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, Elysium, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Norvium Bioscience, and Unique, 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. Twenty 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:	20
Raw Ingredient (Bulk) Api Vendors:	184
Clinical Trials:	16
Patent Applications:	6,281
Drug Prices:	Drug price trends for TOLTERODINE TARTRATE
Drug Sales Revenues:	Drug sales revenues 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
Unichem	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	216917-001	Aug 27, 2024	AB	RX	No	No
Torrent	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	203016-002	Aug 11, 2015	AB	RX	No	No
Ajanta Pharma Ltd	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	213397-002	May 19, 2020	AB	RX	No	No
Apotex Corp	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	200164-001	Sep 25, 2012		DISCN	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	6,911,217*PED
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998	5,550,269*PED
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000	6,911,217*PED
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000	6,770,295*PED

TOLTERODINE TARTRATE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Tolterodine Tartrate

Market Overview

Tolterodine tartrate, an antimuscarinic agent, is primarily used to treat symptoms of overactive bladder (OAB), including urinary frequency, urgency, and incontinence. The market for tolterodine tartrate is experiencing significant growth, driven by several key factors.

Key Market Drivers

Rising Prevalence of OAB

The global increase in the incidence of OAB is a major driver for the demand of tolterodine tartrate. Factors such as aging populations, rising obesity rates, and increasing cases of diabetes contribute to the higher prevalence of OAB, thereby boosting the market[1].

Advancements in Drug Formulations

Pharmaceutical companies are focusing on developing improved formulations of tolterodine tartrate to enhance patient compliance and efficacy. Extended-release formulations, for instance, offer the advantage of once-daily dosing, which is more convenient for patients and can lead to better adherence to treatment regimens[1].

Awareness and Diagnosis

Greater awareness about OAB and better diagnostic facilities have led to an increase in the diagnosis and treatment of the condition. Healthcare professionals are more adept at identifying OAB symptoms, leading to timely intervention and treatment, which in turn drives the demand for tolterodine tartrate[1].

Investment in Research and Development

Continuous investment in R&D by pharmaceutical companies has led to the introduction of new and effective drugs for OAB management. This investment has positively impacted the tolterodine tartrate market by providing more treatment options and improving existing ones[1].

Market Segmentation

Administration Route

The tolterodine tartrate market is segmented by administration route, with oral and transdermal being the primary modes. Oral administration, particularly through tablets, is the most common method due to its ease of use and high patient compliance[1].

Dosage Form

The market is also segmented by dosage form, with tablets and patches being the main types. Extended-release tablets are gaining popularity due to their convenience and efficacy[1].

Indications

Tolterodine tartrate is used for various indications, including overactive bladder, stress urinary incontinence, and nocturia. The primary indication remains the treatment of OAB symptoms[1].

Distribution Channel

The distribution channels for tolterodine tartrate include retail pharmacies, hospitals, and online pharmacies. Retail pharmacies are the most common distribution channel due to their widespread presence and ease of access[1].

Generic vs Branded

The market is divided between generic and branded versions of tolterodine tartrate. Generic versions are becoming increasingly popular due to their lower cost, although branded versions still maintain a significant market share due to their established reputation and marketing efforts[1].

Regional Analysis

The tolterodine tartrate market is analyzed across various global regions, including North America, Europe, Asia-Pacific, South America, Middle East, and Africa. North America is expected to hold the largest market share due to the increased prevalence of chronic renal disorders, higher funding for R&D, and rising disposable income. The Asia-Pacific region is anticipated to be the fastest-growing market due to its large patient population and relatively shorter duration for patent approvals and new drug developments[1][4].

Financial Trajectory

Market Growth

The tolterodine tartrate market is expected to grow at a CAGR of 1.95% during the forecast period from 2024 to 2032. This growth is driven by the increasing demand for effective OAB treatments and advancements in pharmaceutical research[1].

Revenue Estimation

The market size is expected to increase significantly, with major contributions from the North American and Asia-Pacific regions. The revenue growth will be influenced by factors such as the adoption of advanced technology, the presence of large players, and strategic investments in R&D[1][4].

Cost Analysis

The report provides detailed cost analysis, including the cost of production, distribution, and marketing. The cost analysis is crucial for understanding the profitability and competitiveness of the market[1].

Competitive Analysis

The competitive landscape of the tolterodine tartrate market is characterized by the presence of several key players. These players are engaged in various strategies such as new product launches, mergers and acquisitions, and joint ventures to maintain their market position. The competitive analysis includes a financial matrix of major players, their R&D expenditure, and key developments[1].

Challenges and Restraints

Side Effects

Tolterodine tartrate is associated with side effects such as dry mouth, constipation, and increased risk of urinary tract infections (UTIs). These side effects can lead to anticholinergic syndrome in severe cases, which may deter some patients from using the drug[3][4].

Regulatory Policies

Rigid regulatory policies and poor reimbursement frameworks can hinder the market growth. Pharmaceutical companies must navigate these regulatory challenges to ensure the approval and successful launch of their products[4].

Competition

The market faces stiff competition from other antimuscarinic agents and alternative treatments for OAB. This competition can impact the market share of tolterodine tartrate and necessitate continuous innovation and marketing efforts to maintain market position[4].

Opportunities

Healthcare Scenario Improvement

Improvements in the healthcare scenario, including better diagnostic facilities and increased awareness about OAB, present opportunities for the growth of the tolterodine tartrate market. Rising initiatives by market players and successful clinical trials also contribute to these opportunities[4].

Expansion in Drug Portfolio

Pharmaceutical companies are expanding their drug portfolios to include more effective and convenient formulations of tolterodine tartrate. This expansion can attract more patients and healthcare providers, thereby driving market growth[4].

Key Takeaways

• The tolterodine tartrate market is driven by the increasing prevalence of OAB, advancements in drug formulations, and greater awareness and diagnosis of OAB.
• The market is segmented by administration route, dosage form, indications, and distribution channels.
• North America and the Asia-Pacific region are key markets, with the latter expected to be the fastest-growing.
• The market faces challenges such as side effects, regulatory policies, and competition but also has opportunities for growth through improvements in healthcare and expansion in drug portfolios.
• The financial trajectory indicates steady growth with a CAGR of 1.95% from 2024 to 2032.

FAQs

What are the primary indications for tolterodine tartrate?

Tolterodine tartrate is primarily used to treat symptoms of overactive bladder (OAB), including urinary frequency, urgency, and incontinence. It is also used for stress urinary incontinence and nocturia[1].

What are the common side effects of tolterodine tartrate?

Common side effects include dry mouth, constipation, and an increased risk of urinary tract infections (UTIs). In severe cases, it can lead to anticholinergic syndrome[3][4].

How is the tolterodine tartrate market segmented?

The market is segmented by administration route (oral and transdermal), dosage form (tablets and patches), indications (OAB, stress urinary incontinence, and nocturia), and distribution channels (retail pharmacies, hospitals, and online pharmacies)[1].

What are the key drivers of the tolterodine tartrate market?

Key drivers include the rising prevalence of OAB, advancements in drug formulations, greater awareness and diagnosis of OAB, and continuous investment in R&D[1].

Which regions are expected to dominate the tolterodine tartrate market?

North America is expected to hold the largest market share, while the Asia-Pacific region is anticipated to be the fastest-growing market due to its large patient population and favorable regulatory environment[1][4].

What are the challenges faced by the tolterodine tartrate market?

Challenges include side effects associated with the drug, rigid regulatory policies, poor reimbursement frameworks, and stiff competition from other antimuscarinic agents and alternative treatments[4].

Sources

1. Tolterodine Tartrate Market In-depth Analysis - openPR.com
2. Detrol tolterodine tartrate tablets DESCRIPTION DETROL Tablets - FDA
3. N21-228S006 Tolterodine tartrate Clinical - revised BPCA - FDA
4. Global Tolterodine Market - Data Bridge Market Research