AMOXICILLIN; VONOPRAZAN FUMARATE - Generic Drug Details
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What are the generic drug sources for amoxicillin; vonoprazan fumarate and what is the scope of freedom to operate?
Amoxicillin; 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.Amoxicillin; vonoprazan fumarate has one hundred and three patent family members in forty-three countries.
One supplier is listed for this compound.
Summary for AMOXICILLIN; VONOPRAZAN FUMARATE
| International Patents: | 103 |
| US Patents: | 2 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Clinical Trials: | 7 |
| DailyMed Link: | AMOXICILLIN; VONOPRAZAN FUMARATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AMOXICILLIN; VONOPRAZAN FUMARATE
Generic Entry Date for AMOXICILLIN; VONOPRAZAN FUMARATE*:
Constraining patent/regulatory exclusivity:
GENERATING ANTIBIOTIC INCENTIVES NOW Dosage:
CAPSULE, TABLET;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 AMOXICILLIN; 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 |
| First People's Hospital of Foshan | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for AMOXICILLIN; VONOPRAZAN FUMARATE
US Patents and Regulatory Information for AMOXICILLIN; 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 DUAL PAK | amoxicillin; vonoprazan fumarate | CAPSULE, TABLET;ORAL | 215153-001 | May 3, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Phathom | VOQUEZNA DUAL PAK | amoxicillin; vonoprazan fumarate | CAPSULE, TABLET;ORAL | 215153-001 | May 3, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Phathom | VOQUEZNA DUAL PAK | amoxicillin; vonoprazan fumarate | CAPSULE, TABLET;ORAL | 215153-001 | May 3, 2022 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ 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 AMOXICILLIN; 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 |
