In May 2025, the Trump Administration issued an Executive Order to establish the policy of returning pharmaceutical manufacturing to the United States. What impact might these have on both brand and generic manufacturers? Return of Manufacturing On May 5, 2025, the Trump Administration issued an Executive Order which seeks to encourage pharmaceutical manufacturers to increase … Continue reading →
On May 12, 2025, the Trump Administration issued an Executive Order regarding Favored Nation Pricing. What are its potential impacts to the U.S. pharmaceutical market? Favored Nation Pricing The Executive Order seeks to reduce the price Americans pay for prescription drugs primarily in two ways. The first method is to level the pricing that the … Continue reading →
In December 2024, Pacira Pharma filed a PIV case in Illinois over its product Exparel®(bupivacaine) Injectable Suspension. It raises some uncomfortable questions. Bupivacaine and its new formulation Exparel Bupivacaine has been on the US market for over 40 years (really longer). Pacira Pharma developed a new suspension formulation which FDA approved in 2011. We should … Continue reading →
As we move into 2025, some notable topics have surfaced. Steady State in the PIV Market? The number of ANDA’s filed associated with a PIV case has remained steady over the past 5 years. In 2024, there were 167 of them filed, down from 173 in 2023. Since 2020, there have been between 167-179 ANDA’s … Continue reading →
On November 5, 2024, Donald J. Trump won the presidential election in a convincing fashion. One of his allies Robert F. Kennedy, Jr. will play a prominent role in his Administration. Mr. Kennedy has pledged to Make America Healthy Again. Movement in this direction may have profound impacts to pharmaceuticals, vaccines, and food which can … Continue reading →
On June 10, 2024, the New Jersey District Court ordered Teva to remove (or delist) five patents from the Orange Book in a case involving Pro-Air HFA®(albuterol). Of course, the decision analyzed exactly what patents belong in the Orange Book. The Orange Book – A Quick Primer Decades ago, FDA established a book where NDA … Continue reading →
Counting is one of the first things you learn as a child, sort of like this bunny counting carrots in his cart. While counting may seem relatively easy, sometimes it’s not so simple when interpreting patent claims. “pH of 13 or higher” To improve the product’s stability, the developers of Veletri®(epoprostenol) focused on its pH … Continue reading →
A curious PIV case surfaced at the end of October involving Lonsurf®(trifluridine and tipiracil) Tablets and its 9,943,537 patent. It reminds us of some similar behavior of Bristol-Myers from 20+ years ago which brought an aggressive response from the US Federal Trade Commission. On October 20, 2023, Taiho filed a PIV case against ANDA filer … Continue reading →
We can’t let January go by without some personal fanfare. ParagraphFour.com has reached the 20 year mark! “Just put up a website.” The ParagraphFour.com journey started in the summer of 2003 when I had the idea to start researching PIV cases. At the time, legal cases were all over the place and hard to access. … Continue reading →
This year’s Annual Review made me reflect on the Paragraph IV Market over the past years. We have reached a new plateau which indicates that the terrain is a bit rocky at this point for anyone participating. Consistently Fewer ANDA Filings The high-point of the PIV Market was 2015 which saw a record number of … Continue reading →
