Gepirone hydrochloride - Generic Drug Details
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What are the generic drug sources for gepirone hydrochloride and what is the scope of freedom to operate?
Gepirone hydrochloride
is the generic ingredient in one branded drug marketed by Fabre Kramer and is included in one NDA. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.Gepirone hydrochloride has three patent family members in three countries.
There is one drug master file entry for gepirone hydrochloride. One supplier is listed for this compound.
Summary for gepirone hydrochloride
| International Patents: | 3 |
| US Patents: | 1 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 13 |
| Clinical Trials: | 2 |
| Patent Applications: | 234 |
| DailyMed Link: | gepirone hydrochloride at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for gepirone hydrochloride
Generic Entry Date for gepirone hydrochloride*:
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.
Recent Clinical Trials for gepirone hydrochloride
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Duke University | Phase 3 |
| Forest Laboratories | Phase 3 |
| National Institute on Drug Abuse (NIDA) | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for gepirone hydrochloride
US Patents and Regulatory Information for gepirone hydrochloride
| 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 | 021164-004 | 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 | 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 | 7,538,116 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Fabre Kramer | EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164-003 | Sep 22, 2023 | DISCN | Yes | No | 7,538,116 | ⤷ Subscribe | ⤷ Subscribe | ||||
| Fabre Kramer | EXXUA | gepirone hydrochloride | TABLET, EXTENDED RELEASE;ORAL | 021164-003 | 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 | ||||
| >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 gepirone hydrochloride
| 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 |
