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Antibiotics: Impact of Major Patent Expiries and New Drug Entrants

Authors
Cheryl Bourque
John M. Lebbos, M.D.
PhysicianForum -- October 2003

  In This Issue...

Despite the fact that the antibiotic drug market has many efficacious and interchangeable agents, GlaxoSmithKline’s Augmentin and Bayer’s Cipro have achieved $1 billion+ sales status in the United States based on their improved tolerability, convenience, and efficacy compared with many other antibiotics. The patent expiry of these two blockbuster antibiotics will escalate the level of generic competition in this market and increase the barrier to entry of new agents. Both companies have launched extended release versions of these dominant branded antibiotics, but under the scrutiny of managed care and formulary switches to generic agents Augmentin XR and Cipro XR face difficult challenges in securing patient share.

Growing antibiotic resistance among respiratory pathogens is fueling the transition from the use of low-cost agents, such as amoxicillin and the cephalosporins, to broader-spectrum, more expensive agents, such as the novel fluoroquinolones. New drugs positioned to treat patients with antibiotic resistance are needed, as are agents that are highly safe and broadly efficacious in difficult-to-treat patients; however, the commercial opportunities in the antibiotic market are waning for these specific niches and patient populations. Aventis’s Ketek (telithromycin) has the advantage of treating antibiotic-resistant pathogens and thereby satisfies an unmet need in medical management.

Decision Resources’ PhysicianForum survey Antibiotics: Impact of Major Patent Expiries and New Drug Entrants explores the current outpatient treatment practices for respiratory tract infections (e.g., community-acquired pneumonia, chronic bronchitis, acute sinusitis, otitis media). This survey examines how the landscape is changing following the patent expiry of Augmentin and Cipro, and evaluates the potential impact of novel fluoroquinolones and an important member of a new class of antibiotic, Aventis’s Ketek. We surveyed 70 primary care physicians (PCPs) and 20 HMO pharmacy directors and compared their responses to assess similarities and differences.

This study describes the following attitudes and trends in the current antibiotic treatment market:

- Current prescribing patterns for beta-lactams, macrolides, fluoroquinolones, cephalosporins, and tetracyclines for treating respiratory tract infections.

- Choice of antibiotic prescribed by type of respiratory tract infection: physician preference vs. formulary preference.

- Significant factors influencing physician selection of antibiotics to treat respiratory tract infections.

- Antibiotic resistance concerns and their impact on physician prescribing of newer fluoroquinolones and other antibiotic drug classes.

- Physician and pharmacy director positions regarding the new ketolide, telithromycin (Aventis’s Ketek): what types of patients will be targeted to receive Ketek, what drugs will be replaced by Ketek, expected managed care formulary decisions on Ketek.

- Attitudes toward switching current Augmentin and Cipro users to generic agents vs. Augmentin XR and Cipro XR.

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