180-day Exclusivity Period
Definition
[21 U.S.C. § 355j(5)(B)(iv)] States that the first company to file a paragraph IV ANDA for approval of a generic version of a pioneer drug enjoys a 180-day period of exclusivity in which to sell its generic drug.
The related rules section is for members only and includes a compilation of all the rules of law in Quimbee's database relating to this key term.
To access the related rules, please start your free trial or log in.
Mauris finibus odio eu maximus interdum. Ut ultricies suscipit justo in bibendum. Sed eu magna efficitur, luctus lorem ut, tincidunt arcu. Praesent varius sit amet erat hendrerit placerat. In posuere eget ante id facilisis. Integer semper venenatis felis lacinia malesuada.
Mauris finibus odio eu maximus interdum. Ut ultricies suscipit justo in bibendum. Sed eu magna efficitur, luctus lorem ut, tincidunt arcu. Praesent varius sit amet erat hendrerit placerat. In posuere eget ante id facilisis. Integer semper venenatis felis lacinia malesuada.
— Mylan Pharmaceuticals, Inc. v. U.S. Food and Drug Administration
Get full access FREE
With a 7-day free trial membership
Here's why 803,000 law students have relied on our key terms:
- A complete online legal dictionary of law terms and legal definitions
- Over 7,900 key terms written in plain English to help you not only understand the law but master it
- The premier online law dictionary built specifically for law students
- Easy access in class or on the go, accessible both online and through the Quimbee mobile app
- Reliable - written by legal professors and practitioners
- Get instant access to all related rules of law to any specific key term with a Quimbee Study Aid plan