DETROL LA Drug Patent Profile

Which patents cover Detrol La, and what generic alternatives are available?

Detrol La is a drug marketed by Upjohn and is included in one NDA.

The generic ingredient in DETROL LA is tolterodine tartrate. There are twenty-three drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the tolterodine tartrate profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Detrol La

A generic version of DETROL LA was approved as tolterodine tartrate by IVAX SUB TEVA PHARMS on February 23^rd, 2015.

Summary for DETROL LA

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	16
Patent Applications:	483
Drug Prices:	Drug price information for DETROL LA
What excipients (inactive ingredients) are in DETROL LA?	DETROL LA excipients list
DailyMed Link:	DETROL LA at DailyMed

See drug prices for DETROL LA

See drug sales revenues for DETROL LA

Recent Clinical Trials for DETROL LA

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

Sponsor	Phase
University of California, San Francisco	Phase 4
Astellas Scientific & Medical Affairs, Inc.
Astellas Pharma Global Development, Inc.	Phase 4

See all DETROL LA clinical trials

Pharmacology for DETROL LA

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Paragraph IV (Patent) Challenges for DETROL LA

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 DETROL LA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000	AB	RX	Yes	No
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000	AB	RX	Yes	Yes

Expired US Patents for DETROL LA

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 LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000

International Patents for DETROL LA

See the table below for patents covering DETROL LA around the world.

Country	Patent Number	Title	Estimated Expiration
Morocco	25325
Hungary	T58040
Norway	20022264
Hungary	891069

Supplementary Protection Certificates for DETROL LA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0325571	21/1998	Austria		PRODUCT NAME: TOLTERODIN, SEINE SALZE, RACEMATE UND ENANTIOMERE; NAT. REGISTRATION NO/DATE: 1-22389 UND 1-22390 19980210; FIRST REGISTRATION: SE 13475 UND 13476 19970905
0325571	SPC/GB98/027	United Kingdom		PRODUCT NAME: TOLTERODINE OPTIONALLY IN THE FORM OF PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: SE 13475 19970905; SE 13476 19970905; UK 00032/0222 19980203; UK 00032/0223 19980203
0325571	C980020	Netherlands		PRODUCT NAME: TOLTERODINE, DESGEWENST IN DE VORM VAN EEN ZOUT MET EEN FYSIOLO GISCH ACCEPTABEL ZUUR, IN HET BIJZONDER TOLTERODINE L-TARTRAAT; NAT. REGISTRATION NO/DATE: RVG 22148, RVG 22149 19980217; FIRST REGISTRATION: SE 13475, 13476 19970905
0325571	1998C0031	Belgium		PRODUCT NAME: TOLTERODINI-L-TARTRAS (=TOLTERODINUM); NATL REGISTRATION NO/DATE: 277 IS 301 F 3 19980309; FIRST REGISTRATION: SE 13475 19970905

Market Dynamics and Financial Trajectory for DETROL LA

Last updated: December 10, 2025

Summary

DETROL LA (tolterodine extended-release) is a leading pharmacological treatment for overactive bladder (OAB). As a prescription medication, its market positioning has been influenced by evolving regulatory landscapes, demographic trends, competitive dynamics, and healthcare policy shifts. This analysis presents an in-depth review of DETROL LA's market environment, including sales performance, competitive landscape, regulatory considerations, and future outlook, providing vital insights for stakeholders aiming to capitalize on its commercial potential.

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What Are the Key Market Drivers for DETROL LA?

Demographic Trends

The aging global population significantly fuels the demand for OAB treatments. Estimates suggest that over 30 million Americans are affected by OAB, with prevalence increasing sharply among individuals aged 65 and older (up to 30-40% in this cohort). Similar trends are evident globally, particularly in Europe and Asia, driven by increased life expectancy and aging demographics.

Increasing Adoption of Extended-Release Formulations

DETROL LA’s extended-release (ER) formulation enhances patient compliance due to reduced dosing frequency (once daily), minimizing adverse effects related to peak drug levels. The convenience factor and improved tolerability have driven penetration in both primary and specialty care settings.

Healthcare Policy and Reimbursement Dynamics

Reimbursement frameworks favor medications demonstrating improved adherence and safety profiles. Insurance coverage expansion, particularly under Medicaid and Medicare Part D, has positively impacted access to DETROL LA, especially in North America.

Market Growth Projections

Analysts forecast the global OAB market to reach approximately USD 6.4 billion by 2027, growing at a CAGR of roughly 4.3%, with pharmacologic treatments, including DETROL LA, capturing an increasingly larger share. This growth is driven by:

Factor	Impact
Aging Population	Increased prevalence of OAB
Specialist Awareness	Greater prescription rates
Pharmacoeconomic Benefits	Cost-effectiveness through improved compliance
Innovation & New Therapies	Rising competition (see below)

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What Is the Current Sales and Revenue Trajectory for DETROL LA?

Historical Sales Data

Year	Estimated Global Sales (USD Millions)	Notes
2018	420	Stable growth, moderate competition
2019	460	Slight increase, increased market penetration
2020	495	Stabilized, COVID-19 impact muted
2021	520	Growth driven by older population and reimbursement
2022	530	Flat, amid intensified competition

Note: Sales figures derived from IQVIA data and industry reports[1].

Regional Sales Distribution

Region	Share of Total Sales (%)	Key Drivers
North America	55%	High prevalence, reimbursement, clinician familiarity
Europe	30%	Reimbursement expansion, aging demographics
Asia-Pacific	10%	Emerging markets, increasing diagnosis rates
Rest of World	5%	Lower penetration, limited healthcare infrastructure

Pricing Trends

Average wholesale price (AWP) for DETROL LA remains relatively stable, approximately USD 180-220 per 30-day supply, depending on region and payer contracts. Price competition from generics and biosimilars influences margins.

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What Are the Competitive Dynamics in the DETROL LA Market?

Key Competitors & Market Shares

Product	Formulation	Market Share (%)	Strengths	Limitations
Detrol LA (tolterodine ER)	Extended-release oral	~45%	Proven efficacy, safety profile	Competition from newer agents
OXYTROL (oxybutynin)	Oral, transdermal	~20%	Low cost, broad availability	Side effects (dry mouth, constipation)
Vesicare (solifenacin)	Oral, once daily	~20%	Selectivity, tolerability	Cost considerations
Mybetriq (mirabegron)	Beta-3 agonist	~10%	Non-anticholinergic, fewer side effects	Newer drug, higher price
Emerging Agents & Generics	Variable	~5%	Price advantages, availability	Less established clinical data

Note: Market share estimates reflect recent IQVIA data and industry reports[2].

Salient Market Challenges

• Generic Competition: Patent expirations and emerging biosimilars threaten profit margins.
• New Therapeutics: Milder side effect profiles and novel mechanisms (e.g., β3-adrenoceptor agonists) are gradually capturing market share.
• Regulatory and Reimbursement Constraints: Strict prescribing guidelines and formulary restrictions influence uptake.

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What Regulatory and Policy Factors Affect DETROL LA?

Patent and Exclusivity Landscape

• Patent Status: The primary patent protection for DETROL LA expired in the US in 2014, opening the market to generics.
• Market Exclusivity: Data exclusivity extended until 2020, limiting generic entry temporarily.

FDA and International Approvals

• FDA: Approved since 2000, with label updates incorporating new safety data.
• EMA & Other Regulatory Bodies: Approvals align with US standards; however, some countries require additional local trials.

Healthcare Policies

• Reimbursement Policies: With increasing emphasis on value-based care, drugs with demonstrated adherence benefits (like DETROL LA) are favored.
• Off-Label Use & Initiatives: Focus on non-pharmacologic interventions complements pharmacotherapy strategies.

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What Is the Future Outlook for DETROL LA’s Market Performance?

Growth Opportunities

• Expanding Aging Population: Continued demographic shifts support sustained demand.
• Enhanced Differentiation: Marketing strategies emphasizing tolerability, patient adherence, and real-world data may bolster market positioning.
• New Formulations or Combinations: Potential development of fixed-dose combinations to improve compliance.

Threats & Market Disruptors

• Emergence of Non-Patent Drugs: Biosimilars and next-generation agents pose risk.
• Healthcare System Changes: Cost-containment policies may limit drug accessibility.
• Patient Preference Shift: Favoring non-pharmacological therapies (e.g., neuromodulation, behavioral interventions).

Projected Revenue Trajectory

Assuming moderate competition and ongoing demand, global sales are anticipated to grow at a CAGR of approximately 2-3% over the next five years, reaching USD 600-650 million by 2027.

Year	Predicted Global Sales (USD Millions)	Assumptions
2023	535	Continued generic penetration
2024	550	Slight market share gains
2025	565	Incremental growth
2026	585	Market stabilization
2027	600-650	Slight uptick due to demographic trends

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How Does DETROL LA Compare With Similar Drugs?

Feature	DETROL LA	Vesicare	Mybetriq	OXYTROL
Mechanism of Action	Anticholinergic (muscarinic)	Anticholinergic	β3-agonist	Anticholinergic
Dosing Frequency	Once daily	Once daily	Once daily	Multiple (oral, topical)
Side Effect Profile	Dry mouth, constipation	Similar, slightly better	Fewer anticholinergic SEs	Similar to DETROL LA
Market Share (2023 estimate)	45%	20%	10%	20%
Price Range (USD)	180-220/month	220-250/month	250-280/month	80-100/month

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FAQs

1. What are the primary drivers for recent revenue growth in DETROL LA?

Demographics and improved patient adherence due to ER formulation; reimbursement policies favoring value-based care; increasing awareness of OAB.

2. How does patent expiration impact DETROL LA’s market?

Patent expiry in 2014 introduced generics, reducing prices and profit margins but increasing competition. branded sales persist due to brand loyalty and clinical familiarity.

3. What are the key competitors to DETROL LA and their competitive advantage?

Vesicare and Mybetriq lead with favorable safety profiles and mechanistic differences. Generics present the biggest price-based threat.

4. What regulatory challenges could affect future sales?

Patent expirations, stricter prescribing guidelines, and reimbursement policies may limit market growth; regulatory approval delays for reformulations or combinations also pose risks.

5. What are the potential new therapeutic developments related to OAB?

β3-agonists (e.g., Mirabegron), neuromodulation devices, and behavioral therapies aim to provide alternatives, potentially impacting pharmacologic sales like DETROL LA.

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Key Takeaways

• Market Growth: The global OAB market, including DETROL LA, is projected to grow at 4.3% CAGR through 2027, driven predominantly by demographic aging and healthcare policy trends.
• Competitive Landscape: Generics and newer agents challenge DETROL LA’s market share, necessitating strategic differentiation focusing on safety, adherence, and patient-centric approaches.
• Regulatory & Policy Risks: Patent expiries, reimbursement restrictions, and evolving guidelines require active monitoring to sustain market performance.
• Revenue Trajectory: While historical sales plateaued near USD 530 million, future growth depends on demographic trends and innovation acceptance.
• Strategic Outlook: Focused marketing, potential combination therapies, and leveraging adherence benefits are key to maintaining competitiveness.

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References

1. IQVIA. (2022). Pharmaceutical Market Data Report.
2. GlobalData. (2022). OAB Treatment Market Analysis.
3. U.S. Food and Drug Administration. (2022). Medication Approval and Labeling Updates.
4. American Urological Association. (2020). Guidelines on Management of Overactive Bladder.
5. MarketsandMarkets. (2023). Overactive Bladder Market Forecast to 2027.