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-six 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 26^th, 2006.

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Summary for ZUPLENZ

International Patents:	18
US Patents:	2
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	136
Clinical Trials:	5
Patent Applications:	4,207
Drug Prices:	Drug price information for ZUPLENZ
What excipients (inactive ingredients) are in ZUPLENZ?	ZUPLENZ excipients list
DailyMed Link:	ZUPLENZ at DailyMed

Drug patent expirations by year for ZUPLENZ

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

See all ZUPLENZ clinical trials

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
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Patent Expiration: ⤷ Sign Up

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Glossary

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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.

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Country	Patent Number	Title	Estimated Expiration
European Patent Office	2076251	FORMES PHARMACEUTIQUES À BASE DE FILM NON MUCO-ADHÉSIF (NON-MUCOADHESIVE FILM DOSAGE FORMS)	⤷ Sign Up
Denmark	2248519		⤷ Sign Up
China	101626756	Non-mucoadhesive film dosage forms	⤷ Sign Up
Germany	202007019476		⤷ Sign Up
South Korea	101448050		⤷ Sign Up
New Zealand	575900	NON-MUCOADHESIVE FILM DOSAGE FORMS	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

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Summary for ZUPLENZ

Recent Clinical Trials for ZUPLENZ

Patents protecting ZUPLENZ

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