Viewing data from:

DETROL LA

NDA

TOLTERODINE TARTRATE | N021228 | UPJOHN US 2 LLC

2 strengths0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
PFIZER INC. et al v. LUPIN LTD. et al 2:2013cv01778 2 patentsANDA 204689tolterodine tartrate	D.N.J.	2013-03-21	Terminated 2013-11-07	—

Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

75 trials from ClinicalTrials.gov, 66 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
MILADY: A Randomized, Placebo-controlled Safety and Efficacy Trial of SSR240600C in Treatment of Overactive Bladder or Urge Urinary Incontinence.NCT00174798	Phase 2	Completed	Sanofi	118	2005-05 → 2006-05
Effects of GABA-a-Agonists on Pain Mechanisms: An Experimental Study in Healthy Volunteers NCT01011036	Phase 3	Completed	Insel Gruppe AG, University Hospital Bern	17	2009-12 → 2010-06
Studies of Psychiatric Predisposing Factors, Treatment-related Cardiovascular Effects, and Prognostic Factors Associated With Antimuscarinic Drug (Tolterodine) for Female Overactive Bladder Syndrome NCT01503580	N/A	Completed	National Taiwan University Hospital	155	2008-08 → 2013-10
Post-marketing Study to Evaluate the Effect of Mirabegron on the Plasma Concentration of Tolterodine NCT01964183	Phase 4	Completed	Astellas Pharma Inc	24	2013-06 → 2013-08
Overactive Bladder Innovative Therapy Trial (OrBIT)NCT00448175	Phase 4	Completed	Uroplasty, Inc	100	2006-06 → 2008-10
A Study to Test the Effects of Tolterodine Tartrate in Patients With Overactive Bladder (0000-107)NCT00768521	Phase 1	Completed	Merck Sharp & Dohme LLC	20	2008-09-03 → 2009-01-19
Bladder Wall Blood Perfusion Pattern and Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms, and the Association of That Perfusion Pattern and Therapeutic Efficacy of Antimuscarincs for Female Overactive Bladder Syndrome.NCT01282840	N/A	Completed	Far Eastern Memorial Hospital	676	2010-07-20 → 2018-12-26
Comparison of Electrical Pudendal Nerve Stimulation and Tolterodine Tartrate for Urgency-Frequency Syndrome in Women NCT02723279	N/A	Completed	Shanghai Institute of Acupuncture, Moxibustion and Meridian	120	2016-04 → 2017-03
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics NCT04090190	Phase 4	Completed	Brigham and Women's Hospital	20	2019-10-30 → 2021-10-31
Effect Of Detrol LA With Behavioral Intervention In Overactive Bladder Subjects Dissatisfied With Recent OAB Medication.NCT00230789	Phase 4	Completed	Pfizer's Upjohn has merged with Mylan to form Viatris Inc.	417	2005-10 → 2006-12

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 4 NDCs

Highest NADAC/Unit

$0.2660

per ea

Lowest NADAC/Unit

$0.2543

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
59762004701TOLTERODINE TART ER 2 MG CAP	$0.2660	EA	Generic	—	2026-06-17
59762004702TOLTERODINE TART ER 2 MG CAP	$0.2660	EA	Generic	—	2026-06-17
59762004801TOLTERODINE TART ER 4 MG CAP	$0.2543	EA	Generic	—	2026-06-17
59762004802TOLTERODINE TART ER 4 MG CAP	$0.2543	EA	Generic	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 10 NDCs (5 FSS, 5 Big4)

Lowest Price

$0.41

Highest Price

$942.01

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
59762-0048-01TOLTERODINE TARTRATE 4MG CAP,SA	$65.43	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0048-01TOLTERODINE TARTRATE 4MG CAP,SA	$5.96	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0048-02TOLTERODINE TARTRATE 4MG CAP,SA	$217.27	FSS	Mylan Pharmaceuticals, Inc.	12/31/2027
59762-0048-02TOLTERODINE TARTRATE 4MG CAP,SA	$107.23	Big4	Mylan Pharmaceuticals, Inc.	12/31/2027
58151-0103-77DETROL LA 2MG CAP	$942.01	FSS	Mylan Specialty L.P.	01/14/2027
58151-0103-77DETROL LA 2MG CAP	$936.65	Big4	Mylan Specialty L.P.	01/14/2027

Showing 6 of 10 NDCs.

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Detrol La (2024)

Total Spending

$1.1M

Total Claims

1,329

Beneficiaries

411

Avg Cost/Unit

$12.50

Spending Trend

$4.0M(2019)→$3.4M(2020)→$2.2M(2021)→$1.8M(2022)→$1.5M(2023)→$1.1M(2024)

YoY Change:-3.0%

5yr CAGR:+2.1%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

API Supply Chain15 active DMFs8 inactive

15 active API suppliers hold Drug Master Files for this ingredient.

TAPI NL BVTOLTERODINE TARTRATE

DMF 169952003

CIPLA LTDTOLTERODINE TARTRATE USP

DMF 170182003

DR REDDYS LABORATORIES LTDTOLTERODINE TARTRATE

DMF 177362004

INTERQUIM SATOLTERODINE TARTRATE

DMF 195992006

APITORIA PHARMA PRIVATE LTDTOLTERODINE TARTRATE, NON-STERILE DRUG SUBSTANCE

DMF 196492006

AMINO CHEMICALS LTDTOLTERODINE TARTRATE

DMF 200932006

HOLIDAY LABS MEXICO SA DE CVTOLTERODINE TARTRATE

DMF 200962006

ERREGIERRE SPATOLTERODINE TARTRATE

DMF 204832007

HETERO DRUGS LTDTOLTERODINE TARTRATE

DMF 223812009

ORCHID PHARMA LTDTOLTERODINE TARTRATE (NON-STERILE BULK API)

DMF 236292010

MACLEODS PHARMACEUTICALS LTDTOLTERODINE TARTRATE USP

DMF 238432010

UNICHEM LABORATORIES LTDTOLTERODINE TARTRATE USP

DMF 251552011

EMCURE PHARMACEUTICALS LTDTOLTERODINE TARTRATE

DMF 290112015

ALKEM LABORATORIES LTDTOLTERODINE TARTRATE USP

DMF 309942016

MAITHRI LABORATORIES PRIVATE LTDTOLTERODINE TARTRATE USP

DMF 347192020

SUN PHARMACEUTICAL INDUSTRIES LTDInactiveTOLTERODINE TARTRATE

DMF 170262003

ZHEJIANG HISUN PHARMACEUTICAL CO LTDInactiveTOLTERODINE TARTRATE, NON-STERILE ACTIVE PHARMACEUTICAL INGREDIENT

DMF 180302005

LUPIN LTDInactiveTOLTERODINE TARTRATE USP

DMF 193242006

INTERQUIM SAInactiveTOLTERODINE TARTRATE MICRONIZED

DMF 196252006

NATCO PHARMA LTDInactiveTolterodine Tartrate

DMF 211642007

LEK PHARMACEUTICALS DDInactiveTOLTERODINE TARTRATE

DMF 211842007

APOTEX PHARMACHEM INDIA PVT LTDInactiveTOLTERODINE TARTRATE

DMF 229962009

ZAKLADY FARMACEUTYCZNE POLPHARMA SAInactiveTOLTERODINE TARTRATE

DMF 243452010

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

12 letters from Drugs@FDA

Date	Submission	Document
Jul 20, 2018	SUPPL -23	View Letter (PDF)
Aug 3, 2012	SUPPL -21	View Letter (PDF)
Sep 23, 2011	SUPPL -16	View Letter (PDF)
Jan 6, 2010	SUPPL -15	View Letter (PDF)
Sep 15, 2008	SUPPL -12	View Letter (PDF)
Mar 23, 2007	SUPPL -10	View Letter (PDF)
Oct 25, 2005	SUPPL -7	View Letter (PDF)
Jul 21, 2005	SUPPL -8	View Letter (PDF)
Apr 20, 2004	SUPPL -6	View Letter (PDF)
Jan 22, 2004	SUPPL -5	View Letter (PDF)
Jul 28, 2003	SUPPL -4	View Letter (PDF)
Dec 22, 2000	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (2)

Sort:

#001 — 2MG

RLDAB

0 patents0 exclusivities▴

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 22, 2000

No patent or exclusivity listings for this strength.

#002 — 4MG

RLDAB

0 patents0 exclusivities▾

CAPSULE, EXTENDED RELEASE;ORAL | Approved: Dec 22, 2000