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Details for Generic Name: tolterodine tartrate

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Tolterodine tartrate is the generic ingredient in three branded drugs marketed by Pharmacia And Upjohn, Mylan Pharms Inc, Apotex Corp, and Ivax Sub Teva Pharms, and is included in six NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

Summary for Generic Name: tolterodine tartrate

Tradenames:3
Patents:3
Applicants:4
NDAs:6
Drug Master File Entries: see list22
Suppliers / Packaging: see list49
Therapeutic Class:Genitourinary Agents
Formulation / Manufacturing:see details

Pharmacology for Ingredient: tolterodine tartrate

Tentative approvals for TOLTERODINE TARTRATE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL1MG
<disabled><disabled>TABLET; ORAL2MG
<disabled><disabled>TABLET; ORAL2MG

Clinical Trials for: tolterodine tartrate

Tolterodine Drug Use Investigation.(Post Marketing Commitment Plan)
Status: Completed Condition: Overactive Bladder

A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)
Status: Completed Condition: Overactive Bladder

Exploring Predictors of Symptoms Relapse After Discontinuation of Treatment in Overactive Bladder (OAB) Patients
Status: Completed Condition: Overactive Bladder

Dutasteride With Tolterodine ER or Placebo to Treat Lower Urinary Tract Symptoms (LUTS)
Status: Completed Condition: Benign Prostatic Hyperplasia (BPH)

A Study to Evaluate Tolerability and Patient Preference Between Myrbetriq® and Detrol® LA in Subjects With Overactive Bladder (OAB)
Status: Active, not recruiting Condition: Overactive Bladder (OAB)

Pharmacokinetics and Relative Bioavailability Study
Status: Completed Condition: Urinary Bladder, Overactive

Courtesy of ClinicalTrials.org
See more clinical trials for this drug
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ivax Sub Teva Pharms
TOLTERODINE TARTRATE
tolterodine tartrate
TABLET;ORAL077006-001Feb 23, 2015RXNo<disabled><disabled>
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-002Dec 22, 2000RXYes6,630,162*PED<disabled>Y<disabled>
Ivax Sub Teva Pharms
TOLTERODINE TARTRATE
tolterodine tartrate
TABLET;ORAL077006-002Feb 23, 2015RXNo<disabled><disabled>
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-002Dec 22, 2000RXYes6,911,217*PED<disabled>Y<disabled>
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-001Dec 22, 2000RXNo6,911,217*PED<disabled>Y<disabled>
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ISSN: 2162-2639

Preferred citation:

Friedman, Y. Location of pharmaceutical innovation: 2000–2009 Nature Reviews Drug Discovery 9, 835–836 (2010).

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