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Home→Published 2020 → April

Monthly Archives: April 2020

How many defenses should an ANDA filer try?

ParagraphFour.com Posted on April 21, 2020 by parryashfordApril 21, 2020

At ParagraphFour.com, I conduct quite a bit of original research and make it available to our subscribers. Sometimes, I place the findings in a research paper format and publish it on the site or in a journal. I recently updated some research from 2014 which looks at defenses ANDA filers raise in a PIV case. … Continue reading →

Covid-19 and PIV Cases — Courts getting through a rough patch

ParagraphFour.com Posted on April 1, 2020 by parryashfordApril 1, 2020

During the Covid-19 pandemic, the U.S. federal court system is functioning pretty well.  Courts handling PIV cases kept busy in March. The district courts issued a Standing Order reducing their functionality (copy below). The Order stopped jury trials due to the nature of many people gathering for them (jury pools, lawyers, court personnel, etc.) The … Continue reading →

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Latest updates

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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