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 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 |


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
Sponsor | Phase |
---|---|
Theravance Biopharma | Phase 4 |
Mylan Inc. | Phase 4 |
Mylan Pharmaceuticals | Phase 1 |
Pharmacology for YUPELRI
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for YUPELRI
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.
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)
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
Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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)
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)
Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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)
Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Biphenyl compounds useful as muscarinic receptor antagonists
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
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)
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
Crystalline freebase forms of a biphenyl compound
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting YUPELRI
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Try a Trial
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.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Denmark | 2453894 | ⤷ Try a Trial | |
Russian Federation | 2366656 | БИФЕНИЛЬНЫЕ СОЕДИНЕНИЯ, ПОЛЕЗНЫЕ В КАЧЕСТВЕ АНТАГОНИСТОВ МУСКАРИНОВЫХ РЕЦЕПТОРОВ (BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS) | ⤷ Try a Trial |
Japan | 2012533550 | ⤷ Try a Trial | |
China | 1930125 | Biphenyl compounds useful as muscarinic receptor antagonists | ⤷ Try a Trial |
Spain | 2345640 | ⤷ Try a Trial | |
European Patent Office | 1723114 | COMPOSES BIPHENYLE CONVENANT COMME ANTAGONISTES DU RECEPTEUR MUSCARINIQUE (BIPHENYL COMPOUNDS USEFUL AS MUSCARINIC RECEPTOR ANTAGONISTS) | ⤷ Try a Trial |
Japan | 4837653 | ⤷ Try a Trial | |
>Country | >Patent Number | >Title | >Estimated Expiration |