The Paragraph Four Report®
Paragraph IV Activity for October 2020
New Certifications as reported by FDA on October 20, 2020
1. Epinephrine Injection 1mg/mL on 8/13/2020
Comments: Epinephrine has appeared on the PIV List and in PIV cases in the past. This particular filing appears to be the first ANDA filed.
New Cases Filed
1.…[Read more]
Xiidra®(lifitegrast) Ophthalmic Solution
Annual Sales $192M
Company NOVARTIS
Date of First Filing July 13, 2020
Paragraph IV Applicant: Aurobindo
Case Name: NOVARTIS PHARMACEUTICALS CORPORATION v. AUROBINDO PHARMA LTD et al
Court/Case #: Delaware District Court (dedc) 1:2020cv01426
Date Filed: 10/23/20
Judge: Stark
Product…[Read more]
Qbrexza®(glycopyrronium) Topical Cloth
Annual Sales
Company DERMIRA (ELI LILLY)
Date of First Filing January 13, 2020
Paragraph IV Applicant: Perrigo
Case Name: DERMIRA INC et al v. PERRIGO PHARMA INTERNATIONAL DAC
Court/Case #: Delaware District Court (dedc) 1:2020cv01413
Date Filed: 10/21/20
Judge:
Product Strength:…[Read more]
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