Details for New Drug Application (NDA): 021164
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NDA 021164 describes EXXUA, which is a drug marketed by Fabre Kramer and is included in one NDA. It is available from two suppliers. There is one patent protecting this drug. Additional details are available on the EXXUA profile page.
The generic ingredient in EXXUA is gepirone hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gepirone hydrochloride profile page.
The generic ingredient in EXXUA is gepirone hydrochloride. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gepirone hydrochloride profile page.
Summary for 021164
| Tradename: | EXXUA |
| Applicant: | Fabre Kramer |
| Ingredient: | gepirone hydrochloride |
| Patents: | 1 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 021164
Generic Entry Date for 021164*:
Constraining patent/regulatory exclusivity:
NEW CHEMICAL ENTITY 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.
Suppliers and Packaging for NDA: 021164
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164 | NDA | Aytu Therapeutics, LLC | 23594-150 | 23594-150-30 | 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-30) |
| EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164 | NDA | Aytu Therapeutics, LLC | 23594-150 | 23594-150-32 | 32 TABLET, EXTENDED RELEASE in 1 BOTTLE (23594-150-32) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 18.2MG BASE | ||||
| Approval Date: | Sep 22, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | 7,538,116 | Patent Expiration: | Sep 2, 2030 | Product Flag? | Substance Flag? | Delist Request? | |||
| 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 | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | TABLET, EXTENDED RELEASE;ORAL | Strength | EQ 36.3MG BASE | ||||
| Approval Date: | Sep 22, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 22, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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