Kurt R. Karst
Kurt R. Karst provides regulatory counsel to pharmaceutical manufacturers on Hatch-Waxman patent and exclusivity, drug development, pediatric testing, and orphan drugs. He helps clients develop strategies for product lifecycle management, obtaining approval, managing post-marketing issues, and defining periods of exclusivity. As the co-founder and primary author of Hyman, Phelps & McNamara's FDA Law Blog, Mr. Karst often leads the response to new rules and regulations, sharing his interpretation with the broader legal community.
Mr. Karst's knowledge of FDA precedents and timely analysis of developments helps clarify and shape the industry's understanding of Hatch-Waxman, in particular. He is a prolific writer, contributing to the blog and publishing articles in major legal journals. Mr. Karst has co-authored and contributed to several text books, including Generic and Innovator Drugs: A Guide to FDA Approval Requirements; Pharmaceutical, Biotechnology, and Chemical Inventions; Fundamentals of US Regulatory Affairs; and FDLI's Drug and Biologic Approvals: The Complete Guide for Small Businesses-FDA Financial Assistance and Incentives.
Mr. Karst clerked for Hyman Phelps & McNamara while attending law school and served as articles editor for the American University Law Review. Before joining the firm, Mr. Karst lobbied for F. Hoffmann-La Roche Inc. In 1995, he was awarded a Fulbright Scholarship for post-graduate studies in Germany.
Prescription Drugs and Biologics
• Counsels clients on Hatch-Waxman patent and exclusivity matters.
• Develops strategies around exclusivity status and Orange Book Patent Listings.
• Obtains approvals for INDs, NDAs, and ANDAs.
• Helps clients obtain orphan drug designations as part of a broader product strategy.
• Advises clients on PDUFA and GAIN.
• Provides counsel on REMS.
OTC Drugs and Cosmetics
• Helps clients market OTC drugs.
• Advises clients on marketing and unapproved drug enforcement issues.
Awards & Recognition
• Who's Who Legal Directory, Life Sciences, Regulatory Section, 2015
• Who's Who Legal Directory, Life Sciences, Patent Litigation Section, 2015-2016
Articles / Publications
see more articles
• Generic and Innovator Drugs: A Guide to FDA Approval Requirements, Eighth Edition,
• FDA Amendments Act - HPM Issues Detailed Summary and Analysis,
• FDA Announces Proposed Regulations to Overhaul and Expand the Availability of Experimental Drugs and to Clarify Permissible Charges to Patients,
December 12, 2006
• Rep. Waxman and Sens. Schumer and Clinton Introduce Biogenerics Bill,
September 29, 2006
• FDA's Final Compliance Policy Guide for Marketed Unapproved Drugs ─ Is Agency Enforcement at a Crossroads, or Stuck in a Traffic Circle?,
August 11, 2006
see more speaking engagements
• International Conference and Expo on Generic Drug Market and Contract Manufacturing, KRK Speech: “Biosimilars in the United States: A Progress Report and A Peek Into the Future”, November 7-9, 2016
• FDA Boot Camp, Hatch Waxman and BPCIA Overview; and Post Conference Workshop on Hatch Waxman and BPCIA in the Trenches: Deconstructing and Constructing an Exclusivity Dispute, September 21 - 23, 2016
• ACI Paragraph IV Disputes Master Symposium, KRK Panel Member: "Regulatory Exclusivity", September 19-21, 2016
• American Journal of Managed Care Roundtable Audioconference, Topic to be determined, May 4, 2016
• Webinar: Avoiding Drug Substance Patents and Exclusivities: Prodrugs, Deuterated Drugs and 505(b)(2) Applications, April 14, 2016
see more blog entries
• Chemistry Amendment Saves Sun From Forfeiting 180-Day Exclusivity Eligibility for Generic GLEEVEC,
July 13, 2016
• A New “Greater Safety” Orphan Drug Clinical Superiority Precedent: PURIXAN????,
July 5, 2016
• AstraZeneca, iPR Launch Preemptive Lawsuit Against FDA Over Generic CRESTOR Approval,
June 28, 2016
• Lannett Sues FDA Over Temozolomide Capsules ANDA Approval Rescission,
June 28, 2016
• PTO Prevails in Challenge to Drug Eluting Stent PTE Denial, and Encounters Some Interesting Characters Along the Way . . . Including a Unicorn!,
June 27, 2016