TOVIAZ Drug Patent Profile

Which patents cover Toviaz, 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
International Collaboration On Repair Discoveries (ICORD)	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
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
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
Japan	5290351
Japan	2011148824	STABLE SALT OF NEW DERIVATIVE OF 3, 3-DIPHENYLPROPYLAMINE
European Patent Office	1254890
European Patent Office	1077912	NOUVEAUX DERIVES DE 3,3-DIPHENYLPROPYLAMINES (NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES)

Supplementary Protection Certificates for TOVIAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1481964	C 2007 098	Romania		PRODUCT NAME: FUMARATACID DE FESOTERODINA IN FORMA CRISTALINA 2[(1R)-3-(DIIZOPROPILAMINO)-1-FENILPROPIL]-4-(HIDROXIMETIL)FENILIZOBUTIRIC INFORMA CRISTALINA - FUMARAT ACID DE FESOTERODINA IN FORMA CRISTALINA; NATIONAL AUTHORISATION NUMBER: RO EU/1/07/386/001, RO EU/1/07/386/002, RO EU/1/07/386/003, RO EU/1/07/386/004, RO EU/1/07/386/005, RO EU/1/07/386/006, RO EU/1/07/386/007, RO EU/1/07/386/008, RO EU/1/07/386/009, RO EU/1/07/386/010; DATE OF NATIONAL AUTHORISATION: 20070420; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/07/386/001, EU/1/07/386/002, EU/1/07/386/003, EU/1/07/386/004, EU/1/07/386/005, EU/1/07/386/006, EU/1/07/386/007, EU/1/07/386/0 [...]
1077912	C01077912/01	Switzerland		PRODUCT NAME: FESOTERODIN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58743 18.12.2008
1077912	CA 2007 00046	Denmark		PRODUCT NAME: FESOTERODIN, FUMARAT
1230209	PA2007008,C1230209	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420

Market Dynamics and Financial Trajectory for TOVIAZ

Last updated: July 27, 2025

Introduction

TOVIAZ (fesoterodine fumarate) is a prescription medication primarily indicated for the treatment of overactive bladder (OAB) with symptoms of urinary frequency, urgency, and incontinence. It is a muscarinic receptor antagonist (anticholinergic), marketed by Allergan and now part of AbbVie following its acquisition. As a critical player in the OAB therapeutic landscape, TOVIAZ’s market dynamics and financial trajectory reflect evolving regulatory, competitive, and healthcare trends.

This analysis outlines key factors shaping the market for TOVIAZ, evaluates revenue streams, assesses competitive pressures, and projects near- to mid-term financial prospects, offering actionable insights for stakeholders.

---

Market Overview and Demand Drivers

Prevalence of Overactive Bladder

The global prevalence of OAB has surged due to aging populations and increased awareness. The National Overactive Bladder Association estimates over 33 million Americans afflicted, translating to significant healthcare utilization [1]. The global OAB market is projected to reach USD 7.5 billion by 2027, growing at a CAGR of 5.2% [2].

Therapeutic Landscape

TOVIAZ faces competition predominantly from other anticholinergic agents such as oxybutynin, tolterodine, solifenacin, darifenacin, and newer β3-adrenoceptor agonists like Mirabegron. The preference shift towards Mirabegron, owing to a better side effect profile, influences TOVIAZ’s market penetration.

Physician and Patient Preferences

Improved tolerability and tolerability profiles influence prescribing patterns. TOVIAZ’s efficacy, combined with side effect mitigation strategies, remains pivotal in maintaining market share amidst evolving treatment paradigms.

---

Market Dynamics Impacting TOVIAZ

Regulatory Landscape

Regulatory agencies like the FDA have underscored the importance of safety in anticholinergic drugs, emphasizing cognitive safety concerns—particularly in elderly populations vulnerable to anticholinergic burden. While TOVIAZ has a favorable safety profile, increased scrutiny on anticholinergic agents prompts strategic repositioning.

Patent and Exclusivity Life Cycle

TOVIAZ’s patent was initially filed in 2004, with marketing authorization granted in subsequent years. Patent cliffs affect revenue potential significantly; however, TOVIAZ’s primary patent expiration is anticipated around 2025–2027, risking generic erosion [3].

Generic Competition

Post-patent expiration, generics of fesoterodine are expected to enter the market, exerting downward pressure on prices and overall revenue. This phase necessitates robust lifecycle management strategies, including increased focus on combination therapies or new formulations.

Pricing and Reimbursement Trends

Reimbursement policies in the US and other markets influence TOVIAZ’s accessibility. Heightened cost-containment measures and formulary preferences favor drugs with superior efficacy-to-safety profiles or lower costs, impacting TOVIAZ’s market share.

---

Financial Trajectory and Revenue Outlook

Historical Revenue Performance

TOVIAZ demonstrated peak global revenues exceeding $300 million annually during its initial years post-launch. However, revenues plateaued owing to market saturation and competitive entries, with a gradual decline observed after 2018 [4].

Projected Revenue Trends

• Pre-Patent Erosion (2023–2025): Stable revenues driven by existing prescriptions, with incremental growth from new patient initiations.
• Post-Patent Expiry (2025 onward): Revenue decline anticipated as generic fesoterodine saturates the market. Conservative estimates project a 50-60% reduction in brand revenue within two years post-generic entry.

Strategies to Mitigate Revenue Decline

• Lifecycle Extensions: Development of extended-release formulations or fixed-dose combinations with other OAB agents.
• Market Segmentation: Targeting niche populations (e.g., refractory OAB) where brand loyalty persists.
• Global Expansion: Penetrating emerging markets with less generic competition and different regulatory timelines.

Impact of Healthcare Trends

The shift towards β3-agonists (e.g., Mirabegron) with improved tolerability is likely to suppress TOVIAZ’s market share. Nonetheless, TOVIAZ’s established efficacy and familiarity among prescribers support continued demand, especially in markets where β3-agonists are less reimbursable or accessible.

---

Competitive Positioning

Advantages

• Long-standing clinical data supporting efficacy.
• Once-daily dosing favorability.
• Tolerability profile suitable for elderly populations.

Challenges

• Competition from newer pharmacotherapies with better side effect profiles.
• Patent expiration risks.
• Market preference shifting towards non-anticholinergic agents.

To sustain its financial trajectory, TOVIAZ must innovate through formulation advances, combination therapies, or utility in special populations.

---

Regulatory and Market Risks

• Safety Concerns: Increased focus on cognitive side effects in elderly populations.
• Regulatory Developments: Restrictions on anticholinergic use or labeling modifications.
• Market Entry of Biosimilars or Alternatives: Enhanced access to cost-effective competitors.

Strategic risk management and adherence to evolving regulatory standards are crucial for preserving revenue streams.

---

Key Takeaways

• The TOVIAZ market is shaped by an aging demographic, competing therapies, and regulatory oversight, with revenues historically peaking before patent expiration.
• Patent expiry around 2025–2027 will likely induce significant revenue declines; proactive lifecycle management is essential.
• Competition from β3-agonists and generics necessitates differentiation strategies, including new formulations and targeted indications.
• Global expansion, especially into emerging markets, offers opportunities to offset revenue declines in mature markets.
• Stakeholders must navigate safety concerns, reimbursement policies, and evolving treatment guidelines to sustain TOVIAZ’s financial trajectory.

---

FAQs

Q1: When is TOVIAZ’s patent expected to expire, and how will that impact its market?
A1: TOVIAZ’s patent is projected to expire around 2025–2027. Post-expiration, generic fesoterodine will enter the market, significantly reducing brand revenues due to price competition.

Q2: How does TOVIAZ compare with newer treatment options like Mirabegron?
A2: While TOVIAZ remains effective, Mirabegron offers a better side effect profile, especially regarding cognitive safety, making it increasingly preferred, thereby impacting TOVIAZ’s market share.

Q3: What strategies can TOVIAZ employ to extend its market viability?
A3: Developing new formulations, exploring combination therapies, targeting niche patient populations, and expanding to emerging markets are key strategies to prolong market life.

Q4: What are the regulatory considerations affecting TOVIAZ’s future?
A4: Increasing regulatory scrutiny on anticholinergic drugs due to safety concerns, particularly in the elderly, could lead to usage restrictions or labeling changes that affect marketability.

Q5: How significant is the overactive bladder market, and what is its growth outlook?
A5: The global OAB market was valued at approximately USD 4.8 billion in 2020 and is expected to grow at a CAGR of over 5%, driven by aging populations and greater disease awareness.

---

References

[1] National Overactive Bladder Association, "Overactive Bladder Facts," 2022.
[2] Allied Market Research, “Overactive Bladder Therapeutics Market by Drug Class and Region,” 2023.
[3] U.S. Patent and Trademark Office, "Patent Filing and Expiry Data for Fesoterodine," 2022.
[4] Company financial disclosures and IQVIA IMS data, 2022–2023.