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YUPELRI Drug Profile
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» See Plans and PricingWhich 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 fourteen patents protecting this drug.
This drug has seventy 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.
US ANDA Litigation and 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: | 70 |
| US Patents: | 14 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 24 |
| Patent Applications: | 39 |
| Drug Prices: | Drug price information for YUPELRI |
| DailyMed Link: | YUPELRI at DailyMed |
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.
Pharmacology for YUPELRI
| Drug Class | Anticholinergic |
| Mechanism of Action | Cholinergic Antagonists |
US Patents and Regulatory Information for YUPELRI
| 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 | |||
| Mylan Ireland Ltd | YUPELRI | revefenacin | SOLUTION;INHALATION | 210598-001 | Nov 9, 2018 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | 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 | ||||
| >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
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Germany | 602005006757 | Start Trial |
| Portugal | 1723114 | Start Trial |
| Portugal | 2453894 | Start Trial |
| Hong Kong | 1119672 | Start Trial |
| Spain | 2345640 | Start Trial |
| South Korea | 20070011370 | Start Trial |
| Japan | 2012533550 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
