Vivjoa is a drug owned by Mycovia Pharmaceuticals Inc. It is protected by 5 US drug patents filed in 2022 out of which none have expired yet. Vivjoa's patents will be open to challenges from 27 April, 2031. Based on its patents and exclusivities, its generic launch date is estimated to be Mar 17, 2036. Details of Vivjoa'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. | |||
| US9840492 | Antifungal compounds and processes for making |
Mar, 2036
(10 years from now) | Active |
| US10414751 | Antifungal compounds and processes for making |
Mar, 2036
(10 years from now) | Active |
| US8236962 | Metalloenzyme inhibitor compounds |
Apr, 2031
(5 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). | |||
| US11247981 | Metalloenzyme inhibitor compounds |
May, 2033
(7 years from now) | Active |
| US8754227 | Metalloenzyme inhibitor compounds |
Apr, 2031
(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 Vivjoa's patents.
Latest Legal Activities on Vivjoa's Patents
Given below is the list of recent legal activities going on the following patents of Vivjoa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Patent eCofC Notification | 05 Mar, 2024 | US11247981 |
| Mail Patent eCofC Notification | 05 Mar, 2024 | US11247981 |
| Email Notification Critical | 05 Mar, 2024 | US11247981 |
| Recordation of Patent eCertificate of Correction | 05 Mar, 2024 | US11247981 |
| Post Issue Communication - Certificate of Correction | 15 Feb, 2024 | US11247981 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 07 Feb, 2024 | US8236962 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 17 Mar, 2023 | US10414751 |
| Initial letter Re: PTE Application to regulating agency | 08 Jul, 2022 | US8236962 |
| Post Issue Communication - Certificate of Correction | 12 May, 2022 | US11247981 |
| Recordation of Patent Grant Mailed Critical | 15 Feb, 2022 | US11247981 |
FDA has granted several exclusivities to Vivjoa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vivjoa, 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 Vivjoa.
Exclusivity Information
Vivjoa holds 2 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2032. Details of Vivjoa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Chemical Entity Exclusivity(NCE) | Apr 26, 2027 |
| Generating Antibiotic Incentives Now(GAIN) | Apr 26, 2032 |
US patents provide insights into the exclusivity only within the United States, but Vivjoa 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 Vivjoa's family patents as well as insights into ongoing legal events on those patents.
Vivjoa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vivjoa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Mar 17, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vivjoa Generics:
There are no approved generic versions for Vivjoa as of now.
About Vivjoa
Vivjoa is a drug owned by Mycovia Pharmaceuticals Inc. It is used for reducing the incidence of recurrent vulvovaginal candidiasis in females with a history of RVVC who are not of reproductive potential. Vivjoa uses Oteseconazole as an active ingredient. Vivjoa was launched by Mycovia Pharms in 2022.
Approval Date:
Vivjoa was approved by FDA for market use on 26 April, 2022.
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 Vivjoa is 26 April, 2022, its NCE-1 date is estimated to be 27 April, 2031.
Active Ingredient:
Vivjoa uses Oteseconazole as the active ingredient. Check out other Drugs and Companies using Oteseconazole ingredient
Treatment:
Vivjoa is used for reducing the incidence of recurrent vulvovaginal candidiasis in females with a history of RVVC who are not of reproductive potential.
Dosage:
Vivjoa is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 150MG | CAPSULE | Prescription | ORAL |