Vonoprazan fumarate - Generic Drug Details
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What are the generic sources for vonoprazan fumarate and what is the scope of freedom to operate?
Vonoprazan fumarate
is the generic ingredient in one branded drug marketed by Phathom and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.Vonoprazan fumarate has one hundred and three patent family members in forty-three countries.
There is one drug master file entry for vonoprazan fumarate. One supplier is listed for this compound.
Summary for vonoprazan fumarate
| International Patents: | 103 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 7 |
| Patent Applications: | 80 |
| What excipients (inactive ingredients) are in vonoprazan fumarate? | vonoprazan fumarate excipients list |
| DailyMed Link: | vonoprazan fumarate at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vonoprazan fumarate
*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 vonoprazan fumarate
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Sixth Affiliated Hospital, Sun Yat-sen University | Phase 3 |
| The First Affiliated Hospital of Nanchang University | Phase 4 |
| Guangzhou Panyu Central Hospital | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for vonoprazan fumarate
US Patents and Regulatory Information for vonoprazan fumarate
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151-001 | Nov 1, 2023 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151-002 | Nov 1, 2023 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151-002 | Nov 1, 2023 | RX | Yes | Yes | ⤷ 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 vonoprazan fumarate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Dominican Republic | P2011000033 | COMPOSICION FARMACEUTICA | ⤷ Sign Up |
| Ecuador | SP11010855 | COMPOSICIÓN FARMACÉUTICA | ⤷ Sign Up |
| Chile | 2013000224 | Preparacion solida mejorada que comprende un ingrediente farmaceuticamente activo, un plastificante y un acido organico de cadena; metodo para estabilizar una preparacion solida (divisional sol 170-11) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
