Fixed-Combination Drugs New Business Models Drive Profits, Patent Protection
Product Details
But FDCs do not come without hurdles. To be successful, FDCs must overcome:
- Formulation challenges — Will the combination continue to maintain accepted chemistry and safety profiles?
- FDA regulatory requirements — Despite combining two previously approved APIs the FDA is still closely examining new drug applications. The EMEA requires confirmatory clinical trials.
- Patent/exclusivity feasibility
- Pricing and reimbursement — Can a premium price be obtained for FDCs? How will payers evaluate product?
- Rebates and contracting concerns — Are current contracts sufficient to address unique issues presented by FDCs?
- Government price reporting — Will health reform provisions relating to “new formulations” be relevant to FDCs?
Sign up now for an all-new webinar from FDAnews on overcoming hurdles to FDC development. Here’s a taste of what you’ll learn in just 90 profit-building minutes:
- Key questions to ask before you start FDC development
- Important implications of drug patent law
- Possibility of new chemical entity exclusivity from the FDA
- How to evaluate legal implications of product pricing strategies
- Avoiding unintended consequences of various standard commercial contract provisions with respect to FDCs
- Compliance considerations, including government price reporting and antitrust
- Possible impact of health reform proposals on development strategy
We make it easy to learn. Seminars on the web mean no airplanes or hotel rooms in strange cities. They also spell total interactivity. Got questions? Send them in via email. You’ll have your answers before you log off.
Bring along your staff too — in fact, bring everyone in the company who might benefit from participating. We make it easy with one low registration fee per site, regardless of how many participants log on from that site.
As R&D pipelines shrink and the patent cliff draws nearer, FDCs hold out hope for reaching untapped patient segments, protecting existing branded business, and challenging rivals with drugs in the same class.