# Policy on 180-Day Marketing Exclusivity for Drugs Marketed Under Abbreviated New Drug Applications; Clarification
> **Food and Drug Administration** · Clarification. · Published 1997-11-28 · 62 FR 63268
## Document
- **Document number:** 97-31150
- **Category:** fda-drug
- **Sub-agency:** Food and Drug Administration
- **Federal Register citation:** 62 FR 63268
- **CFR reference:** 21 CFR 314
- **Publication date:** 1997-11-28
- **HHS docket:** Docket No. 85N-0214
## Abstract

The Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) is publishing this document to clarify the status of its practices governing 180 days of marketing exclusivity for generic drugs and the approval of abbreviated new drug applications (ANDA's) subject to patent litigation. This document is being published due to recent court decisions interpreting provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (Pub. L. 98-417) (the 1984 amendments).

## Source
- [Federal Register document](https://www.federalregister.gov/documents/1997/11/28/97-31150/policy-on-180-day-marketing-exclusivity-for-drugs-marketed-under-abbreviated-new-drug-applications)
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