Viewing data from:

YUPELRI

NDA

REVEFENACIN | N210598 | MYLAN IRELAND LTD

1 strength10 unique patents0 unique exclusivities

Patent Timeline

10 unique patents by expiration date

Active (10)Today

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

Today

Oct. 31, 2028

Aug. 25, 2031

Jul. 14, 2030

Jul. 14, 2030

Jul. 14, 2030

Oct. 23, 2039

Jul. 14, 2030

Jul. 14, 2030

Aug. 29, 2039

Aug. 29, 2039

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

3 cases on OB patents (1 active) from PACER

Case	Court	Filed	Status	Judge
THERAVANCE BIOPHARMA R&D IP, LLC et al v. EUGIA PHARMA SPECIALITIES LTD. et al 1:2025cv03790 13 patentsANDA 218128, 218089, 217958revefenacin	D.N.J.	2025-05-02	Terminated 2025-06-06	—
Theravance Biopharma R&D IP, LLC et al v. Lupin Inc. et al 1:2023cv00187	D. Del.	2023-02-17	Terminated 2023-03-28	—
THERAVANCE BIOPHARMA R&D IP, LLC et al v. EUGIA PHARMA SPECIALTIES LTD. et al 1:2023cv00926 12 patentsANDA 218089, 218100, 218128, 218088, 217868, 217958revefenacin	D.N.J.	2023-02-16	Active	—

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

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

14 trials from ClinicalTrials.gov, 14 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
TD-4208 Absorption, Distribution, Metabolism and Excretion (ADME) Study in Healthy Male Subjects NCT02772159	Phase 1	Completed	Mylan Inc.	9	2015-06 → 2016-04
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)NCT02459080	Phase 3	Completed	Mylan Inc.	619	2015-09 → 2016-09
A 52-Week Parallel Group Safety Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)NCT02518139	Phase 3	Completed	Mylan Inc.	1,060	2015-09 → 2017-06
Efficacy Study of Nebulized TD-4208 for Chronic Obstructive Pulmonary Disease (COPD)NCT02512510	Phase 3	Completed	Mylan Inc.	611	2015-09 → 2016-09
A 7-Day Cross-over Study of QD (Once Daily) and BID (Twice Daily) TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)NCT02109172	Phase 2	Completed	Mylan Inc.	64	2014-04 → 2014-10
A 42-day Parallel Group Safety Study of Revefenacin and Formoterol, Administered in Sequence and as a Combination, in Participants With COPD NCT03573817	Phase 3	Completed	Mylan Inc.	122	2018-05-31 → 2018-09-25
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment NCT02581592	Phase 1	Completed	Mylan Inc.	16	2015-11 → 2016-04
Thorough QT (TQT) Study of TD-4208 in Healthy Subjects NCT02820311	Phase 1	Completed	Mylan Inc.	48	2016-05 → 2016-07
Effects of TD-4208 on FEV1 in Subjects With Chronic Obstructive Pulmonary Disease (COPD)NCT03064113	Phase 2	Completed	Mylan Inc.	32	2011-05 → 2011-10
A 28-Day Parallel Group Study of TD-4208 in Chronic Obstructive Pulmonary Disease (COPD)NCT02040792	Phase 2	Completed	Mylan Inc.	355	2014-05 → 2014-08

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

$17.48

per ml

Lowest NADAC/Unit

$17.48

per ml

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
49502080693YUPELRI 175 MCG/3 ML SOLUTION	$17.48	ML	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

$806.62

Highest Price

$806.62

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
49502-0806-93YUPELRI 175MCG/3ML SOLN,INHL,3ML	$806.62	FSS	Mylan Specialty L.P.	01/14/2027
49502-0806-93YUPELRI 175MCG/3ML SOLN,INHL,3ML	$806.62	Big4	Mylan Specialty L.P.	01/14/2027

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

Medicare Part D Spending

CMS annual spending data for Yupelri (2024)

Total Spending

$7.2M

Total Claims

5,673

Beneficiaries

1,636

Avg Cost/Unit

$16.81

Spending Trend

$1.2M(2019)→$2.4M(2020)→$1.6M(2021)→$2.2M(2022)→$4.4M(2023)→$7.2M(2024)

YoY Change:+10.0%

5yr CAGR:+7.8%

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

Medicare Part B Spending

CMS physician-administered drug spending for Yupelri (2024)

Total Spending

$175.0M

Total Claims

175,788

Beneficiaries

29,240

ASP Price

$0.19

Spending Trend

$40.7M(2019)→$123.3M(2020)→$138.2M(2021)→$156.0M(2022)→$172.7M(2023)→$175.0M(2024)

YoY Change:-2.7%

5yr CAGR:-2.6%

HCPCS: J7677 — Revefenacin inhalation solution, fda-approved final product, non-compounded, administered through dme, 1 microgram

Source: CMS Medicare Part B Spending by Drug (2024). Shows physician-administered drug costs.

API Supply Chain6 active DMFs

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

INKE SAREVEFENACIN TRIHYDRATE

DMF 364812022

CIPLA LTDREVEFENACIN

DMF 367372022

MSN LABORATORIES PRIVATE LTDREVEFENACIN

DMF 367672022

MANKIND PHARMA LTDREVEFENACIN

DMF 367712022

MEDICHEM MANUFACTURING (MALTA) LTDREVEFENACIN

DMF 368612022

APITORIA PHARMA PRIVATE LTDREVEFENACIN

DMF 371392022

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

Approval Letters

4 letters from Drugs@FDA

Date	Submission	Document
May 26, 2022	SUPPL -3	View Letter (PDF)
Nov 5, 2021	SUPPL -2	View Letter (PDF)
May 22, 2019	SUPPL -1	View Letter (PDF)
Nov 14, 2018	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 175MCG/3ML

RLD

10 patents0 exclusivities▴

SOLUTION;INHALATION | Approved: Nov 9, 2018

Patents (10) · 5 use codes

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7288657	Oct 31, 2028	—	Yes	—	—	—
8541451	Aug 25, 2031	—	Yes	—	—	—
9765028	Jul 14, 2030	—	Yes	—	—	—
10550081	Jul 14, 2030	—	Yes	—	—	—
11008289	Jul 14, 2030	—	—	—		—
11484531	Oct 23, 2039	—	—	—		—
11691948	Jul 14, 2030	—	—	Yes	—	—
11858898	Jul 14, 2030	—	Yes	Yes		—
12048692	Aug 29, 2039	—	—	—		—
12285417	Aug 29, 2039	—	—	—		—