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XOPENEX HFA

NDA

LEVALBUTEROL TARTRATE | N021730 | 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

1 case on OB patents from PACER

Case	Court	Filed	Status	Judge
Cipla Ltd. v. Sunovion Pharmaceuticals Inc. 1:2015cv00424 1 patentlevalbuterol tartrate	D. Del.	2015-05-26	Terminated 2018-04-10	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

31 trials from ClinicalTrials.gov, 29 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)NCT00685126	Phase 3	Completed	Sumitomo Pharma America, Inc.	117	2001-02 → 2002-07
Evaluation of Dupilumab in Patients With Persistent Asthma (Liberty Asthma Quest)NCT02414854	Phase 3	Completed	Sanofi	1,902	2015-04-27 → 2017-11-23
Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma NCT00684866	Phase 2	Completed	Sumitomo Pharma America, Inc.	31	2003-01 → 2003-07
Dose Response Study of Levalbuterol in the Prevention of Exercise Induced Bronchoconstriction Compared to Racemic Albuterol NCT00685425	Phase 3	Completed	Sumitomo Pharma America, Inc.	62	2002-10 → 2003-03
Efficacy and Safety of Levalbuterol in Chronic Obstructive Pulmonary Disease (COPD)NCT00665600	Phase 3	Completed	Sumitomo Pharma America, Inc.	257	2002-02 → 2003-03
Costs & Outcomes of Hospitalization/Treatment With Levalbuterol & Albuterol in Asthma or Chronic Obstructive Pulmonary Disease (COPD) Subjects NCT00667797	Phase 4	Completed	Sumitomo Pharma America, Inc.	486	2003-03 → 2005-05
A Safety, Efficacy and Tolerability Study in Pediatric Subjects With Asthma NCT00809757	Phase 3	Completed	Sumitomo Pharma America, Inc.	197	2008-12 → 2013-06
Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma NCT00685022	Phase 2	Completed	Sumitomo Pharma America, Inc.	49	2003-06 → 2003-08
Evaluation of Dupilumab in Patients With Severe Steroid Dependent Asthma NCT02528214	Phase 3	Completed	Sanofi	210	2015-10-15 → 2017-11-13
Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma NCT00073814	Phase 3	Completed	Sumitomo Pharma America, Inc.	80	2002-12 → 2003-06

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 2 NDCs (1 brand, 1 generic)

Highest NADAC/Unit

$5.02

per gm

Lowest NADAC/Unit

$3.47

per gm

Brand NDCs

Generic NDCs

Avg Brand: $5.02

Avg Generic: $3.47

31% less

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
27437005601XOPENEX HFA 45 MCG INHALER	$5.02	GM	Brand	$3.47	2026-06-17
00591292754LEVALBUTEROL TAR HFA 45 MCG INH	$3.47	GM	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 | 3 NDCs (2 FSS, 1 Big4)

Lowest Price

$22.43

Highest Price

$47.07

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
27437-0056-01XOPENEX HFA	$22.43	FSS	Lupin Pharmaceuticals, Inc.	03/14/2027
00591-2927-54LEVALBUTEROL 45MCG/SPRAY INHL,ORAL,15GM	$47.07	FSS	Teva Pharmaceuticals USA, Inc.	04/30/2026
00591-2927-54LEVALBUTEROL 45MCG/SPRAY INHL,ORAL,15GM	$29.99	Big4	Teva Pharmaceuticals USA, Inc.	04/30/2026

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

Medicare Part D Spending

CMS annual spending data for Xopenex HFA (2024)

Total Spending

$1.5M

Total Claims

15,310

Beneficiaries

6,461

Avg Cost/Unit

$4.57

Spending Trend

$8.5M(2019)→$7.4M(2020)→$2.3M(2021)→$1.7M(2022)→$141K(2023)→$1.5M(2024)

YoY Change:+0.1%

5yr CAGR:+0.1%

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

Approval Letters

7 letters from Drugs@FDA

Date	Submission	Document
Mar 13, 2015	SUPPL -36	View Letter (PDF)
Sep 12, 2013	SUPPL -33	View Letter (PDF)
Aug 1, 2012	SUPPL -24	View Letter (PDF)
Feb 7, 2008	SUPPL -8	View Letter (PDF)
Sep 20, 2006	SUPPL -3	View Letter (PDF)
Apr 7, 2006	SUPPL -6	View Letter (PDF)
Mar 14, 2005	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.045MG BASE/INH

RLD

0 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Mar 11, 2005

No patent or exclusivity listings for this strength.