ISTODAX Drug Patent Profile
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When do Istodax patents expire, and when can generic versions of Istodax launch?
Istodax is a drug marketed by Bristol-myers and is included in one NDA.
The generic ingredient in ISTODAX 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 Istodax
A generic version of ISTODAX was approved as romidepsin by FRESENIUS KABI USA on October 12th, 2021.
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Summary for ISTODAX
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 43 |
| Clinical Trials: | 46 |
| Patent Applications: | 4,652 |
| Drug Prices: | Drug price information for ISTODAX |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ISTODAX |
| What excipients (inactive ingredients) are in ISTODAX? | ISTODAX excipients list |
| DailyMed Link: | ISTODAX at DailyMed |
Recent Clinical Trials for ISTODAX
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| AstraZeneca | Phase 1/Phase 2 |
| GWT-TUD GmbH | Phase 1/Phase 2 |
| Changchun Deng | Phase 1 |
Paragraph IV (Patent) Challenges for ISTODAX
| 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 ISTODAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | AP | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for ISTODAX
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| Bristol-myers | ISTODAX | romidepsin | POWDER;INTRAVENOUS | 022393-001 | Nov 5, 2009 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ISTODAX
| 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 |
International Patents for ISTODAX
See the table below for patents covering ISTODAX around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Finland | 893359 | ⤷ Sign Up | |
| Australia | 8010901 | ⤷ Sign Up | |
| Spain | 2058411 | ⤷ Sign Up | |
| Hungary | 211514 | ⤷ Sign Up | |
| Israel | 90949 | ⤷ Sign Up | |
| Austria | 94561 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 0220817 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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