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Drug Price Competition and Patent Term Restoration Act of 1984
Understanding the Drug Price Competition and Patent Term Restoration Act of 1984
Definition & Meaning
The Drug Price Competition and Patent Term Restoration Act of 1984, commonly known as the Hatch-Waxman Act, is a federal law in the United States that was signed into effect by President Reagan on September 24, 1984. This legislation established a framework for the approval of generic drugs, allowing companies to submit Abbreviated New Drug Applications (ANDAs) to the Food and Drug Administration (FDA) for approval. The Act also grants a 180-day exclusivity period to the first company that files an ANDA for a generic version of a branded drug, which helps encourage competition in the pharmaceutical market.
Table of content
Legal Use & context
The Hatch-Waxman Act is primarily relevant in the pharmaceutical and healthcare sectors. It is used in legal contexts involving drug approval processes, patent law, and competition law. Legal professionals may encounter this Act when dealing with cases related to patent infringement, generic drug marketing, and FDA regulations. Users can manage some aspects of this process themselves by utilizing legal templates available through US Legal Forms, particularly for filing ANDAs or navigating patent challenges.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company develops a new drug and obtains a patent. After a few years, another company files an ANDA to produce a generic version of the drug. If this second company is the first to file, it may receive a 180-day exclusivity period during which no other generic versions can be marketed.
Example 2: A generic drug manufacturer challenges the patent of a branded drug under the provisions of the Hatch-Waxman Act, arguing that the patent is invalid. This could lead to a legal dispute over the patent's validity and the right to market the generic drug. (hypothetical example)
Relevant laws & statutes
The primary statute relevant to the Drug Price Competition and Patent Term Restoration Act is:
21 U.S.C. § 355 - New Drugs
35 U.S.C. § 156 - Extension of patent term
Comparison with related terms
Term
Definition
Key Differences
Abbreviated New Drug Application (ANDA)
A request to the FDA for approval to market a generic drug.
ANDA is a process established by the Hatch-Waxman Act specifically for generic drugs.
New Drug Application (NDA)
A comprehensive application submitted to the FDA for approval of a new drug.
NDA is used for new branded drugs, while ANDA is for generics.
Common misunderstandings
What to do if this term applies to you
If you are involved in the pharmaceutical industry and are considering filing an ANDA, it is advisable to consult with a legal professional who specializes in FDA regulations and patent law. For those looking to navigate the process independently, US Legal Forms offers various legal templates that can assist in preparing the necessary documentation.
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