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Tolterodine tartrate - Generic Drug Details

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Tolterodine tartrate is the generic ingredient in three branded drugs marketed by Ivax Sub Teva Pharms, Macleods Pharms Ltd, Torrent Pharms Ltd, Pharmacia And Upjohn, Mylan Pharms Inc, and Apotex Corp, and is included in eight 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. Fourteen 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:6
NDAs:8
Drug Master File Entries: see list22
Suppliers / Packaging: see list14
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; ORAL1MG

Clinical Trials for: tolterodine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc
TOLTERODINE TARTRATE
tolterodine tartrate
TABLET;ORAL202641-001Nov 27, 2012RXNo<disabled><disabled>
Mylan Pharms Inc
TOLTERODINE TARTRATE
tolterodine tartrate
TABLET;ORAL202641-002Nov 27, 2012RXNo<disabled><disabled>
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-002Dec 22, 2000RXYes6,911,217*PED<disabled>Y<disabled>
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Expired Orange Book Patents for Generic Ingredient: tolterodine tartrate

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pharmacia And Upjohn
DETROL
tolterodine tartrate
TABLET;ORAL020771-001Mar 25, 19985,382,600*PED<disabled>
Pharmacia And Upjohn
DETROL LA
tolterodine tartrate
CAPSULE, EXTENDED RELEASE;ORAL021228-001Dec 22, 20005,382,600*PED<disabled>
Pharmacia And Upjohn
DETROL
tolterodine tartrate
TABLET;ORAL020771-001Mar 25, 19985,559,269*PED<disabled>
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