Xhance is a drug owned by Optinose Us Inc. It is protected by 20 US drug patents filed from 2018 to 2024. Out of these, 14 drug patents are active and 6 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Feb 23, 2036. Details of Xhance's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11554229 | Nasal administration |
Feb, 2036
(11 years from now) | Active |
| US10300229 | Nasal delivery devices |
Jul, 2035
(10 years from now) | Active |
| US10076614 | Nasal delivery devices |
Oct, 2034
(9 years from now) | Active |
| US10478574 | Nasal administration |
Nov, 2033
(8 years from now) | Active |
| US10179216 | Nasal delivery devices |
Jul, 2033
(8 years from now) | Active |
| US11033696 | Nasal delivery devices |
May, 2033
(8 years from now) | Active |
| US12083270 | Delivery device and method |
Apr, 2031
(6 years from now) | Active |
| US10252010 | Nasal delivery devices |
Feb, 2031
(6 years from now) | Active |
| US8978647 | Nasal delivery |
Dec, 2030
(5 years from now) | Active |
| US8550073 | Nasal delivery |
Oct, 2029
(4 years from now) | Active |
| US10076615 | Nasal delivery |
Jul, 2029
(4 years from now) | Active |
| US11602603 | Nasal delivery devices |
Oct, 2028
(3 years from now) | Active |
| US10124132 | Nasal delivery |
Mar, 2027
(2 years from now) | Active |
| US7975690 | Nasal devices |
Dec, 2025
(1 year, 10 days from now) | Active |
| US8522778 | Nasal devices |
Apr, 2024
(7 months ago) |
Expired
|
| US8327844 | Nasal delivery method |
Oct, 2023
(1 year, 1 month ago) |
Expired
|
| US9072857 | Nasal delivery device |
Apr, 2021
(3 years ago) |
Expired
|
| US6715485 | Nasal delivery device |
Sep, 2020
(4 years ago) |
Expired
|
| US9468727 | Nasal delivery |
Jul, 2020
(4 years ago) |
Expired
|
| US8555878 | Nasal delivery device |
Mar, 2020
(4 years ago) |
Expired
|
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 Xhance's patents.
Latest Legal Activities on Xhance's Patents
Given below is the list of recent legal activities going on the following patents of Xhance.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Maintenance Fee Reminder Mailed Critical | 10 Jun, 2024 | US9468727 |
| Expire Patent Critical | 14 Aug, 2023 | US9072857 |
| Recordation of Patent Grant Mailed Critical | 14 Mar, 2023 | US11602603 |
| Patent Issue Date Used in PTA Calculation Critical | 14 Mar, 2023 | US11602603 |
| Maintenance Fee Reminder Mailed Critical | 27 Feb, 2023 | US9072857 |
| Email Notification Critical | 23 Feb, 2023 | US11602603 |
| Issue Notification Mailed Critical | 22 Feb, 2023 | US11602603 |
| Application Is Considered Ready for Issue Critical | 15 Feb, 2023 | US11602603 |
| Dispatch to FDC | 15 Feb, 2023 | US11602603 |
| Issue Fee Payment Received Critical | 14 Feb, 2023 | US11602603 |
FDA has granted several exclusivities to Xhance. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xhance, 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 Xhance.
Exclusivity Information
Xhance holds 2 exclusivities out of which 1 have expired. Its last outstanding exclusivity is set to expire in 2027. Details of Xhance's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Sep 18, 2020 |
| New Indication(I-940) | Mar 15, 2027 |
Several oppositions have been filed on Xhance's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Xhance's generic, the next section provides detailed information on ongoing and past EP oppositions related to Xhance patents.
Xhance's Oppositions Filed in EPO
Xhance has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 27, 2005, by Direct-Haler A/S. This opposition was filed on patent number EP00906570A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP17190469A | Aug, 2021 | Beck Greener LLP | Granted and Under Opposition |
| EP08736896A | Jun, 2021 | Beck Greener LLP | Patent maintained as amended |
| EP13715145A | Sep, 2020 | ELKINGTON AND FIFE LLP | Granted and Under Opposition |
| EP00906570A | Sep, 2005 | Direct-Haler A/S | Opposition rejected |
US patents provide insights into the exclusivity only within the United States, but Xhance 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 Xhance's family patents as well as insights into ongoing legal events on those patents.
Xhance's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xhance's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Feb 23, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xhance Generic API suppliers:
Fluticasone Propionate is the generic name for the brand Xhance. 13 different companies have already filed for the generic of Xhance, with Hikma having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Xhance's generic
Alternative Brands for Xhance
Xhance which is used for treating allergic rhinitis or nasal polyps., has several other brand drugs using the same active ingredient (Fluticasone Propionate). Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Fougera Pharms |
| ||||||||
| Glaxo Grp Ltd |
| ||||||||
| Mylan Speciality Lp |
| ||||||||
| Teva Pharm |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Fluticasone Propionate, Xhance's active ingredient. Check the complete list of approved generic manufacturers for Xhance
About Xhance
Xhance is a drug owned by Optinose Us Inc. It is used for treating allergic rhinitis or nasal polyps. Xhance uses Fluticasone Propionate as an active ingredient. Xhance was launched by Optinose Us Inc in 2017.
Approval Date:
Xhance was approved by FDA for market use on 18 September, 2017.
Active Ingredient:
Xhance uses Fluticasone Propionate as the active ingredient. Check out other Drugs and Companies using Fluticasone Propionate ingredient
Treatment:
Xhance is used for treating allergic rhinitis or nasal polyps.
Dosage:
Xhance is available in spray, metered form for nasal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 0.093MG | SPRAY, METERED | Prescription | NASAL |