On April 15, 2025, President Trump issued an executive order titled “Lowering Drug Prices by Once Again Putting Americans First.” The order reaffirms and seeks to expand on policy initiatives introduced during the president’s...more
4/21/2025
/ Biosimilars ,
Department of Health and Human Services (HHS) ,
Drug Pricing ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Imports ,
Inflation Reduction Act (IRA) ,
Medicare ,
Pharmaceutical Industry ,
Prescription Drugs
For branded drugmakers, the development of a pharmaceutical product approved by the Food and Drug Administration (FDA) all but assures generic competition. As discussed during the first installment of our Hatch-Waxman series,...more
1/9/2025
/ Abbreviated New Drug Application (ANDA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Orange Book ,
Patent Infringement ,
Patent Litigation ,
Patent Term Adjustment ,
Patent Term Extensions ,
Patent Validity ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
USPTO
On June 26, 2020, Chief Judge Leonard Stark dismissed a Hatch-Waxman case without prejudice after Defendant Sandoz Inc. (“Sandoz”) converted its Paragraph IV certifications for certain asserted patents to Paragraph III...more