Exxua is a drug owned by Fabre Kramer Pharmaceuticals Inc. It is protected by 1 US drug patent filed in 2023 out of which none have expired yet. Exxua's patents will be open to challenges from 23 September, 2027. Based on its patents and exclusivities, its generic launch date is estimated to be Sep 22, 2028. Details of Exxua'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). | |||
| US7538116 | Treatment of sexual disorders |
Sep, 2025
(8 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 Exxua's patents.
Latest Legal Activities on Exxua's Patents
Given below is the list of recent legal activities going on the following patents of Exxua.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Second letter to regulating agency to determine regulatory review period | 14 Mar, 2024 | US7538116 |
| Letter from FDA or Dept of Agriculture re PTE application | 06 Feb, 2024 | US7538116 |
| Initial letter Re: PTE Application to regulating agency | 21 Nov, 2023 | US7538116 |
| Patent Term Extension Application under 35 USC 156 Filed | 16 Nov, 2023 | US7538116 |
| Payment of Maintenance Fee, 12th Yr, Small Entity | 25 Sep, 2020 | US7538116 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 05 Sep, 2019 | US7538116 |
| Patent Issue Date Used in PTA Calculation Critical | 26 May, 2009 | US7538116 |
| Recordation of Patent Grant Mailed Critical | 26 May, 2009 | US7538116 |
| Email Notification Critical | 07 May, 2009 | US7538116 |
| Issue Notification Mailed Critical | 06 May, 2009 | US7538116 |
FDA has granted several exclusivities to Exxua. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Exxua, 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 Exxua.
Exclusivity Information
Exxua holds 1 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2028. Details of Exxua's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Sep 22, 2028 |
US patents provide insights into the exclusivity only within the United States, but Exxua 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 Exxua's family patents as well as insights into ongoing legal events on those patents.
Exxua's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Exxua's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Sep 22, 2028 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Exxua Generics:
There are no approved generic versions for Exxua as of now.
About Exxua
Exxua is a drug owned by Fabre Kramer Pharmaceuticals Inc. It is used for treating major depression with sexual dysfunction or without the risk of sexual dysfunction adverse reactions. Exxua uses Gepirone Hydrochloride as an active ingredient. Exxua was launched by Fabre Kramer in 2023.
Approval Date:
Exxua was approved by FDA for market use on 22 September, 2023.
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 Exxua is 22 September, 2023, its NCE-1 date is estimated to be 23 September, 2027.
Active Ingredient:
Exxua uses Gepirone Hydrochloride as the active ingredient. Check out other Drugs and Companies using Gepirone Hydrochloride ingredient
Treatment:
Exxua is used for treating major depression with sexual dysfunction or without the risk of sexual dysfunction adverse reactions.
Dosage:
Exxua is available in tablet, extended release form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 18.2MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 36.3MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 54.5MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |
| EQ 72.6MG BASE | TABLET, EXTENDED RELEASE | Discontinued | ORAL |