Viewing data from:

TIOTROPIUM BROMIDE

ANDA

TIOTROPIUM BROMIDE | A211287 | LUPIN INC

1 strength0 unique patents0 unique exclusivities

Reference Listed Drug: SPIRIVA(TE code: AB)

Hatch-Waxman Litigation

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
BOEHRINGER INGELHEIM PHARMACEUTICALS, INC. et al v. LUPIN ATLANTIS HOLDINGS SA et al 3:2018cv16708 4 patentsANDA 211287tiotropium bromide	D.N.J.	2018-11-30	Terminated 2019-03-15	—

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

Medicare Part D Spending

CMS annual spending data for Tiotropium Bromide (2023)

Total Spending

$25.5M

Total Claims

40,136

Beneficiaries

25,609

Avg Cost/Unit

$13.13

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

API Supply Chain10 active DMFs3 inactive

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

INDUSTRIALE CHIMICA SRLTIOTROPIUM BROMIDE

DMF 271202013

TAPI NL BVTIOTROPIUM BROMIDE

DMF 275242013

WAVELENGTH ENTERPRISES LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 281612013

CERBIOS PHARMA SATIOTROPIUM BROMIDE

DMF 288202015

LUPIN LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 297262016

INKE SATIOTROPIUM BROMIDE MONOHYDRATE (MICRONIZED AND NON-MICRONIZED)

DMF 344102020

VAMSI LABS LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 348082020

CERBIOS PHARMA SATIOTROPIUM BROMIDE MONOHYDRATE

DMF 362812021

ZHEJIANG XIANJU PHARMACEUTICAL CO LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 409932025

BREATHGREEN PHARMACEUTICAL CO LTDTIOTROPIUM BROMIDE MONOHYDRATE

DMF 410342024

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveTIOTROPIUM BROMIDE MONOHYDRATE

DMF 181352005

BOEHRINGER INGELHEIM PHARMA GMBH AND CO KGInactiveTIOTROPIUM BROMIDE MONOHYDRATE

DMF 219392008

NEULAND LABORATORIES LTDInactiveTIOTROPIUM BROMIDE

DMF 224862009

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

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
Jul 13, 2023	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.018MG BASE/INH

0 patents0 exclusivities▴

POWDER;INHALATION | Approved: Jun 20, 2023

No patent or exclusivity listings for this strength.