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.

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 will be eligible for patent challenges on June 15, 2024. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be June 15, 2027. This may change due to patent challenges or generic licensing.

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:	82
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY 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
Jazz Pharmaceuticals	Phase 1
Emory University	Phase 1
National Cancer Institute (NCI)	Phase 1

See all ZEPZELCA clinical trials

Pharmacology for ZEPZELCA

Drug Class	Alkylating Drug
Mechanism of Action	Alkylating Activity

Anatomical Therapeutic Chemical (ATC) Classes for ZEPZELCA

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

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 ⤷ Try a Trial.

This potential generic entry date is based on INDICATED FOR THE TREATMENT OF ADULT PATIENTS WITH METASTATIC SMALL CELL LUNG CANCER (SCLC) WITH DISEASE PROGRESSION ON OR AFTER PLATINUM-BASED CHEMOTHERAPY.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ Try a Trial

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: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial	Y	Y		⤷ Try a Trial
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Jazz	ZEPZELCA	lurbinectedin	POWDER;INTRAVENOUS	213702-001	Jun 15, 2020		RX	Yes	Yes	⤷ 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

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
Russian Federation	2283842	ПРОИЗВОДНЫЕ ЭКТЕИНАСЦИДИНА, ИХ ПРИМЕНЕНИЕ И ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ (ECTEINASCIDIN DERIVATIVES AND PHARMACEUTICAL COMPOSITION)	⤷ Try a Trial
Denmark	1414828		⤷ Try a Trial
New Zealand	530837	Derivatives of ecteinascidin 736 as antitumoral analogs	⤷ Try a Trial
Poland	367940		⤷ Try a Trial
Portugal	1414828		⤷ Try a Trial
Germany	60222775		⤷ Try a Trial
Hong Kong	1065786		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration