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YUPELRI Drug Patent Profile

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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 nineteen 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 have been two patent litigation cases 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

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Summary for YUPELRI

International Patents:	73
US Patents:	19
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	48
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

Drug patent expirations by year for YUPELRI

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

Generic Entry Date for YUPELRI^: ⤷ Try a Trial* Constraining patent/regulatory exclusivity: ⤷ Try a Trial 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 Inc.	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 nineteen US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of YUPELRI is ⤷ Try a Trial.

This potential generic entry date is based on patent ⤷ Try a Trial.
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

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Crystalline freebase forms of a biphenyl compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Crystalline freebase forms of a biphenyl compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

Crystalline freebase forms of a biphenyl compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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Glossary

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

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

Patent: 10273514
Estimated Expiration: ⤷ Try a Trial

Brazil

Patent: 2012000890
Estimated Expiration: ⤷ Try a Trial

Canada

Patent: 65621
Estimated Expiration: ⤷ Try a Trial

Patent: 89129
Estimated Expiration: ⤷ Try a Trial

China

Patent: 2470130
Estimated Expiration: ⤷ Try a Trial

Croatia

Patent: 0151344
Estimated Expiration: ⤷ Try a Trial

Cyprus

Patent: 17075
Estimated Expiration: ⤷ Try a Trial

Denmark

Patent: 53894
Estimated Expiration: ⤷ Try a Trial

European Patent Office

Patent: 53894
Estimated Expiration: ⤷ Try a Trial

Patent: 87490
Estimated Expiration: ⤷ Try a Trial

Hong Kong

Patent: 68050
Estimated Expiration: ⤷ Try a Trial

Patent: 19415
Estimated Expiration: ⤷ Try a Trial

Hungary

Patent: 26414
Estimated Expiration: ⤷ Try a Trial

Israel

Patent: 6995
Estimated Expiration: ⤷ Try a Trial

Japan

Patent: 51174
Estimated Expiration: ⤷ Try a Trial

Patent: 38505
Estimated Expiration: ⤷ Try a Trial

Patent: 12533550
Estimated Expiration: ⤷ Try a Trial

Patent: 15003929
Estimated Expiration: ⤷ Try a Trial

Patent: 16026214
Estimated Expiration: ⤷ Try a Trial

Patent: 17171692
Estimated Expiration: ⤷ Try a Trial

Mexico

Patent: 12000682
Estimated Expiration: ⤷ Try a Trial

Poland

Patent: 53894
Estimated Expiration: ⤷ Try a Trial

Patent: 87490
Estimated Expiration: ⤷ Try a Trial

Portugal

Patent: 53894
Estimated Expiration: ⤷ Try a Trial

San Marino

Patent: 01600019
Estimated Expiration: ⤷ Try a Trial

Singapore

Patent: 8036
Estimated Expiration: ⤷ Try a Trial

Patent: 201407913U
Estimated Expiration: ⤷ Try a Trial

Slovenia

Patent: 53894
Estimated Expiration: ⤷ Try a Trial

South Korea

Patent: 1742252
Estimated Expiration: ⤷ Try a Trial

Patent: 130027004
Estimated Expiration: ⤷ Try a Trial

Spain

Patent: 57553
Estimated Expiration: ⤷ Try a Trial

Patent: 39642
Estimated Expiration: ⤷ Try a Trial

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.

Subscribe to access the full database, or Try a Trial
Country	Patent Number	Title	Estimated Expiration
Japan	5651174		⤷ Try a Trial
Hong Kong	1168050	聯苯化合物的結晶游離碱形式 (CRYSTALLINE FREEBASE FORM OF A BIPHENYL COMPOUND)	⤷ Try a Trial
Croatia	P20151344		⤷ Try a Trial
Portugal	1723114		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2020047225		⤷ Try a Trial
Taiwan	202019389	Methods for treating chronic obstructive pulmonary disease	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Indicators of Generic Entry

Summary for YUPELRI

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

Recent Clinical Trials for YUPELRI

Pharmacology for YUPELRI

Anatomical Therapeutic Chemical (ATC) Classes for YUPELRI

Paragraph IV (Patent) Challenges for YUPELRI

Patents protecting YUPELRI

When does loss-of-exclusivity occur for YUPELRI?

Make Better Decisions: Try a trial or see plans & pricing

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