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-four 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: | 136 |
Clinical Trials: | 5 |
Patent Applications: | 4,051 |
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 |
---|---|
M.D. Anderson Cancer Center | Phase 2 |
Tesaro, Inc. | Phase 2 |
National Cancer Institute (NCI) | 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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Stabilized amine-containing actives in oral film compositions
Patent Number: ⤷ Sign Up
Patent 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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-001 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-002 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-001 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
Aquestive | ZUPLENZ | ondansetron | FILM;ORAL | 022524-002 | Jul 2, 2010 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ 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 ZUPLENZ
See the table below for patents covering ZUPLENZ around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2248519 | ⤷ Sign Up | |
European Patent Office | 2444072 | Formes galéniques de film non mucoadhésifs (Non-mucoadhesive film dosage forms) | ⤷ Sign Up |
Poland | 2248519 | ⤷ Sign Up | |
European Patent Office | 2076251 | FORMES PHARMACEUTIQUES À BASE DE FILM NON MUCO-ADHÉSIF (NON-MUCOADHESIVE FILM DOSAGE FORMS) | ⤷ Sign Up |
New Zealand | 575900 | NON-MUCOADHESIVE FILM DOSAGE FORMS | ⤷ Sign Up |
Germany | 202007019476 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |