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Last Updated: December 8, 2024

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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 twenty 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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Drug patent expirations by year for YUPELRI
Drug Prices for YUPELRI

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DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for YUPELRI
Generic Entry Date for YUPELRI*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Theravance BiopharmaPhase 4
Mylan Inc.Phase 4
Mylan Inc.Phase 1

See all YUPELRI clinical trials

Pharmacology for YUPELRI
Drug ClassAnticholinergic
Mechanism of ActionCholinergic Antagonists
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 twenty US patents.

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

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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

Crystalline freebase forms of a biphenyl compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


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


Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up


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


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

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

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

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline freebase forms of a biphenyl compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Crystalline freebase forms of a biphenyl compound
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Patent: Crystalline freebase forms of a biphenyl compound
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2012000890
Patent: formas de base livre cristalina de um composto bifenil
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 65621
Patent: FORMES A BASE LIBRE CRISTALLINE D'UN COMPOSE BIPHENYLE (CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Patent: 89129
Patent: FORMES A BASE LIBRE CRISTALLINE D'UN COMPOSE BIPHENYLE (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

China

Patent: 2470130
Patent: Crystalline freebase forms of a biphenyl compound
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0151344
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 17075
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 53894
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 53894
Patent: FORME CRISTALLINE D'UNE BASE LIBRE D'UNE COMPOSE DE BIPHENYLE (CRYSTALLINE FREEBASE FORM OF A BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Patent: 87490
Patent: FORMES DE BASE LIBRE CRISTALLINE D'UN COMPOSÉ BIPHÉNYLE (CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 68050
Patent: 聯苯化合物的結晶游離碱形式 (CRYSTALLINE FREEBASE FORM OF A BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Patent: 19415
Patent: 聯苯化合物的結晶游離碱形式 (CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 26414
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 6995
Patent: צורות גבישיות בצורת בסיס חופשי של תרכובת ביפניל (Crystalline freebase forms of a biphenyl compound)
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 51174
Estimated Expiration: ⤷  Sign Up

Patent: 38505
Estimated Expiration: ⤷  Sign Up

Patent: 12533550
Estimated Expiration: ⤷  Sign Up

Patent: 15003929
Patent: ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREE BASE FORMS OF BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Patent: 16026214
Patent: ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Patent: 17171692
Patent: ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREE BASE FORM OF BIPHENYL COMPOUND)
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 12000682
Patent: FORMAS DE BASES LIBRES CRISTALINAS DE UN COMPUESTO DE BIFENILO. (CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND.)
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 53894
Estimated Expiration: ⤷  Sign Up

Patent: 87490
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 53894
Estimated Expiration: ⤷  Sign Up

San Marino

Patent: 01600019
Patent: FORMA DI BASE LIBERA CRISTALLINA DI UN COMPOSTO BIFENILICO
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 8036
Patent: CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND
Estimated Expiration: ⤷  Sign Up

Patent: 201407913U
Patent: CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 53894
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1742252
Estimated Expiration: ⤷  Sign Up

Patent: 130027004
Patent: CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 57553
Estimated Expiration: ⤷  Sign Up

Patent: 39642
Estimated Expiration: ⤷  Sign Up

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
China 102470130 Crystalline freebase forms of a biphenyl compound ⤷  Sign Up
Poland 2987490 ⤷  Sign Up
Japan 2017171692 ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREE BASE FORM OF BIPHENYL COMPOUND) ⤷  Sign Up
Japan 2016026214 ビフェニル化合物の結晶性遊離塩基形 (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND) ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.