Nuvessa is a drug owned by Chemo Research Sl. It is protected by 7 US drug patents filed from 2015 to 2020 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 28, 2032. Details of Nuvessa'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). | |||
| US10238634 | Aqueous-based metronidazole gel formulations |
Jun, 2032
(7 years from now) | Active |
| US8946276 | High dosage mucoadhesive metronidazole aqueous-based gel formulations and their use to treat bacterial vaginosis |
Jun, 2032
(7 years from now) | Active |
| US9198858 | Methods of treating bacterial vaginosis with aqueous-based metronidazole gel formulations |
Jun, 2032
(7 years from now) | Active |
| US10596155 | Aqueous-based metronidazole gel formulations |
Jun, 2032
(7 years from now) | Active |
| US8658678 | Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water |
Jun, 2028
(3 years from now) | Active |
| US7893097 | Methods and compositions for increasing solubility of azole drug compounds that are poorly soluble in water |
Feb, 2028
(3 years from now) | Active |
| US8877792 | Compositions for increasing solubility of azole drug compounds that are poorly soluble in water |
Feb, 2028
(3 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 Nuvessa's patents.
Latest Legal Activities on Nuvessa's Patents
Given below is the list of recent legal activities going on the following patents of Nuvessa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 4th Year, Large Entity | 25 Sep, 2023 | US10596155 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 01 Jun, 2023 | US9198858 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 26 Sep, 2022 | US10238634 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 03 Aug, 2022 | US8946276 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 20 Jul, 2022 | US7893097 |
| Payment of Maintenance Fee, 8th Year, Large Entity | 21 Apr, 2022 | US8877792 |
| Patent Issue Date Used in PTA Calculation Critical | 24 Mar, 2020 | US10596155 |
| Recordation of Patent Grant Mailed Critical | 24 Mar, 2020 | US10596155 |
| Issue Notification Mailed Critical | 04 Mar, 2020 | US10596155 |
| Dispatch to FDC | 20 Feb, 2020 | US10596155 |
FDA has granted several exclusivities to Nuvessa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Nuvessa, 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 Nuvessa.
Exclusivity Information
Nuvessa holds 1 exclusivities. All of its exclusivities have expired in 2017. Details of Nuvessa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Mar 24, 2017 |
US patents provide insights into the exclusivity only within the United States, but Nuvessa 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 Nuvessa's family patents as well as insights into ongoing legal events on those patents.
Nuvessa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Nuvessa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 28, 2032 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Nuvessa Generic API suppliers:
Metronidazole is the generic name for the brand Nuvessa. 38 different companies have already filed for the generic of Nuvessa, with Alembic having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Nuvessa's generic
How can I launch a generic of Nuvessa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Nuvessa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Nuvessa'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 Nuvessa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.013 | 30 Mar, 2022 | 1 | 28 Jun, 2032 |
Alternative Brands for Nuvessa
Nuvessa which is used for treating bacterial vaginosis., has several other brand drugs using the same active ingredient (Metronidazole). 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 | |
|---|---|---|
| Bausch |
| |
| Galderma Labs Lp |
| |
| Labs Juvise |
| |
| Pfizer |
| |
| Saptalis Pharms |
| |
| Teva Pharms |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Metronidazole, Nuvessa's active ingredient. Check the complete list of approved generic manufacturers for Nuvessa
About Nuvessa
Nuvessa is a drug owned by Chemo Research Sl. It is used for treating bacterial vaginosis. Nuvessa uses Metronidazole as an active ingredient. Nuvessa was launched by Chemo Research Sl in 2014.
Approval Date:
Nuvessa was approved by FDA for market use on 24 March, 2014.
Active Ingredient:
Nuvessa uses Metronidazole as the active ingredient. Check out other Drugs and Companies using Metronidazole ingredient
Treatment:
Nuvessa is used for treating bacterial vaginosis.
Dosage:
Nuvessa is available in gel form for vaginal use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.3% | GEL | Prescription | VAGINAL |