TOLTERODINE TARTRATE - Generic Drug Details

What are the generic drug sources for tolterodine tartrate and what is the scope of freedom to operate?

Tolterodine tartrate is the generic ingredient in three branded drugs marketed by Upjohn, Ajanta Pharma Ltd, Aurobindo Pharma Usa, Hetero Labs Ltd Iii, Inventia Hlthcare, Teva Pharms Usa, Torrent, Unichem, Utopic Pharms, Apotex Corp, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Pharmobedient, Pts Consulting, and Rising, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for tolterodine tartrate. Eighteen suppliers are listed for this compound. There are two tentative approvals for this compound.

Summary for TOLTERODINE TARTRATE

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	18
Raw Ingredient (Bulk) Api Vendors:	184
Clinical Trials:	16
Drug Prices:	Drug price trends for TOLTERODINE TARTRATE
What excipients (inactive ingredients) are in TOLTERODINE TARTRATE?	TOLTERODINE TARTRATE excipients list
DailyMed Link:	TOLTERODINE TARTRATE at DailyMed

See drug prices for TOLTERODINE TARTRATE

See drug sales revenues for TOLTERODINE TARTRATE

Recent Clinical Trials for TOLTERODINE TARTRATE

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

Sponsor	Phase
Shanghai Institute of Acupuncture, Moxibustion and Meridian	N/A
RenJi Hospital	N/A
University of California, San Francisco	Phase 4

See all TOLTERODINE TARTRATE clinical trials

Generic filers with tentative approvals for TOLTERODINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
		2MG	TABLET; ORAL
		1MG	TABLET; ORAL
		2MG	TABLET; ORAL

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

Pharmacology for TOLTERODINE TARTRATE

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for TOLTERODINE TARTRATE

Muscarinic Antagonists

Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for TOLTERODINE TARTRATE

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

Paragraph IV (Patent) Challenges for TOLTERODINE TARTRATE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DETROL LA	Extended-release Capsules	tolterodine tartrate	2 mg and 4 mg	021228	1	2007-07-30

US Patents and Regulatory Information for TOLTERODINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma Usa	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	201486-002	Oct 31, 2013		DISCN	No	No
Hetero Labs Ltd V	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	204397-001	Aug 2, 2021	AB	RX	No	No
Rising	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	210775-002	Dec 30, 2019	AB	RX	No	No
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000	AB	RX	Yes	Yes
Macleods Pharms Ltd	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	203409-002	Aug 31, 2015	AB	RX	No	No
Inventia Hlthcare	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	204562-001	Aug 19, 2019	AB	RX	No	No

Expired US Patents for TOLTERODINE TARTRATE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-001	Mar 25, 1998
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998

Market Dynamics and Financial Trajectory for Tolterodine Tartrate

Last updated: July 28, 2025

Introduction

Tolterodine tartrate stands as a significant player within the pharmacological landscape, primarily prescribed for overactive bladder (OAB) management. As an antimuscarinic agent, it offers targeted symptomatic relief, which has spurred a consistent demand. Analyzing its market dynamics and financial trajectory reveals both opportunities and challenges shaped by clinical efficacy, market competition, regulatory frameworks, and evolving healthcare paradigms.

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Product Profile and Therapeutic Significance

Tolterodine tartrate, marketed under brands such as Detrol and Detrol LA, selectively inhibits muscarinic receptors in the bladder detrusor muscle, reducing involuntary contractions. Its efficacy in improving urinary frequency, urgency, and incontinence has cemented its role among OAB therapies. The drug’s extended-release formulation enhances patient compliance by minimizing peak-trough fluctuations.

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Market Landscape and Key Drivers

Growing Prevalence of Overactive Bladder

The global prevalence of OAB is projected to escalate due to aging populations and increased awareness of urinary disorders. The International Continence Society estimates that approximately 12-17% of the adult population suffers from OAB symptoms worldwide [1]. This demographic shift fuels sustained demand for effective pharmacotherapy, underpinning the market growth for tolterodine tartrate.

Clinical Efficacy and Safety Profile

Clinical trials and post-marketing studies affirm tolterodine's superior tolerability compared to earlier antimuscarinics, with lower incidences of dry mouth and cognitive side effects—particularly crucial given the elderly demographic. Such safety advantages bolster prescriber confidence and promote continued utilization.

Formulation Innovations and Delivery

Availability of extended-release formulations (e.g., Detrol LA) has improved patient adherence, expanding the treatment market. Advancements in drug delivery techniques contribute to increased market penetration by optimizing therapeutic outcomes.

Healthcare Policy and Reimbursement Dynamics

Reimbursement policies in developed markets like the U.S. and Europe favor medications with proven safety and efficacy. Inclusion of tolterodine in formularies and guidelines by bodies such as the American Urological Association (AUA) sustains market access, reinforcing revenue streams.

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Market Challenges and Competition

Emerging Therapeutic Alternatives

The pharmaceutical landscape for OAB is increasingly competitive, with newer agents targeting different mechanisms. Beta-3 adrenergic agonists like mirabegron offer a non-antimuscarinic approach, with benefits including fewer anticholinergic side effects, especially cognitive impairment. The advent of such drugs challenges tolterodine's dominance.

Patent Expirations and Generic Competition

Patents protecting branded formulations of tolterodine have begun to lapse in various jurisdictions, inviting generic competition. Generic versions typically enter the market at 20-30% lower prices, exerting downward pressure on revenues and margins for branded formulations.

Regulatory and Off-Label Risks

Regulatory scrutiny concerning long-term safety and off-label use potential can influence market dynamics adversely. Any safety signals or regulatory restrictions could diminish demand.

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Financial Trajectory Analysis

Historical Revenue Trends

Historically, tolterodine tartrate generated substantial revenues in mid-2000s, driven by robust sales of brand formulations like Detrol and Detrol LA. The product's market share was bolstered by its efficacy and safety profile, accommodating a broad patient base.

Impact of Patent Cliffs

As patents expired, revenue trajectories experienced a decline in developed markets due to the proliferation of generics. For instance, in the U.S., generic versions entered around 2010–2012, reducing per-unit costs and pressuring revenue streams.

Future Revenue Projections

Despite generic competition, revenues may stabilize owing to:

• Increasing prevalence of OAB.
• Limited penetration of newer agents among certain populations preferring familiar treatments.
• Ongoing patent protections in emerging markets.

Market analysts forecast a compound annual growth rate (CAGR) of approximately 2-4% over the next five years, driven mainly by emerging markets and aging populations [2].

Market Penetration in Emerging Markets

Emerging markets present growth opportunities due to increasing healthcare access, rising awareness, and affordability of generic formulations. Local manufacturing and regulatory advancements support this trajectory, though market penetration remains sensitive to local economic factors.

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Strategic Considerations for Stakeholders

• Pharmaceutical Companies: Investment in formulation improvements, combination therapies, and targeted marketing can sustain relevance amid competitive pressures.
• Healthcare Providers: Awareness of new therapeutic alternatives and personalized medicine approaches influence prescribing patterns.
• Policy Makers: Supportive regulatory environments and reimbursement strategies for innovative formulations can shape market evolution.

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Regulatory and Patent Landscape

The patent landscape significantly influences financial trajectories. Patent litigations and extensions, often pursued to prolong exclusivity, can temporarily shield revenues but may attract scrutiny or be contested, affecting long-term profitability [3].

Regional regulatory approvals—such as in Europe via the EMA or in the U.S. via the FDA—dictate product access and commercial viability. Fast-track approvals for formulations with proven improved safety profiles may accelerate market growth.

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Emerging Trends and Future Outlook

Personalized Medicine and Pharmacogenomics

Advances in understanding genetic factors influencing drug response (e.g., polymorphisms in muscarinic receptor genes) could tailor therapy, optimizing efficacy and minimizing adverse effects, potentially expanding tolterodine’s market niche.

Combination Therapies

Combining tolterodine with other agents—such as beta-3 agonists or behavioral therapies—could improve patient outcomes, opening new revenue avenues.

Digital Health Integration

Digital therapeutics and remote monitoring could enhance adherence and treatment efficacy, indirectly influencing tolterodine’s sales by improving clinical outcomes.

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Conclusion

Tolterodine tartrate maintains a vital role in managing overactive bladder amid an evolving pharmaceutical landscape. Its market dynamics are shaped by demographic trends, clinical advantages, and competitive pressures from emerging therapies. Despite patent expirations and generics, the drug’s continued relevance depends on strategic positioning, formulation innovations, and shifting healthcare policies. The financial outlook, while challenged by generic competition, remains moderately positive, especially considering growth in emerging markets and demographic trends.

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Key Takeaways

• The global OAB prevalence sustains long-term demand for tolterodine tartrate, especially with an aging population.
• Competitive pressures include newer therapies like beta-3 agonists, but tolterodine’s established safety profile maintains its demand.
• Patent expirations have pressured revenues, but generic competition and market expansion in emerging economies offer growth opportunities.
• Innovations in drug formulations and combination therapies will be pivotal to sustaining profitability.
• Strategic engagement with regulatory and reimbursement frameworks will determine future market success.

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FAQs

1. How does tolterodine tartrate compare to newer OAB treatments?
Tolterodine offers a well-established safety profile, particularly beneficial for elderly patients. Newer agents like mirabegron provide alternatives with fewer anticholinergic side effects, appealing to certain patient subsets, but tolterodine remains a cost-effective and frequently prescribed therapy.

2. What are the main challenges facing tolterodine’s market growth?
Key challenges include patent expirations leading to generic competition, emergence of alternative drug classes, and the need for formulation innovations to maintain treatment adherence.

3. Which regions present the highest growth potential for tolterodine?
Emerging markets such as China, India, and Latin America offer significant growth potential due to increasing healthcare infrastructure, affordability, and awareness campaigns around urinary health.

4. How might pharmacogenomics influence the future sales of tolterodine?
Personalized treatment based on genetic profiling could optimize dosing and reduce adverse effects, potentially broadening tolterodine’s use and increasing adherence.

5. What role do regulatory agencies play in tolterodine’s market trajectory?
Regulatory approvals determine market access and safety compliance. Positive regulatory decisions can facilitate new formulations or indications, while restrictions or safety concerns might hinder sales.

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Sources:

[1] International Continence Society (ICS). Global OAB prevalence estimates, 2020.
[2] MarketWatch Reports. Pharmaceutical market projections for OAB therapies, 2022.
[3] Pharmaceutical Patent Watch. Patent expiration timelines and legal considerations, 2021.