Quimbee logo
DMCA.com Protection Status

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.

Related Rules


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