TAMPA, FL, May 19, 2025 (GLOBE NEWSWIRE) -- SCIENTURE HOLDINGS, INC. NASDAQ: SCNX), a holding company for existing and planned pharmaceutical operating companies focused on providing enhanced value to ...
Phathom believes applicable law mandates a 10-year NCE exclusivity period (from date of first approval of drug containing vonoprazan) benefitting all vonoprazan-based products, with exclusivity until ...
Expansion to FTC’s Orange Book Campaign Leads to Calls for More Clarity from Pharmaceutical Industry
“The FTC acts as if the agency is being perfectly clear on what it’s subjecting companies to, but there’s never been a conversation around what it means for a patent to claim a drug product.” – Hans ...
To advance policies that secure the future of a leading U.S. innovative industry, it is important in this instance to gain a deeper understanding of what generic drugs are, what the FTC is challenging ...
SAN DIEGO, Aug. 19, 2025 /PRNewswire/ -- Evofem Biosciences, Inc. (OTCID: EVFM) today announced that a newly-issued U.S. patent which covers SOLOSEC® (secnidazole) 2 g oral granules and one of its ...
“There is no dispute that the Inhaler Patents contain no claim for the active ingredient at issue, albuterol sulfate. Amneal contends that the Inhaler Patents do not meet the requirement that they ...
It’s well past time for the U.S. FDA to end its silence on what device patents can be listed in the Orange Book as part of a drug-device combination product, Sen. Bill Cassidy (R-La.) said in an Oct.
The U.S. Federal Trade Commission (FTC) is not done with its crackdown on what it views as improper listing of patents with the FDA. After an initial round of challenges launched in November against ...
Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.
Some results have been hidden because they may be inaccessible to you
Show inaccessible results
Feedback