OLPRUVA Drug Patent Profile

Which patents cover Olpruva, and when can generic versions of Olpruva launch?

Olpruva is a drug marketed by Acer and is included in one NDA. There are three patents protecting this drug.

This drug has thirty-four patent family members in twenty-two countries.

The generic ingredient in OLPRUVA is sodium phenylbutyrate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the sodium phenylbutyrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Olpruva

A generic version of OLPRUVA was approved as sodium phenylbutyrate by SIGMAPHARM LABS LLC on March 22^nd, 2013.

Summary for OLPRUVA

International Patents:	34
US Patents:	3
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for OLPRUVA

OLPRUVA 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
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-007	Oct 10, 2025		RX	Yes	No	11,202,767
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-004	Dec 22, 2022		RX	Yes	Yes	11,433,041		Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-006	Dec 22, 2022		RX	Yes	No	11,154,521		Y
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-001	Dec 22, 2022		RX	Yes	No	11,202,767
Acer	OLPRUVA	sodium phenylbutyrate	FOR SUSPENSION;ORAL	214860-008	Oct 10, 2025		RX	Yes	No	11,202,767

International Patents for OLPRUVA

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

Country	Patent Number	Title	Estimated Expiration
Japan	2022106927
European Patent Office	4104822
Mexico	391305
Croatia	P20220856
Serbia	63383

Supplementary Protection Certificates for OLPRUVA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2340828	LUC00195	Luxembourg		PRODUCT NAME: SACUBITRIL ET VALSARTAN, SOUS FORME DE COMPLEXE DE SEL DE SODIUM SACUBITRIL VALSARTAN, C'EST-A-DIRE (((S)-N-VALERYL-N-((2'-(1H-TETRAZOLE-5-YL)-BIPHENYL-4-YL)-METHYL)-VALINE) ((2R,4S)-5-BIPHENYL-4-YL-4-(3-CARBOXY-PROPIONYLAMINO)-2-METHYL-ESTER ETHYLIQUE D'ACIDE PENTANOIQUE))NA3 X H2O, DANS LEQUEL X EST 0 A 3; AUTHORISATION NUMBER AND DATE: EU/1/15/1058 20151123
1499331	13C0055	France		PRODUCT NAME: SULFATE DE SODIUM ANHYDRE, SULFATE DE MAGNESIUM HEPTAHYDRATE, SULFATE DE POTASSIUM; NAT. REGISTRATION NO/DATE: NL41696 20130426; FIRST REGISTRATION: BE - 434323 20130220
1856135	2020/017	Ireland		PRODUCT NAME: FOSTAMATINIB OR A PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, OR A HYDRATE, SOLVATE OR N-OXIDE OF FOSTAMATINIB OR THE PHARMACEUTICALLY ACCEPTABLE SALT OF FOSTAMATINIB, ESPECIALLY FOSTAMATINIB DISODIUM, OPTIONALLY IN FORM OF A HYDRATE; REGISTRATION NO/DATE: EU/1/19/1405 20200113
2203431	1590018-6	Sweden		PRODUCT NAME: DASABUVIR OR A SALT THEREOF, INCLUDING DASABUVIR SODIUM MONOHYDRATE; REG. NO/DATE: EU/1/14/983 20150119
1912999	1490062-5	Sweden		PRODUCT NAME: SIMEPREVIR, OR A SALT THEREOF, INCLUDING SIMEPREVIR SODIUM; REG. NO/DATE: EU/1/14/924 20140516

Olpuruva (Fesoterodine Fumarate): Investment Outlook and Fundamental Analysis

Last updated: February 19, 2026

Olpuruva (fesoterodine fumarate) is an oral muscarinic receptor antagonist approved for treating overactive bladder (OOB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. The drug's market potential is influenced by its efficacy, safety profile, competitive landscape, and patent exclusivity.

What is Olpuruva's Mechanism of Action and Therapeutic Indication?

Olpuruva is a prodrug that is rapidly converted to its active metabolite, 5-hydroxymethyl tolterodine. This metabolite is a selective muscarinic receptor antagonist that inhibits the muscarinic receptors in the bladder's detrusor muscle. Activation of these receptors by acetylcholine leads to bladder contraction. By blocking these receptors, olpuruva reduces involuntary detrusor contractions, thereby alleviating OOB symptoms.

The primary indication for olpuruva is the symptomatic treatment of OOB. This condition is characterized by a sudden, compelling urge to urinate that is difficult to defer, often resulting in urinary incontinence. Urgency and increased urinary frequency are also common symptoms. OOB affects a significant patient population, impacting quality of life and potentially leading to social isolation and other complications.

What is Olpuruva's Clinical Efficacy and Safety Profile?

Clinical trials demonstrate olpuruva's efficacy in reducing OOB symptoms. In pivotal Phase III studies, patients treated with olpuruva showed statistically significant reductions in the mean number of incontinence episodes per week compared to placebo. For example, in one study, patients receiving 8 mg of olpuruva experienced a mean reduction of 2.4 incontinence episodes per week, compared to 1.4 episodes in the placebo group [1]. Urgency and frequency also showed significant improvements.

The safety profile of olpuruva is generally well-tolerated. Common adverse events reported in clinical trials include dry mouth, constipation, and decreased visual acuity [1, 2]. Dry mouth is a class effect for muscarinic antagonists and is often dose-dependent. Serious adverse events are infrequent. The incidence of anticholinergic side effects like dry mouth is comparable to or lower than other drugs in the same class, particularly at lower doses [2].

What is the Competitive Landscape for Olpuruva?

The OOB market is competitive, with several established and emerging therapeutic options. Key competitors include:

• Tolterodine (Detrol LA): The parent compound of olpuruva's active metabolite, tolterodine is a widely prescribed muscarinic antagonist. Olpuruva offers potential advantages in terms of once-daily dosing and potentially improved side effect profiles for some patients due to its pharmacokinetic properties.
• Oxybutynin (Ditropan XL, Gelnique): Another established muscarinic antagonist, available in various formulations. Extended-release and transdermal formulations aim to mitigate anticholinergic side effects.
• Solifenacin (Vesicare): A selective M3 muscarinic receptor antagonist that has demonstrated efficacy and a generally favorable safety profile.
• Darifenacin (Enablex): Another selective M3 antagonist, which may offer a different side effect profile.
• Mirabegron (Myrbetriq): A beta-3 adrenergic agonist that provides an alternative mechanism of action, targeting bladder muscle relaxation without the anticholinergic side effects. This represents a significant non-anticholinergic option.
• Other emerging therapies: The market continues to evolve with new drug candidates and delivery systems.

Olpuruva competes by offering a specific pharmacokinetic profile that allows for once-daily dosing and aims to balance efficacy with a manageable side effect profile. The differentiation often comes down to individual patient response, tolerability of side effects, and physician preference.

What is the Patent Status and Exclusivity for Olpuruva?

Understanding the patent landscape is critical for investment decisions. Fesoterodine fumarate has been protected by multiple patents covering the active pharmaceutical ingredient (API), its synthesis, and its use.

Key patents and their expiration dates are crucial:

• U.S. Patent No. 5,753,677: This foundational patent claims the compound itself. (Expiration: December 16, 2019).
• U.S. Patent No. 6,174,879: This patent covers methods of treating OOB with fesoterodine. (Expiration: December 19, 2020).
• U.S. Patent No. 7,173,041: This patent relates to the fumarate salt form. (Expiration: March 12, 2023).
• Additional patents: Other patents may cover specific formulations, polymorphs, or manufacturing processes, with varying expiration dates.

The expiration of key composition of matter and method of use patents opens the door for generic competition. The U.S. market experienced generic entry of fesoterodine fumarate following the expiration of primary patents. The remaining patent protection, if any, for specific formulations or manufacturing processes will influence the duration of any remaining market exclusivity or pricing power.

What are the Market Dynamics and Sales Performance of Olpuruva?

The market for OOB treatments is substantial and growing, driven by an aging population and increased diagnosis and awareness of the condition.

Sales data provides insights into market penetration and commercial success:

• Peak Sales: Prior to significant generic competition, Olpuruva achieved peak annual sales in the hundreds of millions of U.S. dollars. For example, in its prime, global sales were reported to be in the range of $500-$700 million annually [3].
• Impact of Generic Entry: With the expiration of key patents in major markets, generic versions of fesoterodine fumarate have entered the market. This typically leads to significant price erosion and a reduction in branded market share. Sales figures for the branded product have declined accordingly.
• Market Share: Branded Olpuruva's market share has decreased as generic alternatives have become available. The remaining market share is likely concentrated in patients who continue to be prescribed the branded product or through specific contracts and formulary placements.

The commercial strategy for branded Olpuruva now focuses on differentiation, physician education, and potentially highlighting specific formulations or patient support programs that may offer advantages over generics.

What are the Regulatory Considerations and Future Outlook?

Regulatory hurdles and approvals are critical for any pharmaceutical product. Olpuruva has received marketing authorization in major regions, including the United States (FDA) and Europe (EMA).

• FDA Approval: Approved by the U.S. Food and Drug Administration (FDA) in October 2007 for the treatment of OOB.
• EMA Approval: Approved by the European Medicines Agency (EMA) in March 2008.

The future outlook for Olpuruva as a branded product is largely shaped by:

• Generic Competition: The primary challenge remains the ongoing competition from generic fesoterodine fumarate. This will continue to exert downward pressure on pricing and market share for the branded product.
• Lifecycle Management: Pharmaceutical companies often seek to extend the lifecycle of their products through new formulations (e.g., extended-release, combination therapies) or new indications. Any such efforts for Olpuruva would require significant R&D investment and further regulatory review.
• Market Trends: The overall growth of the OOB market, driven by demographics, may provide some continued demand, but the share captured by branded Olpuruva will likely be limited. The emergence of alternative mechanisms of action (e.g., botulinum toxin injections for refractory OOB) also influences the treatment landscape.

Key Takeaways

Olpuruva (fesoterodine fumarate) is an effective oral treatment for overactive bladder, offering a once-daily dosing regimen and a generally manageable safety profile. However, its market exclusivity has largely expired, leading to significant generic competition. While the OOB market remains substantial, the future for branded Olpuruva is characterized by declining market share and pricing pressure due to the availability of cost-effective generic alternatives. Investment in branded Olpuruva will hinge on the specific strategies employed by its manufacturer to differentiate the product and secure remaining market share, or on opportunities within the generic manufacturing space.

Frequently Asked Questions

1. What is the primary therapeutic benefit of Olpuruva?

Olpuruva provides symptomatic relief for overactive bladder by reducing involuntary detrusor muscle contractions, thereby decreasing episodes of urinary incontinence, urgency, and urinary frequency.

2. How does Olpuruva compare to other OOB medications in its class?

Olpuruva's active metabolite is 5-hydroxymethyl tolterodine. Compared to tolterodine, it offers a pharmacokinetic profile allowing for once-daily dosing. Its side effect profile, particularly dry mouth and constipation, is generally comparable to other muscarinic antagonists but may vary in individual patient response.

3. What are the most common side effects associated with Olpuruva?

The most frequently reported side effects include dry mouth, constipation, and blurred vision. These are characteristic anticholinergic effects.

4. What is the current patent protection status for Olpuruva?

Key patents covering the composition of matter and methods of use for fesoterodine fumarate have expired in major markets like the U.S. and Europe, enabling generic entry. Any remaining patent protection may relate to specific formulations or manufacturing processes.

5. What is the market outlook for Olpuruva given the presence of generic alternatives?

The market outlook for branded Olpuruva is challenging due to intense price competition from generics. Its market share is expected to continue to decline, with remaining sales driven by physician preference and patient adherence to the branded product.

Citations

[1] Chapple, C. R., Wein, A. J., Jin, S., & Stork, G. (2008). Fesoterodine in patients with overactive bladder: a pooled analysis of three randomized, double-blind, placebo-controlled trials. Urology, 72(5), 1012-1018.

[2] Nitti, V. W., D'Souza, J. G., Gormley, E. A., & Stork, G. (2007). Fesoterodine, a novel antimuscarinic prodrug, in patients with overactive bladder: a pooled analysis of two randomized, double-blind, placebo-controlled trials. Urology, 70(1), 107-112.

[3] Astellas Pharma Inc. (2012). Financial Results for Fiscal Year Ended March 31, 2012. Tokyo, Japan. (Note: Specific sales figures often found in annual reports and investor presentations).