zepzelca Drug Patent Profile
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Which patents cover Zepzelca, and when can generic versions of Zepzelca launch?
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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Questions you can ask:
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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
Generic Entry Date for zepzelca*:
Constraining patent/regulatory exclusivity:
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
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Poland | 218295 | ⤷ Sign Up | |
Hungary | 229779 | Ecteinascidin analogues, their use in the preparation of a medicament for treatment of cancer and pharmaceutical compositions containing the compounds | ⤷ Sign Up |
European Patent Office | 1806349 | ⤷ Sign Up | |
Austria | 374777 | ⤷ Sign Up | |
South Korea | 20040032150 | ⤷ Sign Up | |
Japan | 2005501093 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |