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. Twenty 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:	79
Clinical Trials:	16
Patent Applications:	56
Drug Prices:	Drug price information for DETROL
Drug Sales Revenues:	Drug sales revenues 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	020771-002	Mar 25, 1998	5,559,269*PED
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	5,550,269*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
Finland	109900
Canada	1340223	3,3-DIPHENYLPROPYLAMINES ET LEURS COMPOSITIONS PHARMACEUTIQUES; UTILISATION DANS DES SYSTEMES CHOLINERGIQUES (3,3-DIPHENYLPROPYL AMINES AND PHARMACEUTICAL COMPOSITIONS AND CHOLINERGIC USES THEREOF)
Hungary	T58040
Spain	2029384

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

DETROL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DETROL (Tolterodine Tartrate)

Overview of DETROL (Tolterodine Tartrate)

DETROL, known generically as tolterodine tartrate, is a muscarinic receptor antagonist used primarily to treat symptoms of overactive bladder (OAB), including urinary frequency, urgency, and incontinence[5].

Market Growth Drivers

Increasing Prevalence of Overactive Bladder (OAB)

The global market for tolterodine tartrate is driven significantly by the rising prevalence of OAB. Factors such as aging populations, increasing obesity rates, and higher cases of diabetes contribute to the growing incidence of OAB, thereby increasing the demand for tolterodine tartrate[4].

Advancements in Drug Formulations

Pharmaceutical companies are continuously developing improved formulations of tolterodine tartrate, such as extended-release versions, which offer the convenience of once-daily dosing and enhance patient compliance and efficacy[4].

Greater Awareness and Diagnosis

Increased awareness about OAB and better diagnostic facilities have led to more diagnoses and treatments of the condition. Healthcare professionals are now more adept at identifying OAB symptoms, resulting in timely intervention and treatment[4].

Investment in Research and Development

Continuous investment in research and development by pharmaceutical companies has introduced new and effective drugs for OAB management, positively impacting the tolterodine tartrate market[4].

Market Size and Forecast

The tolterodine tartrate market has shown significant growth, with the market share valued at approximately $2.77 billion in 2023 and projected to reach $2.82 billion by the end of the forecast period. The market is expected to grow at a healthy CAGR of 3.60% from 2021 to 2028[1][4].

Geographical Analysis

North America

North America is expected to hold the largest market share due to the increased prevalence of chronic renal disorders, higher funding for research and development, and an increase in disposable income. The region's advanced healthcare infrastructure and higher awareness about OAB also contribute to its dominant position[1].

Asia-Pacific

The Asia-Pacific region is anticipated to be the fastest-growing market due to its large patient population and the relatively shorter duration for patent approvals and the development of new drugs. This region offers lucrative opportunities for market expansion[1].

Middle East and Africa

These regions are expected to deliver significant opportunities due to the growing geriatric population and increasing healthcare needs. The market here is driven by the need for effective treatments for OAB and other related conditions[1].

Financial Trajectory

Revenue Impact of Patent Expirations

The financial trajectory of DETROL has been impacted by the expiration of its patent. For instance, Pfizer's Detrol IR and Detrol LA lost exclusivity in the majority of European markets in September 2012, leading to increased generic competition and a subsequent decline in revenues[3].

Comparative Economic Impact

Studies have shown that extended-release tolterodine (tolterodine ER) has a slightly lower total cost compared to oxybutynin ER and oxybutynin IR, which can influence market preference and revenue. The compliance and persistence rates of tolterodine ER are also higher, contributing to its economic viability[2].

Market Competition

The market for OAB treatments is highly competitive, with key players such as Astellas Pharma Inc, Pfizer Inc, Teva Pharmaceutical Industries Limited, and Allergan PLC. The competition is driven by the development of new formulations and the expiration of patents, which opens up the market to generic versions[4].

Challenges and Restraints

Regulatory Policies

Rigid regulatory policies and the high cost associated with drug development and approval are significant restraints on the market growth. Additionally, poor reimbursement frameworks and side effects associated with the consumption of these drugs can hinder market expansion[1].

Lack of Expertise and Alternatives

The lack of expertise in developing the correct formulation and dosage of drugs, along with the rise of alternative treatments, poses challenges to the market. Stiff competition among market players also affects the financial trajectory of DETROL[1].

Opportunities

Improvement in Healthcare Scenario

Improvements in the healthcare scenario, including better diagnostic tools and increased awareness, offer opportunities for market growth. Rising initiatives by market players, expansion in drug portfolios, and successful clinical trials are also expected to propel the market forward[1].

Clinical Trials and Drug Approvals

Successful clinical trials, such as Pfizer's online clinical trials for Detrol LA, which were reviewed by the FDA, help in gathering awareness about the safety and efficacy of the drug. Such initiatives can lead to increased market acceptance and revenue[1].

Key Takeaways

• The tolterodine tartrate market is driven by the increasing prevalence of OAB, advancements in drug formulations, and greater awareness and diagnosis.
• North America holds the largest market share, while the Asia-Pacific region is expected to be the fastest-growing market.
• The financial trajectory is influenced by patent expirations, comparative economic impact, and market competition.
• Challenges include rigid regulatory policies, high costs, and the rise of alternative treatments.
• Opportunities lie in improvements in the healthcare scenario, rising initiatives by market players, and successful clinical trials.

FAQs

What is the primary use of DETROL (tolterodine tartrate)?

DETROL is primarily used to treat symptoms of overactive bladder (OAB), including urinary frequency, urgency, and incontinence.

What are the key drivers of the tolterodine tartrate market?

The key drivers include the increasing prevalence of OAB, advancements in drug formulations, greater awareness and diagnosis, and continuous investment in research and development.

Which region is expected to hold the largest market share for tolterodine tartrate?

North America is expected to hold the largest market share due to the increased prevalence of chronic renal disorders and higher funding for research and development.

How has the expiration of patents affected the financial trajectory of DETROL?

The expiration of patents has led to increased generic competition, resulting in a decline in revenues for branded versions of DETROL.

What are the main challenges facing the tolterodine tartrate market?

The main challenges include rigid regulatory policies, high costs, poor reimbursement frameworks, side effects associated with the drugs, and the rise of alternative treatments.

Sources

1. Global Tolterodine Market - Industry Trends and Forecast to 2028. Data Bridge Market Research.
2. Economic impact of extended-release tolterodine versus immediate- and extended-release oxybutynin. PubMed.
3. Appendix A 2013 Financial Report - Annual Reports. Annual Reports.
4. Tolterodine Tartrate Market In-depth Analysis. openPR.com.
5. Tolterodine: Uses, Interactions, Mechanism of Action. DrugBank.