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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for ZEPZELCA
*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 |
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
| 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.
Make Better Decisions: Try a trial or see plans & pricing
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.
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