Viewing data from:

BROVANA

NDA

ARFORMOTEROL TARTRATE | N021912 | LUPIN INC

1 strength0 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

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 Brovana (2023)

Total Spending

$394K

Total Claims

631

Beneficiaries

188

Avg Cost/Unit

$6.90

Spending Trend

$17.1M(2019)→$11.8M(2020)→$5.0M(2021)→$889K(2022)→$394K(2023)

YoY Change:-8.2%

5yr CAGR:-6.7%

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

API Supply Chain5 active DMFs

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

CIPLA LTDARFORMOTEROL TARTRATE

DMF 229682009

MSN LABORATORIES PRIVATE LTDARFORMOTEROL TARTRATE [ROUTE CODE - "LT"]

DMF 280132014

ALIVUS LIFE SCIENCES LTDARFORMOTEROL TARTRATE

DMF 288682015

INKE SAARFORMOTEROL TARTRATE (FORM D)

DMF 329902018

INKE SAARFORMOTEROL TARTRATE (FORM A)

DMF 364352022

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

Approval Letters

11 letters from Drugs@FDA

Date	Submission	Document
Jun 4, 2019	SUPPL -32	View Letter (PDF)
Mar 4, 2014	SUPPL -23	View Letter (PDF)
Aug 13, 2012	SUPPL -20	View Letter (PDF)
Aug 13, 2012	SUPPL -18	View Letter (PDF)
Sep 7, 2011	SUPPL -16	View Letter (PDF)
Jul 18, 2011	SUPPL -6	View Letter (PDF)
Feb 18, 2011	SUPPL -15	View Letter (PDF)
Feb 7, 2011	SUPPL -12	View Letter (PDF)
Jun 3, 2010	SUPPL -11	View Letter (PDF)
Jan 9, 2008	SUPPL -1	View Letter (PDF)
Oct 13, 2006	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.015MG BASE/2ML

RLD

0 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Oct 6, 2006

No patent or exclusivity listings for this strength.