The Paragraph Four Report®
Paragraph IV Activity for November 2019
New Certifications as reported by FDA on November 5 and 19, 2019
1. Vraylar®(cariprazine) Capsules 1.5mg, 3mg, 4.5mg, and 6mg on 9/17/2019
2. Tasigna®(nilotinib) Capsules 50mg on 10/17/2019
3. Protonix®(pantoprazole) Delayed-release Oral Suspension 40mg on 9/1…[Read more]
Desyrel®(trazodone) Tablets
Annual Sales N/A
Company PRAGMA PHARMACEUTICALS
Date of First Filing Not yet reported by FDA (see Special Note below)
Paragraph IV Applicant: Aurobindo
Case Name: AZIENDE CHIMICHE RIUNITE ANGELINI FRANCESCO ACRAFSPA v. AUROBINDO PHARMA USA INC.
Court/Case #: Delaware District Court (dedc)…[Read more]
Lenvima®(lenvatinib) Capsules
Annual Sales 37B JPY
Company EISAI
Date of First Filing February 13, 2019
Paragraph IV Applicant: Shilpa
Case Name: EISAI R&D MANAGEMENT CO LTD et al v. SHILPA MEDICARE LIMITED njdc
Court/Case #: New Jersey District Court (njdc) 3:2019cv19998
Date Filed: 11/8/19
Judge: Wolfson
Product…[Read more]
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