Lurbinectedin - Generic Drug Details

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What are the generic sources for lurbinectedin and what is the scope of freedom to operate?

Lurbinectedin is the generic ingredient in one branded drug marketed by Jazz and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Lurbinectedin has thirty-two patent family members in twenty-three countries.

One supplier is listed for this compound.

Summary for lurbinectedin

International Patents:	32
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	36
Patent Applications:	184
What excipients (inactive ingredients) are in lurbinectedin?	lurbinectedin excipients list
DailyMed Link:	lurbinectedin at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for lurbinectedin

Generic Entry Date for lurbinectedin^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up Dosage: POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for lurbinectedin

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
PharmaMar	Phase 2/Phase 3
Stand Up To Cancer	Phase 1/Phase 2
Children's Hospital of Philadelphia	Phase 1/Phase 2

See all lurbinectedin clinical trials

Pharmacology for lurbinectedin

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for lurbinectedin

L01XX	Other antineoplastic agents
L01X	OTHER ANTINEOPLASTIC AGENTS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for LURBINECTEDIN

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ZEPZELCA	Powder for Injection	lurbinectedin	4 mg/vial	213702	5	2024-06-17

US Patents and Regulatory Information for lurbinectedin

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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
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for lurbinectedin

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Country	Patent Number	Title	Estimated Expiration
Denmark	1414828		⤷ Sign Up
China	1564822		⤷ Sign Up
Germany	60222775		⤷ Sign Up
Australia	2002313540		⤷ Sign Up
Hungary	0401174		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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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.