LIVE Online Seminar

Understanding ANDAs and Paragraph IV Patent Certifications

  • Date: December 9 , 2016
  • Time: 10:00 AM PST | 01:00 PM EST
  • Duration: 60 Minutes

About the Seminar

The regulatory requirements for generic drugs include, but not limited to, same active ingredients, same dosage form, same route of administration,  same strength, and same conditions of use compared to brand name drug product (RLD: reference listed drug).

In 1984, the Drug Price Competition and Patent Term Restoration Act (P.L. 98-417), was signed into law, which is now called “the Hatch-Waxman Act.”  The Hatch-Waxman Act is intended to expedite and streamline FDA drug review and approvals for generic drugs including and patent litigation involving generic drugs.

According to the Hatch-Waxman Act, generic drug firms can file either one of two applications to obtain FDA approval of a generic drug: 1).  An Abbreviated New Drug Application (ANDA); 2). 505(b)(2) Application. Under the Hatch-Waxman Act, there are certain market exclusivity periods for NDAs (non-patent based and patent based).

New chemical entity (NCE) exclusivity (5 years) is non-patent based.  A generic drug firm is barred from filing an ANDA due to NCE exclusivity (5 years from the first NDA approval). However, a generic drug firm may file an ANDA with a Paragraph IV patent certification pursuant to the Hatch-Waxman Act, allowing a generic drug firm to challenge a brand name drug firm’s patent exclusivity for the RLD.

This seminar is intended to help industry better understand ANDA process. In particular, it is further intended to cover Paragraphs 1-4 certifications with major focus on Paragraph IV certifications.

At the end of this seminar, you should be able to understand regulatory requirements for ANDA filings with focus on paragraph IV (para IV) certifications.  

About the Areas to Be Discussed

  • Laws and Regulations
  • Definition
  • Hatch-Waxman Act
  • Orange Book
  • Regulatory Requirements for Generic ANDA and 505(b)(2) Filings
  • Patent-Based and Non-Patent Based Exclusivities
  • Patent Certifications
  • Paragraph IV Patent Certifications
  • Reference Listed Drug (RLD)
  • ANDAs Containing a Paragraph IV Certification
  • Patent Litigations
  • PASS-IT Recommendations: Best Practices

About the Intended Attendee(s)

  • CEOs
  • VPs
  • Regulatory Affairs
  • Scientists
  • Engineers
  • Healthcare Professionals
  • Consultants
  • Legal Counsel
  • Anyone interested in the topic

About the Seminar Speaker

Dr. David Lim, Ph.D., RAC, ASQ-CQA

Dr. David Lim, Ph.D, RAC, ASQ-CQA (Dr. Lim) Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global laws, regulations, rules and guidance applicable to medical products.  In particular, Dr. Lim provides seminars on various areas and focused-topics in regulatory affairs, clinical affairs, quality and regulatory compliance.

Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed the industry’s first PMA seminar series delivered online, helping global regulatory affairs professionals become a PMA pro. Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past eight years.  Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009.  Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker.  Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim serves as a member of the advisory board for inspection insider at FDA News. Dr. Lim also contributes to FDA, providing FDA guidance information for free to the FDA regulated industry. 

Registration Options

LIVE (one attendee): $299 


LIVE (≤ 3 attendees): $599 

LIVE (≥ 4 attendees): $799 

LIVE & Recorded$399 

Understanding ANDAs and Paragraph IV Patent Certifications