Viewing data from:

BEVESPI AEROSPHERE

NDA

FORMOTEROL FUMARATE; GLYCOPYRROLATE | N208294 | ASTRAZENECA PHARMACEUTICALS LP

1 strength7 unique patents0 unique exclusivities

Patent Timeline

7 unique patents by expiration date

Active (7)Today

2027

2028

2029

2030

2031

Today

May. 28, 2030

May. 28, 2030

May. 28, 2030

Mar. 17, 2031

May. 28, 2030

May. 28, 2030

May. 28, 2030

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

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

3 trials from ClinicalTrials.gov, 3 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Pharmacokinetics and Safety Study of PT010 in Healthy Subjects NCT02189304	Phase 1	Completed	Pearl Therapeutics, Inc.	59	2014-06-01 → 2014-09-01
A Study to Assess the PK and Safety of PT010 in Subjects With COPD Following Single and Repeat Dose NCT03250182	Phase 1	Completed	Pearl Therapeutics, Inc.	30	2017-08-11 → 2017-12-07
Multi-Center Study to Assess the Efficacy and Safety of PT003, PT005, and PT001 in Subjects With Moderate to Very Severe COPD (PINNACLE 2)NCT01854658	Phase 3	Completed	Pearl Therapeutics, Inc.	1,615	2013-07 → 2015-03

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

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$40.88

per gm

Lowest NADAC/Unit

$40.88

per gm

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00310460012BEVESPI AEROSPHERE INHALER	$40.88	GM	Brand	—	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 | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$328.73

Highest Price

$413.53

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00310-4600-12BEVESPI AEROSPHERE 9/4.8 MCG	$413.53	FSS	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026
00310-4600-12BEVESPI AEROSPHERE 9/4.8 MCG	$328.73	Big4	ASTRAZENECA PHARMACEUTICALS LP	09/30/2026

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

Medicare Part D Spending

CMS annual spending data for Bevespi Aerosphere (2024)

Total Spending

$65.5M

Total Claims

125,109

Beneficiaries

31,184

Avg Cost/Unit

$38.54

Spending Trend

$68.1M(2019)→$73.0M(2020)→$77.6M(2021)→$69.4M(2022)→$66.8M(2023)→$65.5M(2024)

YoY Change:-7.3%

5yr CAGR:+1.9%

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

Approval Letters

3 letters from Drugs@FDA

Date	Submission	Document
Nov 9, 2020	SUPPL -9	View Letter (PDF)
Jun 4, 2019	SUPPL -5	View Letter (PDF)
Apr 27, 2016	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 0.0048MG/INH;0.0090MG/INH

RLD

7 patents0 exclusivities▴

AEROSOL, METERED;INHALATION | Approved: Apr 25, 2016

Patents (7) · 7 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Delist
8324266	May 28, 2030	—	—	—	—
8703806	May 28, 2030	—	—	—	—
8808713	May 28, 2030	—	—	Yes	—
8815258	Mar 17, 2031	—	—	—	—
9415009	May 28, 2030	—	—	—	—
9463161	May 28, 2030	—	—	Yes	—
10716753	May 28, 2030	—	—	Yes	—