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Last Updated: June 29, 2022

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 sixteen patents protecting this drug.

This drug has seventy-one 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 will be eligible for patent challenges on November 9, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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.

Indicators of Generic Entry

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Summary for YUPELRI
International Patents:71
US Patents:16
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 40
Clinical Trials: 2
Patent Applications: 125
Drug Prices: Drug price information for YUPELRI
What excipients (inactive ingredients) are in YUPELRI?YUPELRI excipients list
DailyMed Link:YUPELRI at DailyMed
Drug patent expirations by year for YUPELRI
Drug Prices for YUPELRI

See drug prices for YUPELRI

DrugPatentWatch® Estimated Generic Entry Opportunity 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 Action Cholinergic Antagonists

US Patents and Regulatory Information for YUPELRI

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

Based on analysis by DrugPatentWatch, the earliest date for a generic version of YUPELRI is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Crystalline freebase forms of a biphenyl compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline freebase forms of a biphenyl compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: FOR THE MAINTENANCE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline freebase forms of a biphenyl compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Crystalline freebase forms of a biphenyl compound
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

FDA Regulatory Exclusivity protecting YUPELRI

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Mylan Ireland Ltd YUPELRI revefenacin SOLUTION;INHALATION 210598-001 Nov 9, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Brazil

Patent: 2012000890
Estimated Expiration: See Plans and Pricing

Canada

Patent: 65621
Estimated Expiration: See Plans and Pricing

Patent: 89129
Estimated Expiration: See Plans and Pricing

China

Patent: 2470130
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0151344
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 17075
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 53894
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 53894
Estimated Expiration: See Plans and Pricing

Patent: 87490
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 68050
Estimated Expiration: See Plans and Pricing

Patent: 19415
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 26414
Estimated Expiration: See Plans and Pricing

Israel

Patent: 6995
Estimated Expiration: See Plans and Pricing

Japan

Patent: 51174
Estimated Expiration: See Plans and Pricing

Patent: 38505
Estimated Expiration: See Plans and Pricing

Patent: 12533550
Estimated Expiration: See Plans and Pricing

Patent: 15003929
Estimated Expiration: See Plans and Pricing

Patent: 16026214
Estimated Expiration: See Plans and Pricing

Patent: 17171692
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 12000682
Estimated Expiration: See Plans and Pricing

Poland

Patent: 53894
Estimated Expiration: See Plans and Pricing

Patent: 87490
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 53894
Estimated Expiration: See Plans and Pricing

San Marino

Patent: 01600019
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 8036
Estimated Expiration: See Plans and Pricing

Patent: 201407913U
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 53894
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1742252
Estimated Expiration: See Plans and Pricing

Patent: 130027004
Estimated Expiration: See Plans and Pricing

Spain

Patent: 57553
Estimated Expiration: See Plans and Pricing

Patent: 39642
Estimated Expiration: See Plans and Pricing

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
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) See Plans and Pricing
South Korea 101742252 See Plans and Pricing
Israel 216995 צורות גבישיות בצורת בסיס חופשי של תרכובת ביפניל (Crystalline freebase forms of a biphenyl compound) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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

Serving leading biopharmaceutical companies globally:

Express Scripts
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Boehringer Ingelheim
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Colorcon
Johnson and Johnson

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.