TheraRadar
Data updated: Jun 28, 2026

SERNIVO (betamethasone dipropionate) · PRIMUS PHARMS

Dermatology Approved 2016-02-05

Sernivo (betamethasone dipropionate) is a topical corticosteroid spray indicated for the treatment of mild to moderate plaque psoriasis in adults 18 years of age and older. It is used to manage the inflammatory and pruritic (itching) manifestations of the condition.

How SERNIVO Works

Betamethasone dipropionate is a corticosteroid that influences cellular signaling, immune function, and protein regulation. While the exact mechanism of action in the treatment of plaque psoriasis is not fully established, it is recognized for its anti-inflammatory, antipruritic, and vasoconstrictive properties.

1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Prescription
First Approved
2016-02-05
Patent Cliff
2030

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Routes
TOPICAL
Dosage Forms
SPRAY

Companies

Active Ingredient: BETAMETHASONE DIPROPIONATE

SERNIVO Approval History

2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2016 to 2025
Sep 2025 SUPPL
Mfg · Manufacturing (CMC)
Mar 2020 SUPPL
Label · Labeling
Nov 2018 SUPPL
Label · Labeling

What SERNIVO Treats

1 indications

SERNIVO is approved for 1 conditions since its original approval in 2016. These indications span multiple therapeutic areas including oncology, immunology, and more.

Source: FDA Label

SERNIVO Competitive Set

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

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Clinical Trial Registry

2 trials
Trial Sponsor ID Phase Status Title
NCT03999229 STUDY20221492 5R01HL126900 Ph 1 recruiting S-Nitrosylation (SNO) Therapy During Autologous Blood Transfusion
NCT06332612 MROSF 8420224AROM Ph 1, Ph 2 completed Metformin Repurposing in Oral Submucous Fibrosis: Unveiling In Vitro Signaling Pathways, Progressing to Clinical Trial
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Key Completed Trials

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Trial Timeline

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

SERNIVO FDA Label Details

Indications & Usage

FDA Label (PDF)

Betamethasone dipropionate cream (augmented) is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age or older. Betamethasone dipropionate cream (augmented), 0.05% is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.

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7 OB patents · 1 families · 33 international docs across 6 countries

SERNIVO Patents & Exclusivity

Latest Patent: Aug 2030

Patents (7 active)

US9775851 Expires Aug 31, 2030
US9364485 Expires Aug 31, 2030
US9655907 Expires Aug 31, 2030
US10179137 Expires Aug 31, 2030
US9433630 Expires Aug 31, 2030
US9877974 Expires Aug 31, 2030
US9439911 Expires Aug 31, 2030
Source: FDA Orange Book

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Patent Timeline

  • Cliff: 2030
  • 7 active patents

Trial Analysis

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  • Development stage analysis

Competitive Landscape

  • 20 similar drugs
  • Same target/indication analysis
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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.