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Home→Published 2020 → September

Monthly Archives: September 2020

No Longer Competing PIV Cases

ParagraphFour.com Posted on September 23, 2020 by parryashfordSeptember 23, 2020

The Competing Cases In the last blog post, I highlighted two competing PIV cases involving the same product, patent, and legal issue. The West Virginia District Court had found claims of the patent invalid due to lack of written description. This case is currently on appeal. Meanwhile, a case in Delaware District Court had already … Continue reading →

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Makena®(hydroxyprogesterone) Injection
Annual Sales
Company COVIS PHARMA (AMAG)
Date of First Filing September 28, 2020

Paragraph IV Applicant: Aurobindo
Case Name: COVIS PHARMA GMBH et al v. EUGIA PHARMA SPECIALTIES LTD et al
Court/Case #: Delaware District Court (dedc) 1:2021cv00003
Date Filed: 1/4/21
Judge: Connelly
Product…Read more

Profile picture of parryashford 2 weeks, 4 days ago

The Paragraph Four Report®
Paragraph IV Activity for December 2020

New Certifications as reported by FDA on December 1, 2020

1. Minocin®(minocycline) Injection 100 mg/vial on 10/16/2020

Comments: Minocycline has appeared on the PIV List before but this is the first for the injection form.

New Cases Filed

1. Product: A…Read more

Profile picture of parryashford 3 weeks, 4 days ago

Pemfexy®(pemetrexed) Injection
Annual Sales
Company EAGLE
Date of First Filing Not applicable

Paragraph IV Applicant: Shilpa
Case Name: EAGLE PHARMACEUTICALS INC et al v. SHILPA MEDICARE LIMITED
Court/Case #: New Jersey District Course (njdc) 2:2020cv20270
Date Filed: 12/28/20
Judge: Vazquez
Product Strength: 25…Read more

Profile picture of parryashford 3 weeks, 6 days ago
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