YUPELRI Drug Patent Profile

Which patents cover Yupelri, and when can generic versions of Yupelri launch?

Yupelri is a drug marketed by Mylan Ireland Ltd and is included in one NDA. There are eighteen patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-three patent family members in thirty-one countries.

The generic ingredient in YUPELRI is revefenacin. One supplier is listed for this compound. Additional details are available on the revefenacin profile page.

DrugPatentWatch^® Generic Entry Outlook for Yupelri

Yupelri was eligible for patent challenges on November 9, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 25, 2031. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for YUPELRI

International Patents:	73
US Patents:	18
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	46
Clinical Trials:	2
Patent Applications:	131
Drug Prices:	Drug price information for YUPELRI
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for YUPELRI
What excipients (inactive ingredients) are in YUPELRI?	YUPELRI excipients list
DailyMed Link:	YUPELRI at DailyMed

See drug prices for YUPELRI

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for YUPELRI

NDA:

210598

Dosage:

SOLUTION;INHALATION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for YUPELRI

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Theravance Biopharma	Phase 4
Mylan Inc.	Phase 4
Mylan Pharmaceuticals	Phase 1

See all YUPELRI clinical trials

Pharmacology for YUPELRI

Drug Class	Anticholinergic
Mechanism of Action	Cholinergic Antagonists

Anatomical Therapeutic Chemical (ATC) Classes for YUPELRI

R03BB	Anticholinergics
R03B	OTHER DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES, INHALANTS
R03	DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
R	Respiratory system

Paragraph IV (Patent) Challenges for YUPELRI

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
YUPELRI	Inhalation Solution	revefenacin	175 mcg/3 mL	210598	7	2022-11-09

US Patents and Regulatory Information for YUPELRI

YUPELRI is protected by eighteen US patents and one FDA Regulatory Exclusivity.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting YUPELRI

FDA Regulatory Exclusivity protecting YUPELRI

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes			Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes			Y	Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes				Y
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes
Mylan Ireland Ltd	YUPELRI	revefenacin	SOLUTION;INHALATION	210598-001	Nov 9, 2018		RX	Yes	Yes

International Patents for YUPELRI

When does loss-of-exclusivity occur for YUPELRI?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Croatia

Cyprus

Denmark

European Patent Office

Hong Kong

Hungary

Israel

Japan

Mexico

Poland

Portugal

San Marino

Singapore

Slovenia

South Korea

Spain

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering YUPELRI around the world.

Country	Patent Number	Title	Estimated Expiration
Denmark	2453894
Russian Federation	2366656	БИФЕНИЛЬНЫЕ СОЕДИНЕНИЯ, ПОЛЕЗНЫЕ В КАЧЕСТВЕ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ (BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS)
Japan	2012533550
China	1930125	Biphenyl compounds useful as muscarinic receptor antagonists
Spain	2345640
European Patent Office	1723114	COMPOSES BIPHENYLE CONVENANT COMME ANTAGONISTES DU RECEPTEUR MUSCARINIQUE (BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS)
Japan	4837653