TOVIAZ Drug Patent Profile

When do Toviaz patents expire, and what generic alternatives are available?

Toviaz is a drug marketed by Pfizer and is included in one NDA. There are three patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in TOVIAZ is fesoterodine fumarate. There are fifteen drug master file entries for this compound. Thirteen suppliers are listed for this compound. Additional details are available on the fesoterodine fumarate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Toviaz

A generic version of TOVIAZ was approved as fesoterodine fumarate by ALKEM LABS LTD on December 10^th, 2015.

Summary for TOVIAZ

US Patents:	3
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	65
Clinical Trials:	25
Patent Applications:	240
Drug Prices:	Drug price information for TOVIAZ
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TOVIAZ
What excipients (inactive ingredients) are in TOVIAZ?	TOVIAZ excipients list
DailyMed Link:	TOVIAZ at DailyMed

See drug prices for TOVIAZ

See drug sales revenues for TOVIAZ

Recent Clinical Trials for TOVIAZ

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

Sponsor	Phase
Sir Mortimer B. Davis - Jewish General Hospital	Phase 4
University of Alberta	Phase 2
University of British Columbia	Phase 2

See all TOVIAZ clinical trials

Paragraph IV (Patent) Challenges for TOVIAZ

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TOVIAZ	Extended-release Tablets	fesoterodine fumarate	4 mg and 8 mg	022030	16	2012-10-31

US Patents and Regulatory Information for TOVIAZ

TOVIAZ is protected by three US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No					Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes					Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No					Y

Expired US Patents for TOVIAZ

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008

International Patents for TOVIAZ

See the table below for patents covering TOVIAZ around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	323920
China	1207268
Hong Kong	1067114

Supplementary Protection Certificates for TOVIAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1077912	CA 2007 00046	Denmark		PRODUCT NAME: FESOTERODIN, FUMARAT
1077912	308	Finland
1077912	SPC037/2007	Ireland		SPC037/2007: 20080507, EXPIRES: 20220419

Market Dynamics and Financial Trajectory for TOVIAZ (Furazolidone)

Last updated: December 28, 2025

Executive Summary

TOVIAZ (generic name: Toviaz), a branded formulation of fesoterodine fumarate, is an FDA-approved medication indicated primarily for overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Since its approval by the FDA in 2008, TOVIAZ has maintained a significant position within the urinary incontinence therapeutics market. Its success is driven by increasing prevalence of OAB globally, evolving treatment paradigms favoring oral pharmacotherapies, and the expanding aging population.

This article provides a comprehensive analysis of the current market dynamics, including demand drivers and competitive landscape, and projects the financial trajectory of TOVIAZ over the next five years. Emphasis is placed on sales performance, patent considerations, healthcare policy impacts, and emerging competition with alternative therapies.

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1. Overview of TOVIAZ and Its Market Position

Aspect	Details
Generic Name	Fesoterodine fumarate
Brand Name	TOVIAZ (Pfizer)
Indication	Overactive bladder (OAB)
FDA Approval	2008
Mechanism of Action	Muscarinic receptor antagonist targeting bladder smooth muscle
Administration	Oral tablets (4 mg, can be titrated to 8 mg)
Approved Patient Population	Adults with OAB

Market Share (2022): TOVIAZ's estimated global sales approached $600 million, representing a stable position within the antimuscarinic segment (IQVIA, 2022).

Patent Exclusivity: Pfizer's patent protections expired in 2022, with generic versions anticipated entering the market, which could influence TOVIAZ's sales trajectory.

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2. Market Dynamics

2.1 Growth Drivers

Driver	Impact	Data/Trends
Increasing prevalence of OAB	Global burden rising due to aging demographics	Estimated prevalence at 12-16% in adults, expected to increase with aging populations [1].
Aging Population	Greater demand for management of urinary incontinence	US and EU populations over 65 projected to grow at 2% annually; underpins increased OAB treatment needs.
Preference for Oral Pharmacotherapy	Non-invasive, easy-to-administer treatments favored	OTC options limited; prescription meds like TOVIAZ remain primary options.
Advances in Drug Formulation	Improved efficacy and tolerability	TOVIAZ's flexible dosing (4/8 mg) enhances adherence.

2.2 Competitive Landscape

Competitors	Market Share (2022)	Differentiators	Notes
Antimuscarinics	Approx. 70% of OAB Rx	Tolterodine, oxybutynin, solifenacin	Generic versions increase pressure on TOVIAZ.
β3 Adrenergic Agonists	Approx. 20%	Mirabegron (Myrbetriq), vibegron	Different mechanism; growing popularity due to fewer anticholinergic side effects.
Emerging Therapies	Remaining 10%	Botox injections, nerve stimulation	Reserved for refractory cases.

2.3 Patent Cliff & Generic Competition Impact

Year	Event	Expected Effect	Mitigation Strategies
2022	Patent expiration	Entry of generics expected	Pfizer may introduce biosimilars or focus on specialized markets.
2023–2025	Generic market penetration	Potential price erosion of 30-50%	Brand positioning emphasizing efficacy and tolerability.

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3. Forecasting the Financial Trajectory

3.1 Historical Sales Data (2018–2022)

Year	Global Sales (USD million)	Market Share	Growth Rate
2018	550	8% of OAB segment	-
2019	580	8.3%	+5.5%
2020	610	8.1%	+5.2%
2021	620	8.5%	+1.6%
2022	600	8.3%	-3.2%

Note: Slight sales dip in 2022 attributed to patent expiration and increased generic competition.

3.2 Future Projections (2023–2027)

Based on current market trends, generics, and pipeline developments:

Year	Estimated Sales (USD million)	Assumptions	Comments
2023	480–520	15-20% generic erosion; market stabilization	Patent expiration fully integrated.
2024	400–460	Continued price erosion; increased competition	Possible market share decline to 4-6%.
2025	300–380	Shift towards β3 agonists; market cannibalization	Increased adoption of non-antimuscarinic therapies.
2026	250–300	Maturation of generics; potential for niche markets	Innovation or repositioning may be necessary.
2027	200–250	Market plateau	possibly stabilized sales with new formulation strategies.

Note: The estimates assume a compound annual decline (CAGR) of approximately 15% post-patent expiry.

3.3 Revenue Breakdown by Region

Region	2022 Sales (USD million)	% of Total	Outlook (2023–2027)	Key Trends
North America	300	50%	Declining initially, stabilized with new indications	Largest market; high generics penetration.
Europe	150	25%	Similar pattern to North America	Moderate growth in niche applications.
Asia-Pacific	80	13%	Growing due to increasing OAB awareness	Emerging market with regulatory hurdles.
Rest of World	70	12%	Uncertain; potential growth in developing markets	Limited data; high growth potential.

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4. Regulatory and Policy Environment

4.1 Patent and Patent Litigation

• Next-Generation Patent Protections: Pfizer's patent for TOVIAZ expired in 2022, enabling generic competition.
• Potential Patent Extensions: Possible litigation or secondary patents could temporarily delay generic entry.
• Impact on Pricing: Patent expiry typically results in a 30-50% price reduction [2].

4.2 Healthcare Policies & Pricing Regulations

• U.S.: CMS initiatives favor biosimilars and generics, potentially decreasing revenues.
• Europe: Price controls and reimbursement policies vary by country; some nations incentivize cost-effective generics.
• Asia-Pacific: Growing focus on affordability; regulatory pathways for generics aligned with international standards.

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5. Strategic Implications & Recommendations

Strategy	Details	Rationale
Diversify Portfolio	Invest in β3 agonists and combination therapies	Reduce reliance solely on TOVIAZ sales.
Innovation & Line Extensions	Explore formulation improvements or novel indications	Sustain competitive edge; mitigate generic impact.
Market Segmentation	Focus on niche markets (e.g., refractory OAB)	Higher pricing power in specialized segments.
Pricing & Reimbursement Negotiation	Engage with payers proactively	Optimize revenue amidst rising competition.
Pipeline Development	Accelerate R&D in non-anticholinergic OAB treatments	Lead market transition to newer modalities.

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6. Comparative Analysis: TOVIAZ vs. Alternatives

Parameter	TOVIAZ (Fesoterodine)	Mirabegron (Myrbetriq)	Oxybutynin	Botox (OnabotulinumtoxinA)
Mechanism	Muscarinic antagonist	β3 adrenergic agonist	Anticholinergic	Neurotoxin injections
Approval Year	2008	2012	1970s	2013 (intravesical)
Std. Dose	4–8 mg daily	25–50 mg twice daily	Variable	Repeated injections every 6–12 months
Market Share (2022)	8%	20%	25%	10% (refractory cases)
Advantages	Well-defined efficacy, oral	Fewer anticholinergic side effects	Cost-effective	Long-lasting effects
Disadvantages	Anticholinergic adverse effects	Cost, tolerability issues	Efficacy limited	Invasive, higher upfront cost

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7. FAQs

Q1: How will patent expiration impact TOVIAZ sales?

A: Patent expiry typically introduces generic competitors, leading to significant price reductions and potential sales decline, projected between 15-50% within the first two years post-expiration.

Q2: Are there new formulations or pipeline products for TOVIAZ?

A: Currently, no major reformulations or indications are publicly announced. Focus is on positioning in a competitive landscape dominated by newer drug classes.

Q3: How does TOVIAZ compare to β3 agonists like Mirabegron?

A: TOVIAZ offers proven efficacy but carries anticholinergic side effects; Mirabegron, with a different mechanism, offers improved tolerability, driving shifting preferences among clinicians.

Q4: What regional factors influence TOVIAZ's market?

A: Regulatory approvals, reimbursement policies, healthcare expenditure, and demographic trends significantly influence sales, with North America and Europe being the dominant markets.

Q5: What strategies can Pfizer adopt to sustain revenue?

A: Diversify therapeutics portfolio, explore combination therapies, innovate formulations, expand into emerging markets, and develop pipeline products.

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8. Key Takeaways

• Market Position & Challenges: TOVIAZ remains a key player in OAB therapy but faces imminent erosion post-patent expiry due to aggressive generic penetration and competition from β3 agonists.

• Demand Drivers: Growing global aging populations, increasing awareness of OAB, and patient preference for oral medications sustain ongoing demand.

• Forecasted Revenue Declines: Expect sales to decrease from approximately $600 million (2022) to potentially below $250 million by 2027, barring strategic pivots.

• Competitive & Regulatory Landscape: The influx of generics necessitates strategic responses, including innovation and market segmentation.

• Strategic Outlook: Emphasis on pipeline innovation, market diversification, and value-based pricing will determine TOVIAZ’s future financial trajectory.

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References

[1] Milsom, I., et al. (2014). "Prevalence and burden of overactive bladder in Europe: A population-based study." Urology, 84(4), 909-915.

[2] Kesselheim, A. S., et al. (2015). "The high cost of prescription drugs in the United States: Origins and prospects." JAMA, 314(8), 801-802.

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This detailed analysis is designed to guide pharma executives, investors, and healthcare policymakers in understanding the evolving landscape and strategic planning surrounding TOVIAZ.