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

See drug prices for ROMIDEPSIN

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

See all ROMIDEPSIN clinical trials

Pharmacology for ROMIDEPSIN

Drug Class	Histone Deacetylase Inhibitor
Mechanism of Action	Bile Salt Export Pump Inhibitors Histone Deacetylase Inhibitors Organic Anion Transporter 1 Inhibitors Organic Anion Transporting Polypeptide 1B1 Inhibitors Organic Anion Transporting Polypeptide 1B3 Inhibitors Organic Cation Transporter 2 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ROMIDEPSIN

L01XH	Histone deacetylase (HDAC) inhibitors
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Pharms Usa Inc	ROMIDEPSIN	romidepsin	SOLUTION;INTRAVENOUS	208574-002	Mar 13, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Fresenius Kabi Usa	ROMIDEPSIN	romidepsin	POWDER;INTRAVENOUS	206254-001	Oct 12, 2021	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa Inc	ROMIDEPSIN	romidepsin	SOLUTION;INTRAVENOUS	208574-001	Mar 13, 2020		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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 ROMIDEPSIN

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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 ROMIDEPSIN

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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

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