Fesoterodine fumarate - Generic Drug Details

What are the generic sources for fesoterodine fumarate and what is the scope of freedom to operate?

Fesoterodine fumarate is the generic ingredient in two branded drugs marketed by Accord Hlthcare, Actavis Labs Fl Inc, Alembic, Alkem Labs Ltd, Amneal Pharms Ny, Ani Pharms, Aurobindo Pharma, Chartwell Rx, Dr Reddys, Hetero Labs Ltd V, Zydus Pharms, and Pfizer, and is included in twelve NDAs. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

There are fourteen drug master file entries for fesoterodine fumarate. Thirteen suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for fesoterodine fumarate

US Patents:	3
Tradenames:	2
Applicants:	12
NDAs:	12
Drug Master File Entries:	14
Finished Product Suppliers / Packagers:	13
Raw Ingredient (Bulk) Api Vendors:	72
Clinical Trials:	10
Patent Applications:	267
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for fesoterodine fumarate
What excipients (inactive ingredients) are in fesoterodine fumarate?	fesoterodine fumarate excipients list
DailyMed Link:	fesoterodine fumarate at DailyMed

Recent Clinical Trials for fesoterodine fumarate

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

Sponsor	Phase
University of North Carolina, Chapel Hill	Phase 3
National Institute on Aging (NIA)	Phase 3
Mayo Clinic	Phase 4

See all fesoterodine fumarate clinical trials

Generic filers with tentative approvals for FESOTERODINE FUMARATE

Applicant	Application No.	Strength	Dosage Form
		8MG	TABLET, EXTENDED RELEASE;ORAL
		4MG	TABLET, EXTENDED RELEASE;ORAL
		8MG	TABLET, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Anatomical Therapeutic Chemical (ATC) Classes for fesoterodine fumarate

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

Paragraph IV (Patent) Challenges for FESOTERODINE FUMARATE

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 fesoterodine fumarate

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Chartwell Rx	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204983-001	Jan 5, 2023		DISCN	No	No
Aurobindo Pharma	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	205007-002	Feb 17, 2017	AB	RX	No	No
Actavis Labs Fl Inc	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204868-002	Jan 4, 2023		DISCN	No	No
Zydus Pharms	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	204946-001	Oct 3, 2017	AB	RX	No	No
Aurobindo Pharma	FESOTERODINE FUMARATE	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	205007-001	Feb 17, 2017	AB	RX	No	No
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008	AB	RX	Yes	No

Expired US Patents for fesoterodine fumarate

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	022030-002	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	022030-001	Oct 31, 2008
Pfizer	TOVIAZ	fesoterodine fumarate	TABLET, EXTENDED RELEASE;ORAL	022030-001	Oct 31, 2008

Fesoterodine fumarate Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Fesoterodine Fumarate

Introduction to Fesoterodine Fumarate

Fesoterodine fumarate is a medication used to treat overactive bladder (OAB) in adults, characterized by symptoms of urinary incontinence, urgency, and frequency. It is available in extended-release tablet form, typically in doses of 4 mg and 8 mg per day[2].

Market Size and Growth

The global overactive bladder treatment market, which includes fesoterodine fumarate, is projected to grow significantly. By 2028, the market is expected to reach USD 5,333.92 million from USD 4,295.93 million in 2021, with a Compound Annual Growth Rate (CAGR) of 3.1% from 2022 to 2028[1].

Competitive Landscape

The market for overactive bladder treatments is highly competitive, with several key players. Companies such as Pfizer Inc., Astellas Pharma Inc., AbbVie Inc., and Teva Pharmaceuticals Industries Ltd. are major competitors. However, the entry of generic versions has significantly impacted the market dynamics.

Dr. Reddy's Laboratories, for instance, launched a generic version of fesoterodine fumarate extended-release tablets, which is a direct competitor to Pfizer's Toviaz. This generic launch has the potential to threaten Pfizer's revenues, which have consistently been over $200 million annually for Toviaz[4].

Regulatory Approvals and Impact

Recent regulatory approvals have been crucial for the market trajectory of fesoterodine fumarate. In 2022, Alembic Pharmaceuticals received approval from the US FDA for its generic version of fesoterodine fumarate extended-release tablets. Similarly, Zydus Pharmaceuticals Inc. received approval for Mirabegron Extended-Release Tablets, which, although not a direct competitor, indicates a favorable regulatory environment for extended-release formulations[1].

Geographical Distribution

The market for fesoterodine fumarate is segmented geographically into North America, Europe, Asia Pacific, the Middle East & Africa, and South & Central America. North America, particularly the US, has been a significant market due to the high prevalence of overactive bladder and the availability of advanced healthcare facilities. However, the Asia Pacific region is expected to grow with the fastest CAGR due to expanding healthcare access and rising chronic disease prevalence[1][3].

Financial Performance

Pfizer's Toviaz, the branded version of fesoterodine fumarate, has been a lucrative product, generating over $200 million in annual sales. However, with the introduction of generic versions, there has been a slight decline in sales. For example, Toviaz sales slipped around 5% to $238 million in 2021[4].

The generic launch by Dr. Reddy's Laboratories is expected to further impact Pfizer's revenue from Toviaz, as generic versions typically offer more affordable alternatives, attracting price-sensitive consumers. This competition is likely to drive down the market share and revenue of the branded product.

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the overactive bladder treatment market. While it presented challenges in terms of healthcare access and resource allocation, it also highlighted the need for effective and convenient treatment options. The pandemic's impact on the geriatric population, who are more prone to overactive bladder, has increased the demand for such treatments[1].

Sustained Release Formulations

Fesoterodine fumarate's extended-release formulation is a key factor in its market success. Sustained release excipients, which are crucial for these formulations, are in high demand due to their ability to enhance patient compliance and therapeutic effectiveness. The global sustained release excipients market is expected to grow at a CAGR of 8.5% from 2023 to 2033, driven by the increasing need for controlled and targeted drug delivery systems[3].

Clinical Trials and Safety Profile

The safety and efficacy of fesoterodine fumarate have been established through extensive clinical trials. Phase 2 and 3 trials involving over 2,800 patients showed that the most common adverse events were dry mouth and constipation, with most events being mild to moderate in intensity. Long-term open-label extension studies also supported the safety profile of the drug[2].

Key Takeaways

• Market Growth: The overactive bladder treatment market, including fesoterodine fumarate, is projected to reach USD 5,333.92 million by 2028.
• Competitive Landscape: The entry of generic versions, such as Dr. Reddy's Laboratories' fesoterodine fumarate, is expected to impact the market share of branded products like Pfizer's Toviaz.
• Geographical Distribution: North America is a significant market, but the Asia Pacific region is expected to grow with the fastest CAGR.
• Financial Performance: Branded products like Toviaz have seen slight declines in sales due to generic competition.
• COVID-19 Impact: The pandemic has increased the demand for effective and convenient treatment options.
• Sustained Release Formulations: The demand for sustained release excipients is driving the growth of extended-release formulations like fesoterodine fumarate.

FAQs

Q: What is fesoterodine fumarate used for? A: Fesoterodine fumarate is used to treat overactive bladder (OAB) in adults, characterized by symptoms of urinary incontinence, urgency, and frequency.

Q: What are the common adverse events associated with fesoterodine fumarate? A: The most common adverse events are dry mouth and constipation, with most events being mild to moderate in intensity.

Q: How has the COVID-19 pandemic impacted the overactive bladder treatment market? A: The pandemic has increased the demand for effective and convenient treatment options, despite presenting challenges in healthcare access and resource allocation.

Q: What is the projected market size for the overactive bladder treatment market by 2028? A: The global overactive bladder treatment market is projected to reach USD 5,333.92 million by 2028.

Q: Which region is expected to grow with the fastest CAGR in the overactive bladder treatment market? A: The Asia Pacific region is expected to grow with the fastest CAGR due to expanding healthcare access and rising chronic disease prevalence.

Sources:

1. The Insight Partners, "Overactive Bladder Treatment Market Revenue Report, Trends, Growth, Demand & Forecast to 2028 - COVID-19 Impact and Global Analysis By Pharmacotherapy, and Disease Type".
2. Drugs.com, "Fesoterodine Tablets: Package Insert / Prescribing Info".
3. Market.us, "Sustained Release Excipients Market Size, Share | CAGR Of 8.5%".
4. FiercePharma, "Dr. Reddy's launches extended-release rival to $200M Pfizer drug".