Xofluza is a drug owned by Genentech Inc. It is protected by 10 US drug patents filed from 2018 to 2024 out of which none have expired yet. Xofluza's patents have been open to challenges since 24 October, 2022. Based on its patents and exclusivities, its generic launch date is estimated to be Apr 21, 2041. Details of Xofluza'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. | |||
| US10759814 | Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof |
Aug, 2037
(12 years from now) | Active |
| US10392406 | Substituted polycyclic pyridone derivatives and prodrugs thereof |
Apr, 2036
(11 years from now) | Active |
| US8987441 | Substituted polycyclic carbamoyl pyridone derivative prodrug |
Sep, 2031
(6 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11925648 | Solid dosage form having excellent stability |
Apr, 2041
(16 years from now) | Active |
| US12064438 | Pharmaceutical preparation excellent in light stability and dissolution property |
Oct, 2039
(14 years from now) | Active |
| US11261198 | Process for preparing substituted polycyclic pyridone derivative and crystal thereof |
Sep, 2038
(13 years from now) | Active |
| US11306106 | Pharmaceutical compositions containing substituted polycyclic pyridone derivatives and prodrug thereof |
Aug, 2037
(12 years from now) | Active |
| US10633397 | Substituted polycyclic pyridone derivatives and prodrugs thereof |
Apr, 2036
(11 years from now) | Active |
| US8927710 | Substituted polycyclic carbamoylpyridone derivative |
May, 2031
(6 years from now) | Active |
| US9815835 | Substituted polycyclic carbamolypyridone derivative |
Jun, 2030
(5 years 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 Xofluza's patents.
Latest Legal Activities on Xofluza's Patents
Given below is the list of recent legal activities going on the following patents of Xofluza.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Mail Patent eGrant Notification | 12 Mar, 2024 | US11925648 |
| Patent eGrant Notification | 12 Mar, 2024 | US11925648 |
| Recordation of Patent eGrant | 12 Mar, 2024 | US11925648 |
| Recordation of Patent Grant Mailed Critical | 12 Mar, 2024 | US11925648 |
| Email Notification Critical | 12 Mar, 2024 | US11925648 |
| Patent Issue Date Used in PTA Calculation Critical | 12 Mar, 2024 | US11925648 |
| Email Notification Critical | 22 Feb, 2024 | US11925648 |
| Issue Notification Mailed Critical | 21 Feb, 2024 | US11925648 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 14 Feb, 2024 | US10759814 |
| Dispatch to FDC | 08 Feb, 2024 | US11925648 |
FDA has granted several exclusivities to Xofluza. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Xofluza, 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 Xofluza.
Exclusivity Information
Xofluza holds 2 exclusivities. All of its exclusivities have expired in 2023. Details of Xofluza's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Indication(I-811) | Oct 16, 2022 |
| New Chemical Entity Exclusivity(NCE) | Oct 24, 2023 |
US patents provide insights into the exclusivity only within the United States, but Xofluza 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 Xofluza's family patents as well as insights into ongoing legal events on those patents.
Xofluza's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Xofluza's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Apr 21, 2041 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Xofluza Generics:
There are no approved generic versions for Xofluza as of now.
How can I launch a generic of Xofluza before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Xofluza's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Xofluza'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 Xofluza -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 40 mg and 80 mg | 24 Oct, 2022 | 1 | 25 Sep, 2038 |
About Xofluza
Xofluza is a drug owned by Genentech Inc. It is used for prevention and treatment of influenza. Xofluza uses Baloxavir Marboxil as an active ingredient. Xofluza was launched by Genentech Inc in 2020.
Approval Date:
Xofluza was approved by FDA for market use on 23 November, 2020.
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 Xofluza is 23 November, 2020, its NCE-1 date is estimated to be 24 October, 2022.
Active Ingredient:
Xofluza uses Baloxavir Marboxil as the active ingredient. Check out other Drugs and Companies using Baloxavir Marboxil ingredient
Treatment:
Xofluza is used for prevention and treatment of influenza.
Dosage:
Xofluza is available in the following dosage forms - tablet form for oral use, for suspension form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 2MG/ML | FOR SUSPENSION | Prescription | ORAL |
| 80MG | TABLET | Prescription | ORAL |
| 20MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | TABLET | Discontinued | ORAL |
| 40MG | TABLET | Prescription | ORAL |