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Last Updated: January 30, 2023

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, Aurobindo Pharma Usa, Hetero Labs Ltd Iii, Inventia Hlthcare, 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-two drug master file entries for tolterodine tartrate. Nineteen 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

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SponsorPhase
Shanghai Institute of Acupuncture, Moxibustion and MeridianN/A
RenJi HospitalN/A
University of California, San FranciscoPhase 4

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Generic filers with tentative approvals for TOLTERODINE TARTRATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing2MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing1MGTABLET; ORAL
See Plans and PricingSee Plans and Pricing2MGTABLET; 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 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
Upjohn DETROL tolterodine tartrate TABLET;ORAL 020771-002 Mar 25, 1998 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ivax Sub Teva Pharms TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 077006-002 Feb 23, 2015 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva Pharms Usa TOLTERODINE TARTRATE tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 079141-001 Nov 22, 2016 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Unichem TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 205399-002 Aug 5, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Unique Pharm Labs TOLTERODINE TARTRATE tolterodine tartrate TABLET;ORAL 204721-002 Jan 24, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-001 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-002 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
Upjohn DETROL LA tolterodine tartrate CAPSULE, EXTENDED RELEASE;ORAL 021228-002 Dec 22, 2000 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.