TOVIAZ Drug Patent Profile

When do Toviaz patents expire, and when can generic versions of Toviaz launch?

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. Twelve 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:	1
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
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	022030-002	Oct 31, 2008	AB	RX	Yes	Yes					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
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	022030-001	Oct 31, 2008

International Patents for TOVIAZ

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

Country	Patent Number	Title	Estimated Expiration
Australia	748057
Slovakia	15472000	3,3-DIFENYLPROPYLAMÍNY, FARMACEUTICKÉ PROSTRIEDKY, �x53;PÔSOB ICH VÝROBY A POUŽITIE (NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES)
Japan	5650924
Norway	20022314
Hungary	227608	STABLE SALTS OF 3,3-DIPHENYLPROPYLAMINES AND PREPARATION THEREOF
Slovakia	6572002	STABLE SALTS OF NOVEL DERIVATIVES OF 3,3-DIPHENYLPROPYLAMINES
Japan	2014111589	STABLE SALT OF NOVEL DERIVATIVE OF 3,3-DIPHENYLPROPYLAMINE

Supplementary Protection Certificates for TOVIAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1077912	308	Finland
1077912	SPC037/2007	Ireland		SPC037/2007: 20080507, EXPIRES: 20220419
1077912	07C0050	France		PRODUCT NAME: FESOTERODINE ET SES SELS AVEC DES ACIDES PHYSIOLOGIQUEMENT ACCEPTABLES NOTAMMENT L ACIDE FUMARIQUE; REGISTRATION NO/DATE IN FRANCE: EU/1/07/386/001 DU 20070420; REGISTRATION NO/DATE AT EEC: EU/1/07/386/001 DU 20070420
1077912	CA 2007 00046	Denmark		PRODUCT NAME: FESOTERODIN, FUMARAT
1230209	PA2007008	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
1077912	SZ 47/2007	Austria		PRODUCT NAME: FESOTERODINE UND IHRE SALZE MIT PHYSIOLOGISCH ANNEHMBAREN SAEUREN, EINSCHLIESSLICH FUMARSAEURE
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 [...]

TОВIAZ Market Dynamics and Financial Trajectory

Last updated: February 19, 2026

TovIAZ, a branded prescription medication, targets overactive bladder (OAB) with urinary incontinence, urgency, and frequency. Its active ingredient is fesoterodine fumarate, a muscarinic receptor antagonist. The drug's market performance is shaped by patent exclusivity, generic competition, and prescribing trends.

What is TovIAZ's Patent Status and Exclusivity Timeline?

TovIAZ (fesoterodine fumarate) has faced patent expirations and subsequent generic entry, significantly impacting its market share and revenue. The primary U.S. patent for TovIAZ, U.S. Patent No. 6,858,654, was set to expire in August 2022. However, the U.S. Food and Drug Administration (FDA) approved generics prior to this date.

• Original Patent Expiration: August 2022 (U.S. Patent No. 6,858,654) [1]
• Generic Approvals: Several generic versions of fesoterodine fumarate have received FDA approval. For example, Teva Pharmaceuticals received tentative approval for its generic version in October 2019, and it became commercially available following patent challenges and subsequent settlements [2]. Other manufacturers, including Mylan (now Viatris) and generic pharmaceutical companies, have also entered the market.
• Exclusivity Periods: Brand-name drugs often benefit from various exclusivity periods granted by the FDA beyond patent protection. These can include New Chemical Entity (NCE) exclusivity, orphan drug exclusivity, and pediatric exclusivity. For TovIAZ, the primary exclusivity drivers were patent protection and potentially market-based factors.

The expiration of key patents and the subsequent FDA approvals of generic equivalents have led to a significant price erosion and a decline in TovIAZ's market share. Pharmaceutical companies with generic versions of fesoterodine fumarate have been able to offer lower-cost alternatives, shifting prescribing patterns away from the branded product.

How Has TovIAZ's Revenue Evolved?

TovIAZ's revenue trajectory has been characterized by strong initial growth followed by a steep decline post-generic entry. Pfizer, the originator of TovIAZ, reported significant net sales during its period of market exclusivity.

• Peak Sales: While specific peak annual sales figures for TovIAZ are not always publicly broken out in detail by Pfizer in recent years, in earlier reporting periods, the drug was a notable contributor to Pfizer's urology portfolio. For instance, in 2017, Toviaz reported $707 million in global sales [3]. This figure represents a substantial revenue stream prior to significant generic pressure.
• Post-Generic Impact: Following the introduction of generic fesoterodine fumarate, TovIAZ's net sales have experienced a substantial decrease. Manufacturers of branded drugs typically see their revenue fall by 80-90% or more once generics enter the market. This trend is consistent with the pharmaceutical industry's experience.
• Recent Reporting: In recent Pfizer financial reports, TovIAZ is often grouped within broader product categories, making precise current sales figures difficult to isolate. However, the overall trend for branded OAB medications facing generic competition is a consistent decline in net sales.

The financial trajectory clearly demonstrates the significant impact of patent expiry and generic competition on a branded pharmaceutical product. The market shifts rapidly once lower-cost alternatives become available and are adopted by payers and prescribers.

What is the Competitive Landscape for Overactive Bladder Treatments?

The market for OAB treatments is highly competitive, featuring a range of therapeutic classes, including anticholinergics and beta-3 adrenergic agonists. TovIAZ (fesoterodine fumarate) competes with both branded and generic options.

• Key Therapeutic Classes:

  • Anticholinergics: This class includes drugs that block muscarinic receptors to reduce bladder muscle contractions. Besides fesoterodine fumarate, other OAB anticholinergics include:
    • Oxybutynin (e.g., Ditropan XL, generic oxybutynin)
    • Tolterodine (e.g., Detrol LA, generic tolterodine)
    • Solifenacin (e.g., VESIcare, generic solifenacin)
    • Darifenacin (e.g., Enablex)
    • Trospium chloride (e.g., Sanctura XR)
  • Beta-3 Adrenergic Agonists: These drugs relax the detrusor muscle. The primary competitor in this class is:
    • Mirabegron (e.g., Myrbetriq)
  • OnabotulinumtoxinA: For refractory OAB, injections of botulinum toxin are an option (e.g., Botox).

• Market Share Dynamics: Branded drugs like TovIAZ and VESIcare initially capture significant market share. However, as their patents expire, generic versions of these drugs, along with established generic anticholinergics, become dominant due to their lower cost. Myrbetriq (mirabegron) represents a significant branded competitor that does not have direct generic equivalents in the same way as the anticholinergics.

• Impact of Generics: The availability of generic fesoterodine fumarate directly competes with branded TovIAZ. Payers and pharmacy benefit managers (PBMs) often incentivize the use of generics through formulary placement and lower co-pays, further driving down demand for branded products.

The competitive landscape is characterized by a high degree of therapeutic interchangeability within the anticholinergic class, making price and payer formulary decisions critical. The emergence of a distinct mechanistic class (beta-3 agonists) provides alternative treatment options, but the cost-effectiveness of generics often dictates market share.

What are the Prescribing Trends for Fesoterodine Fumarate?

Prescribing trends for fesoterodine fumarate, both branded TovIAZ and its generic equivalents, are influenced by physician preference, patient response, side effect profiles, and payer mandates.

• Initial Adoption: TovIAZ was adopted by physicians for its efficacy in managing OAB symptoms. Its dosing regimen and tolerability profile were factors in its uptake.
• Shift to Generics: Post-patent expiry, a significant shift has occurred towards generic fesoterodine fumarate. This is a predictable outcome driven by cost savings for patients and healthcare systems. Electronic Health Record (EHR) systems often default to generic selection, further accelerating this trend.
• Comparison with Other Agents:
  • Anticholinergics: Prescribers consider the side effect profiles of different anticholinergics. Dry mouth, constipation, and cognitive impairment are common concerns. Some agents may be perceived as having a more favorable side effect profile than others, though this can be patient-specific.
  • Mirabegron (Myrbetriq): This drug offers an alternative mechanism for patients who do not tolerate or respond to anticholinergics. It generally has a different side effect profile, with hypertension being a key consideration.
• Payer Influence: Insurance formularies heavily influence prescribing. Preferred placement for generic fesoterodine fumarate, or prior authorization requirements for branded TovIAZ or even other branded OAB drugs, directs physician prescribing behavior.
• Data on Market Share: Pharmaceutical market data reports (e.g., IQVIA) consistently show a sharp decline in branded TovIAZ prescriptions as generic market share grows. While specific real-time prescription data is proprietary, the trend is universally understood to be a transition to generic alternatives.

The overall prescribing trend for fesoterodine fumarate has moved from a branded product with strong initial adoption to a predominantly generic market, with physicians selecting based on cost, efficacy, and tolerability within the broader OAB treatment landscape.

What is the Global Market Size and Growth Potential for OAB Treatments?

The global market for OAB treatments is substantial and projected to grow, driven by an aging population, increased disease awareness, and advancements in treatment options. However, the growth within specific segments, like branded anticholinergics such as TovIAZ, is challenged by genericization.

• Market Size: The global OAB market was valued at approximately $2.5 billion to $3 billion in recent years and is projected to grow at a compound annual growth rate (CAGR) of 3-5% over the next decade [4]. This growth is propelled by a rising prevalence of OAB, particularly in older demographics.
• Drivers of Growth:
  • Aging Population: The incidence of OAB increases with age, and the global population is aging, leading to a larger patient pool.
  • Increased Diagnosis and Awareness: Greater awareness among healthcare professionals and the public is leading to more diagnoses and subsequent treatment seeking.
  • Technological Advancements: Development of new drug formulations, delivery systems, and therapeutic approaches (e.g., minimally invasive procedures, neuromodulation) contributes to market expansion.
  • Unmet Needs: A significant percentage of OAB patients remain undertreated or have refractory symptoms, creating demand for improved therapies.
• Impact of Generics on Market Value: While the volume of OAB treatments may increase, the overall market value can be suppressed by the widespread availability of generic drugs. The segment for branded drugs like TovIAZ that have faced generic competition will see its contribution to market value diminish. Growth in this segment is largely driven by newer branded entrants (e.g., mirabegron, novel formulations) or treatments for refractory OAB.
• Regional Variations: The market size and growth rates vary by region due to differences in healthcare infrastructure, insurance coverage, regulatory environments, and patient demographics. Developed markets in North America and Europe represent the largest share, while emerging markets in Asia-Pacific are expected to exhibit higher growth rates.

The OAB market presents a dichotomy: an expanding patient base driving overall volume growth, offset by significant price pressure from generic competition, particularly for established drug classes like anticholinergics.

Key Takeaways

• TovIAZ (fesoterodine fumarate) patents have expired, leading to the market entry of multiple generic versions.
• The net sales of branded TovIAZ have significantly declined following genericization, a trend typical for pharmaceuticals post-patent expiry.
• The OAB treatment market is highly competitive, withfesoterodine fumarate generics competing against other generic anticholinergics and branded alternatives like mirabegron.
• Prescribing trends have shifted from branded TovIAZ to lower-cost generic fesoterodine fumarate, influenced by payer policies and physician choice.
• The global OAB market is growing due to an aging population and increased diagnosis, but generic competition limits value growth for established branded products.

Frequently Asked Questions

What are the primary side effects associated with fesoterodine fumarate?

Common side effects of fesoterodine fumarate include dry mouth, constipation, and urinary tract infections. Less common but more serious side effects can involve cognitive impairment, especially in older adults, and urinary retention.

How does generic fesoterodine fumarate differ from branded TovIAZ?

Generic fesoterodine fumarate is bioequivalent to branded TovIAZ, meaning it delivers the same amount of active ingredient into the bloodstream over the same period. The difference lies primarily in the inactive ingredients and the manufacturing process, and significantly, in price.

What are the alternative treatments for overactive bladder if fesoterodine fumarate is not effective or tolerated?

Alternative treatments include other anticholinergic medications (solifenacin, oxybutynin, tolterodine), beta-3 adrenergic agonists (mirabegron), onabotulinumtoxinA injections, and behavioral therapies.

How do payers (insurance companies) influence the use of TovIAZ and its generics?

Payers often implement formulary tiering and prior authorization requirements. Generic fesoterodine fumarate is typically placed on lower, more cost-effective tiers, while branded TovIAZ may be on a higher tier or require prior authorization, incentivizing the use of generics.

Can patients switch between branded TovIAZ and generic fesoterodine fumarate?

Yes, patients can typically switch between branded TovIAZ and generic fesoterodine fumarate, or vice versa, under the guidance of their healthcare provider. The key is to ensure the generic is therapeutically equivalent and that the transition does not impact treatment efficacy or tolerability.

Citations

[1] U.S. Patent No. 6,858,654. (n.d.). United States Patent and Trademark Office. [2] Teva Pharmaceuticals USA, Inc. (2019, October 28). Teva Announces Tentative Approval For Its Abbreviated New Drug Application For Fesoterodine Fumarate Tablets. [Press release]. [3] Pfizer Inc. (2018). Pfizer Inc. 2017 Annual Report on Form 10-K. U.S. Securities and Exchange Commission. [4] Grand View Research. (2023). Overactive Bladder Treatment Market Size, Share & Trends Analysis Report.