Drug Price Trends for FESOTERODINE ER

Average Pharmacy Cost for FESOTERODINE ER

These are average pharmacy acquisition costs (net of discounts) from a US national survey

Drug Name	NDC	Price/Unit ($)	Unit	Date
FESOTERODINE ER 4 MG TABLET	31722-0033-30	0.83014	EACH	2025-02-19
FESOTERODINE ER 4 MG TABLET	67877-0064-30	0.83014	EACH	2025-02-19
FESOTERODINE ER 4 MG TABLET	43598-0247-30	0.83014	EACH	2025-02-19
FESOTERODINE ER 4 MG TABLET	62332-0175-30	0.83014	EACH	2025-02-19
FESOTERODINE ER 4 MG TABLET	68382-0479-06	0.83014	EACH	2025-02-19
FESOTERODINE ER 4 MG TABLET	65862-0766-30	0.83014	EACH	2025-02-19

Market Analysis and Price Projections for Fesoterodine ER

Introduction to Fesoterodine ER

Fesoterodine fumarate extended-release (ER) tablets, marketed under the brand name Toviaz, are an antimuscarinic agent used to treat overactive bladder (OAB) symptoms, including urge urinary incontinence, urgency, and frequency in adults. It is also indicated for the treatment of neurogenic detrusor overactivity in pediatric patients aged 6 years and older weighing more than 25 kg[4].

Market Size and Demand

The market for fesoterodine fumarate ER tablets is substantial, driven by the prevalence of overactive bladder and the need for effective treatments. According to IQVIA data, the estimated market size for fesoterodine fumarate extended-release tablets (4 mg and 8 mg) was approximately USD 225 million for the 12 months ending September 2021[1].

Competitive Landscape

The market for OAB treatments is competitive, with several other medications available, including oxybutynin and mirabegron (Myrbetriq).

• Toviaz (Fesoterodine): Toviaz is a prescription-only medication specifically indicated for urinary incontinence and frequency. It has an average rating of 5.2 out of 10 from user reviews, with 33% of reviewers reporting a positive effect[5].
• Oxybutynin: Available in both prescription and over-the-counter (OTC) forms, oxybutynin is another common treatment for OAB symptoms. It is known for side effects such as dry mouth and constipation[5].
• Myrbetriq (Mirabegron): This is a prescription-only medication used to relieve symptoms of OAB, including urinary incontinence and frequency. It is also used to treat neurogenic detrusor overactivity[5].

Generic Competition

The recent tentative approval by the US FDA for Alembic Pharmaceuticals' generic version of fesoterodine fumarate ER tablets is expected to impact the market dynamics significantly. This generic version is therapeutically equivalent to Pfizer's Toviaz Extended-Release Tablets (4 mg and 8 mg)[1].

Pricing and Cost Considerations

The cost of Toviaz can be significant for patients. Here are some key pricing points:

• Brand Name: The cost for Toviaz 4 mg or 8 mg oral tablets, extended release, is around $315 for a supply of 30 tablets, depending on the pharmacy[2].
• Generic Version: While the pricing for the generic version is not yet available, it is generally expected to be lower than the brand name, potentially reducing the overall market price and increasing accessibility for patients.

Patient Assistance Programs

To make the medication more affordable, several patient assistance programs are available:

• Rx Outreach Medications: Offers medications, including Toviaz, for a fee of $20 for up to a 180-day supply, subject to eligibility criteria[2].
• Patient Access Network Foundation (PAN): Provides assistance to patients with health insurance that covers the qualifying medication, subject to specific eligibility requirements[2].

Side Effects and Safety Profile

Fesoterodine ER tablets have a well-documented safety profile. Common side effects include dry mouth, constipation, and dry eyes. Serious adverse events are rare but can include urinary retention, diverticulitis, and QT interval prolongation[3].

Dosage and Administration

The recommended starting dosage of Toviaz is 4 mg orally once daily, which can be increased to 8 mg after one week if needed. Dosing adjustments are necessary for patients with renal impairment[3].

Market Projections

Given the tentative approval of the generic version, here are some market projections:

• Price Reduction: The introduction of a generic version is likely to reduce the average market price of fesoterodine fumarate ER tablets, making the medication more accessible to a wider patient population.
• Increased Market Share: Generic competition often leads to increased market share for the generic product due to its lower price point, potentially reducing the market share of the brand name Toviaz.
• Volume Growth: With the generic version available, the overall volume of fesoterodine fumarate ER tablets sold is expected to increase as more patients can afford the treatment.

Key Takeaways

• Market Size: The market for fesoterodine fumarate ER tablets is significant, with an estimated size of USD 225 million.
• Generic Competition: The tentative approval of a generic version by Alembic Pharmaceuticals will likely reduce prices and increase accessibility.
• Pricing: The brand name Toviaz is currently priced around $315 for a 30-tablet supply, with generic prices expected to be lower.
• Patient Assistance: Various patient assistance programs are available to help make the medication more affordable.
• Safety Profile: Common side effects include dry mouth and constipation, with rare serious adverse events.

FAQs

1. What is fesoterodine fumarate ER used for? Fesoterodine fumarate ER is used to treat overactive bladder symptoms, including urge urinary incontinence, urgency, and frequency in adults, and neurogenic detrusor overactivity in pediatric patients[4].

2. How much does Toviaz cost? The cost for Toviaz 4 mg or 8 mg oral tablets, extended release, is around $315 for a supply of 30 tablets, depending on the pharmacy[2].

3. Is there a generic version of Toviaz available? Yes, Alembic Pharmaceuticals has received tentative approval from the US FDA for a generic version of fesoterodine fumarate ER tablets[1].

4. What are the common side effects of fesoterodine fumarate ER? Common side effects include dry mouth, constipation, and dry eyes. Serious adverse events are rare but can include urinary retention and QT interval prolongation[3].

5. Are there patient assistance programs available for Toviaz? Yes, programs like Rx Outreach Medications and the Patient Access Network Foundation (PAN) offer assistance to make the medication more affordable[2].

Cited Sources:

1. Economic Times: Alembic Pharma gets tentative USFDA nod for fesoterodine fumarate extended-release tablets.
2. Drugs.com: Toviaz Prices, Coupons, Copay Cards & Patient Assistance.
3. FDA: TOVIAZ® (fesoterodine) Label.
4. DrugBank: Fesoterodine: Uses, Interactions, Mechanism of Action.
5. Drugs.com: Toviaz Alternatives Compared.