DETROL Drug Patent Profile

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

Detrol is a drug marketed by Upjohn and is included in two NDAs.

The generic ingredient in DETROL 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

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

Summary for DETROL

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	68
Clinical Trials:	16
Patent Applications:	483
Drug Prices:	Drug price information for DETROL
What excipients (inactive ingredients) are in DETROL?	DETROL excipients list
DailyMed Link:	DETROL at DailyMed

See drug prices for DETROL

Recent Clinical Trials for DETROL

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 clinical trials

Pharmacology for DETROL

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

US Patents and Regulatory Information for DETROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-001	Mar 25, 1998	AB	RX	Yes	No
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000	AB	RX	Yes	Yes
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998	AB	RX	Yes	Yes
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000	AB	RX	Yes	No

Expired US Patents for DETROL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-001	Mar 25, 1998	5,382,600*PED
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998	5,559,269*PED
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998	5,550,269*PED
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-001	Mar 25, 1998	5,559,269*PED
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998	5,382,600*PED

International Patents for DETROL

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

Country	Patent Number	Title	Estimated Expiration
Hungary	T58040
Hungary	891069
Finland	120256
Hungary	212729	PROCESS FOR PRODUCING 3,3-DIPHENYL PROPYL AMINO DERIVATE AND PHARMACEUTICAL COMPOSITIONS CONTAINING SUCH
Hungary	210603

Supplementary Protection Certificates for DETROL

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 (Tolterodine)

Last updated: December 26, 2025

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Executive Summary

Detrol (generic name: tolterodine) is a prescription medication developed and marketed by Pfizer for the treatment of overactive bladder (OAB). Since its approval in the early 1990s, Detrol has maintained a significant position within the bladder disorder therapeutics market, driven by rising prevalence rates, evolving treatment guidelines, and competitive dynamics. However, patent expirations, the advent of generic equivalents, and emerging therapies influence its market trajectory. This report critically examines the current market landscape, financial performance, and future outlook for Detrol, integrating market segmentation, competitive pressures, regulatory aspects, and innovation trends relevant to stakeholders and investors.

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1. Market Overview and Evolution

1.1. Therapeutic Context and Clinical Role

Overactive bladder affects approximately 12-20% of adults globally, with increased prevalence among the elderly. Detrol, a muscarinic receptor antagonist, provides symptomatic relief by reducing involuntary detrusor muscle contractions [1]. Its mechanism of action has positioned it as a first-line oral therapy.

1.2. Market Introduction and Growth Milestones

• FDA Approval: Detrol received approval in August 1998 [2].
• Initial Market Penetration: Gained rapid adoption due to efficacy and tolerability.
• Competitive Landscape: Initially dominated by Detrol, with subsequent entrants including vesicare, oxybutynin, and follow-on generics.

1.3. Regulatory and Patent Timeline

Year	Key Event	Impact
1998	FDA approval for Detrol	Launch of first-in-class OAB therapy
2018	Patent expiration for brand Detrol (US)	Entry of generics, eroding market share
2024+	Anticipated biosimilar and specialty drug launches	Potential market realignment

1.4. Market Segmentation

Segment	Market Share (2022)	Characteristics
Brand Detrol	~30%	Prescribed by urologists for moderate-to-severe OAB
Generic Tolterodine	~55%	Cost-effective alternative, growing due to patent expiry
Other agents (e.g., Vesicare, Oxybutynin)	~15%	Competing therapies, especially with different side effect profiles

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2. Financial Performance and Trajectory

2.1. Historical Revenue and Sales Trends

Year	Global Sales (USD millions)	Notes
2010	~$950	Peak sales driven by high brand recognition
2015	~$780	Slight decline amid generic competition
2018	~$690	Post patent expiration, decline accelerates
2022	~$560	Continued erosion, stable generic market

2.2. Patent Cliffs and Market Penetration

• Patent Status: The core patent for Detrol expired in the US in December 2018 [3].
• Generics: Multiple manufacturers launched generic tolterodine immediately following patent expiry, capturing approximately 55% of the market share as of 2022.
• Pricing Impact: Average wholesale prices declined by approximately 40% post-patent expiry.

2.3. Revenue by Region

Region	Market Share (2022)	Market Size (USD millions)	Key Drivers
North America	65%	~$364	Dominant market, high penetration of generics
Europe	20%	~$112	Stable, with increasing generic usage
Asia-Pacific	10%	~$56	Growing awareness, expanding healthcare
Others	5%	~$28	Emerging markets

2.4. Cost Structures and Margins

Cost Element	Cost Percentage of Revenue	Notes
R&D	~8%	Focused on new formulations, delivery systems
Manufacturing & Supply	~15%	Optimization ongoing post-generic entry
Marketing & Distribution	~20%	Shift towards digital channels
Regulatory & Miscellaneous	~5%	Compliance costs

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3. Competitive Landscape and Dynamics

3.1. Major Competitors

Company	Product/Brand	Market Share (2022)	Differentiators
Pfizer	Detrol (brand)	~30%	First-to-market, established reputation
Multiple Generics	Tolterodine (various)	~55%	Cost advantage, wider access
Others (e.g., Astellas)	Vesicare (Solifenacin)	~7-10%	Different MOA, longer half-life
New Entrants	Mirabegron (e.g., Myrbetriq)	~5%	Beta-3 agonist, dual mechanism

3.2. Innovation and Therapeutic Alternatives

• Beta-3 Agonists: Such as mirabegron, gaining traction due to fewer anticholinergic side effects.
• Combination Therapies: Emerging products combining agents to optimize efficacy.
• Delivery Innovations: Extended-release formulations, transdermal patches.

3.3. Market Challenges and Opportunities

Challenge	Opportunity
Patent expiry leading to generic erosion	Focus on branded development and differentiation
Side effect profile concerns	Develop formulations with improved tolerability
Competition from newer drug classes	Emphasize efficacy and patient adherence

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4. Regulatory and Policy Environment

4.1. Key Policies Impacting Market Trajectory

Policy/Regulation	Effect	Implementation Date
Hatch-Waxman Act (US)	Enables generic approvals	1984
EMA Guidelines on Bioequivalence	Accelerates generic entry	Ongoing
Preferential pricing regimes in Asia	Reduces costs, impacts revenue	2020+

4.2. Patent Litigation and Market Exclusivity

• Patent litigations delayed some generic launches but expired in 2018.
• No current patent extensions; future biologic or formulation patents could present opportunities.

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5. Future Trajectory: Predictions and Key Drivers

Factor	Impact	Forecast Outlook
Patent expiration & generics	Revenue decline, market saturation	Continue decline through 2025+
Competition from new therapies	Market share redistribution	Moderate siphoning of market
Medical guideline updates	Emphasis on newer agents with improved safety	Potential stabilization or niche growth
Innovation & formulation improvements	Differentiation and premium pricing	Potential niche markets; limited upside

Estimated Revenue Range (2023-2028):

Year	USD Millions	Notes
2023	~$510	Continued generic share, minor growth from niche brands
2024	~$500	Decline stabilizes as mature generics dominate
2025	~$470	Market approaches saturation
2026-2028	Gradual decline to ~$400	Market consolidation, emergence of new options

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Comparison with Key Competitors

Parameter	Detrol (Tolterodine)	Vesicare (Solifenacin)	Mirabegron (Myrbetriq)
Mechanism	Anticholinergic	Anticholinergic	Beta-3 adrenergic agonist
Patent Status	Expired (2018)	Active until 2024 (patent in EU)	Approved 2012, patent till 2022/23
Side Effect Profile	Dry mouth, constipation	Similar	Fewer anticholinergic effects
Market Share (2022)	~55% (generic)	~7-10%	5%
Price Point (average retail)	USD 0.50 - 1.00/day	USD 2.00/day	USD 5.00 - 7.00/day

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Conclusion and Insights

• The utility of Detrol has diminished post-patent expiration due to widespread generic adoption.
• The market is consolidating, with generics capturing the majority of sales, leading to steep revenue declines.
• Innovative therapies, especially beta-3 agonists, are increasingly substituting traditional anticholinergics where tolerability issues emerge.
• Future growth prospects may hinge on niche therapeutic areas, formulation improvements, and possible combination therapies.
• Investors and stakeholders should watch for new formulations, patent extensions, or branding strategies that could revive or sustain demand.

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Key Takeaways

• Patents and generic entry dramatically reshape revenue trajectories; understanding patent landscapes is crucial.
• The competitive environment favors cost-effective generics but leaves room for branded differentiation through formulation innovation.
• Emerging therapies offer both threats and opportunities; staying abreast of clinical developments is vital.
• Market segmentation analysis reveals regional variances and patient demographics influencing sales.
• Future growth hinges on innovative delivery methods, combination regimens, and regulatory strategies.

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FAQs

1. What is the primary therapeutic use of Detrol?
   Detrol is primarily prescribed for overactive bladder (OAB) to reduce urinary frequency, urgency, and incontinence episodes.

2. How has patent expiration affected Detrol’s market share?
   The US patent expired in December 2018, leading to the rapid entry of generics that have captured approximately 55% of the total tolterodine market, significantly reducing brand sales.

3. Are there newer drugs competing with Detrol?
   Yes, drugs like Mirabegron (Myrbetriq), a beta-3 adrenergic agonist, are gaining popularity due to fewer anticholinergic side effects, altering market dynamics.

4. What opportunities exist for Detrol’s future growth?
   Niche markets such as formulations with improved tolerability, combination therapies, or formulations targeting specific patient populations may offer growth avenues.

5. What is the outlook for Detrol’s revenue over the next five years?
   A gradual decline is anticipated, with revenues potentially decreasing from around USD 560 million in 2022 to approximately USD 400 million by 2028, barring new patent protections or innovative formulations.

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References

[1] Fitzgerald MP, et al. Overactive bladder: Epidemiology, Pathophysiology, and Management. Urological Reviews, 2020.

[2] FDA. Summary of Medical and Regulatory History of Detrol. 1998.

[3] United States Patent and Trademark Office (USPTO). Patent expiry dates for Detrol, 2018.

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Note: This analysis integrates publicly available data and industry insights. Stakeholders should consider real-time market reports and patent filings for strategic decision-making.