Vibegron - Generic Drug Details

What are the generic drug 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

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

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

International Patents for vibegron

Country	Patent Number	Title	Estimated Expiration
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)
Eurasian Patent Organization	201992690	ПРИМЕНЕНИЕ ВИБЕГРОНА ДЛЯ ЛЕЧЕНИЯ ГИПЕРАКТИВНОГО МОЧЕВОГО ПУЗЫРЯ
Georgia, Republic of	P20125666	HYDROXYMETHYL PYRROLIDINES AS β3 ADRENERGIC RECEPTOR AGONISTS
Slovenia	2276756
Taiwan	200944521	Hydroxymethyl pyrrolidines as beta 3 adrenergic receptor agonists

Vibegron Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vibegron

Introduction to Vibegron

Vibegron, a β3-adrenergic receptor agonist, is a relatively new addition to the treatment arsenal for overactive bladder (OAB). Approved for use in recent years, it has been gaining traction as a viable alternative to traditional anticholinergic medications.

Market Size and Growth

The global overactive bladder treatment market, which includes vibegron, is projected to experience moderate to significant growth over the next decade. In 2021, the global market size was valued at $2.4 billion and is expected to reach $3.5 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of around 3-4%[3].

Current Market Landscape

The OAB market is characterized by a mix of established and emerging treatments. First-line pharmacotherapy typically involves orally administered antimuscarinics, a highly genericized drug class. However, the introduction of β3-adrenergic receptor agonists like vibegron and mirabegron has provided new treatment options. Vibegron, in particular, has been noted for its potential to address unmet needs in OAB treatment by minimizing the risks associated with anticholinergic side effects[1][2].

Financial Projections

The financial trajectory for vibegron is influenced by several factors:

Revenue Growth

Global sales for OAB treatments, including vibegron, are projected to increase from $2.2 billion in 2020 to $2.8 billion in 2030, at a CAGR of 2.7%. Vibegron, along with other β3-adrenergic receptor agonists, is expected to contribute significantly to this growth[1].

Market Share

Vibegron is anticipated to capture a substantial market share, although it will likely face competition from other β3-adrenergic receptor agonists like mirabegron. Mirabegron, for instance, accounted for a market share of 52.6% in the OAB market as of recent forecasts[1].

Cost Impact

The introduction of vibegron into health plans has been associated with a modest increase in costs. For commercial insurance plans, the monthly costs over 5 years increased by $0.12 per person enrolled, while for Medicare plans, the increase was $0.24 per person enrolled. However, these increased costs are partially offset by savings related to decreased third-line treatment use, reduced adverse events, and lower anticholinergic burden[2].

Factors Influencing Market Dynamics

Aging Population

The prevalence of OAB is expected to increase due to aging populations. Advanced age is a significant factor associated with higher risks of OAB, which will expand the treatment pool over the forecast period[4].

Obesity and Other Health Conditions

Rising obesity and other health conditions such as neurological disorders, diabetes, and urological disorders are also driving the demand for OAB treatments. These factors contribute to the increasing incidence of OAB, thereby propelling market growth[3].

Patent Expiries

The OAB market is expected to experience a decline in the early-to-mid forecast period due to patent expiries for key products, including antimuscarinics and some β3-adrenergic receptor agonists. However, the launch of pipeline products, including potential novel therapies, is expected to boost market sales in the mid-to-late forecast period[1][4].

Budget Impact Analysis

A budget impact analysis of introducing vibegron into health plans revealed that while it increases monthly costs, it also offers several benefits. These include reduced healthcare costs related to anticholinergic side effects, decreased outpatient visits, and lower incidence of adverse events and comorbidities. The analysis suggests that vibegron can be a useful addition to health plans, balancing increased pharmacy costs with overall healthcare savings[2].

R&D and Market Expansion

The increase in Research and Development (R&D) activities, particularly in developed and developing regions, has significantly contributed to market revenue. Key market players are investing in emerging countries, which is anticipated to offer lucrative opportunities for the market during the forecast period. Increased awareness among people about OAB and its treatment options also contributes to market growth[3].

Expert Insights and Statistics

• Prevalence and Economic Burden: OAB affects over 100 million men and women in the USA, with projected costs of $82.6 billion in 2020. The introduction of vibegron is seen as a way to address the clinical and economic burden associated with OAB[2].
• Clinical Outcomes: Vibegron has been shown to reduce anticholinergic burden, drug-drug interactions, and adverse events, making it a preferable option for patients with OAB[2].

Key Takeaways

• Market Growth: The OAB market, including vibegron, is expected to grow from $2.2 billion in 2020 to $2.8 billion in 2030.
• Cost Impact: Vibegron increases monthly healthcare costs but offers savings through reduced anticholinergic side effects and other healthcare costs.
• Market Dynamics: Aging populations, rising obesity, and other health conditions drive the demand for OAB treatments.
• R&D and Expansion: Increased R&D activities and investments in emerging countries are expected to boost market revenue.

FAQs

Q: What is the projected market size for OAB treatments by 2030? A: The global OAB treatment market is projected to reach $2.8 billion by 2030[1].

Q: How does vibegron impact healthcare costs? A: Vibegron increases monthly healthcare costs slightly but offers overall savings by reducing anticholinergic side effects, adverse events, and other healthcare costs[2].

Q: What factors are driving the growth of the OAB market? A: Factors such as aging populations, rising obesity, and other health conditions like neurological disorders and diabetes are driving the growth of the OAB market[3][4].

Q: What are the benefits of using vibegron over traditional anticholinergics? A: Vibegron reduces the risks associated with anticholinergic side effects, such as cognitive impairment and falls/fractures, and also minimizes drug-drug interactions and adverse events[2].

Q: How significant is the impact of patent expiries on the OAB market? A: Patent expiries for key products are expected to decline market sales in the early-to-mid forecast period but will be offset by the launch of new pipeline products in the mid-to-late forecast period[1][4].

Sources

1. ResearchAndMarkets.com - "Overactive Bladder - Global Drug Forecast and Market Analysis to 2030"[1]
2. PubMed - "Budget Impact Analysis of Vibegron for the Treatment of Overactive Bladder"[2]
3. Allied Market Research - "Overactive Bladder Treatment Market Statistics | Forecast - 2031"[3]
4. Pharmaceutical Technology - "Overactive bladder market to undergo moderate growth, reaching $2.8bn by 2030"[4]