VIBEGRON - Generic Drug Details

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What are the generic sources for vibegron and what is the scope of freedom to operate?

Vibegron is the generic ingredient in one branded drug marketed by Urovant and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vibegron has seventy-three patent family members in forty-one countries.

One supplier is listed for this compound.

Summary for VIBEGRON

International Patents:	73
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	27
Clinical Trials:	11
Patent Applications:	66
What excipients (inactive ingredients) are in VIBEGRON?	VIBEGRON excipients list
DailyMed Link:	VIBEGRON at DailyMed

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

Generic Entry Date for VIBEGRON^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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 VIBEGRON

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Urovant Sciences GmbH	Phase 2/Phase 3
Urovant Sciences GmbH	Phase 4
Urovant Sciences GmbH	Phase 2

See all VIBEGRON clinical trials

Pharmacology for VIBEGRON

Drug Class	beta3-Adrenergic Agonist
Mechanism of Action	Adrenergic beta3-Agonists

Anatomical Therapeutic Chemical (ATC) Classes for VIBEGRON

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

US Patents and Regulatory Information for VIBEGRON

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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
Urovant	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Urovant	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up		Y		⤷ Sign Up
Urovant	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Urovant	GEMTESA	vibegron	TABLET;ORAL	213006-001	Dec 23, 2020		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 VIBEGRON

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Country	Patent Number	Title	Estimated Expiration
Israel	208215	הידרוקסימתיל פירולידינים, הרכב רוקחי המכיל אותם ושימוש שלהם להכנת תרופה (Hydroxymethyl pyrrolidines, pharmaceutical compositions comprising same and use thereof for preparation of medicaments)	⤷ Sign Up
Ukraine	101367	ГІДРОКСИМЕТИЛПІРОЛІДИНИ ЯК АГОНІСТИ АДРЕНЕРГІЧНИХ РЕЦЕПТОРІВ β3[Normal;heading 1;heading 2;heading 3;ГИДРОКСИМЕТИЛПИРРОЛИДИНЫ КАК АГОНИСТЫ АДРЕНЕРГИЧЕСКИХ РЕЦЕПТОРОВ β3 (Normal;heading 1;heading 2;heading 3;HYDROXYMETHYL PYRROLIDINES AS BETA 3 ADRENERGIC RECEPTOR AGONISTS)	⤷ Sign Up
Japan	2011201897	HYDROXYMETHYL PYRROLIDINE AS BETA 3 ADRENERGIC RECEPTOR AGONIST	⤷ Sign Up
South Korea	20200012949	과민성 방광의 치료를 위한 비베그론의 용도	⤷ Sign Up
>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.