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

No clinical trials found on ClinicalTrials.gov for this drug

Medicare Part D Spending

CMS annual spending data for Detrol La (2023)

Total Spending

$1.5M

Total Claims

1,762

Beneficiaries

493

Avg Cost/Unit

$12.89

Spending Trend

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

YoY Change:+7.8%

5yr CAGR:+2.6%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain14 active DMFs7 inactive

14 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

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

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