Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

The Medicare Modernization Act of 2003:The Effect on Entry of Generic Drugs into the Marketplace

By Andrea J. Kamage and Robert C. Millonig

The Hatch-Waxman Act, enacted in 1984, first permitted the marketing of generic pharmaceuticals based on a showing of bioequivalence, not safety and efficacy, through the use of an Abbreviated New Drug Application (“ANDA”). By significantly lowering the barrier to entry for generics, this change provided the impetus for rapid growth of the generic pharmaceutical industry in the United States. In exchange for this barrier lowering, Congress provided the holder of the previously approved new drug application (“NDA”) with patent term extensions based on FDA regulatory delay.

Under the Hatch-Waxman Act, the NDA holder must submit information to the FDA regarding patents that cover the drug product or a method of using it. The FDA then lists these patents in the “Orange Book.” A company seeking FDA approval to market a generic version of the product by submitting an ANDA must make at least one of four types of certifications to the FDA regarding patents. One type is a “Paragraph IV certification,” which certifies that a patent listed in the Orange Book for a drug product is invalid or will not be infringed by the ANDA product.

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs Image

A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.

Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It Image

Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?

Blockchain Domains: New Developments for Brand Owners Image

Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.

Coverage Issues Stemming from Dry Cleaner Contamination Suits Image

In recent years, there has been a growing number of dry cleaners claiming to be "organic," "green," or "eco-friendly." While that may be true with respect to some, many dry cleaners continue to use a cleaning method involving the use of a solvent called perchloroethylene, commonly known as perc. And, there seems to be an increasing number of lawsuits stemming from environmental problems associated with historic dry cleaning operations utilizing this chemical.