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Author Archives: parryashford

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Purdue to Settle OxyContin®(oxycodone) Cases — Too little, too late? (Part III)

ParagraphFour.com Posted on December 3, 2019 by parryashfordDecember 31, 2019

In response to the efforts of Purdue Pharma to settle and resolve its litigation, I started a blog post considering the behavior of Purdue. Part I covered citizens petitions and Part II covered Paragraph IV patent cases. Both establish that, in spite of the fact of the well-known risks of addiction of its product, Purdue … Continue reading →

Purdue to Settle OxyContin®(oxycodone) Cases — Too little, too late? (Part II)

ParagraphFour.com Posted on November 19, 2019 by parryashfordDecember 31, 2019

In response to the efforts of Purdue Pharma to settle and resolve its litigation, I started a blog post considering the behavior of Purdue. Part I covered citizens petitions. Petitions filed with FDA provide insight into the story and establish that: (1) the risk of oxycodone addiction and abuse was well-known by the early 2000’s … Continue reading →

Purdue to Settle OxyContin®(oxycodone) Cases — Too little, too late? (Part I)

ParagraphFour.com Posted on November 5, 2019 by parryashfordOctober 23, 2019

In early September, news reports surfaced regarding a $10-12 Billion settlement Purdue Pharma LP proposed to reduce its liability and to end the thousands of lawsuits filed against it.1 The primary driver of the lawsuits has been dozens of states claiming that they have been damaged by the additional cost of medical care to treat … Continue reading →

Eye Drops, Indian Tribes and Patents: competitive behavior that isn’t pretty

ParagraphFour.com Posted on October 15, 2019 by parryashfordDecember 31, 2019

A recent U.S. Supreme Court decision brought an end to legal strategy involving Allergan and its product Restasis®(cyclosporine). The strategy appears to have been borne out of the frustration that pharmaceutical competition can bring and leaves us with a perception that is not so positive, to put it mildly. Like most industries, the pharmaceutical business … Continue reading →

ParagraphFour.com Re-Launch – The PIV Blog

ParagraphFour.com Posted on August 28, 2019 by parryashfordSeptember 25, 2019

September 2019 marks an important moment for ParagraphFour.com with the re-launch of its new website. The revision to the site is a bit bittersweet. It’s joyous and exciting to refresh the look, feel and navigation of the site as well as take advantage of the enhanced features a new database can bring. But it is … Continue reading →

Major Revisions to the FDA PIV List

ParagraphFour.com Posted on August 19, 2019 by parryashfordDecember 31, 2019

On June 18, 2019, FDA posted its PIV List with some major revisions and additional data fields. Over the past 20 years, FDA has maintained the same format with basic information including the drug name (generic and branded trade name), dosage form, and strength. If memory serves me well, around 2004, it added the Date … 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, 1 day 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 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, 3 days ago
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