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Last Updated: August 17, 2022

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: 22
Clinical Trials: 4
Patent Applications: 89
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
Drug Prices for ZEPZELCA

See drug prices for ZEPZELCA

DrugPatentWatch® Estimated Generic Entry Opportunity Date for ZEPZELCA
Generic Entry Date for ZEPZELCA*:
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:
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

SponsorPhase
Jazz PharmaceuticalsPhase 1
Emory UniversityPhase 1
National Cancer Institute (NCI)Phase 1

See all ZEPZELCA clinical trials

Pharmacology for ZEPZELCA
Drug Class Alkylating Drug
Mechanism of ActionAlkylating Activity

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 See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

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: See Plans and Pricing

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