Sernivo is a drug owned by Primus Pharmaceuticals Inc. It is protected by 7 US drug patents filed from 2016 to 2019 out of which none have expired yet. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 31, 2030. Details of Sernivo'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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US9655907 | Topical formulations comprising a steroid |
Aug, 2030
(6 years from now) | Active |
| US9775851 | Topical formulations comprising a steroid |
Aug, 2030
(6 years from now) | Active |
| US9877974 | Topical formulations comprising a steroid |
Aug, 2030
(6 years from now) | Active |
| US9439911 | Topical formulations comprising a steroid |
Aug, 2030
(6 years from now) | Active |
| US9364485 | Topical formulations comprising a steroid |
Aug, 2030
(6 years from now) | Active |
| US10179137 | Topical formulations comprising a steroid |
Aug, 2030
(6 years from now) | Active |
| US9433630 | Topical formulations comprising a steroid |
Aug, 2030
(6 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 Sernivo's patents.
Latest Legal Activities on Sernivo's Patents
Given below is the list of recent legal activities going on the following patents of Sernivo.
| Event | Date | Patent/Publication |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Yr, Small Entity | 06 Mar, 2024 | US9433630 |
| Payment of Maintenance Fee, 8th Yr, Small Entity | 14 Dec, 2023 | US9364485 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 15 Jul, 2022 | US10179137 |
| Payment of Maintenance Fee, 4th Yr, Small Entity | 30 Jul, 2021 | US9877974 |
| Email Notification | 26 Apr, 2021 | US10179137 |
| Change in Power of Attorney (May Include Associate POA) | 26 Apr, 2021 | US10179137 |
| Correspondence Address Change | 22 Apr, 2021 | US10179137 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 22 Apr, 2021 | US10179137 |
| Applicant Has Filed a Verified Statement of Small Entity Status in Compliance with 37 CFR 1.27 | 21 Apr, 2021 | US9877974 |
| Change in Power of Attorney (May Include Associate POA) | 21 Apr, 2021 | US9877974 |
FDA has granted several exclusivities to Sernivo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Sernivo, 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 Sernivo.
Exclusivity Information
Sernivo holds 1 exclusivities. All of its exclusivities have expired in 2019. Details of Sernivo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Dosage Form(NDF) | Feb 05, 2019 |
US patents provide insights into the exclusivity only within the United States, but Sernivo 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 Sernivo's family patents as well as insights into ongoing legal events on those patents.
Sernivo's family patents
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Generic Launch
Generic Release Date:
Sernivo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 31, 2030 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Sernivo Generics:
Betamethasone Dipropionate is the generic name for the brand Sernivo. 21 different companies have already filed for the generic of Sernivo, with Taro having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Sernivo's generic
How can I launch a generic of Sernivo before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Sernivo's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Sernivo'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 Sernivo -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 0.0005 | 15 Feb, 2018 | 1 | 17 Jun, 2020 | 31 Aug, 2030 | Eligible |
About Sernivo
Sernivo is a drug owned by Primus Pharmaceuticals Inc. It is used for treating plaque psoriasis. Sernivo uses Betamethasone Dipropionate as an active ingredient. Sernivo was launched by Primus Pharms in 2016.
Market Authorisation Date:
Sernivo was approved by FDA for market use on 05 February, 2016.
Active Ingredient:
Sernivo uses Betamethasone Dipropionate as the active ingredient. Check out other Drugs and Companies using Betamethasone Dipropionate ingredient
Treatment:
Sernivo is used for treating plaque psoriasis.
Dosage:
Sernivo is available in spray form for topical use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| EQ 0.05% BASE/SPRAY | SPRAY | Prescription | TOPICAL |