Nuvessa Patent Expiration

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
US9198858 Methods of treating bacterial vaginosis with 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
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.

Given below is the list of recent legal activities going on the following patents of Nuvessa.

Activity Date Patent Number
Patent litigations
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 24 Mar, 2020 US10596155
Recordation of Patent Grant Mailed 24 Mar, 2020 US10596155
Issue Notification Mailed 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

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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

Nuvessa has patent protection in a total of 9 countries. It has a significant patent presence in the US with 55.6% of its patents being US patents. 1 country has all of their patents expired or invalidated which has opened up potential generic launch opportunities in this particular country. Click below to unlock the full patent family tree for Nuvessa.

Family Patents

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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 Generics:

Metronidazole is the generic name for the brand Nuvessa. 37 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
Metrogel-vaginal
Galderma Labs Lp
Metrogel
Labs Juvise
Pylera
Pfizer
Flagyl Er
Saptalis Pharms
Likmez
Teva Pharms
Vandazole


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