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
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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EXXUA
Generic Entry Date for EXXUA*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY NDA:
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.
Anatomical Therapeutic Chemical (ATC) Classes for EXXUA
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 ⤷ Try a Trial.
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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Fabre Kramer | EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164-001 | Sep 22, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fabre Kramer | EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164-004 | Sep 22, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fabre Kramer | EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164-002 | Sep 22, 2023 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Fabre Kramer | EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164-004 | Sep 22, 2023 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ 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 EXXUA
See the table below for patents covering EXXUA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| World Intellectual Property Organization (WIPO) | 2005053697 | ⤷ Try a Trial | |
| Argentina | 048128 | UN TRATAMIENTO DE LA DIFUNCION SEXUAL | ⤷ Try a Trial |
| European Patent Office | 1694332 | TRAITEMENT DE TROUBLES SEXUELS (TREATMENT OF SEXUAL DISORDERS) | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2024, www.DrugPatentWatch.com.
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