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Understanding Authorized Generic Drug [Food and Drugs]: A Comprehensive Guide
Definition & meaning
An authorized generic drug is a medication that is chemically identical to a brand-name drug and has been approved by the FDA. It is marketed under its chemical name but may have different packaging, labeling, or branding compared to the original brand-name product. These drugs are produced by the same manufacturer as the brand-name drug or by a different company under a licensing agreement. They are typically sold at a lower price than their brand-name counterparts, making them a more affordable option for consumers.
Table of content
Legal use & context
Authorized generic drugs are relevant in the pharmaceutical and healthcare industries. They are often used in discussions about drug pricing, patent law, and healthcare regulations. Legal professionals may encounter this term when dealing with cases related to drug approval processes, patent disputes, or consumer rights regarding medication access. Users can manage related legal matters using templates available through US Legal Forms, which provide guidance on necessary forms and procedures.
Key legal elements
Real-world examples
Here are a couple of examples of abatement:
Example 1: A pharmaceutical company produces an authorized generic version of a popular blood pressure medication. While the active ingredient and formulation are the same as the brand-name drug, it is sold under a different label and at a lower price.
Example 2: A hospital uses an authorized generic drug for its patients to reduce costs while ensuring they receive the same therapeutic benefits as the brand-name version. (hypothetical example)
Relevant laws & statutes
The primary regulation governing authorized generic drugs is the Federal Food, Drug, and Cosmetic Act, specifically section 505(c), which outlines the approval process for new drugs. Additionally, the FDA provides guidelines on the marketing and labeling of these drugs.
Comparison with related terms
Term
Definition
Key Difference
Generic Drug
A drug that is equivalent to a brand-name drug in dosage form, strength, route of administration, quality, and performance characteristics.
Authorized generics are marketed under their chemical name and may differ in branding, while generics can be produced by different manufacturers.
Brand-name Drug
The original product developed by a pharmaceutical company, protected by patent.
Brand-name drugs are typically more expensive and have exclusive marketing rights until their patent expires.
Common misunderstandings
What to do if this term applies to you
If you are considering switching to an authorized generic drug, consult your healthcare provider to ensure it is appropriate for your treatment. You can also explore US Legal Forms for templates related to medication management and patient rights. If you face legal issues regarding drug access or pricing, consider seeking professional legal assistance.
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