Benzoyl peroxide; erythromycin - Generic Drug Details

What are the generic sources for benzoyl peroxide; erythromycin and what is the scope of patent protection?

Benzoyl peroxide; erythromycin is the generic ingredient in three branded drugs marketed by Biofrontera, Valeant Intl, Encube, and Rising, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

Three suppliers are listed for this compound.

Summary for benzoyl peroxide; erythromycin

US Patents:	0
Tradenames:	3
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	3
Clinical Trials:	6
DailyMed Link:	benzoyl peroxide; erythromycin at DailyMed

Recent Clinical Trials for benzoyl peroxide; erythromycin

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

Sponsor	Phase
Chang Gung Memorial Hospital	Phase 1/Phase 2
Mahidol University	Phase 4
Stiefel, a GSK Company	Phase 4

See all benzoyl peroxide; erythromycin clinical trials

Pharmacology for benzoyl peroxide; erythromycin

Drug Class	Macrolide Antimicrobial Macrolide
Physiological Effect	Decreased Sebaceous Gland Activity

Anatomical Therapeutic Chemical (ATC) Classes for benzoyl peroxide; erythromycin

D10AE	Peroxides
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

D10AF	Antiinfectives for treatment of acne
D10A	ANTI-ACNE PREPARATIONS FOR TOPICAL USE
D10	ANTI-ACNE PREPARATIONS
D	Dermatologicals

J01FA	Macrolides
J01F	MACROLIDES, LINCOSAMIDES AND STREPTOGRAMINS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for benzoyl peroxide; erythromycin

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Rising	ERYTHROMYCIN AND BENZOYL PEROXIDE	benzoyl peroxide; erythromycin	GEL;TOPICAL	065385-001	Sep 18, 2015	AB	RX	No	No
Biofrontera	AKTIPAK	benzoyl peroxide; erythromycin	GEL;TOPICAL	050769-001	Nov 27, 2000		DISCN	Yes	No
Encube	ERYTHROMYCIN AND BENZOYL PEROXIDE	benzoyl peroxide; erythromycin	GEL;TOPICAL	065112-001	Mar 29, 2004		DISCN	No	No

Benzoyl peroxide; erythromycin Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Benzoyl Peroxide; Erythromycin

Introduction

Benzoyl peroxide and erythromycin are commonly used in combination to treat various skin conditions, particularly acne. This combination therapy has been a staple in dermatological treatments due to its efficacy in reducing bacterial infections and inflammation. Here, we delve into the market dynamics and financial trajectory of this drug combination.

Market Segmentation

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

By Formulation

• The combination is available in various formulations, including gels, topical solutions, and ointments. For instance, the FDA has guidelines for benzoyl peroxide and erythromycin topical gel, emphasizing the importance of bioequivalence studies to ensure the efficacy and safety of generic versions[5].

By Disease Indication

• This combination is primarily used to treat acne, including upper and lower respiratory tract infections, skin and soft tissue infections, and other bacterial infections[1].

By Distribution Channel

• The distribution channels include retail pharmacies, online pharmacies, and hospitals. The rise of online pharmacies has significantly impacted the market, offering convenience and better discounts, which is expected to drive growth in the segment[4].

Market Drivers

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

Increasing Prevalence of Acne

• Acne is a chronic skin condition affecting a significant portion of the global population. According to the National Library of Medicine, acne affects 9.4% of the global population, making it the eighth most prevalent disease worldwide. This high prevalence is a major driver for the acne drug market, including treatments like benzoyl peroxide and erythromycin[3].

Rising Skin Awareness and Cosmetic Concerns

• Growing awareness about skin health and increasing cosmetic concerns are driving the demand for effective acne treatments. Lifestyle changes, hormonal fluctuations, and dietary changes also contribute to the rising cases of acne, thereby boosting the market[3].

Regulatory Approvals

• Regulatory approvals play a crucial role in market growth. For example, the FDA approval for generic versions of erythromycin and benzoyl peroxide products by companies like Teligent, Inc., and Akorn, Inc., has expanded the market by providing more affordable options[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 link between erythromycin and higher risks of epilepsy and cerebral palsy in newborn babies is a significant concern[1].

Availability of Alternatives

• The increasing availability of alternative antibiotics like azithromycin can also impact the demand for erythromycin-based treatments[1].

Competitive Analysis

The market for benzoyl peroxide and erythromycin is highly competitive, with several key players:

Key Players

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

Innovations and Product Launches

• Innovations such as the launch of new formulations and combination therapies are driving competition. For instance, Bausch Health Companies Inc. received FDA approval for Cabtreo, a triple combination topical treatment powered with a retinoid for acne, which indicates the ongoing innovation in the sector[3].

Regional Dynamics

The global market for benzoyl peroxide and erythromycin is segmented into several regions:

North America

• North America holds a dominant position in the market due to the rising number of regulatory approvals and the increasing prevalence of skin and soft tissue infections. The U.S. market, in particular, is significant due to the high demand for skincare products and the presence of major beauty and skincare brands[1][4].

Europe, Asia-Pacific, Latin America, and Middle East & Africa

• These regions also contribute to the market growth, driven by increasing awareness about skin health, lifestyle changes, and the growing younger population prone to acne[4].

Financial Trajectory

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

Market Size and Growth Rate

• The global acne medication market, which includes benzoyl peroxide and erythromycin, was valued at USD 11.57 billion in 2023 and is projected to reach USD 19.17 billion by 2033, growing at a CAGR of 5.18%[4].

Segment Growth

• The topical retinoids segment, which often includes benzoyl peroxide and erythromycin combinations, is expected to register the fastest CAGR over the forecast period. Online pharmacies are also expected to grow significantly, driven by the COVID-19 pandemic and increased internet connectivity[3][4].

Key Takeaways

• The market for benzoyl peroxide and erythromycin is driven by the increasing prevalence of acne, regulatory approvals, and rising skin awareness.
• Despite growth drivers, the market faces restraints such as allergic reactions and the availability of alternative treatments.
• North America dominates the market, but other regions are also contributing to the growth.
• The financial trajectory indicates a steady growth rate, with the market expected to expand significantly by 2033.

FAQs

Q: What are the primary uses of benzoyl peroxide and erythromycin? A: Benzoyl peroxide and erythromycin are primarily used to treat acne and other bacterial skin infections.

Q: Which region dominates the market for benzoyl peroxide and erythromycin? A: North America holds a dominant position in the market due to regulatory approvals and the high prevalence of skin and soft tissue infections.

Q: What are the major restraints affecting the market growth? A: Allergic reactions to erythromycin, side effects, and the availability of alternative antibiotics are significant restraints.

Q: How is the rise of online pharmacies impacting the market? A: The rise of online pharmacies is driving growth by offering convenience, better discounts, and increased accessibility to medications.

Q: What is the projected market size for the acne medication market by 2033? A: The global acne medication market, including benzoyl peroxide and erythromycin, is projected to reach USD 19.17 billion by 2033[4].

Cited Sources

1. Coherent Market Insights - Erythromycin Market - Share, Size and Industry Analysis
2. PubMed - Strategy of acne therapy with long-term antibiotics
3. Grand View Research - Acne Drugs Market Size, Share And Trends Report, 2030
4. Precedence Research - Acne Medication Market Size to Reach USD 19.17 Bn by 2033
5. FDA - Benzoyl Peroxide; Erythromycin Topical Gel - Draft Guidance