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ZEPZELCA Drug Patent Profile

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When do Zepzelca patents expire, and what generic alternatives are available?

Zepzelca is a drug marketed by Jazz and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in ZEPZELCA is lurbinectedin. One supplier is listed for this compound. Additional details are available on the lurbinectedin profile page.

DrugPatentWatch^® Generic Entry Outlook for Zepzelca

Zepzelca was eligible for patent challenges on June 15, 2024.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 13, 2029. This may change due to patent challenges or generic licensing.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

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Summary for ZEPZELCA

International Patents:	32
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	32
Clinical Trials:	4
Patent Applications:	56
Drug Prices:	Drug price information for ZEPZELCA
What excipients (inactive ingredients) are in ZEPZELCA?	ZEPZELCA excipients list
DailyMed Link:	ZEPZELCA at DailyMed

Drug patent expirations by year for ZEPZELCA

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

Generic Entry Date for ZEPZELCA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up NDA: 213702 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 ZEPZELCA

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

Sponsor	Phase
Emory University	Phase 1
National Cancer Institute (NCI)	Phase 1
Jazz Pharmaceuticals	Phase 1

See all ZEPZELCA clinical trials

Pharmacology for ZEPZELCA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Paragraph IV (Patent) Challenges for ZEPZELCA

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 ZEPZELCA

ZEPZELCA is protected by one US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of ZEPZELCA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting ZEPZELCA

Ecteinascidin analogs for use as antitumour agents
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF ADULT PATIENTS WITH SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY.

FDA Regulatory Exclusivity protecting ZEPZELCA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up

INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY
Exclusivity Expiration: ⤷ Sign Up

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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	Y	Y		⤷ 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				⤷ 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 ZEPZELCA

See the table below for patents covering ZEPZELCA around the world.

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Country	Patent Number	Title	Estimated Expiration
Poland	367940		⤷ Sign Up
European Patent Office	2270018		⤷ Sign Up
Spain	2294151		⤷ Sign Up
Austria	374777		⤷ Sign Up
European Patent Office	1414828	ANALOGUES ANTITUMORAUX (ANTITUMORAL ANALOGS)	⤷ Sign Up
Japan	4684552		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration