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Last Updated: May 2, 2024

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
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^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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
First Affiliated Hospital of Shantou University Medical College	Phase 4

See all vonoprazan fumarate clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for vonoprazan fumarate

A02BC	Proton pump inhibitors
A02B	DRUGS FOR PEPTIC ULCER AND GASTRO-OESOPHAGEAL REFLUX DISEASE (GORD)
A02	DRUGS FOR ACID RELATED DISORDERS
A	Alimentary tract and metabolism

US Patents and Regulatory Information for vonoprazan fumarate

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Glossary

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-002	Nov 1, 2023		RX	Yes	Yes	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Phathom	VOQUEZNA	vonoprazan fumarate	TABLET;ORAL	215151-001	Nov 1, 2023		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial		Y		⤷ Try a Trial
>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

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Country	Patent Number	Title	Estimated Expiration
Jordan	2791	مثبط إفراز الحمض (ACID SECRETION INHIBITOR)	⤷ Try a Trial
Tunisia	2011000030	PHARACEUTICAL COMPOSITION	⤷ Try a Trial
Russian Federation	2008112153	1-ГЕТЕРОЦИКЛИЛСУЛЬФОНИЛ, 2-АМИНОМЕТИЛ, 5-(ГЕТЕРО)АРИЛ ЗАМЕЩЕННЫЕ 1-Н-ПИРРОЛ ПРОИЗВОДНЫЕ В КАЧЕСТВЕ ИНГИБИТОРОВ СЕКРЕЦИИ КИСЛОТЫ	⤷ Try a Trial
Austria	E504567		⤷ Try a Trial
Japan	5204426		⤷ Try a Trial
Eurasian Patent Organization	201201451	ФАРМАЦЕВТИЧЕСКАЯ КОМПОЗИЦИЯ	⤷ Try a Trial
European Patent Office	1919865	DÉRIVÉS DE 1-H-PYRROLE SUBSTITUÉS PAR UN GROUPE 1-HÉTÉROCYCLYLSULFONYLE, 2-AMINOMÉTHYLE, 5-(HÉTÉRO)ARYLE EN TANT QU'INHIBITEURS DES SÉCRÉTIONS ACIDES (1-HETEROCYCLYLSULFONYL, 2-AMINOMETHYL, 5- (HETERO-) ARYL SUBSTITUTED 1-H-PYRROLE DERIVATIVES AS ACID SECRETION INHIBITORS)	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

Summary for vonoprazan fumarate

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for vonoprazan fumarate

Recent Clinical Trials for vonoprazan fumarate

Anatomical Therapeutic Chemical (ATC) Classes for vonoprazan fumarate

Make Better Decisions: Try a trial or see plans & pricing

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for vonoprazan fumarate