May 7 2019
9:00 AM

​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.