Tolterodine tartrate - Generic Drug Details

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, 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, 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.

Summary for tolterodine tartrate

US Patents:	0
Tradenames:	3
Applicants:	16
NDAs:	17
Drug Master File Entries:	22
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	174
Clinical Trials:	16
Patent Applications:	7,068
Formulation / Manufacturing:	see details
Drug Prices:	Drug price trends for tolterodine tartrate
Drug Sales Revenues:	Drug sales revenues for tolterodine tartrate
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

See drug sales revenues for tolterodine tartrate

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Pharms Inc	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	202641-002	Nov 27, 2012		DISCN	No	No
Apotex Corp	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	200164-002	Sep 25, 2012		DISCN	No	No
Torrent	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	203016-001	Aug 11, 2015	AB	RX	No	No
Athem	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	210775-001	Dec 30, 2019	AB	RX	No	No
Unique	TOLTERODINE TARTRATE	tolterodine tartrate	TABLET;ORAL	204721-002	Jan 24, 2020	AB	RX	No	No
Inventia Hlthcare	TOLTERODINE TARTRATE	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	204562-002	Aug 19, 2019	AB	RX	No	No

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	021228-002	Dec 22, 2000
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-001	Dec 22, 2000
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998
Upjohn	DETROL	tolterodine tartrate	TABLET;ORAL	020771-002	Mar 25, 1998
Upjohn	DETROL LA	tolterodine tartrate	CAPSULE, EXTENDED RELEASE;ORAL	021228-002	Dec 22, 2000