Last Updated: August 3, 2026

BENZACLIN Drug Patent Profile


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When do Benzaclin patents expire, and when can generic versions of Benzaclin launch?

Benzaclin is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in BENZACLIN is benzoyl peroxide; clindamycin phosphate. There are seventeen drug master file entries for this compound. Fourteen suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; clindamycin phosphate profile page.

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Summary for BENZACLIN
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for BENZACLIN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756-001 Dec 21, 2000 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bausch BENZACLIN benzoyl peroxide; clindamycin phosphate GEL;TOPICAL 050756-002 Apr 20, 2007 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis for Benzaclin

Last updated: February 23, 2026

Benzaclin is a topical dermatological medication combining benzoyl peroxide and clindamycin. It is approved for acne treatment and marketed by various pharmaceutical companies. This assessment evaluates its market position, growth potential, and key financial and regulatory factors relevant for investment decisions.

Market Overview

Product Profile

  • Composition: Benzoyl peroxide (5%) and clindamycin phosphate (1%)
  • Indication: Moderate to severe acne vulgaris
  • Formulation: Topical gel, prescription-only

Market Size and Trends

  • The global acne treatment market was valued at approximately USD 4.2 billion in 2021.
  • CAGR forecast of 4.5% from 2022 to 2027 (MarketWatch, 2022)
  • Top markets: US, Europe, China
  • Rising acne prevalence among adolescents and adults drives demand

Competition Landscape

  • Major competitors include Differin (adapalene), Epiduo (adapalene and benzoyl peroxide), and generic formulations.
  • Benzaclin faces generic competition but maintains a niche due to the combination therapy.
  • Patent status influences pricing power; Benzaclin’s patents expired in 2018, increasing generic penetration.

Regulatory and Patent Position

  • FDA Approval: Approved since the 1980s for acne vulgaris.
  • No current patent protections; off-patent in key markets.
  • Regulatory barriers are low; generic entry affects pricing and profitability.

Financial and Pricing Analysis

Pricing Dynamics

  • Brand-name Benzaclin sells at approximately USD 500-700 per month in the US.
  • Generics priced 30-50% lower.
  • Insurance coverage influences patient access and margins.

Revenue Streams

  • Primary revenue from prescriptions prescribed by dermatologists and general practitioners.
  • Market penetration is higher in developed economies; emerging markets show growth potential.

Cost Factors

  • Manufacturing costs are moderate, subject to raw material prices.
  • Marketing and distribution costs are significant for brand maintenance.

Growth and Investment Outlook

Drivers

  • Increasing acne prevalence, especially among adults.
  • Rising awareness of dermatological health.
  • Potential pipeline products expanding indications.

Risks

  • Patent expiry leading to increased generics.
  • Competitive landscape with newer therapies (e.g., topical antibiotics, oral treatments).
  • Regulatory changes impacting drug approval or reimbursement.

Strategic Considerations

  • Licensing or partnership opportunities for exclusive formulations or new indications.
  • Focused marketing in high-growth regions like Asia.
  • Investment in R&D for improved formulations or combination therapies.

Summary

Benzaclin holds a mature but stable position in the acne treatment market. Its revenue depends on generic penetration, pricing strategies, and regional market growth. Investment attractiveness depends on balance between current sales performance and future growth driven by market expansion and pipeline development.


Key Takeaways

  • Benzaclin is an established dermatological product with a broad global footprint.
  • Its patent expiry in 2018 has increased generic competition, pressuring margins.
  • The acne market is expanding, supported by rising prevalence and awareness.
  • Growth depends on market penetration and new product development.
  • Risks include intense competition and regulatory shifts.

FAQs

1. What factors determine Benzaclin's market share?
Market share depends on prescription volume, pricing strategies, brand loyalty, and competition from generics and alternative treatments.

2. How does patent expiry affect Benzaclin’s profitability?
Patent expiry leads to increased generic competition, reducing prices and profit margins.

3. Which regions offer the highest growth potential for Benzaclin?
Emerging markets like China, India, and Southeast Asia present growth opportunities due to rising acne prevalence and increasing healthcare access.

4. What are the key regulatory barriers?
The drug faces low regulatory barriers due to its well-established approval status; however, new formulations require regulatory review.

5. What R&D opportunities exist for Benzaclin?
Potential exists in developing longer-acting formulations, combination therapies for resistant acne, or expanding indications beyond acne vulgaris.


References

  1. MarketWatch. (2022). Global acne treatment market report. Retrieved from https://www.marketwatch.com/
  2. U.S. Food and Drug Administration. (2023). Approved dermatology drugs. Retrieved from https://www.fda.gov/
  3. EvaluatePharma. (2022). Pharmacy pipeline report. Retrieved from https://www.evaluate.com/
  4. IMS Health. (2021). Prescription trends in dermatology. Retrieved from https://www.imshealth.com
  5. European Medicines Agency. (2022). Regulatory updates on topical antibiotics. Retrieved from https://www.ema.europa.eu/

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