Opportunities in the U.S. Pharmaceutical Market for Mexican Manufacturers

​Buchanan will co-host a breakfast symposium "Opportunities in the U.S. Pharmaceutical Market for Mexican Manufacturers" on May 7, from 9 a.m. to 1 p.m., in Mexico City in partnership with Arochi & Lindner, S.C.

Matt Fedowitz, Ed Allera, Barbara Binzak-Blumenfield and Mike Strazzella will speak at the event.

Topics include:

The current state of the generic market in the U.S. and the competitive landscape

• The U.S. generic and biosimilar market, distribution of products and the requirement for automatic generic switch.
• U.S. Generic ANDA approval process.
• How do companies get paid?
• Why are Indian manufacturers dominating the U.S. market?
• Perception of the MX manufacturers.

Barriers to entry

• Target products in the U.S> and FDA's Orange Book.
• Patented products - the Hatch-Waxman framework and challenging patents.
• Non-patented products.
• Regulatory issues.

Opportunities

• Market segments based on sales.
• Production of API for DMF sourcing.
• Drug shortages in the U.S. and opportunities therein.
• 502(b)(2) products opportunities related thereto.
• Identification of products unique to the Mexican market that are not available in the U.S.