Why don’t I see some antibiotic drugs products listed in the Patent and Exclusivity section of the Orange Book?
Title I of the 1984 Amendments did not apply to drug products submitted or approved under the former Section 507 of the Federal Food, Drug, and Cosmetic Act (antibiotic products). Therefore, (1) holders of approved applications for antibiotic products did not need to submit the patent information required of other NDA application holders, (2) these antibiotic products were not eligible for exclusivity protection, and (3) applicants submitting abbreviated applications for these antibiotic products were not required to provide the patent certification statement that was included in ANDAs. Antibiotics submitted after the effective date of the Food and Drug Administration Modernization Act (FDAMA) are covered or subject to the provisions of Title I. See Guidance for Industry and Reviewers Repeal of Section 507 of the Federal Food, Drug and Cosmetic Act for more information.
