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parryashford

@parryashford

active 11 hours, 24 minutes ago

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Closed doors yield no real clues
How many defenses should an ANDA filer try?
Covid-19 and PIV Cases — Courts getting through a rough patch
FTC Resumes Attacks on PIV Settlements
2019 Annual Review – PIV Market Correction?

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Latest updates

The Paragraph Four Report®
Paragraph IV Activity for April 2020

New Certifications as reported by FDA on April 7, 2020

Comments: FDA did not report any new certifications in April.

New Cases Filed

1. Product: Imvexxy®(estradiol) Vaginal Inserts
Case: THERAPEUTICSMD INC v. TEVA PHARMACEUTICALS USA INC et al njdc 2:2020cv03485 0…[Read more]

3 weeks, 6 days ago

Bijuva®(estradiol and progesterone) Capsules
Annual Sales
Company THERAPEUTICS MD
Date of First Filing January 6, 2020

Paragraph IV Applicant: Amneal
Case Name: THERAPEUTICSMD INC v. AMNEAL PHARMACEUTICALS INC et al
Court/Case #: New Jersey District Court (njdc) 3:2020cv05256
Date Filed: 4/29/2020
Judge: Wolfson
Product…[Read more]

4 weeks ago

Legal Defenses in PIV Cases 2015-2019 – Chart

As a supplement to my PIV Blog Post of April 21, 2020 regarding the Success of Legal Defenses in PIV Cases, below is the complete data set of legal defenses raised in PIV cases and their rates of success. This research complements a paper I published in 2013 (“Legal Defenses and Outcomes in P…[Read more]

1 month ago

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