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. 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:	72
Clinical Trials:	25
Patent Applications:	142
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	7,807,715*PED				Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes	7,807,715*PED				Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No	8,088,398*PED				Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No	8,501,723*PED				Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes	8,501,723*PED				Y
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	AB	RX	Yes	Yes	8,088,398*PED				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	022030-001	Oct 31, 2008	7,985,772
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	7,985,772
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	8,338,478
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	7,384,980
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-002	Oct 31, 2008	8,338,478
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	7,855,230

International Patents for TOVIAZ

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

Country	Patent Number	Title	Estimated Expiration
Iceland	2124
Japan	4658895
Czech Republic	299721	Lécivo pro lécení mocové inkontinence (Medicament for treating urinary incontinence)
Russian Federation	2199525	NOVEL DERIVATIVES OF 3,3-DIPHENYLROPYLAMINES, METHODS OF THEIR SYNTHESIS (VERSIONS) AND PHARMACEUTICAL COMPOSITION COMPRISING THEREOF
Slovakia	288185
Hungary	230434	3,3-Difenil-propil-amin-származékok, eljárás elõállításukra, azokat tartalmazó gyógyászati készítmények és alkalmazásuk (Novel derivatives of 3,3-diphenylpropyl-amines, process for their production, their use and pharmaceutical compositions containing the same)

Supplementary Protection Certificates for TOVIAZ

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1077912	308	Finland
1077912	91365	Luxembourg		91365, EXPIRES: 20220420
1077912	SPC037/2007	Ireland		SPC037/2007: 20080507, EXPIRES: 20220419
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 [...]
1230209	PA2007008	Lithuania		PRODUCT NAME: FESOTERODINUM; REGISTRATION NO/DATE: EU/1/07/386/001 - EU/1/07/386/010 20070420
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

Overview of Toviaz

Toviaz, a once-daily extended-release treatment for overactive bladder (OAB), was approved by the FDA in 2008. It is indicated for the treatment of OAB symptoms, including urge urinary incontinence, urgency, and frequency in adults.

Market Performance

Historical Sales

Toviaz has been a significant revenue generator for Pfizer, consistently bringing in more than $200 million annually. However, in 2021, its sales slipped by around 5% to $238 million[4].

Market Share and Competition

Toviaz has faced increasing competition, particularly with the launch of generic equivalents. Dr. Reddy's Laboratories introduced a therapeutic generic equivalent, fesoterodine fumarate extended-release tablets, which is available in the same doses as Toviaz (4 mg and 8 mg). This generic launch poses a threat to Toviaz's sales, as it offers a more affordable alternative to patients[4].

Financial Impact of Generic Competition

Revenue Erosion

The introduction of generic versions of Toviaz is expected to lead to significant revenue erosion. Generic competition often results in price reductions and market share loss for the branded drug. This trend is evident in the pharmaceutical industry, where generic launches can reduce branded drug sales by up to 80% or more within the first year[4].

Patent Expirations

The patent expiration of Toviaz has opened the door for generic manufacturers to enter the market. This is a critical factor in the financial trajectory of Toviaz, as it marks the end of Pfizer's exclusive marketing rights and allows other companies to produce and sell generic versions of the drug[4].

Market Dynamics in the OAB Segment

Growth Drivers and Barriers

The overactive bladder drug market, which includes Toviaz, is influenced by several factors. The market is expected to grow at a CAGR of more than 2% from 2021 to 2030, driven by the increasing prevalence of OAB due to aging populations and rising obesity. However, this growth is tempered by factors such as the scarcity of late-stage pipeline drugs and the generic sales erosion of key brands like VESIcare, Myrbetriq, and Toviaz[1].

Stigma and Treatment Adherence

Low rates of diagnosis and treatment due to stigma and misinformation surrounding OAB also impact the market. Poor persistence and adherence to drug therapy further complicate the financial outlook for Toviaz and other OAB treatments[1].

Financial Trajectory

Current Financials

As of 2021, Toviaz generated $238 million in sales, which, although lower than previous years, still represents a significant revenue stream for Pfizer. However, the financial trajectory is likely to decline with the increasing presence of generic competitors[4].

Future Projections

Given the competitive landscape and the impact of generic competition, the financial performance of Toviaz is expected to decline. The launch of generic equivalents will likely reduce Pfizer's revenue from Toviaz substantially over the coming years. This trend is consistent with the broader pharmaceutical industry, where branded drugs typically experience significant sales drops following the introduction of generic alternatives[4].

Key Players and Market Share

Pfizer's Position

Pfizer, the original manufacturer of Toviaz, has seen its market share in the OAB segment threatened by generic entrants. While Toviaz remains a notable player, its market share is expected to diminish as generic versions gain traction[4].

Other Key Players

Other companies, such as Allergan, Astellas, Urovant Sciences, Bayer, and Taiho Pharmaceuticals, are also active in the OAB market. These companies are developing new therapies and pipeline agents, which could further alter the market dynamics and impact Toviaz's financial trajectory[1].

Regulatory and Competitive Landscape

FDA Approvals and Generic Filings

The FDA approval of generic versions of Toviaz, such as Dr. Reddy's fesoterodine fumarate extended-release tablets, has significantly altered the competitive landscape. Dr. Reddy's had 90 generic filings pending approval at the FDA as of May 2022, including 24 applications with first-to-file status, indicating a robust pipeline of potential competitors[4].

Conclusion

The financial trajectory of Toviaz is marked by declining sales due to generic competition and patent expirations. While it has been a profitable drug for Pfizer, the introduction of generic equivalents and the broader market dynamics in the OAB segment suggest a challenging future for Toviaz.

Key Takeaways

• Toviaz has historically generated over $200 million in annual sales but faced a 5% decline in 2021.
• Generic competition, particularly from Dr. Reddy's Laboratories, poses a significant threat to Toviaz's sales.
• The OAB drug market is expected to grow at a CAGR of more than 2% from 2021 to 2030, driven by increasing prevalence but hindered by generic sales erosion and low treatment adherence.
• Stigma and misinformation surrounding OAB further complicate the market.
• Pfizer's revenue from Toviaz is expected to decline substantially due to generic competition.

FAQs

Q: What is Toviaz used for?

A: Toviaz is used for the treatment of overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and frequency in adults.

Q: How has the sales performance of Toviaz been in recent years?

A: Toviaz has consistently generated over $200 million annually, but its sales slipped by around 5% to $238 million in 2021.

Q: What impact does generic competition have on Toviaz?

A: The introduction of generic versions of Toviaz, such as Dr. Reddy's fesoterodine fumarate extended-release tablets, is expected to significantly reduce Pfizer's revenue from Toviaz due to price competition and market share loss.

Q: What are the key drivers and barriers in the OAB drug market?

A: The market is driven by increasing prevalence due to aging populations and rising obesity but is hindered by generic sales erosion, scarcity of late-stage pipeline drugs, and low rates of diagnosis and treatment due to stigma and poor adherence.

Q: How does the regulatory landscape affect Toviaz?

A: The FDA approval of generic versions of Toviaz has opened the market to competition, and companies like Dr. Reddy's have multiple generic filings pending, further threatening Toviaz's market share.

Sources:

1. Overactive Bladder: Global Drug Forecast and Market Analysis to 2030 - GlobalData
2. Viatris Reports Strong Financial and Operational Results for the Third Quarter 2023 - Viatris Newsroom
3. UCB Annual Report 2016 - UCB
4. Dr. Reddy's launches extended-release rival to $200M Pfizer drug - FiercePharma