The Future of Generic Drug Competition
Deconstructing FDA and Congressional Initiatives

Monday, Dec. 9, 2019 • 1:30 p.m. - 3:00 p.m. EST

Current and future measures by FDA and Congress to incentivize generic drug competition will have enormous impact on how quickly your drug gets to market.

What does this mean for 180-exclusivity? How can you obtain expedited approval and related marketing exclusivities?

Are you ready?

Get a handle on the new generic drug regulations landscape to your best advantage. This webinar is a must to gain insights into various ways to obtain expected approval and related marketing exclusivities.

Webinar Takeaways:

  • The nuances of the implementation of FDA’s Drug Competition Action Plan (DCAP), including efforts to improve the efficiency of the generic drug development, review and approval process; maximizing scientific and regulatory clarity with respect to complex generic drugs; and closing loopholes that allow brand-name drug companies to “game” FDA rules in ways that delay the generic competition Congress intended
  • What the various pathways are to expedite approval of generic drug applications and the advantages and disadvantages of each method
  • How to expeditiously obtain 180-day exclusivity
  • How a sponsor can forfeit exclusivity
  • How REMS standards are being used to reduce generic competition and what can be done to combat that effort 
  • How FDA’s citizen petition process is being used to reduce generic competition and what can be done to combat that effort
  • What Congressional initiatives and measures are being proposed to spur generic drug competition

When you understand the new generic drug competition initiatives, you can successfully navigate the incentives that the FDA has put in place. Join us by registering today.

Who Will Benefit

  • Regulatory Counsel
  • Regulatory Affairs Personnel
  • REMS Managers
  • Legislative and Policy Professionals
  • Legal Professionals

Webinar plus USB Audio Recording/Transcript
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Meet Your Presenters

Chad Landmon, Esq.

Chairs the FDA and IP practice groups
Axinn, Veltrop & Harkrider LLP

Chad Landmon, Esq. chairs the FDA and IP practice groups at Axinn, Veltrop & Harkrider LLP. He has extensive experience assisting pharmaceutical companies with bringing their products to market, including navigating the complex drug approval pathway at FDA. Mr. Landmon’s experience with FDA matters also includes litigation and advocacy surrounding generic drug marketing exclusivities and application approval standards.

Neema Kumar, Esq.

Senior IP Counsel
Hikma Pharmaceuticals USA Inc.

Neema Kumar, Esq. is Senior IP Counsel at Hikma Pharmaceuticals USA Inc., a New Jersey-based pharmaceutical company that develops, manufactures and markets a broad range of branded, injectable and non-injectable medicines across the U.S., MENA region and Europe. She is responsible for all U.S. intellectual property matters, including patent litigation, counseling and prosecution. Prior to joining Hikma, Ms. Kumar worked at the law firm of Winston & Strawn LLP advising pharmaceutical clients on patent litigation, counseling and diligence issues.

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