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 ten patents protecting this drug and one Paragraph IV challenge.
The generic ingredient in YUPELRI is revefenacin. There is one drug master file entry for this compound. 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 nine 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.
There are two tentative approvals for the generic drug (revefenacin), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
AI Deep Research
Questions you can ask:
- What is the 5 year forecast for YUPELRI?
- What are the global sales for YUPELRI?
- What is Average Wholesale Price for YUPELRI?
Summary for YUPELRI
| US Patents: | 10 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 2 |
| Patent Applications: | 284 |
| 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 |
|---|---|
| Mylan Inc. | Phase 4 |
| Theravance Biopharma | 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 ten US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of YUPELRI is ⤷ Start Trial.
This potential generic entry date is based on patent ⤷ Start 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.
| 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 | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | ⤷ Start Trial | ||||
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | RX | Yes | Yes | ⤷ Start Trial | ⤷ Start Trial | Y | ⤷ Start Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for YUPELRI
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | ⤷ Start Trial | ⤷ Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent 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: ⤷ Start Trial
Brazil
Patent: 2012000890
Patent: formas de base livre cristalina de um composto bifenil
Estimated Expiration: ⤷ Start Trial
Canada
Patent: 65621
Patent: FORMES A BASE LIBRE CRISTALLINE D'UN COMPOSE BIPHENYLE (CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND)
Estimated Expiration: ⤷ Start Trial
Patent: 89129
Patent: FORMES A BASE LIBRE CRISTALLINE D'UN COMPOSE BIPHENYLE (CRYSTALLINE FREEBASE FORMS OF BIPHENYL COMPOUND)
Estimated Expiration: ⤷ Start Trial
China
Patent: 2470130
Patent: Crystalline freebase forms of a biphenyl compound
Estimated Expiration: ⤷ Start Trial
Croatia
Patent: 0151344
Estimated Expiration: ⤷ Start Trial
Cyprus
Patent: 17075
Estimated Expiration: ⤷ Start Trial
Denmark
Patent: 53894
Estimated Expiration: ⤷ Start Trial
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: ⤷ Start Trial
Patent: 87490
Patent: FORMES DE BASE LIBRE CRISTALLINE D'UN COMPOSÉ BIPHÉNYLE (CRYSTALLINE FREEBASE FORMS OF A BIPHENYL COMPOUND)
Estimated Expiration: ⤷ Start Trial
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: ⤷ Start Trial
Patent: 19415
Estimated Expiration: ⤷ Start Trial
Hungary
Patent: 26414
Estimated Expiration: ⤷ Start Trial
Israel
Patent: 6995
Estimated Expiration: ⤷ Start Trial
Japan
Patent: 51174
Estimated Expiration: ⤷ Start Trial
Patent: 38505
Estimated Expiration: ⤷ Start Trial
Patent: 12533550
Estimated Expiration: ⤷ Start Trial
Patent: 15003929
Estimated Expiration: ⤷ Start Trial
Patent: 16026214
Estimated Expiration: ⤷ Start Trial
Patent: 17171692
Estimated Expiration: ⤷ Start Trial
Mexico
Patent: 12000682
Estimated Expiration: ⤷ Start Trial
Poland
Patent: 53894
Estimated Expiration: ⤷ Start Trial
Patent: 87490
Estimated Expiration: ⤷ Start Trial
Portugal
Patent: 53894
Estimated Expiration: ⤷ Start Trial
San Marino
Patent: 01600019
Estimated Expiration: ⤷ Start Trial
Singapore
Patent: 201407913U
Estimated Expiration: ⤷ Start Trial
Patent: 8036
Estimated Expiration: ⤷ Start Trial
Slovenia
Patent: 53894
Estimated Expiration: ⤷ Start Trial
South Korea
Patent: 1742252
Estimated Expiration: ⤷ Start Trial
Patent: 130027004
Estimated Expiration: ⤷ Start Trial
Spain
Patent: 57553
Estimated Expiration: ⤷ Start Trial
Patent: 39642
Estimated Expiration: ⤷ Start 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 |
|---|---|---|---|
| Argentina | 048032 | COMPUESTOS DE BIFENILO UTILES COMO ANTAGONISTAS DE RECEPTORES MUSCARINICOS, UN PROCESO PARA SU PREPARACION, COMPOSICIONES FARMACEUTICAS QUE LOS CONTIENEN, SU USO EN LA FABRICACION DE UN MEDICAMENTO PARA EL TRATAMIENTO DE AFECCIONES PULMONARES Y UN METODO PARA ESTUDIAR UNA MUESTRA BIOLOGICA QUE LOS C | ⤷ Start Trial |
| Argentina | 104444 | DERIVADO DE ÁCIDO BIFENIL CARBÁMICO Y SUS SALES | ⤷ Start Trial |
| Austria | E395335 | ⤷ Start Trial | |
| Austria | E467617 | ⤷ Start Trial | |
| >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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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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