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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Summary for YUPELRI
| International Patents: | 73 |
| US Patents: | 20 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 48 |
| Clinical Trials: | 2 |
| Patent Applications: | 110 |
| 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
*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 |
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 | ||||
| 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 | Y | Y | ⤷ 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 |
|---|---|---|---|
| South Korea | 20130027004 | CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND | ⤷ Sign Up |
| Portugal | 1723114 | ⤷ Sign Up | |
| Croatia | P20151344 | ⤷ Sign Up | |
| Singapore | 178036 | CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND | ⤷ Sign Up |
| Denmark | 2453894 | ⤷ Sign Up | |
| Japan | 4837653 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Make Better Decisions: Try a trial or see plans & pricing
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.
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