Opportunities in the U.S. Pharmaceutical Market for Mexican Manufacturers
May 7 2019
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.
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.
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.