Mitigating The Detrimental Economic Impact Of Generic Drugs Strategies for Marketing and Selling An Authorized Generic In The U.S

Karl M. Nobert

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This new course provides attendees with a road-map for the marketing and sale of an Authorized Generic Drug product in the United States. The term Authorized Generic ("AG") refers to a situation when a Brand Drug Company (i.e., the owner of an approved New Drug Application) repackages its own approved drug product to market and sell it as a "generic drug" before third-party generics enter the market.

The course explains the difference between a Brand Drug, a Generic Drug and an Authorized Generic. It identifies FDA's relevant statutory and regulatory requirements, and supporting Guidance Documents, governing the commercialization of such products including the definition of the term found at 21 CFR 314.3. The instructor discusses who may sell an AG, when an AG may be sold; and the impact of the Hatch-Waxman Act on the third-party owner of the first FDA-approved generic. Some of the other topics covered include selecting an appropriate trade name, product labeling and providing FDA with notice of marketing. Knowing the rules and regulations governing the marketing and sale of an AG allows a Brand Company to extend a drug's life cycle and reduce the overall loss of market share to third-party generics.

Course Objective

Attendees will leave the class clearly understanding the requirements for marketing and selling an Authorized Generic Drug product in the United States. Not only will the course present a step-by-step pathway for introducing an AG to the market, it will also provide attendees with strategies for expediting the process and mitigating the risk of FDA enforcement action. It will also provide participants with competitive insight into:

  • Determining whether an FDA approved drug product is appropriate for copying as an AG.
  • The similarities and differences between a Brand Drug, a Generic Drug and an AG.
  • The requirements for marketing and selling an AG.
  • How to select an appropriate Trade Name for the new product.
  • The proper labeling, marketing and advertising of an AG.
  • The need for a National Drug Code ("NDC") number.
  • How to provide FDA with Notice of an AG.
  • What internal business changes may be needed (i.e., drafting and adoption of new appropriate SOPs).
  • Effectively responding to FDA inquiries and enforcement action.

Course Outline

  • What is an Authorized Generic Drug Product?
  • Differences Between Marketed Drug Products
  • The Drug Life Cycle
  • Overview of the FDA's Drug Regulatory Structure
  • Relevant FDA Statutory and Regulatory Requirements
  • Supporting FDA Guidance Documents and Other Resources
  • The Regulatory Pathway to Market for an AG
  • Eligibility for AG Marketing 
  • Selecting an Appropriate Product Trade Name
  • The AG Product Label
  • The National Drug Code Number
  • Providing Required Notification to FDA
  • Processes and Timelines
  • Possible Internal Business Changes
  • Standard Operating Procedures ("SOPs")
  • Good Manufacturing Practice (GMP) Considerations
  • Properly Labeling and Marketing an AG
  • Mitigating the Risk of FDA Enforcement Action
  • Responding to FDA Inquiries and Enforcement Action
  • Marketing and Competitive Strategies
  • Question

Target Audience

This 90-minute overview will be of value to drug regulatory professionals, project team members, in-house legal counsel, and a company's marketing and advertising departments.  The course is also valuable for individuals responsible for product, business and market development in the pharmaceutical industry. The course will benefit the following stakeholders:

  • Project Team Members.
  • Regulatory Affairs.
  • In-House Counsel and Legal Affairs.
  • Product Development Professionals.
  • Business Development Professionals.
  • Market Development Professionals.
  • Drug Industry Consultants.
  • Industry Watchers.
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Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Karl M. Nobert,

Karl M. Nobert focuses his practice on the representation and counseling of clients in the food and drug industry including advising clients on matters related to the regulation of human prescription and nonprescription drugs, human and veterinary biological products including regenerative medicine, medical devices, food and dietary supplements. Karl also assists clients with the preparation of FDA submissions including human and veterinary new drug and generic drug applications; 510(k) premarket notifications, premarket approval applications, recalls and market withdrawals, GRAS self-affirmations and notifications, and product listings and establishment registrations. He represents clients before the Food and Drug Administration (FDA), United States Department of Agriculture (USDA) and Federal Trade Commission (FTC). Karl also represents clients in State food and drug law matters on various regulatory matters including wholesaler/distributor licensing and registration. Karl currently serves as Legal Advisor to the International Veterinary Regenerative Medicine Society (IVRMS) and is a member of the National Thoroughbred Racing Associations (NTRA) Safety and Integrity Alliance Subcommittee on Aftercare. He is the author of numerous articles and frequently presents on various FDA regulatory topics.

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