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EXXUA Drug Patent Profile

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Which patents cover Exxua, and when can generic versions of Exxua launch?

Exxua is a drug marketed by Fabre Kramer and is included in one NDA. There is one patent protecting this drug.

This drug has three patent family members in three countries.

The generic ingredient in EXXUA is gepirone hydrochloride. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the gepirone hydrochloride profile page.

DrugPatentWatch^® Generic Entry Outlook for Exxua

Exxua will be eligible for patent challenges on September 22, 2027. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be September 22, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for EXXUA

International Patents:	3
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
What excipients (inactive ingredients) are in EXXUA?	EXXUA excipients list
DailyMed Link:	EXXUA at DailyMed

Drug patent expirations by year for EXXUA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EXXUA

Generic Entry Date for EXXUA^: ⤷ Subscribe* Constraining patent/regulatory exclusivity: NEW CHEMICAL ENTITY NDA: 021164 Dosage: TABLET, EXTENDED RELEASE;ORAL

^*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.

US Patents and Regulatory Information for EXXUA

EXXUA is protected by one US patents and one FDA Regulatory Exclusivity.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EXXUA is ⤷ Subscribe.

This potential generic entry date is based on NEW CHEMICAL ENTITY.
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 EXXUA

Patent Number: 7,538,116
Patent Expiration: ⤷ Subscribe
Patented Use: TREATMENT OF SUBJECTS WITH MAJOR DEPRESSION WITH SEXUAL DYSFUNCTION CAUSED BY EITHER MAJOR DEPRESSION OR PRIOR TREATMENTS, OR TREATMENT OF SUBJECTS WITH MAJOR DEPRESSION WITHOUT THE RISK OF SEXUAL DYSFUNCTION ADVERSE REACTIONS

FDA Regulatory Exclusivity protecting EXXUA

NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Subscribe

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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
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-001	Sep 22, 2023		DISCN	Yes	No	7,538,116	⤷ Subscribe				⤷ Subscribe
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-004	Sep 22, 2023		DISCN	Yes	No	7,538,116	⤷ Subscribe				⤷ Subscribe
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-002	Sep 22, 2023		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-004	Sep 22, 2023		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-001	Sep 22, 2023		DISCN	Yes	No	⤷ Subscribe	⤷ Subscribe				⤷ Subscribe
Fabre Kramer	EXXUA	gepirone hydrochloride	TABLET, EXTENDED RELEASE;ORAL	021164-002	Sep 22, 2023		DISCN	Yes	No	7,538,116	⤷ Subscribe				⤷ Subscribe
>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 EXXUA

See the table below for patents covering EXXUA around the world.

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Country	Patent Number	Title	Estimated Expiration
Argentina	048128	UN TRATAMIENTO DE LA DIFUNCION SEXUAL	⤷ Subscribe
World Intellectual Property Organization (WIPO)	2005053697		⤷ Subscribe
European Patent Office	1694332	TRAITEMENT DE TROUBLES SEXUELS (TREATMENT OF SEXUAL DISORDERS)	⤷ Subscribe
>Country	>Patent Number	>Title	>Estimated Expiration