidepsin | SOLUTION;INTRAVENOUS | 208574-001 | Mar 13, 2020 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Teva Pharms Usa Inc | ROMIDEPSIN | romidepsin | SOLUTION;INTRAVENOUS | 208574-002 | Mar 13, 2020 | DISCN | Yes | 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 |
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 |
