ZUPLENZ Drug Patent Profile
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Which patents cover Zuplenz, and when can generic versions of Zuplenz launch?
Zuplenz is a drug marketed by Aquestive and is included in one NDA. There are two patents protecting this drug.
This drug has eighteen patent family members in fourteen countries.
The generic ingredient in ZUPLENZ is ondansetron. There are twenty-eight drug master file entries for this compound. Thirty-three suppliers are listed for this compound. Additional details are available on the ondansetron profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Zuplenz
A generic version of ZUPLENZ was approved as ondansetron by CHARTWELL MOLECULES on December 26th, 2006.
Summary for ZUPLENZ
| International Patents: | 18 |
| US Patents: | 2 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 133 |
| Clinical Trials: | 5 |
| Patent Applications: | 3,071 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | Drug price information for ZUPLENZ |
| What excipients (inactive ingredients) are in ZUPLENZ? | ZUPLENZ excipients list |
| DailyMed Link: | ZUPLENZ at DailyMed |
Recent Clinical Trials for ZUPLENZ
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 2 |
| M.D. Anderson Cancer Center | Phase 2 |
| Tesaro, Inc. | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for ZUPLENZ
US Patents and Regulatory Information for ZUPLENZ
ZUPLENZ is protected by two US patents.
Patents protecting ZUPLENZ
Non-mucoadhesive film dosage forms
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Stabilized amine-containing actives in oral film compositions
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-001 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-002 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-001 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-002 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ 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 ZUPLENZ
See the table below for patents covering ZUPLENZ around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Brazil | PI0719840 | FORMAS DE DOSAGEM DE PELÍCULAS NÃO-MUCOADESIVA | ⤷ Try a Trial |
| European Patent Office | 2076251 | FORMES PHARMACEUTIQUES À BASE DE FILM NON MUCO-ADHÉSIF (NON-MUCOADHESIVE FILM DOSAGE FORMS) | ⤷ Try a Trial |
| Hungary | E038022 | ⤷ Try a Trial | |
| World Intellectual Property Organization (WIPO) | 2008040534 | ⤷ Try a Trial | |
| South Korea | 101448050 | ⤷ Try a Trial | |
| >Country | >Patent Number | >Title | >Estimated 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.
ISSN: 2162-2639
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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