Paragraph IV Patent Certifications

On January 30, 2017, FDA published Paragraph IV patent certifications to the following drugs.

Drug Name Dosage Form Strength RLD Date of Submission
Aprepitant for Oral Suspension 125 mg/Kit Emend 11/23/2016
Liraglutide Injection 18 mg/3 mL prefilled syringe Victoza 12/12/2016

I. The following patents are listed for Emend (Oral Suspension) in Orange Book

Patent No Patent Expiration Remarks
6,096,742 Jul 1, 2018 Relates to polymorphic Forms I and II of Aprepitant
8,258,132 Sep 26, 2027 Relates to composition comprising Aprepitant with a specific particle size diameter

II. The following patents are listed for Victoza in Orange Book

Patent No Patent Expiration Remarks
6,004,297 Jan 28, 2019 Relates to an injection syringe for apportioning set doses of a medicine from a cartridge
6,268,343 Aug 22, 2022 (inclusive of PTE) Relates to product
6,458,924 Aug 22, 2017 Relates to product
7,235,627 Aug 22, 2017  Relates to product
8,114,833 Aug 13, 2025 Relates to Formulation and MOT
8,846,618 Jun 27, 2022 Relates to Formulation and a process for its preparation
9,265,893 Sep 23, 2032  Relates to Technology
RE41956 (6,582,404) Jan 21, 2021  Relates to Technology
RE43834 Jan 28, 2019  Relates to Technology