> ## Content Index
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# Generic Drug Exclusivity Guidance in Comment Period
- URL: https://www.fdaweb.com/generic-drug-exclusivity-guidance-in-comment-period/
- Published: 2017-03-01T12:00:00.000Z
- Updated: 2026-09-14T22:09:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5138098

A Duane Morris client alert says that FDA will receive comments until 3/14 on a [draft guidance](https://www.fdaweb.com/draft-guide-on-generic-180-day-exclusivity/) that uses a question-and-answer format to discuss generic drug 180-day marketing exclusivity. The [alert](http://www.duanemorris.com/alerts/fda%5Fdraft%5Fguidance%5Ffor%5Findustry%5Fon%5F180%5Fday%5Fexclusivity%5F0317.html?ref=fdaweb.com#.WLckTl624m9.twitter) says the guidance consolidates court decisions and application-specific decisions FDA has taken in citizen petition responses, litigation, and other documents. It also clarifies how the agency generally deals with issues regarding 180-day exclusivity for generic drug products, including: 

- when pre-Medicare Modernization Act statutory provisions apply;
- which applicant qualifies as first applicant;
- notice of Paragraph IV certification;
- how many first applicants;
- effect of 180-day exclusivity on other applicants; and
- factors that can shorten the 180-day exclusivity.