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Last Updated: October 26, 2020

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Tolterodine tartrate - Generic Drug Details

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What are the generic sources for tolterodine tartrate and what is the scope of patent protection?

Tolterodine tartrate is the generic ingredient in three branded drugs marketed by Upjohn, Ajanta Pharma Ltd, Hetero Labs Ltd Iii, Inventia Hlthcare, Mylan, Teva Pharms Usa, Torrent, Apotex Corp, Invatech, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Unichem Labs Ltd, and Unique Pharm Labs, and is included in fifteen NDAs. There are three patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Tolterodine tartrate has one hundred and thirty-seven patent family members in forty-four countries.

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

Drug Prices for tolterodine tartrate

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Drug Sales Revenue Trends for tolterodine tartrate

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Recent Clinical Trials for tolterodine tartrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
RenJi HospitalN/A
Shanghai Institute of Acupuncture, Moxibustion and MeridianN/A
Federal University of São PauloPhase 4

See all tolterodine tartrate clinical trials

Generic filers with tentative approvals for TOLTERODINE TARTRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial2MGTABLET; ORAL
  Start Trial  Start Trial1MGTABLET; ORAL
  Start Trial  Start Trial2MGTABLET; 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
Medical Subject Heading (MeSH) Categories for tolterodine tartrate
Paragraph IV (Patent) Challenges for TOLTERODINE TARTRATE
Tradename Dosage Ingredient NDA Submissiondate
DETROL LA CAPSULE, EXTENDED RELEASE;ORAL tolterodine tartrate 021228 2007-07-30
DETROL TABLET;ORAL tolterodine tartrate 020771

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
Unique Pharm Labs TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 204721-001 Jan 24, 2020 AB RX No No   Start Trial   Start Trial   Start Trial
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000 AB RX Yes No   Start Trial   Start Trial   Start Trial
Apotex Corp TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 200164-001 Sep 25, 2012 DISCN No No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for tolterodine tartrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998   Start Trial   Start Trial
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000   Start Trial   Start Trial
Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-001 Mar 25, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for tolterodine tartrate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0325571 C980020 Netherlands   Start Trial 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 SPC/GB98/027 United Kingdom   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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