Vonoprazan fumarate - Generic Drug Details
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What are the generic sources for vonoprazan fumarate and what is the scope of patent protection?
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
Generic Entry Date for vonoprazan fumarate*:
Constraining patent/regulatory exclusivity:
Dosage:
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 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 |
| Shunde Hospital of Southern Medical University | 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 | 215151-002 | Nov 1, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151-001 | Nov 1, 2023 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151-002 | Nov 1, 2023 | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | Y | ⤷ Subscribe | |||
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151-001 | Nov 1, 2023 | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | ||||
| Phathom | VOQUEZNA | vonoprazan fumarate | TABLET;ORAL | 215151-001 | Nov 1, 2023 | RX | 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 vonoprazan fumarate
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Slovenia | 1919865 | ⤷ Subscribe | |
| Ukraine | 103332 | ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ, КОТОРАЯ СОДЕРЖИТ НЕПЕПТИДНЫЙ АКТИВНЫЙ АГЕНТ С ПЕРВИЧНОЙ ИЛИ ВТОРИЧНОЙ АМИНОГРУППОЙ;ФАРМАЦЕВТИЧНА КОМПОЗИЦІЯ, ЩО МІСТИТЬ НЕПЕПТИДНИЙ АКТИВНИЙ АГЕНТ З ПЕРВИННОЮ АБО ВТОРИННОЮ АМІНОГРУПОЮ (PHARMACEUTICAL COMPOSITION CONTAINING A NONPEPTIDIC ACTIVE AGENT HAVING A PRIMARY OR SECONDARY AMINO GROUP) | ⤷ Subscribe |
| Taiwan | 201010992 | Pharmaceutical composition | ⤷ Subscribe |
| Portugal | 2327692 | ⤷ Subscribe | |
| Cyprus | 1111922 | ⤷ Subscribe | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
