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Last Updated: June 14, 2025

ERYTHROMYCIN AND BENZOYL PEROXIDE Drug Patent Profile


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When do Erythromycin And Benzoyl Peroxide patents expire, and what generic alternatives are available?

Erythromycin And Benzoyl Peroxide is a drug marketed by Encube and Rising and is included in two NDAs.

The generic ingredient in ERYTHROMYCIN AND BENZOYL PEROXIDE is benzoyl peroxide; erythromycin. There are seventeen drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the benzoyl peroxide; erythromycin profile page.

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Summary for ERYTHROMYCIN AND BENZOYL PEROXIDE
US Patents:0
Applicants:2
NDAs:2
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 6
Patent Applications: 54
What excipients (inactive ingredients) are in ERYTHROMYCIN AND BENZOYL PEROXIDE?ERYTHROMYCIN AND BENZOYL PEROXIDE excipients list
DailyMed Link:ERYTHROMYCIN AND BENZOYL PEROXIDE at DailyMed
Drug patent expirations by year for ERYTHROMYCIN AND BENZOYL PEROXIDE
Recent Clinical Trials for ERYTHROMYCIN AND BENZOYL PEROXIDE

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

SponsorPhase
Chang Gung Memorial HospitalPhase 1/Phase 2
Mahidol UniversityPhase 4
Stiefel, a GSK CompanyPhase 4

See all ERYTHROMYCIN AND BENZOYL PEROXIDE clinical trials

Pharmacology for ERYTHROMYCIN AND BENZOYL PEROXIDE

US Patents and Regulatory Information for ERYTHROMYCIN AND BENZOYL PEROXIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Encube ERYTHROMYCIN AND BENZOYL PEROXIDE benzoyl peroxide; erythromycin GEL;TOPICAL 065112-001 Mar 29, 2004 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Rising ERYTHROMYCIN AND BENZOYL PEROXIDE benzoyl peroxide; erythromycin GEL;TOPICAL 065385-001 Sep 18, 2015 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Erythromycin and Benzoyl Peroxide: Market Dynamics and Financial Trajectory

Introduction

Erythromycin and benzoyl peroxide are widely used in the treatment of various infections and acne, respectively. The combination of these two agents has shown significant efficacy in treating acne and other skin infections. Here, we delve into the market dynamics and financial trajectory of erythromycin and benzoyl peroxide, highlighting key factors influencing their market growth.

Market Segmentation

The market for erythromycin and benzoyl peroxide can be segmented in several ways:

By Formulation

  • Erythromycin is available in various formulations such as tablets, topical solutions, ointments, and gels. The combination of erythromycin and benzoyl peroxide is particularly popular in topical gel formulations[1][2][4].

By Therapeutic Indications

  • Erythromycin is used to treat a range of infections including respiratory tract infections, skin and soft tissue infections, and genitourinary infections. When combined with benzoyl peroxide, it is primarily used for treating acne[1][5].

By Distribution Channel

  • The distribution channels include hospitals, pharmacies, and online retailers. Prescription medicines, which often include erythromycin and benzoyl peroxide combinations, dominate the market[3].

Market Drivers

Several factors are driving the growth of the erythromycin and benzoyl peroxide market:

Rising Prevalence of Infectious Diseases

  • The increasing prevalence of respiratory tract infections and other infectious diseases is a significant driver. For instance, lower respiratory tract infections (LRIs) resulted in 2.74 million deaths and 103.0 million disability-adjusted life-years (DALYs) globally in 2015[1].

Growing Acne Incidence

  • The rising incidence of acne, particularly among adolescents and young adults, is driving the demand for effective acne treatments. The global acne medication market is expected to grow from USD 12.3 billion in 2022 to USD 18.5 billion by 2032[3].

Regulatory Approvals

  • Recent regulatory approvals for erythromycin formulations have expanded market access. For example, Amneal Pharmaceuticals received FDA approval for Erythromycin Tablets USP in 2018, and ANI Pharmaceuticals launched Erythromycin Ethylsuccinate for oral suspension in 2016[1].

Market Restraints

Despite the growth drivers, there are several restraints affecting the market:

Allergic Reactions and Side Effects

  • Allergic reactions to erythromycin, such as swelling of the mouth, face, lips, tongue, or throat, can hinder market growth. Additionally, the use of erythromycin during pregnancy is associated with higher risks of epilepsy and cerebral palsy in newborns[1].

Availability of Alternatives

  • The increasing availability of alternative antibiotics like azithromycin can reduce the demand for erythromycin. However, the combination with benzoyl peroxide remains a preferred option for acne treatment due to its synergistic effects[1][4].

Synergistic Effects of Erythromycin and Benzoyl Peroxide

The combination of erythromycin and benzoyl peroxide has been shown to be more effective than using either agent alone:

Enhanced Anti-Propionibacterial Activity

  • Studies have demonstrated that the combination of 5% benzoyl peroxide and 3% erythromycin reduces total propionibacterial numbers and prevents the selection of resistant strains more effectively than erythromycin alone[2][4].

Clinical Improvement in Acne

  • Clinical trials have shown significant improvements in acne grades and lesion counts when using the combination therapy. For example, a study showed a median improvement of 78% at 6 months when treating acne with erythromycin and benzoyl peroxide[5].

Regional Dynamics

The market for erythromycin and benzoyl peroxide varies by region:

North America

  • North America is expected to hold a dominant position in the erythromycin market due to rising regulatory approvals and the increasing prevalence of skin and soft tissue infections. The region also has a significant share in the acne medication market, with 41.4% of the global market share in 2022[1][3].

Other Regions

  • Other regions, including Europe, Asia Pacific, Latin America, Middle East, and Africa, also contribute to the market growth, driven by the rising incidence of infectious diseases and acne.

Competitive Analysis

The market is highly competitive with several key players:

Key Players

  • Companies such as ANI Pharmaceuticals, Akorn, Inc., Aceto Corporation, Teligent, Inc., Abbvie, Inc., Abbott Laboratories, Pfizer, Inc., Sanofi-Aventis, and Allergan, Plc are actively involved in the development, manufacturing, and marketing of erythromycin and benzoyl peroxide products[1].

Financial Trajectory

The financial trajectory of the erythromycin and benzoyl peroxide market is promising:

Market Size and Growth

  • The global erythromycin market is expected to grow significantly due to the rising prevalence of infectious diseases and the increasing demand for effective acne treatments. The acne medication market, which includes erythromycin and benzoyl peroxide combinations, is projected to reach USD 18.5 billion by 2032, growing at a CAGR of 4.2% from 2023 to 2032[1][3].

Revenue Streams

  • Revenue is generated through the sale of prescription and over-the-counter medications. The prescription segment dominates the market, with a significant portion coming from the combination of erythromycin and benzoyl peroxide for acne treatment[3].

Key Takeaways

  • The combination of erythromycin and benzoyl peroxide is highly effective in treating acne and other skin infections.
  • The market is driven by the rising prevalence of infectious diseases and acne, as well as recent regulatory approvals.
  • Despite restraints such as allergic reactions and the availability of alternatives, the synergistic effects of the combination therapy maintain its market position.
  • North America is a dominant region in the market, but other regions also contribute significantly.
  • The financial trajectory is positive, with the market expected to grow substantially over the forecast period.

FAQs

Q: What are the primary therapeutic indications for erythromycin?

A: Erythromycin is used to treat various infections including respiratory tract infections, skin and soft tissue infections, genitourinary infections, and others[1].

Q: How does the combination of erythromycin and benzoyl peroxide work?

A: The combination works by the antibiotic (erythromycin) killing susceptible bacteria and the benzoyl peroxide eliminating resistant strains, thereby preventing the overgrowth of resistant bacteria[2][4].

Q: What are the potential side effects of using erythromycin?

A: Potential side effects include allergic reactions such as swelling of the mouth, face, lips, tongue, or throat, and increased risks of epilepsy and cerebral palsy in newborns if used during pregnancy[1].

Q: Which region dominates the erythromycin market?

A: North America is expected to hold a dominant position in the erythromycin market due to rising regulatory approvals and the increasing prevalence of skin and soft tissue infections[1].

Q: What is the projected growth of the acne medication market, which includes erythromycin and benzoyl peroxide combinations?

A: The global acne medication market is projected to grow from USD 12.3 billion in 2022 to USD 18.5 billion by 2032, at a CAGR of 4.2% from 2023 to 2032[3].

Sources

  1. Coherent Market Insights: Erythromycin Market - Share, Size and Industry Analysis.
  2. PubMed: The effects of acne treatment with a combination of benzoyl peroxide and erythromycin.
  3. The Brainy Insights: Acne Medication Market Share, Statistics, Size & Industry Growth.
  4. Karger: Synergistic Activity of Benzoyl Peroxide and Erythromycin.
  5. PubMed: Strategy of acne therapy with long-term antibiotics.
Last updated: 2024-12-22

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