Tolterodine tartrate - Generic Drug Details

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What are the generic drug sources for tolterodine tartrate and what is the scope of freedom to operate?

Tolterodine tartrate is the generic ingredient in three branded drugs marketed by Upjohn, Ajanta Pharma Ltd, Aurobindo Pharma Usa, Hetero Labs Ltd Iii, Inventia Hlthcare, Teva Pharms Usa, Torrent, Unichem, Utopic Pharms, Apotex Corp, Elysium, Hetero Labs Ltd V, Ivax Sub Teva Pharms, Macleods Pharms Ltd, Norvium Bioscience, and Unique, and is included in eighteen NDAs. Additional information is available in the individual branded drug profile pages.

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

Summary for tolterodine tartrate

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	18
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	20
Raw Ingredient (Bulk) Api Vendors:	184
Clinical Trials:	16
Patent Applications:	5,872
Drug Prices:	Drug price trends for tolterodine tartrate
Drug Sales Revenues:	Drug sales revenues for tolterodine tartrate
What excipients (inactive ingredients) are in tolterodine tartrate?	tolterodine tartrate excipients list
DailyMed Link:	tolterodine tartrate at DailyMed

See drug prices for tolterodine tartrate

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

Sponsor	Phase
Shanghai Institute of Acupuncture, Moxibustion and Meridian	N/A
RenJi Hospital	N/A
University of California, San Francisco	Phase 4

See all tolterodine tartrate clinical trials

Generic filers with tentative approvals for TOLTERODINE TARTRATE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	1MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	2MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	2MG	TABLET; 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

Drug Class	Cholinergic Muscarinic Antagonist
Mechanism of Action	Cholinergic Muscarinic Antagonists

Medical Subject Heading (MeSH) Categories for tolterodine tartrate

Muscarinic Antagonists
Urological Agents

Anatomical Therapeutic Chemical (ATC) Classes for tolterodine tartrate

G04BD	Drugs for urinary frequency and incontinence
G04B	UROLOGICALS
G04	UROLOGICALS
G	Genito-urinary system and sex hormones

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Unichem	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	205399-001	Aug 5, 2020	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Torrent	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	203016-001	Aug 11, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Elysium	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	210775-001	Dec 30, 2019	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Teva Pharms Usa	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	079141-002	Nov 22, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unichem	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	216917-001	Aug 27, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Unichem	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	216917-002	Aug 27, 2024	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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

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

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