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Last Updated: October 24, 2021

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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, Amta, Hetero Labs Ltd Iii, Inventia Hlthcare, Mylan, Teva Pharms Usa, Torrent, Apotex Corp, Athem, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Mylan Pharms Inc, Unichem, and Unique Pharm Labs, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for tolterodine tartrate. Eighteen 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
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all tolterodine tartrate clinical trials

Generic filers with tentative approvals for TOLTERODINE TARTRATE
Applicant Application No. Strength Dosage Form
⤷  Free Forever Trial⤷  Free Forever Trial2MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever Trial1MGTABLET; ORAL
⤷  Free Forever Trial⤷  Free Forever 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
Hetero Labs Ltd Iii TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 206419-002 Dec 12, 2017 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Apotex Corp TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 200164-001 Sep 25, 2012 DISCN No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Inventia Hlthcare TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 204562-001 Aug 19, 2019 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Hetero Labs Ltd V TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 204397-001 Aug 2, 2021 AB RX No No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998 AB RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000 AB RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever 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 LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-002 Dec 22, 2000 ⤷  Free Forever Trial ⤷  Free Forever Trial
Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998 ⤷  Free Forever Trial ⤷  Free Forever Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Merck
McKinsey
Medtronic
Colorcon
Express Scripts

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