Yupelri is a drug owned by Mylan Ireland Ltd. It is protected by 20 US drug patents filed from 2018 to 2024 out of which none have expired yet. Yupelri's patents have been open to challenges since 09 November, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 23, 2039. Details of Yupelri's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8541451 | Crystalline freebase forms of a biphenyl compound |
Aug, 2031
(6 years from now) | Active |
| US9765028 | Crystalline freebase forms of a biphenyl compound |
Jul, 2030
(5 years from now) | Active |
| US10550081 | Crystalline freebase forms of a biphenyl compound |
Jul, 2030
(5 years from now) | Active |
| US11858898 | Crystalline freebase forms of a biphenyl compound |
Jul, 2030
(5 years from now) | Active |
| US7288657 | Biphenyl compounds useful as muscarinic receptor antagonists |
Oct, 2028
(3 years from now) | Active |
| US7910608 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US7585879 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11484531 | Methods for treating chronic obstructive pulmonary disease |
Oct, 2039
(14 years from now) | Active |
| US12048692 | Methods for treating chronic obstructive pulmonary disease |
Aug, 2039
(14 years from now) | Active |
| US11008289 | Crystalline freebase forms of a biphenyl compound |
Jul, 2030
(5 years from now) | Active |
| US11691948 | Crystalline freebase forms of a biphenyl compound |
Jul, 2030
(5 years from now) | Active |
| US7491736 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US7521041 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US10106503 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US10343995 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US11247969 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US8273894 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US8053448 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US7550595 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
| US8034946 | Biphenyl compounds useful as muscarinic receptor antagonists |
Mar, 2025
(3 months from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Yupelri's patents.
Latest Legal Activities on Yupelri's Patents
Given below is the list of recent legal activities going on the following patents of Yupelri.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Email Notification Critical | 03 May, 2024 | US7585879 |
| Change in Power of Attorney (May Include Associate POA) Critical | 03 May, 2024 | US7585879 |
| Email Notification Critical | 25 Apr, 2024 | US7288657 |
| Change in Power of Attorney (May Include Associate POA) Critical | 25 Apr, 2024 | US7288657 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 25 Mar, 2024 | US8273894 |
| Notice of Final Determination -Election Required | 22 Mar, 2024 | US7585879 |
| Notice of Final Determination -Election Required | 22 Mar, 2024 | US7288657 |
| Recordation of Patent eCertificate of Correction | 20 Feb, 2024 | US11858898 |
| Mail Patent eCofC Notification | 20 Feb, 2024 | US11858898 |
| Email Notification Critical | 20 Feb, 2024 | US11858898 |
FDA has granted several exclusivities to Yupelri. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Yupelri, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Yupelri.
Exclusivity Information
Yupelri holds 1 exclusivities. All of its exclusivities have expired in 2023. Details of Yupelri's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Nov 09, 2023 |
US patents provide insights into the exclusivity only within the United States, but Yupelri is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Yupelri's family patents as well as insights into ongoing legal events on those patents.
Yupelri's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Yupelri's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 23, 2039 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Yupelri Generics:
There are no approved generic versions for Yupelri as of now.
How can I launch a generic of Yupelri before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Yupelri's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Yupelri's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Yupelri -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 175 mcg/3 mL | 09 Nov, 2022 | 7 | 23 Oct, 2039 |
About Yupelri
Yupelri is a drug owned by Mylan Ireland Ltd. It is used for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). Yupelri uses Revefenacin as an active ingredient. Yupelri was launched by Mylan Ireland Ltd in 2018.
Approval Date:
Yupelri was approved by FDA for market use on 09 November, 2018.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Yupelri is 09 November, 2018, its NCE-1 date is estimated to be 09 November, 2022.
Active Ingredient:
Yupelri uses Revefenacin as the active ingredient. Check out other Drugs and Companies using Revefenacin ingredient
Treatment:
Yupelri is used for maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD).
Dosage:
Yupelri is available in solution form for inhalation use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 175MCG/3ML | SOLUTION | Prescription | INHALATION |