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
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 |


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
Sponsor | Phase |
---|---|
Theravance Biopharma | Phase 4 |
Mylan Inc. | Phase 4 |
Mylan Inc. | Phase 1 |
Pharmacology for YUPELRI
Drug Class | Anticholinergic |
Mechanism of Action | Cholinergic Antagonists |
Anatomical Therapeutic Chemical (ATC) Classes for YUPELRI
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 |