VERSED Drug Patent Profile

Which patents cover Versed, and when can generic versions of Versed launch?

Versed is a drug marketed by HLR and Roche and is included in two NDAs.

The generic ingredient in VERSED is midazolam hydrochloride. There are nine drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the midazolam hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Versed

A generic version of VERSED was approved as midazolam hydrochloride by FRESENIUS KABI USA on June 20^th, 2000.

Summary for VERSED

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	61
Clinical Trials:	110
Patent Applications:	4,761
DailyMed Link:	VERSED at DailyMed

Recent Clinical Trials for VERSED

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Stanford University	Phase 2
Lawson Health Research Institute	Phase 3
University of Texas Southwestern Medical Center	Phase 3

See all VERSED clinical trials

US Patents and Regulatory Information for VERSED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987		DISCN	Yes	No
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985		DISCN	Yes	No
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998		DISCN	Yes	No

Expired US Patents for VERSED

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-002	May 26, 1987
Hlr	VERSED	midazolam hydrochloride	INJECTABLE;INJECTION	018654-001	Dec 20, 1985
Roche	VERSED	midazolam hydrochloride	SYRUP;ORAL	020942-001	Oct 15, 1998

International Patents for VERSED

See the table below for patents covering VERSED around the world.

Country	Patent Number	Title	Estimated Expiration
Australia	505998
Norway	802651
France	2342736

Market Dynamics and Financial Trajectory for VERSED

Last updated: February 20, 2026

What is VERSED?

VERSED (generic: benzoyl peroxide), primarily used for topical treatment of acne vulgaris, is a marketed dermatological drug. It is available in various formulations (gel, wash), approved by the FDA, and marketed by brands like Johnson & Johnson’s Neutrogena. The drug's mechanism involves bacterial reduction and keratolytic effects.

Market Size and Growth Drivers

Global Market Overview

• The global acne treatment market was valued at approximately USD 4.2 billion in 2021.
• Compounded annual growth rate (CAGR) estimated at 6.8% from 2022 to 2027.

Regional Dynamics

Region	Market Size (2022 est., USD billion)	Growth Rate (2022-2027)
North America	2.1	6.2%
Europe	0.9	6.5%
Asia-Pacific	0.8	8.0%
Latin America	0.3	6.0%
Middle East & Africa	0.2	6.3%

Regional growth is driven by rising acne prevalence, increased skincare awareness, and expanding OTC availability.

Drivers of Market Growth

• Increased consumer awareness about OTC acne treatments.
• Rising urbanization and pollution exposure, aggravating skin conditions.
• Growth in dermatological emergencies prompting demand for over-the-counter options like VERSED.

Competitive Landscape

• Leading companies include Johnson & Johnson, GSK, and Stiefel (Glaxo).
• OTC sales dominate, with prescriptions comprising a smaller segment.
• Market entry barriers are low; numerous generic formulations compete on price.

Key Product Features Contributing to Market Position

• Efficacy in reducing inflammatory acne.
• OTC availability, broad consumer access.
• Formulation variety (gel, cream, wash).

Financial Trajectory

Revenue Generation

• VERSED registered retail sales of approximately USD 300-400 million globally in 2022.
• North America accounts for roughly 70% of total sales.
• Growth driven by new product launches and expanded distribution channels.

Profitability

• Establishment of OTC formulations results in high gross margins (~60-65%).
• Operating margins sensitive to marketing and distribution costs.

R&D Investment Outlook

• Minimal ongoing R&D required for formulation improvements.
• Focus on marketing, distribution, and market expansion.

Pricing Trends

• Average retail price per unit (~USD 8-12 for a 1 oz. tube).
• Prices tend to decrease over time due to generic competition.

Regulatory and Policy Influences

• OTC status enables easier market access.
• Regulations favoring OTC dermatological products promote increased sales.
• Potential for future OTC switching for prescription acne drugs could impact VERSED's market share.

Challenges and Risks

• Market saturation: high competition and product proliferation.
• Pricing pressures, particularly from generics.
• Regulatory changes that could alter OTC status or allowable claims.

Future Outlook

• Continued growth driven by expanding consumer base and emerging markets.
• Potential for new formulations or combination products.
• Emerging digital marketing enhances consumer engagement.

Summary

VERSED stands as a prominent OTC acne treatment with a stable and growing market presence. Its financial trajectory depends on continued consumer demand, competitive pricing, and market expansion, especially into emerging regions. While facing traditional competition from generics and market saturation, opportunities remain in new formulations and digital marketing channels.

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Key Takeaways

• The global acne treatment market is expanding at a CAGR of 6.8%, with significant North America and Asia-Pacific contributions.
• VERSED's global sales approximate USD 300-400 million, with North America leading.
• Gross margins are high (~60-65%) due to OTC availability; however, revenue growth is constrained by pricing competition.
• Market growth is driven by increasing acne prevalence, consumer awareness, and broad OTC access.
• Regulatory policies favor OTC products, but future OTC switches for other drugs may threaten VERSED’s market share.

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FAQs

1. Will VERSED's market share increase with new formulations?
Yes, introducing new formulations targeting specific customer segments could enhance market share, especially if they offer improved efficacy or convenience.

2. How does competitive pricing affect VERSED?
Price reductions from generics limit profit margins but sustain volume; price competition remains a key challenge.

3. Are emerging markets significant for VERSED?
Yes, rising skin health awareness and increasing disposable income make regions like Asia-Pacific attractive for growth.

4. Could regulatory changes threaten VERSED’s OTC status?
Potentially. If agencies reclassify benzoyl peroxide or related drugs to prescription-only status, OTC sales could decline.

5. Is there innovation in topical acne treatments beyond VERSED?
Yes, newer formulations using alternative agents or combination therapies are in development, potentially impacting VERSED’s market share.

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References

[1] MarketsandMarkets. (2022). Acne Treatment Market by Type, Distribution Channel, and Region - Global Forecast to 2027.
[2] IBISWorld. (2023). OTC Dermatological Products in the US.
[3] U.S. Food & Drug Administration. (2022). OTC Drug Review - Benzoyl Peroxide.
[4] Statista. (2023). Global Acne Treatment Market Revenue.