Mylan

FTC Issues Policy Statement on Orange Book Patent Gaming: Pharmaceutical Evergreening as Unfair Competition Under Section 5

2023-09-01 00:00:00 +0000 UTC | Importance: 9/10

The Federal Trade Commission issues a policy statement declaring that improper patent listings in the FDA’s ‘Orange Book’ (Approved Drug Products with Therapeutic Equivalence Evaluations) constitute potential unfair methods of competition under Section 5 of the FTC Act or unlawful …

FTC Andrew N. Ferguson FDA Amphastar Mylan +2 more intellectual-property pharmaceutical-patents patent-evergreening orange-book ftc +3 more

AbbVie Humira Patent Thicket Delays US Biosimilars Until 2023 Despite 2016 Patent Expiration and European Competition

2018-10-16 00:00:00 +0000 UTC | Importance: 9/10

AbbVie reached settlement agreements with eight biosimilar manufacturers that allowed immediate biosimilar competition in Europe starting October 16, 2018, but delayed all US market entry until 2023—seven years after Humira’s original patent expired in December 2016. The settlements ended …

AbbVie Amgen Samsung Bioepis Mylan Boehringer Ingelheim +3 more pharmaceutical-industry patent-abuse drug-pricing healthcare evergreening +2 more

Mylan EpiPen Price Increases 550% in Nine Years, CEO Heather Bresch Testifies Before Congress

2016-08-24 00:00:00 +0000 UTC | Importance: 9/10

In August 2016, Mylan CEO Heather Bresch faced intense scrutiny when it was revealed that EpiPen prices had increased from approximately $103 in 2007 to over $608 by 2016—a nearly 550% price increase for a life-saving allergy treatment. The scandal exposed pharmaceutical price gouging, the failure …

Mylan Heather Bresch U.S. Congress healthcare pharmaceutical-price-gouging regulatory-capture corruption corporate-crime